Trial Outcomes & Findings for Carbon Nanoparticle-Loaded Iron [CNSI-Fe(II)] in the Treatment of Advanced Solid Tumor (NCT NCT06048367)

Last Updated: 2025-08-03

Results Overview

This primary outcome measure is centered on the assessment of CNSI-Fe(II)'s safety and tolerability throughout the study. It encompasses the following assessments: Dose-Limiting Toxicity (DLT): This assessment involves the ongoing monitoring of adverse events, with a focus on determining their nature, severity, and frequency. Adverse events will be systematically categorized and reported according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Maximum Tolerated Dose (MTD): The MTD is a critical outcome measure representing the highest injectable dose in humans that can be safely administered without causing excessive adverse effects. The determination of MTD will be based on the careful observation and analysis of DLT data. The MTD was not determined in this Phase I study, and the MAD is 150mg. Units of Measure: DLT: Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0. MTD: Milligrams (mg) of CNSI-Fe(II).

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

19 participants

Primary outcome timeframe

21 days

Results posted on

2025-08-03

Participant Flow

The recruitment period for this study is from October 14, 2022, to October 30, 2024, and the recruitment locations are all hospitals.

Participant milestones

Participant milestones
Measure	CNSI-Fe(II) 30 mg 30 mg CNSI-Fe(II) 30 mg: The trial comprises a treatment period, including the DLT evaluation period with a duration of 21 days, and a maintenance treatment period. If the subject completes DLT evaluation without intolerable toxicity, an additional dose may be administered based on the investigator's determination of the benefits outweighing the risks. The original protocol planned for three dose groups: 30 mg, 60 mg, and 90 mg. The protocol was amended on March 28, 2024, to add 120 mg and 150 mg dose groups. A single tumor lesion amenable to intratumoral injection will be selected, regardless of tumor size, number, or location. The drug should be administered at the dose specified for the current dose cohort. The injection volume should be adjusted based on the size of the injected lesion.	CNSI-Fe(II) 60 mg 60 mg CNSI-Fe(II) 60 mg: The trial comprises a treatment period, including the DLT evaluation period with a duration of 21 days, and a maintenance treatment period. If the subject completes DLT evaluation without intolerable toxicity, an additional dose may be administered based on the investigator's determination of the benefits outweighing the risks. The original protocol planned for three dose groups: 30 mg, 60 mg, and 90 mg. The protocol was amended on March 28, 2024, to add 120 mg and 150 mg dose groups. A single tumor lesion amenable to intratumoral injection will be selected, regardless of tumor size, number, or location. The drug should be administered at the dose specified for the current dose cohort. The injection volume should be adjusted based on the size of the injected lesion.	CNSI-Fe(II) 90 mg 90 mg CNSI-Fe(II) 90 mg: The trial comprises a treatment period, including the DLT evaluation period with a duration of 21 days, and a maintenance treatment period. If the subject completes DLT evaluation without intolerable toxicity, an additional dose may be administered based on the investigator's determination of the benefits outweighing the risks. The original protocol planned for three dose groups: 30 mg, 60 mg, and 90 mg. The protocol was amended on March 28, 2024, to add 120 mg and 150 mg dose groups. A single tumor lesion amenable to intratumoral injection will be selected, regardless of tumor size, number, or location. The drug should be administered at the dose specified for the current dose cohort. The injection volume should be adjusted based on the size of the injected lesion.	CNSI-Fe(II) 120 mg 120 mg CNSI-Fe(II) 120 mg: The dosing regimen is the same as that for the 30 mg, 60 mg, and 90 mg dose groups. Additionally, if a single lesion cannot accommodate the full corresponding dose of the investigational drug, additional lesions may be selected for simultaneous injection. When multiple lesions are injected, the drug distribution should be allocated proportionally according to the size of each lesion or determined based on the investigator's assessment of an appropriate distribution.	CNSI-Fe(II) 150 mg 150 mg CNSI-Fe(II) 150 mg: The dosing regimen is the same as that for the 30 mg, 60 mg, and 90 mg dose groups. Additionally, if a single lesion cannot accommodate the full corresponding dose of the investigational drug, additional lesions may be selected for simultaneous injection. When multiple lesions are injected, the drug distribution should be allocated proportionally according to the size of each lesion or determined based on the investigator's assessment of an appropriate distribution.
Overall Study STARTED	3	4	6	3	3
Overall Study COMPLETED	3	3	5	1	3
Overall Study NOT COMPLETED	0	1	1	2	0

Reasons for withdrawal

Reasons for withdrawal
Measure	CNSI-Fe(II) 30 mg 30 mg CNSI-Fe(II) 30 mg: The trial comprises a treatment period, including the DLT evaluation period with a duration of 21 days, and a maintenance treatment period. If the subject completes DLT evaluation without intolerable toxicity, an additional dose may be administered based on the investigator's determination of the benefits outweighing the risks. The original protocol planned for three dose groups: 30 mg, 60 mg, and 90 mg. The protocol was amended on March 28, 2024, to add 120 mg and 150 mg dose groups. A single tumor lesion amenable to intratumoral injection will be selected, regardless of tumor size, number, or location. The drug should be administered at the dose specified for the current dose cohort. The injection volume should be adjusted based on the size of the injected lesion.	CNSI-Fe(II) 60 mg 60 mg CNSI-Fe(II) 60 mg: The trial comprises a treatment period, including the DLT evaluation period with a duration of 21 days, and a maintenance treatment period. If the subject completes DLT evaluation without intolerable toxicity, an additional dose may be administered based on the investigator's determination of the benefits outweighing the risks. The original protocol planned for three dose groups: 30 mg, 60 mg, and 90 mg. The protocol was amended on March 28, 2024, to add 120 mg and 150 mg dose groups. A single tumor lesion amenable to intratumoral injection will be selected, regardless of tumor size, number, or location. The drug should be administered at the dose specified for the current dose cohort. The injection volume should be adjusted based on the size of the injected lesion.	CNSI-Fe(II) 90 mg 90 mg CNSI-Fe(II) 90 mg: The trial comprises a treatment period, including the DLT evaluation period with a duration of 21 days, and a maintenance treatment period. If the subject completes DLT evaluation without intolerable toxicity, an additional dose may be administered based on the investigator's determination of the benefits outweighing the risks. The original protocol planned for three dose groups: 30 mg, 60 mg, and 90 mg. The protocol was amended on March 28, 2024, to add 120 mg and 150 mg dose groups. A single tumor lesion amenable to intratumoral injection will be selected, regardless of tumor size, number, or location. The drug should be administered at the dose specified for the current dose cohort. The injection volume should be adjusted based on the size of the injected lesion.	CNSI-Fe(II) 120 mg 120 mg CNSI-Fe(II) 120 mg: The dosing regimen is the same as that for the 30 mg, 60 mg, and 90 mg dose groups. Additionally, if a single lesion cannot accommodate the full corresponding dose of the investigational drug, additional lesions may be selected for simultaneous injection. When multiple lesions are injected, the drug distribution should be allocated proportionally according to the size of each lesion or determined based on the investigator's assessment of an appropriate distribution.	CNSI-Fe(II) 150 mg 150 mg CNSI-Fe(II) 150 mg: The dosing regimen is the same as that for the 30 mg, 60 mg, and 90 mg dose groups. Additionally, if a single lesion cannot accommodate the full corresponding dose of the investigational drug, additional lesions may be selected for simultaneous injection. When multiple lesions are injected, the drug distribution should be allocated proportionally according to the size of each lesion or determined based on the investigator's assessment of an appropriate distribution.
Overall Study Withdrawal by Subject	0	0	0	1	0

Baseline Characteristics

Carbon Nanoparticle-Loaded Iron [CNSI-Fe(II)] in the Treatment of Advanced Solid Tumor

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	CNSI-Fe(II) 30 mg n=3 Participants 30 mg CNSI-Fe(II) 30 mg: The trial comprises a treatment period, including the DLT evaluation period with a duration of 21 days, and a maintenance treatment period. If the subject completes DLT evaluation without intolerable toxicity, an additional dose may be administered based on the investigator's determination of the benefits outweighing the risks. The original protocol planned for three dose groups: 30 mg, 60 mg, and 90 mg. The protocol was amended on March 28, 2024, to add 120 mg and 150 mg dose groups. A single tumor lesion amenable to intratumoral injection will be selected, regardless of tumor size, number, or location. The drug should be administered at the dose specified for the current dose cohort. The injection volume should be adjusted based on the size of the injected lesion.	CNSI-Fe(II) 60 mg n=4 Participants 60 mg CNSI-Fe(II) 60 mg: The trial comprises a treatment period, including the DLT evaluation period with a duration of 21 days, and a maintenance treatment period. If the subject completes DLT evaluation without intolerable toxicity, an dditional dose may be administered based aon the investigator's determination of the benefits outweighing the risks. The original protocol planned for three dose groups: 30 mg, 60 mg, and 90 mg. The protocol was amended on March 28, 2024, to add 120 mg and 150 mg dose groups. A single tumor lesion amenable to intratumoral injection will be selected, regardless of tumor size, number, or location. The drug should be administered at the dose specified for the current dose cohort. The injection volume should be adjusted based on the size of the injected lesion.	CNSI-Fe(II) 90 mg n=6 Participants 90 mg CNSI-Fe(II) 90 mg: The trial comprises a treatment period, including the DLT evaluation period with a duration of 21 days, and a maintenance treatment period. If the subject completes DLT evaluation without intolerable toxicity, an additional dose may be administered based on the investigator's determination of the benefits outweighing the risks. The original protocol planned for three dose groups: 30 mg, 60 mg, and 90 mg. The protocol was amended on March 28, 2024, to add 120 mg and 150 mg dose groups. A single tumor lesion amenable to intratumoral injection will be selected, regardless of tumor size, number, or location. The drug should be administered at the dose specified for the current dose cohort. The injection volume should be adjusted based on the size of the injected lesion.	CNSI-Fe(II) 120 mg n=3 Participants 120 mg CNSI-Fe(II) 120 mg: The dosing regimen is the same as that for the 30 mg, 60 mg, and 90 mg dose groups. Additionally, if a single lesion cannot accommodate the full corresponding dose of the investigational drug, additional lesions may be selected for simultaneous injection. When multiple lesions are injected, the drug distribution should be allocated proportionally according to the size of each lesion or determined based on the investigator's assessment of an appropriate distribution.	CNSI-Fe(II) 150 mg n=3 Participants 150 mg CNSI-Fe(II) 150 mg: The dosing regimen is the same as that for the 30 mg, 60 mg, and 90 mg dose groups. Additionally, if a single lesion cannot accommodate the full corresponding dose of the investigational drug, additional lesions may be selected for simultaneous injection. When multiple lesions are injected, the drug distribution should be allocated proportionally according to the size of each lesion or determined based on the investigator's assessment of an appropriate distribution.	Total n=19 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants	3 Participants n=4 Participants	3 Participants n=21 Participants	15 Participants n=10 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	4 Participants n=10 Participants
Age, Continuous	55.3 years STANDARD_DEVIATION 4.16 • n=5 Participants	61.3 years STANDARD_DEVIATION 6.85 • n=7 Participants	62.5 years STANDARD_DEVIATION 8.96 • n=5 Participants	50.7 years STANDARD_DEVIATION 5.86 • n=4 Participants	55.0 years STANDARD_DEVIATION 1.00 • n=21 Participants	58.1 years STANDARD_DEVIATION 7.53 • n=10 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	3 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	3 Participants n=21 Participants	8 Participants n=10 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	1 Participants n=7 Participants	6 Participants n=5 Participants	3 Participants n=4 Participants	0 Participants n=21 Participants	11 Participants n=10 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants
Race (NIH/OMB) Asian	3 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants	3 Participants n=4 Participants	3 Participants n=21 Participants	19 Participants n=10 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants
Region of Enrollment China	3 participants n=5 Participants	4 participants n=7 Participants	6 participants n=5 Participants	3 participants n=4 Participants	3 participants n=21 Participants	19 participants n=10 Participants
body weight	62.83 weight (kg) STANDARD_DEVIATION 12.48 • n=5 Participants	57.45 weight (kg) STANDARD_DEVIATION 4.10 • n=7 Participants	61.77 weight (kg) STANDARD_DEVIATION 3.12 • n=5 Participants	63.97 weight (kg) STANDARD_DEVIATION 11.04 • n=4 Participants	54.67 weight (kg) STANDARD_DEVIATION 2.08 • n=21 Participants	60.25 weight (kg) STANDARD_DEVIATION 6.92 • n=10 Participants

PRIMARY outcome

Timeframe: 21 days

Outcome measures

Outcome measures
Measure	CNSI-Fe(II) 30 mg n=3 Participants 30 mg CNSI-Fe(II) 30 mg: The trial comprises a treatment period, including the DLT evaluation period with a duration of 21 days, and a maintenance treatment period. If the subject completes DLT evaluation without intolerable toxicity, an additional dose may be administered based on the investigator's determination of the benefits outweighing the risks. The original protocol planned for three dose groups: 30 mg, 60 mg, and 90 mg. The protocol was amended on March 28, 2024, to add 120 mg and 150 mg dose groups. A single tumor lesion amenable to intratumoral injection will be selected, regardless of tumor size, number, or location. The drug should be administered at the dose specified for the current dose cohort. The injection volume should be adjusted based on the size of the injected lesion.	CNSI-Fe(II) 60 mg n=3 Participants 60 mg CNSI-Fe(II) 60 mg: The trial comprises a treatment period, including the DLT evaluation period with a duration of 21 days, and a maintenance treatment period. If the subject completes DLT evaluation without intolerable toxicity, an additional dose may be administered based on the investigator's determination of the benefits outweighing the risks. The original protocol planned for three dose groups: 30 mg, 60 mg, and 90 mg. The protocol was amended on March 28, 2024, to add 120 mg and 150 mg dose groups. A single tumor lesion amenable to intratumoral injection will be selected, regardless of tumor size, number, or location. The drug should be administered at the dose specified for the current dose cohort. The injection volume should be adjusted based on the size of the injected lesion.	CNSI-Fe(II) 90 mg n=6 Participants 90 mg CNSI-Fe(II) 90 mg: The trial comprises a treatment period, including the DLT evaluation period with a duration of 21 days, and a maintenance treatment period. If the subject completes DLT evaluation without intolerable toxicity, an additional dose may be administered based on the investigator's determination of the benefits outweighing the risks. The original protocol planned for three dose groups: 30 mg, 60 mg, and 90 mg. The protocol was amended on March 28, 2024, to add 120 mg and 150 mg dose groups. A single tumor lesion amenable to intratumoral injection will be selected, regardless of tumor size, number, or location. The drug should be administered at the dose specified for the current dose cohort. The injection volume should be adjusted based on the size of the injected lesion.	CNSI-Fe(II) 120 mg n=3 Participants 120 mg CNSI-Fe(II) 120 mg: The dosing regimen is the same as that for the 30 mg, 60 mg, and 90 mg dose groups. Additionally, if a single lesion cannot accommodate the full corresponding dose of the investigational drug, additional lesions may be selected for simultaneous injection. When multiple lesions are injected, the drug distribution should be allocated proportionally according to the size of each lesion or determined based on the investigator's assessment of an appropriate distribution.	CNSI-Fe(II) 150 mg n=3 Participants 150 mg CNSI-Fe(II) 150 mg: The dosing regimen is the same as that for the 30 mg, 60 mg, and 90 mg dose groups. Additionally, if a single lesion cannot accommodate the full corresponding dose of the investigational drug, additional lesions may be selected for simultaneous injection. When multiple lesions are injected, the drug distribution should be allocated proportionally according to the size of each lesion or determined based on the investigator's assessment of an appropriate distribution.
Safety and Tolerability Assessment of CNSI-Fe(II) Number of patients with DLT	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Safety and Tolerability Assessment of CNSI-Fe(II) Number of patients who did not reach DLT	3 Participants	3 Participants	5 Participants	3 Participants	3 Participants

SECONDARY outcome

Timeframe: 72 h

Outcome measures

Outcome measures
Measure	CNSI-Fe(II) 30 mg n=3 Participants 30 mg CNSI-Fe(II) 30 mg: The trial comprises a treatment period, including the DLT evaluation period with a duration of 21 days, and a maintenance treatment period. If the subject completes DLT evaluation without intolerable toxicity, an additional dose may be administered based on the investigator's determination of the benefits outweighing the risks. The original protocol planned for three dose groups: 30 mg, 60 mg, and 90 mg. The protocol was amended on March 28, 2024, to add 120 mg and 150 mg dose groups. A single tumor lesion amenable to intratumoral injection will be selected, regardless of tumor size, number, or location. The drug should be administered at the dose specified for the current dose cohort. The injection volume should be adjusted based on the size of the injected lesion.	CNSI-Fe(II) 60 mg n=4 Participants 60 mg CNSI-Fe(II) 60 mg: The trial comprises a treatment period, including the DLT evaluation period with a duration of 21 days, and a maintenance treatment period. If the subject completes DLT evaluation without intolerable toxicity, an additional dose may be administered based on the investigator's determination of the benefits outweighing the risks. The original protocol planned for three dose groups: 30 mg, 60 mg, and 90 mg. The protocol was amended on March 28, 2024, to add 120 mg and 150 mg dose groups. A single tumor lesion amenable to intratumoral injection will be selected, regardless of tumor size, number, or location. The drug should be administered at the dose specified for the current dose cohort. The injection volume should be adjusted based on the size of the injected lesion.	CNSI-Fe(II) 90 mg n=6 Participants 90 mg CNSI-Fe(II) 90 mg: The trial comprises a treatment period, including the DLT evaluation period with a duration of 21 days, and a maintenance treatment period. If the subject completes DLT evaluation without intolerable toxicity, an additional dose may be administered based on the investigator's determination of the benefits outweighing the risks. The original protocol planned for three dose groups: 30 mg, 60 mg, and 90 mg. The protocol was amended on March 28, 2024, to add 120 mg and 150 mg dose groups. A single tumor lesion amenable to intratumoral injection will be selected, regardless of tumor size, number, or location. The drug should be administered at the dose specified for the current dose cohort. The injection volume should be adjusted based on the size of the injected lesion.	CNSI-Fe(II) 120 mg n=3 Participants 120 mg CNSI-Fe(II) 120 mg: The dosing regimen is the same as that for the 30 mg, 60 mg, and 90 mg dose groups. Additionally, if a single lesion cannot accommodate the full corresponding dose of the investigational drug, additional lesions may be selected for simultaneous injection. When multiple lesions are injected, the drug distribution should be allocated proportionally according to the size of each lesion or determined based on the investigator's assessment of an appropriate distribution.	CNSI-Fe(II) 150 mg n=3 Participants 150 mg CNSI-Fe(II) 150 mg: The dosing regimen is the same as that for the 30 mg, 60 mg, and 90 mg dose groups. Additionally, if a single lesion cannot accommodate the full corresponding dose of the investigational drug, additional lesions may be selected for simultaneous injection. When multiple lesions are injected, the drug distribution should be allocated proportionally according to the size of each lesion or determined based on the investigator's assessment of an appropriate distribution.
PK Parameters Assessment: Cmax (ng/mL) Profile Assessment of CNSI-Fe(II) of First Dosage	6903.00 concentration (ng/mL) Standard Deviation 6200.77	6982.50 concentration (ng/mL) Standard Deviation 3547.65	3520.33 concentration (ng/mL) Standard Deviation 3610.57	8626.67 concentration (ng/mL) Standard Deviation 10698.73	13961.67 concentration (ng/mL) Standard Deviation 17868.76

SECONDARY outcome

Timeframe: 72 h

Outcome measures

Outcome measures
Measure	CNSI-Fe(II) 30 mg n=3 Participants 30 mg CNSI-Fe(II) 30 mg: The trial comprises a treatment period, including the DLT evaluation period with a duration of 21 days, and a maintenance treatment period. If the subject completes DLT evaluation without intolerable toxicity, an additional dose may be administered based on the investigator's determination of the benefits outweighing the risks. The original protocol planned for three dose groups: 30 mg, 60 mg, and 90 mg. The protocol was amended on March 28, 2024, to add 120 mg and 150 mg dose groups. A single tumor lesion amenable to intratumoral injection will be selected, regardless of tumor size, number, or location. The drug should be administered at the dose specified for the current dose cohort. The injection volume should be adjusted based on the size of the injected lesion.	CNSI-Fe(II) 60 mg n=4 Participants 60 mg CNSI-Fe(II) 60 mg: The trial comprises a treatment period, including the DLT evaluation period with a duration of 21 days, and a maintenance treatment period. If the subject completes DLT evaluation without intolerable toxicity, an additional dose may be administered based on the investigator's determination of the benefits outweighing the risks. The original protocol planned for three dose groups: 30 mg, 60 mg, and 90 mg. The protocol was amended on March 28, 2024, to add 120 mg and 150 mg dose groups. A single tumor lesion amenable to intratumoral injection will be selected, regardless of tumor size, number, or location. The drug should be administered at the dose specified for the current dose cohort. The injection volume should be adjusted based on the size of the injected lesion.	CNSI-Fe(II) 90 mg n=6 Participants 90 mg CNSI-Fe(II) 90 mg: The trial comprises a treatment period, including the DLT evaluation period with a duration of 21 days, and a maintenance treatment period. If the subject completes DLT evaluation without intolerable toxicity, an additional dose may be administered based on the investigator's determination of the benefits outweighing the risks. The original protocol planned for three dose groups: 30 mg, 60 mg, and 90 mg. The protocol was amended on March 28, 2024, to add 120 mg and 150 mg dose groups. A single tumor lesion amenable to intratumoral injection will be selected, regardless of tumor size, number, or location. The drug should be administered at the dose specified for the current dose cohort. The injection volume should be adjusted based on the size of the injected lesion.	CNSI-Fe(II) 120 mg n=3 Participants 120 mg CNSI-Fe(II) 120 mg: The dosing regimen is the same as that for the 30 mg, 60 mg, and 90 mg dose groups. Additionally, if a single lesion cannot accommodate the full corresponding dose of the investigational drug, additional lesions may be selected for simultaneous injection. When multiple lesions are injected, the drug distribution should be allocated proportionally according to the size of each lesion or determined based on the investigator's assessment of an appropriate distribution.	CNSI-Fe(II) 150 mg n=3 Participants 150 mg CNSI-Fe(II) 150 mg: The dosing regimen is the same as that for the 30 mg, 60 mg, and 90 mg dose groups. Additionally, if a single lesion cannot accommodate the full corresponding dose of the investigational drug, additional lesions may be selected for simultaneous injection. When multiple lesions are injected, the drug distribution should be allocated proportionally according to the size of each lesion or determined based on the investigator's assessment of an appropriate distribution.
PK Parameters Assessment: Tmax (h) Profile Assessment of CNSI-Fe(II) of First Dosage	0.15 time (h) Standard Deviation 0.08	0.41 time (h) Standard Deviation 0.43	0.33 time (h) Standard Deviation 0.31	0.18 time (h) Standard Deviation 0.09	0.20 time (h) Standard Deviation 0.06

SECONDARY outcome

Timeframe: 72 h

Outcome measures

Outcome measures
Measure	CNSI-Fe(II) 30 mg n=3 Participants 30 mg CNSI-Fe(II) 30 mg: The trial comprises a treatment period, including the DLT evaluation period with a duration of 21 days, and a maintenance treatment period. If the subject completes DLT evaluation without intolerable toxicity, an additional dose may be administered based on the investigator's determination of the benefits outweighing the risks. The original protocol planned for three dose groups: 30 mg, 60 mg, and 90 mg. The protocol was amended on March 28, 2024, to add 120 mg and 150 mg dose groups. A single tumor lesion amenable to intratumoral injection will be selected, regardless of tumor size, number, or location. The drug should be administered at the dose specified for the current dose cohort. The injection volume should be adjusted based on the size of the injected lesion.	CNSI-Fe(II) 60 mg n=4 Participants 60 mg CNSI-Fe(II) 60 mg: The trial comprises a treatment period, including the DLT evaluation period with a duration of 21 days, and a maintenance treatment period. If the subject completes DLT evaluation without intolerable toxicity, an additional dose may be administered based on the investigator's determination of the benefits outweighing the risks. The original protocol planned for three dose groups: 30 mg, 60 mg, and 90 mg. The protocol was amended on March 28, 2024, to add 120 mg and 150 mg dose groups. A single tumor lesion amenable to intratumoral injection will be selected, regardless of tumor size, number, or location. The drug should be administered at the dose specified for the current dose cohort. The injection volume should be adjusted based on the size of the injected lesion.	CNSI-Fe(II) 90 mg n=6 Participants 90 mg CNSI-Fe(II) 90 mg: The trial comprises a treatment period, including the DLT evaluation period with a duration of 21 days, and a maintenance treatment period. If the subject completes DLT evaluation without intolerable toxicity, an additional dose may be administered based on the investigator's determination of the benefits outweighing the risks. The original protocol planned for three dose groups: 30 mg, 60 mg, and 90 mg. The protocol was amended on March 28, 2024, to add 120 mg and 150 mg dose groups. A single tumor lesion amenable to intratumoral injection will be selected, regardless of tumor size, number, or location. The drug should be administered at the dose specified for the current dose cohort. The injection volume should be adjusted based on the size of the injected lesion.	CNSI-Fe(II) 120 mg n=3 Participants 120 mg CNSI-Fe(II) 120 mg: The dosing regimen is the same as that for the 30 mg, 60 mg, and 90 mg dose groups. Additionally, if a single lesion cannot accommodate the full corresponding dose of the investigational drug, additional lesions may be selected for simultaneous injection. When multiple lesions are injected, the drug distribution should be allocated proportionally according to the size of each lesion or determined based on the investigator's assessment of an appropriate distribution.	CNSI-Fe(II) 150 mg n=3 Participants 150 mg CNSI-Fe(II) 150 mg: The dosing regimen is the same as that for the 30 mg, 60 mg, and 90 mg dose groups. Additionally, if a single lesion cannot accommodate the full corresponding dose of the investigational drug, additional lesions may be selected for simultaneous injection. When multiple lesions are injected, the drug distribution should be allocated proportionally according to the size of each lesion or determined based on the investigator's assessment of an appropriate distribution.
PK Parameters Assessment: AUC (ng•h/mL) Profile Assessment of CNSI-Fe(II) of First Dosage AUC(0 ~ 72 h)	16748.60 h*ng/mL Standard Deviation 9698.84	25231.99 h*ng/mL Standard Deviation 7924.80	13664.73 h*ng/mL Standard Deviation 9241.15	36728.03 h*ng/mL Standard Deviation 48218.01	64118.50 h*ng/mL Standard Deviation 77650.64
PK Parameters Assessment: AUC (ng•h/mL) Profile Assessment of CNSI-Fe(II) of First Dosage AUC (0 ~ ∞)	17715.81 h*ng/mL Standard Deviation 9468.52	30514.46 h*ng/mL Standard Deviation 13955.09	18430.79 h*ng/mL Standard Deviation 12946.52	41790.83 h*ng/mL Standard Deviation 49972.22	67276.22 h*ng/mL Standard Deviation 75429.26

SECONDARY outcome

Timeframe: 72 h

Outcome measures

Outcome measures
Measure	CNSI-Fe(II) 30 mg n=3 Participants 30 mg CNSI-Fe(II) 30 mg: The trial comprises a treatment period, including the DLT evaluation period with a duration of 21 days, and a maintenance treatment period. If the subject completes DLT evaluation without intolerable toxicity, an additional dose may be administered based on the investigator's determination of the benefits outweighing the risks. The original protocol planned for three dose groups: 30 mg, 60 mg, and 90 mg. The protocol was amended on March 28, 2024, to add 120 mg and 150 mg dose groups. A single tumor lesion amenable to intratumoral injection will be selected, regardless of tumor size, number, or location. The drug should be administered at the dose specified for the current dose cohort. The injection volume should be adjusted based on the size of the injected lesion.	CNSI-Fe(II) 60 mg n=4 Participants 60 mg CNSI-Fe(II) 60 mg: The trial comprises a treatment period, including the DLT evaluation period with a duration of 21 days, and a maintenance treatment period. If the subject completes DLT evaluation without intolerable toxicity, an additional dose may be administered based on the investigator's determination of the benefits outweighing the risks. The original protocol planned for three dose groups: 30 mg, 60 mg, and 90 mg. The protocol was amended on March 28, 2024, to add 120 mg and 150 mg dose groups. A single tumor lesion amenable to intratumoral injection will be selected, regardless of tumor size, number, or location. The drug should be administered at the dose specified for the current dose cohort. The injection volume should be adjusted based on the size of the injected lesion.	CNSI-Fe(II) 90 mg n=6 Participants 90 mg CNSI-Fe(II) 90 mg: The trial comprises a treatment period, including the DLT evaluation period with a duration of 21 days, and a maintenance treatment period. If the subject completes DLT evaluation without intolerable toxicity, an additional dose may be administered based on the investigator's determination of the benefits outweighing the risks. The original protocol planned for three dose groups: 30 mg, 60 mg, and 90 mg. The protocol was amended on March 28, 2024, to add 120 mg and 150 mg dose groups. A single tumor lesion amenable to intratumoral injection will be selected, regardless of tumor size, number, or location. The drug should be administered at the dose specified for the current dose cohort. The injection volume should be adjusted based on the size of the injected lesion.	CNSI-Fe(II) 120 mg n=3 Participants 120 mg CNSI-Fe(II) 120 mg: The dosing regimen is the same as that for the 30 mg, 60 mg, and 90 mg dose groups. Additionally, if a single lesion cannot accommodate the full corresponding dose of the investigational drug, additional lesions may be selected for simultaneous injection. When multiple lesions are injected, the drug distribution should be allocated proportionally according to the size of each lesion or determined based on the investigator's assessment of an appropriate distribution.	CNSI-Fe(II) 150 mg n=3 Participants 150 mg CNSI-Fe(II) 150 mg: The dosing regimen is the same as that for the 30 mg, 60 mg, and 90 mg dose groups. Additionally, if a single lesion cannot accommodate the full corresponding dose of the investigational drug, additional lesions may be selected for simultaneous injection. When multiple lesions are injected, the drug distribution should be allocated proportionally according to the size of each lesion or determined based on the investigator's assessment of an appropriate distribution.
PK Parameters Assessment: t1/2 (h) Profile Assessment of CNSI-Fe(II) of First Dosage	1.96 time (h) Standard Deviation 0.92	4.28 time (h) Standard Deviation 1.80	3.04 time (h) Standard Deviation 2.04	5.06 time (h) Standard Deviation 2.21	3.60 time (h) Standard Deviation 0.48

SECONDARY outcome

Timeframe: Observation period for a single dose is 21~28 days, the observation period for two doses is doubled.

Complete Response (CR): According to the modified Response Evaluation Criteria in Solid Tumors (RECIST v1.1) (lesions treated with local injection are defined as target lesions, and lesions not treated with local injection are defined as non-target lesions), target lesions are evaluated by contrast-enhanced CT/MRI. All target lesions must disappear, and the short diameter of all pathological lymph nodes must decrease to \<10 mm.

Outcome measures

Outcome measures
Measure	CNSI-Fe(II) 30 mg n=3 Participants 30 mg CNSI-Fe(II) 30 mg: The trial comprises a treatment period, including the DLT evaluation period with a duration of 21 days, and a maintenance treatment period. If the subject completes DLT evaluation without intolerable toxicity, an additional dose may be administered based on the investigator's determination of the benefits outweighing the risks. The original protocol planned for three dose groups: 30 mg, 60 mg, and 90 mg. The protocol was amended on March 28, 2024, to add 120 mg and 150 mg dose groups. A single tumor lesion amenable to intratumoral injection will be selected, regardless of tumor size, number, or location. The drug should be administered at the dose specified for the current dose cohort. The injection volume should be adjusted based on the size of the injected lesion.	CNSI-Fe(II) 60 mg n=4 Participants 60 mg CNSI-Fe(II) 60 mg: The trial comprises a treatment period, including the DLT evaluation period with a duration of 21 days, and a maintenance treatment period. If the subject completes DLT evaluation without intolerable toxicity, an additional dose may be administered based on the investigator's determination of the benefits outweighing the risks. The original protocol planned for three dose groups: 30 mg, 60 mg, and 90 mg. The protocol was amended on March 28, 2024, to add 120 mg and 150 mg dose groups. A single tumor lesion amenable to intratumoral injection will be selected, regardless of tumor size, number, or location. The drug should be administered at the dose specified for the current dose cohort. The injection volume should be adjusted based on the size of the injected lesion.	CNSI-Fe(II) 90 mg n=5 Participants 90 mg CNSI-Fe(II) 90 mg: The trial comprises a treatment period, including the DLT evaluation period with a duration of 21 days, and a maintenance treatment period. If the subject completes DLT evaluation without intolerable toxicity, an additional dose may be administered based on the investigator's determination of the benefits outweighing the risks. The original protocol planned for three dose groups: 30 mg, 60 mg, and 90 mg. The protocol was amended on March 28, 2024, to add 120 mg and 150 mg dose groups. A single tumor lesion amenable to intratumoral injection will be selected, regardless of tumor size, number, or location. The drug should be administered at the dose specified for the current dose cohort. The injection volume should be adjusted based on the size of the injected lesion.	CNSI-Fe(II) 120 mg n=3 Participants 120 mg CNSI-Fe(II) 120 mg: The dosing regimen is the same as that for the 30 mg, 60 mg, and 90 mg dose groups. Additionally, if a single lesion cannot accommodate the full corresponding dose of the investigational drug, additional lesions may be selected for simultaneous injection. When multiple lesions are injected, the drug distribution should be allocated proportionally according to the size of each lesion or determined based on the investigator's assessment of an appropriate distribution.	CNSI-Fe(II) 150 mg n=3 Participants 150 mg CNSI-Fe(II) 150 mg: The dosing regimen is the same as that for the 30 mg, 60 mg, and 90 mg dose groups. Additionally, if a single lesion cannot accommodate the full corresponding dose of the investigational drug, additional lesions may be selected for simultaneous injection. When multiple lesions are injected, the drug distribution should be allocated proportionally according to the size of each lesion or determined based on the investigator's assessment of an appropriate distribution.
Evaluated as CR (Complete Response) in the Preliminary Efficacy Assessment.	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Observation period for a single dose is 21~28 days, the observation period for two doses is doubled.

Partial Response (PR): According to the modified RECIST v1.1 (lesions treated with local injection are defined as target lesions, and lesions not treated with local injection are defined as non-target lesions), target lesions are evaluated by contrast-enhanced CT/MRI. The sum of the diameters of target lesions must decrease by at least 30% compared to baseline.

Outcome measures

Outcome measures
Measure	CNSI-Fe(II) 30 mg n=3 Participants 30 mg CNSI-Fe(II) 30 mg: The trial comprises a treatment period, including the DLT evaluation period with a duration of 21 days, and a maintenance treatment period. If the subject completes DLT evaluation without intolerable toxicity, an additional dose may be administered based on the investigator's determination of the benefits outweighing the risks. The original protocol planned for three dose groups: 30 mg, 60 mg, and 90 mg. The protocol was amended on March 28, 2024, to add 120 mg and 150 mg dose groups. A single tumor lesion amenable to intratumoral injection will be selected, regardless of tumor size, number, or location. The drug should be administered at the dose specified for the current dose cohort. The injection volume should be adjusted based on the size of the injected lesion.	CNSI-Fe(II) 60 mg n=4 Participants 60 mg CNSI-Fe(II) 60 mg: The trial comprises a treatment period, including the DLT evaluation period with a duration of 21 days, and a maintenance treatment period. If the subject completes DLT evaluation without intolerable toxicity, an additional dose may be administered based on the investigator's determination of the benefits outweighing the risks. The original protocol planned for three dose groups: 30 mg, 60 mg, and 90 mg. The protocol was amended on March 28, 2024, to add 120 mg and 150 mg dose groups. A single tumor lesion amenable to intratumoral injection will be selected, regardless of tumor size, number, or location. The drug should be administered at the dose specified for the current dose cohort. The injection volume should be adjusted based on the size of the injected lesion.	CNSI-Fe(II) 90 mg n=5 Participants 90 mg CNSI-Fe(II) 90 mg: The trial comprises a treatment period, including the DLT evaluation period with a duration of 21 days, and a maintenance treatment period. If the subject completes DLT evaluation without intolerable toxicity, an additional dose may be administered based on the investigator's determination of the benefits outweighing the risks. The original protocol planned for three dose groups: 30 mg, 60 mg, and 90 mg. The protocol was amended on March 28, 2024, to add 120 mg and 150 mg dose groups. A single tumor lesion amenable to intratumoral injection will be selected, regardless of tumor size, number, or location. The drug should be administered at the dose specified for the current dose cohort. The injection volume should be adjusted based on the size of the injected lesion.	CNSI-Fe(II) 120 mg n=3 Participants 120 mg CNSI-Fe(II) 120 mg: The dosing regimen is the same as that for the 30 mg, 60 mg, and 90 mg dose groups. Additionally, if a single lesion cannot accommodate the full corresponding dose of the investigational drug, additional lesions may be selected for simultaneous injection. When multiple lesions are injected, the drug distribution should be allocated proportionally according to the size of each lesion or determined based on the investigator's assessment of an appropriate distribution.	CNSI-Fe(II) 150 mg n=3 Participants 150 mg CNSI-Fe(II) 150 mg: The dosing regimen is the same as that for the 30 mg, 60 mg, and 90 mg dose groups. Additionally, if a single lesion cannot accommodate the full corresponding dose of the investigational drug, additional lesions may be selected for simultaneous injection. When multiple lesions are injected, the drug distribution should be allocated proportionally according to the size of each lesion or determined based on the investigator's assessment of an appropriate distribution.
Evaluated as PR (Partial Response) in the Preliminary Efficacy Assessment.	1 Participants	1 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Observation period for a single dose is 21~28 days, the observation period for two doses is doubled.

Stable Disease (SD): According to the modified RECIST v1.1 (lesions treated with local injection are defined as target lesions, and lesions not treated with local injection are defined as non-target lesions), target lesions are evaluated by contrast-enhanced CT/MRI. The reduction in target lesions does not meet the criteria for PR, and the increase does not meet the criteria for Progressive Disease (PD). The smallest sum of diameters observed during the study is used as a reference.

Outcome measures

Outcome measures
Measure	CNSI-Fe(II) 30 mg n=3 Participants 30 mg CNSI-Fe(II) 30 mg: The trial comprises a treatment period, including the DLT evaluation period with a duration of 21 days, and a maintenance treatment period. If the subject completes DLT evaluation without intolerable toxicity, an additional dose may be administered based on the investigator's determination of the benefits outweighing the risks. The original protocol planned for three dose groups: 30 mg, 60 mg, and 90 mg. The protocol was amended on March 28, 2024, to add 120 mg and 150 mg dose groups. A single tumor lesion amenable to intratumoral injection will be selected, regardless of tumor size, number, or location. The drug should be administered at the dose specified for the current dose cohort. The injection volume should be adjusted based on the size of the injected lesion.	CNSI-Fe(II) 60 mg n=4 Participants 60 mg CNSI-Fe(II) 60 mg: The trial comprises a treatment period, including the DLT evaluation period with a duration of 21 days, and a maintenance treatment period. If the subject completes DLT evaluation without intolerable toxicity, an additional dose may be administered based on the investigator's determination of the benefits outweighing the risks. The original protocol planned for three dose groups: 30 mg, 60 mg, and 90 mg. The protocol was amended on March 28, 2024, to add 120 mg and 150 mg dose groups. A single tumor lesion amenable to intratumoral injection will be selected, regardless of tumor size, number, or location. The drug should be administered at the dose specified for the current dose cohort. The injection volume should be adjusted based on the size of the injected lesion.	CNSI-Fe(II) 90 mg n=5 Participants 90 mg CNSI-Fe(II) 90 mg: The trial comprises a treatment period, including the DLT evaluation period with a duration of 21 days, and a maintenance treatment period. If the subject completes DLT evaluation without intolerable toxicity, an additional dose may be administered based on the investigator's determination of the benefits outweighing the risks. The original protocol planned for three dose groups: 30 mg, 60 mg, and 90 mg. The protocol was amended on March 28, 2024, to add 120 mg and 150 mg dose groups. A single tumor lesion amenable to intratumoral injection will be selected, regardless of tumor size, number, or location. The drug should be administered at the dose specified for the current dose cohort. The injection volume should be adjusted based on the size of the injected lesion.	CNSI-Fe(II) 120 mg n=3 Participants 120 mg CNSI-Fe(II) 120 mg: The dosing regimen is the same as that for the 30 mg, 60 mg, and 90 mg dose groups. Additionally, if a single lesion cannot accommodate the full corresponding dose of the investigational drug, additional lesions may be selected for simultaneous injection. When multiple lesions are injected, the drug distribution should be allocated proportionally according to the size of each lesion or determined based on the investigator's assessment of an appropriate distribution.	CNSI-Fe(II) 150 mg n=3 Participants 150 mg CNSI-Fe(II) 150 mg: The dosing regimen is the same as that for the 30 mg, 60 mg, and 90 mg dose groups. Additionally, if a single lesion cannot accommodate the full corresponding dose of the investigational drug, additional lesions may be selected for simultaneous injection. When multiple lesions are injected, the drug distribution should be allocated proportionally according to the size of each lesion or determined based on the investigator's assessment of an appropriate distribution.
Evaluated as SD (Stable Disease) in the Preliminary Efficacy Assessment.	1 Participants	2 Participants	5 Participants	3 Participants	3 Participants

SECONDARY outcome

Timeframe: Observation period for a single dose is 21~28 days, the observation period for two doses is doubled.

Progressive Disease (PD): According to the modified RECIST v1.1 (lesions treated with local injection are defined as target lesions, and lesions not treated with local injection are defined as non-target lesions), target lesions are evaluated by contrast-enhanced CT/MRI. The sum of the diameters of target lesions increases by at least 20% compared to the smallest sum recorded during the study (or baseline if it is the smallest).

Outcome measures

Outcome measures
Measure	CNSI-Fe(II) 30 mg n=3 Participants 30 mg CNSI-Fe(II) 30 mg: The trial comprises a treatment period, including the DLT evaluation period with a duration of 21 days, and a maintenance treatment period. If the subject completes DLT evaluation without intolerable toxicity, an additional dose may be administered based on the investigator's determination of the benefits outweighing the risks. The original protocol planned for three dose groups: 30 mg, 60 mg, and 90 mg. The protocol was amended on March 28, 2024, to add 120 mg and 150 mg dose groups. A single tumor lesion amenable to intratumoral injection will be selected, regardless of tumor size, number, or location. The drug should be administered at the dose specified for the current dose cohort. The injection volume should be adjusted based on the size of the injected lesion.	CNSI-Fe(II) 60 mg n=4 Participants 60 mg CNSI-Fe(II) 60 mg: The trial comprises a treatment period, including the DLT evaluation period with a duration of 21 days, and a maintenance treatment period. If the subject completes DLT evaluation without intolerable toxicity, an additional dose may be administered based on the investigator's determination of the benefits outweighing the risks. The original protocol planned for three dose groups: 30 mg, 60 mg, and 90 mg. The protocol was amended on March 28, 2024, to add 120 mg and 150 mg dose groups. A single tumor lesion amenable to intratumoral injection will be selected, regardless of tumor size, number, or location. The drug should be administered at the dose specified for the current dose cohort. The injection volume should be adjusted based on the size of the injected lesion.	CNSI-Fe(II) 90 mg n=5 Participants 90 mg CNSI-Fe(II) 90 mg: The trial comprises a treatment period, including the DLT evaluation period with a duration of 21 days, and a maintenance treatment period. If the subject completes DLT evaluation without intolerable toxicity, an additional dose may be administered based on the investigator's determination of the benefits outweighing the risks. The original protocol planned for three dose groups: 30 mg, 60 mg, and 90 mg. The protocol was amended on March 28, 2024, to add 120 mg and 150 mg dose groups. A single tumor lesion amenable to intratumoral injection will be selected, regardless of tumor size, number, or location. The drug should be administered at the dose specified for the current dose cohort. The injection volume should be adjusted based on the size of the injected lesion.	CNSI-Fe(II) 120 mg n=3 Participants 120 mg CNSI-Fe(II) 120 mg: The dosing regimen is the same as that for the 30 mg, 60 mg, and 90 mg dose groups. Additionally, if a single lesion cannot accommodate the full corresponding dose of the investigational drug, additional lesions may be selected for simultaneous injection. When multiple lesions are injected, the drug distribution should be allocated proportionally according to the size of each lesion or determined based on the investigator's assessment of an appropriate distribution.	CNSI-Fe(II) 150 mg n=3 Participants 150 mg CNSI-Fe(II) 150 mg: The dosing regimen is the same as that for the 30 mg, 60 mg, and 90 mg dose groups. Additionally, if a single lesion cannot accommodate the full corresponding dose of the investigational drug, additional lesions may be selected for simultaneous injection. When multiple lesions are injected, the drug distribution should be allocated proportionally according to the size of each lesion or determined based on the investigator's assessment of an appropriate distribution.
Evaluated as PD (Progressive Disease) in the Preliminary Efficacy Assessment.	1 Participants	1 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 72 h post second dosage (The second dosing occurs 22~35 days after first dosing. For patient in 30 mg group, 23 days; for patients in 60 mg group, 26 and 22 days; for patients in 90 mg group, 23, 35 and 28 days; for patient in 120 mg group, 28 days.)

This secondary outcome measure focuses on assessing the pharmacokinetic (PK) profile of CNSI-Fe(II) in patients with advanced solid tumors. Assessment Details: PK Parameters Assessment: This assessment involves the analysis of the drug's absorption, distribution, metabolism, and excretion (ADME) in patients. It will provide insights into how CNSI-Fe(II) behaves in the human body. The first assessed parameter is maximum plasma concentration (Cmax). Cmax of second dosage: The number of patients receiving the second dose in the 30 mg, 60 mg, 90 mg, 120 mg, and 150 mg dose groups was: 1, 2, 3, 1, and 0, respectively. Due to the requirement for mean ± SD data presentation, the number of evaluable subjects in 30 mg, 120 mg, 150 mg groups was fewer than two, making SD calculation impossible. Therefore, only data from the 60 mg and 90 mg dose cohorts were included. Units of Measure: Cmax: Nanograms per milliliter (ng/mL) (serum iron ion concentrations changes from baseline)

Outcome measures

Outcome measures
Measure	CNSI-Fe(II) 30 mg n=2 Participants 30 mg CNSI-Fe(II) 30 mg: The trial comprises a treatment period, including the DLT evaluation period with a duration of 21 days, and a maintenance treatment period. If the subject completes DLT evaluation without intolerable toxicity, an additional dose may be administered based on the investigator's determination of the benefits outweighing the risks. The original protocol planned for three dose groups: 30 mg, 60 mg, and 90 mg. The protocol was amended on March 28, 2024, to add 120 mg and 150 mg dose groups. A single tumor lesion amenable to intratumoral injection will be selected, regardless of tumor size, number, or location. The drug should be administered at the dose specified for the current dose cohort. The injection volume should be adjusted based on the size of the injected lesion.	CNSI-Fe(II) 60 mg n=3 Participants 60 mg CNSI-Fe(II) 60 mg: The trial comprises a treatment period, including the DLT evaluation period with a duration of 21 days, and a maintenance treatment period. If the subject completes DLT evaluation without intolerable toxicity, an additional dose may be administered based on the investigator's determination of the benefits outweighing the risks. The original protocol planned for three dose groups: 30 mg, 60 mg, and 90 mg. The protocol was amended on March 28, 2024, to add 120 mg and 150 mg dose groups. A single tumor lesion amenable to intratumoral injection will be selected, regardless of tumor size, number, or location. The drug should be administered at the dose specified for the current dose cohort. The injection volume should be adjusted based on the size of the injected lesion.	CNSI-Fe(II) 90 mg 90 mg CNSI-Fe(II) 90 mg: The trial comprises a treatment period, including the DLT evaluation period with a duration of 21 days, and a maintenance treatment period. If the subject completes DLT evaluation without intolerable toxicity, an additional dose may be administered based on the investigator's determination of the benefits outweighing the risks. The original protocol planned for three dose groups: 30 mg, 60 mg, and 90 mg. The protocol was amended on March 28, 2024, to add 120 mg and 150 mg dose groups. A single tumor lesion amenable to intratumoral injection will be selected, regardless of tumor size, number, or location. The drug should be administered at the dose specified for the current dose cohort. The injection volume should be adjusted based on the size of the injected lesion.	CNSI-Fe(II) 120 mg 120 mg CNSI-Fe(II) 120 mg: The dosing regimen is the same as that for the 30 mg, 60 mg, and 90 mg dose groups. Additionally, if a single lesion cannot accommodate the full corresponding dose of the investigational drug, additional lesions may be selected for simultaneous injection. When multiple lesions are injected, the drug distribution should be allocated proportionally according to the size of each lesion or determined based on the investigator's assessment of an appropriate distribution.	CNSI-Fe(II) 150 mg 150 mg CNSI-Fe(II) 150 mg: The dosing regimen is the same as that for the 30 mg, 60 mg, and 90 mg dose groups. Additionally, if a single lesion cannot accommodate the full corresponding dose of the investigational drug, additional lesions may be selected for simultaneous injection. When multiple lesions are injected, the drug distribution should be allocated proportionally according to the size of each lesion or determined based on the investigator's assessment of an appropriate distribution.
PK Parameters Assessment: Cmax (ng/mL) Profile Assessment of CNSI-Fe(II) of Second Dosage	3371.50 concentration (ng/mL) Standard Deviation 296.28	8623.00 concentration (ng/mL) Standard Deviation 8582.28	—	—	—

SECONDARY outcome

Population: The number of patients receiving the second dose in the 30 mg, 60 mg, 90 mg, 120 mg, and 150 mg dose groups was: 1, 2, 3, 1, and 0, respectively.

This secondary outcome measure focuses on assessing the pharmacokinetic (PK) profile of CNSI-Fe(II) in patients with advanced solid tumors. Assessment Details: PK Parameters Assessment: This assessment involves the analysis of the drug's absorption, distribution, metabolism, and excretion (ADME) in patients. It will provide insights into how CNSI-Fe(II) behaves in the human body. The second assessed parameter is time to maximum plasma concentration (Tmax). Tmax of second dosage: The number of patients receiving the second dose in the 30 mg, 60 mg, 90 mg, 120 mg, and 150 mg dose groups was: 1, 2, 3, 1, and 0, respectively. Due to the requirement for mean ± SD data presentation, the number of evaluable subjects in 30 mg, 120 mg, 150 mg groups was fewer than two, making SD calculation impossible. Therefore, only data from the 60 mg and 90 mg dose cohorts were included. Units of Measure: Tmax: Hours (h)

Outcome measures

Outcome measures
Measure	CNSI-Fe(II) 30 mg n=2 Participants 30 mg CNSI-Fe(II) 30 mg: The trial comprises a treatment period, including the DLT evaluation period with a duration of 21 days, and a maintenance treatment period. If the subject completes DLT evaluation without intolerable toxicity, an additional dose may be administered based on the investigator's determination of the benefits outweighing the risks. The original protocol planned for three dose groups: 30 mg, 60 mg, and 90 mg. The protocol was amended on March 28, 2024, to add 120 mg and 150 mg dose groups. A single tumor lesion amenable to intratumoral injection will be selected, regardless of tumor size, number, or location. The drug should be administered at the dose specified for the current dose cohort. The injection volume should be adjusted based on the size of the injected lesion.	CNSI-Fe(II) 60 mg n=3 Participants 60 mg CNSI-Fe(II) 60 mg: The trial comprises a treatment period, including the DLT evaluation period with a duration of 21 days, and a maintenance treatment period. If the subject completes DLT evaluation without intolerable toxicity, an additional dose may be administered based on the investigator's determination of the benefits outweighing the risks. The original protocol planned for three dose groups: 30 mg, 60 mg, and 90 mg. The protocol was amended on March 28, 2024, to add 120 mg and 150 mg dose groups. A single tumor lesion amenable to intratumoral injection will be selected, regardless of tumor size, number, or location. The drug should be administered at the dose specified for the current dose cohort. The injection volume should be adjusted based on the size of the injected lesion.	CNSI-Fe(II) 90 mg 90 mg CNSI-Fe(II) 90 mg: The trial comprises a treatment period, including the DLT evaluation period with a duration of 21 days, and a maintenance treatment period. If the subject completes DLT evaluation without intolerable toxicity, an additional dose may be administered based on the investigator's determination of the benefits outweighing the risks. The original protocol planned for three dose groups: 30 mg, 60 mg, and 90 mg. The protocol was amended on March 28, 2024, to add 120 mg and 150 mg dose groups. A single tumor lesion amenable to intratumoral injection will be selected, regardless of tumor size, number, or location. The drug should be administered at the dose specified for the current dose cohort. The injection volume should be adjusted based on the size of the injected lesion.	CNSI-Fe(II) 120 mg 120 mg CNSI-Fe(II) 120 mg: The dosing regimen is the same as that for the 30 mg, 60 mg, and 90 mg dose groups. Additionally, if a single lesion cannot accommodate the full corresponding dose of the investigational drug, additional lesions may be selected for simultaneous injection. When multiple lesions are injected, the drug distribution should be allocated proportionally according to the size of each lesion or determined based on the investigator's assessment of an appropriate distribution.	CNSI-Fe(II) 150 mg 150 mg CNSI-Fe(II) 150 mg: The dosing regimen is the same as that for the 30 mg, 60 mg, and 90 mg dose groups. Additionally, if a single lesion cannot accommodate the full corresponding dose of the investigational drug, additional lesions may be selected for simultaneous injection. When multiple lesions are injected, the drug distribution should be allocated proportionally according to the size of each lesion or determined based on the investigator's assessment of an appropriate distribution.
PK Parameters Assessment: Tmax (h) Profile Assessment of CNSI-Fe(II) of Second Dosage	0.08 time (h) Standard Deviation 0.00	0.14 time (h) Standard Deviation 0.09	—	—	—

SECONDARY outcome

Population: The number of patients receiving the second dose in the 30 mg, 60 mg, 90 mg, 120 mg, and 150 mg dose groups was: 1, 2, 3, 1, and 0, respectively.

This secondary outcome measure focuses on assessing the pharmacokinetic (PK) profile of CNSI-Fe(II) in patients with advanced solid tumors. Assessment Details: PK Parameters Assessment: This assessment involves the analysis of the drug's absorption, distribution, metabolism, and excretion (ADME) in patients. It will provide insights into how CNSI-Fe(II) behaves in the human body. The third assessed parameter is area under the concentration-time curve (AUC). AUC of second dosage: The number of patients receiving the second dose in the 30 mg, 60 mg, 90 mg, 120 mg, and 150 mg dose groups was: 1, 2, 3, 1, and 0, respectively. Due to the requirement for mean ± SD data presentation, the number of evaluable subjects in 30 mg, 120 mg, 150 mg groups was fewer than two, making SD calculation impossible. Units of Measure: AUC: Nanograms per hour per milliliter (ng•h/mL)

Outcome measures

Outcome measures
Measure	CNSI-Fe(II) 30 mg n=2 Participants 30 mg CNSI-Fe(II) 30 mg: The trial comprises a treatment period, including the DLT evaluation period with a duration of 21 days, and a maintenance treatment period. If the subject completes DLT evaluation without intolerable toxicity, an additional dose may be administered based on the investigator's determination of the benefits outweighing the risks. The original protocol planned for three dose groups: 30 mg, 60 mg, and 90 mg. The protocol was amended on March 28, 2024, to add 120 mg and 150 mg dose groups. A single tumor lesion amenable to intratumoral injection will be selected, regardless of tumor size, number, or location. The drug should be administered at the dose specified for the current dose cohort. The injection volume should be adjusted based on the size of the injected lesion.	CNSI-Fe(II) 60 mg n=3 Participants 60 mg CNSI-Fe(II) 60 mg: The trial comprises a treatment period, including the DLT evaluation period with a duration of 21 days, and a maintenance treatment period. If the subject completes DLT evaluation without intolerable toxicity, an additional dose may be administered based on the investigator's determination of the benefits outweighing the risks. The original protocol planned for three dose groups: 30 mg, 60 mg, and 90 mg. The protocol was amended on March 28, 2024, to add 120 mg and 150 mg dose groups. A single tumor lesion amenable to intratumoral injection will be selected, regardless of tumor size, number, or location. The drug should be administered at the dose specified for the current dose cohort. The injection volume should be adjusted based on the size of the injected lesion.	CNSI-Fe(II) 90 mg 90 mg CNSI-Fe(II) 90 mg: The trial comprises a treatment period, including the DLT evaluation period with a duration of 21 days, and a maintenance treatment period. If the subject completes DLT evaluation without intolerable toxicity, an additional dose may be administered based on the investigator's determination of the benefits outweighing the risks. The original protocol planned for three dose groups: 30 mg, 60 mg, and 90 mg. The protocol was amended on March 28, 2024, to add 120 mg and 150 mg dose groups. A single tumor lesion amenable to intratumoral injection will be selected, regardless of tumor size, number, or location. The drug should be administered at the dose specified for the current dose cohort. The injection volume should be adjusted based on the size of the injected lesion.	CNSI-Fe(II) 120 mg 120 mg CNSI-Fe(II) 120 mg: The dosing regimen is the same as that for the 30 mg, 60 mg, and 90 mg dose groups. Additionally, if a single lesion cannot accommodate the full corresponding dose of the investigational drug, additional lesions may be selected for simultaneous injection. When multiple lesions are injected, the drug distribution should be allocated proportionally according to the size of each lesion or determined based on the investigator's assessment of an appropriate distribution.	CNSI-Fe(II) 150 mg 150 mg CNSI-Fe(II) 150 mg: The dosing regimen is the same as that for the 30 mg, 60 mg, and 90 mg dose groups. Additionally, if a single lesion cannot accommodate the full corresponding dose of the investigational drug, additional lesions may be selected for simultaneous injection. When multiple lesions are injected, the drug distribution should be allocated proportionally according to the size of each lesion or determined based on the investigator's assessment of an appropriate distribution.
PK Parameters Assessment: AUC (ng•h/mL) Profile Assessment of CNSI-Fe(II) of Second Dosage AUC (0 ~ 72 h)	13002.57 h*ng/mL Standard Deviation 3458.25	32017.68 h*ng/mL Standard Deviation 34657.49	—	—	—
PK Parameters Assessment: AUC (ng•h/mL) Profile Assessment of CNSI-Fe(II) of Second Dosage AUC (0 ~ ∞)	14865.68 h*ng/mL Standard Deviation 1617.36	33650.19 h*ng/mL Standard Deviation 34384.97	—	—	—

SECONDARY outcome

Population: The number of patients receiving the second dose in the 30 mg, 60 mg, 90 mg, 120 mg, and 150 mg dose groups was: 1, 2, 3, 1, and 0, respectively.

This secondary outcome measure focuses on assessing the pharmacokinetic (PK) profile of CNSI-Fe(II) in patients with advanced solid tumors. Assessment Details: PK Parameters Assessment: This assessment involves the analysis of the drug's absorption, distribution, metabolism, and excretion (ADME) in patients. It will provide insights into how CNSI-Fe(II) behaves in the human body. The fourth assessed parameter is elimination half-life (t1/2). t1/2 of second dosage: The number of patients receiving the second dose in the 30 mg, 60 mg, 90 mg, 120 mg, and 150 mg dose groups was: 1, 2, 3, 1, and 0, respectively. Due to the requirement for mean ± SD data presentation, the number of evaluable subjects in 30 mg, 120 mg, 150 mg groups was fewer than two, making SD calculation impossible. Units of Measure: t1/2: Hours (h)

Outcome measures

Outcome measures
Measure	CNSI-Fe(II) 30 mg n=2 Participants 30 mg CNSI-Fe(II) 30 mg: The trial comprises a treatment period, including the DLT evaluation period with a duration of 21 days, and a maintenance treatment period. If the subject completes DLT evaluation without intolerable toxicity, an additional dose may be administered based on the investigator's determination of the benefits outweighing the risks. The original protocol planned for three dose groups: 30 mg, 60 mg, and 90 mg. The protocol was amended on March 28, 2024, to add 120 mg and 150 mg dose groups. A single tumor lesion amenable to intratumoral injection will be selected, regardless of tumor size, number, or location. The drug should be administered at the dose specified for the current dose cohort. The injection volume should be adjusted based on the size of the injected lesion.	CNSI-Fe(II) 60 mg n=3 Participants 60 mg CNSI-Fe(II) 60 mg: The trial comprises a treatment period, including the DLT evaluation period with a duration of 21 days, and a maintenance treatment period. If the subject completes DLT evaluation without intolerable toxicity, an additional dose may be administered based on the investigator's determination of the benefits outweighing the risks. The original protocol planned for three dose groups: 30 mg, 60 mg, and 90 mg. The protocol was amended on March 28, 2024, to add 120 mg and 150 mg dose groups. A single tumor lesion amenable to intratumoral injection will be selected, regardless of tumor size, number, or location. The drug should be administered at the dose specified for the current dose cohort. The injection volume should be adjusted based on the size of the injected lesion.	CNSI-Fe(II) 90 mg 90 mg CNSI-Fe(II) 90 mg: The trial comprises a treatment period, including the DLT evaluation period with a duration of 21 days, and a maintenance treatment period. If the subject completes DLT evaluation without intolerable toxicity, an additional dose may be administered based on the investigator's determination of the benefits outweighing the risks. The original protocol planned for three dose groups: 30 mg, 60 mg, and 90 mg. The protocol was amended on March 28, 2024, to add 120 mg and 150 mg dose groups. A single tumor lesion amenable to intratumoral injection will be selected, regardless of tumor size, number, or location. The drug should be administered at the dose specified for the current dose cohort. The injection volume should be adjusted based on the size of the injected lesion.	CNSI-Fe(II) 120 mg 120 mg CNSI-Fe(II) 120 mg: The dosing regimen is the same as that for the 30 mg, 60 mg, and 90 mg dose groups. Additionally, if a single lesion cannot accommodate the full corresponding dose of the investigational drug, additional lesions may be selected for simultaneous injection. When multiple lesions are injected, the drug distribution should be allocated proportionally according to the size of each lesion or determined based on the investigator's assessment of an appropriate distribution.	CNSI-Fe(II) 150 mg 150 mg CNSI-Fe(II) 150 mg: The dosing regimen is the same as that for the 30 mg, 60 mg, and 90 mg dose groups. Additionally, if a single lesion cannot accommodate the full corresponding dose of the investigational drug, additional lesions may be selected for simultaneous injection. When multiple lesions are injected, the drug distribution should be allocated proportionally according to the size of each lesion or determined based on the investigator's assessment of an appropriate distribution.
PK Parameters Assessment: t1/2 (h) Profile Assessment of CNSI-Fe(II) of Second Dosage	3.24 time (h) Standard Deviation 0.57	4.52 time (h) Standard Deviation 2.91	—	—	—

SECONDARY outcome

Timeframe: at -1 h of a time frame of 72 h

Outcome measures

Outcome measures
Measure	CNSI-Fe(II) 30 mg n=3 Participants 30 mg CNSI-Fe(II) 30 mg: The trial comprises a treatment period, including the DLT evaluation period with a duration of 21 days, and a maintenance treatment period. If the subject completes DLT evaluation without intolerable toxicity, an additional dose may be administered based on the investigator's determination of the benefits outweighing the risks. The original protocol planned for three dose groups: 30 mg, 60 mg, and 90 mg. The protocol was amended on March 28, 2024, to add 120 mg and 150 mg dose groups. A single tumor lesion amenable to intratumoral injection will be selected, regardless of tumor size, number, or location. The drug should be administered at the dose specified for the current dose cohort. The injection volume should be adjusted based on the size of the injected lesion.	CNSI-Fe(II) 60 mg n=4 Participants 60 mg CNSI-Fe(II) 60 mg: The trial comprises a treatment period, including the DLT evaluation period with a duration of 21 days, and a maintenance treatment period. If the subject completes DLT evaluation without intolerable toxicity, an additional dose may be administered based on the investigator's determination of the benefits outweighing the risks. The original protocol planned for three dose groups: 30 mg, 60 mg, and 90 mg. The protocol was amended on March 28, 2024, to add 120 mg and 150 mg dose groups. A single tumor lesion amenable to intratumoral injection will be selected, regardless of tumor size, number, or location. The drug should be administered at the dose specified for the current dose cohort. The injection volume should be adjusted based on the size of the injected lesion.	CNSI-Fe(II) 90 mg n=6 Participants 90 mg CNSI-Fe(II) 90 mg: The trial comprises a treatment period, including the DLT evaluation period with a duration of 21 days, and a maintenance treatment period. If the subject completes DLT evaluation without intolerable toxicity, an additional dose may be administered based on the investigator's determination of the benefits outweighing the risks. The original protocol planned for three dose groups: 30 mg, 60 mg, and 90 mg. The protocol was amended on March 28, 2024, to add 120 mg and 150 mg dose groups. A single tumor lesion amenable to intratumoral injection will be selected, regardless of tumor size, number, or location. The drug should be administered at the dose specified for the current dose cohort. The injection volume should be adjusted based on the size of the injected lesion.	CNSI-Fe(II) 120 mg n=3 Participants 120 mg CNSI-Fe(II) 120 mg: The dosing regimen is the same as that for the 30 mg, 60 mg, and 90 mg dose groups. Additionally, if a single lesion cannot accommodate the full corresponding dose of the investigational drug, additional lesions may be selected for simultaneous injection. When multiple lesions are injected, the drug distribution should be allocated proportionally according to the size of each lesion or determined based on the investigator's assessment of an appropriate distribution.	CNSI-Fe(II) 150 mg n=3 Participants 150 mg CNSI-Fe(II) 150 mg: The dosing regimen is the same as that for the 30 mg, 60 mg, and 90 mg dose groups. Additionally, if a single lesion cannot accommodate the full corresponding dose of the investigational drug, additional lesions may be selected for simultaneous injection. When multiple lesions are injected, the drug distribution should be allocated proportionally according to the size of each lesion or determined based on the investigator's assessment of an appropriate distribution.
PK Parameters Assessment: Serum Iron Concentration at 1 h Before First Dosage	0.00 concentration (ng/mL) Standard Deviation 0.00	0.00 concentration (ng/mL) Standard Deviation 0.00	0.00 concentration (ng/mL) Standard Deviation 0.00	0.00 concentration (ng/mL) Standard Deviation 0.00	0.00 concentration (ng/mL) Standard Deviation 0.00

SECONDARY outcome

Timeframe: at 5 min of a time frame of 72 h

Outcome measures

Outcome measures
Measure	CNSI-Fe(II) 30 mg n=3 Participants 30 mg CNSI-Fe(II) 30 mg: The trial comprises a treatment period, including the DLT evaluation period with a duration of 21 days, and a maintenance treatment period. If the subject completes DLT evaluation without intolerable toxicity, an additional dose may be administered based on the investigator's determination of the benefits outweighing the risks. The original protocol planned for three dose groups: 30 mg, 60 mg, and 90 mg. The protocol was amended on March 28, 2024, to add 120 mg and 150 mg dose groups. A single tumor lesion amenable to intratumoral injection will be selected, regardless of tumor size, number, or location. The drug should be administered at the dose specified for the current dose cohort. The injection volume should be adjusted based on the size of the injected lesion.	CNSI-Fe(II) 60 mg n=4 Participants 60 mg CNSI-Fe(II) 60 mg: The trial comprises a treatment period, including the DLT evaluation period with a duration of 21 days, and a maintenance treatment period. If the subject completes DLT evaluation without intolerable toxicity, an additional dose may be administered based on the investigator's determination of the benefits outweighing the risks. The original protocol planned for three dose groups: 30 mg, 60 mg, and 90 mg. The protocol was amended on March 28, 2024, to add 120 mg and 150 mg dose groups. A single tumor lesion amenable to intratumoral injection will be selected, regardless of tumor size, number, or location. The drug should be administered at the dose specified for the current dose cohort. The injection volume should be adjusted based on the size of the injected lesion.	CNSI-Fe(II) 90 mg n=6 Participants 90 mg CNSI-Fe(II) 90 mg: The trial comprises a treatment period, including the DLT evaluation period with a duration of 21 days, and a maintenance treatment period. If the subject completes DLT evaluation without intolerable toxicity, an additional dose may be administered based on the investigator's determination of the benefits outweighing the risks. The original protocol planned for three dose groups: 30 mg, 60 mg, and 90 mg. The protocol was amended on March 28, 2024, to add 120 mg and 150 mg dose groups. A single tumor lesion amenable to intratumoral injection will be selected, regardless of tumor size, number, or location. The drug should be administered at the dose specified for the current dose cohort. The injection volume should be adjusted based on the size of the injected lesion.	CNSI-Fe(II) 120 mg n=3 Participants 120 mg CNSI-Fe(II) 120 mg: The dosing regimen is the same as that for the 30 mg, 60 mg, and 90 mg dose groups. Additionally, if a single lesion cannot accommodate the full corresponding dose of the investigational drug, additional lesions may be selected for simultaneous injection. When multiple lesions are injected, the drug distribution should be allocated proportionally according to the size of each lesion or determined based on the investigator's assessment of an appropriate distribution.	CNSI-Fe(II) 150 mg n=3 Participants 150 mg CNSI-Fe(II) 150 mg: The dosing regimen is the same as that for the 30 mg, 60 mg, and 90 mg dose groups. Additionally, if a single lesion cannot accommodate the full corresponding dose of the investigational drug, additional lesions may be selected for simultaneous injection. When multiple lesions are injected, the drug distribution should be allocated proportionally according to the size of each lesion or determined based on the investigator's assessment of an appropriate distribution.
PK Parameters Assessment: Serum Iron Concentration at 5 Min of First Dosage	3627.00 concentration (ng/mL) Standard Deviation 908.42	6117.00 concentration (ng/mL) Standard Deviation 4136.63	3363.50 concentration (ng/mL) Standard Deviation 3725.84	2081.00 concentration (ng/mL) Standard Deviation 1623.52	3453.50 concentration (ng/mL) Standard Deviation 1030.25

SECONDARY outcome

Timeframe: at 10 min of a time frame of 72 h

Outcome measures

Outcome measures
Measure	CNSI-Fe(II) 30 mg n=3 Participants 30 mg CNSI-Fe(II) 30 mg: The trial comprises a treatment period, including the DLT evaluation period with a duration of 21 days, and a maintenance treatment period. If the subject completes DLT evaluation without intolerable toxicity, an additional dose may be administered based on the investigator's determination of the benefits outweighing the risks. The original protocol planned for three dose groups: 30 mg, 60 mg, and 90 mg. The protocol was amended on March 28, 2024, to add 120 mg and 150 mg dose groups. A single tumor lesion amenable to intratumoral injection will be selected, regardless of tumor size, number, or location. The drug should be administered at the dose specified for the current dose cohort. The injection volume should be adjusted based on the size of the injected lesion.	CNSI-Fe(II) 60 mg n=4 Participants 60 mg CNSI-Fe(II) 60 mg: The trial comprises a treatment period, including the DLT evaluation period with a duration of 21 days, and a maintenance treatment period. If the subject completes DLT evaluation without intolerable toxicity, an additional dose may be administered based on the investigator's determination of the benefits outweighing the risks. The original protocol planned for three dose groups: 30 mg, 60 mg, and 90 mg. The protocol was amended on March 28, 2024, to add 120 mg and 150 mg dose groups. A single tumor lesion amenable to intratumoral injection will be selected, regardless of tumor size, number, or location. The drug should be administered at the dose specified for the current dose cohort. The injection volume should be adjusted based on the size of the injected lesion.	CNSI-Fe(II) 90 mg n=6 Participants 90 mg CNSI-Fe(II) 90 mg: The trial comprises a treatment period, including the DLT evaluation period with a duration of 21 days, and a maintenance treatment period. If the subject completes DLT evaluation without intolerable toxicity, an additional dose may be administered based on the investigator's determination of the benefits outweighing the risks. The original protocol planned for three dose groups: 30 mg, 60 mg, and 90 mg. The protocol was amended on March 28, 2024, to add 120 mg and 150 mg dose groups. A single tumor lesion amenable to intratumoral injection will be selected, regardless of tumor size, number, or location. The drug should be administered at the dose specified for the current dose cohort. The injection volume should be adjusted based on the size of the injected lesion.	CNSI-Fe(II) 120 mg n=3 Participants 120 mg CNSI-Fe(II) 120 mg: The dosing regimen is the same as that for the 30 mg, 60 mg, and 90 mg dose groups. Additionally, if a single lesion cannot accommodate the full corresponding dose of the investigational drug, additional lesions may be selected for simultaneous injection. When multiple lesions are injected, the drug distribution should be allocated proportionally according to the size of each lesion or determined based on the investigator's assessment of an appropriate distribution.	CNSI-Fe(II) 150 mg n=3 Participants 150 mg CNSI-Fe(II) 150 mg: The dosing regimen is the same as that for the 30 mg, 60 mg, and 90 mg dose groups. Additionally, if a single lesion cannot accommodate the full corresponding dose of the investigational drug, additional lesions may be selected for simultaneous injection. When multiple lesions are injected, the drug distribution should be allocated proportionally according to the size of each lesion or determined based on the investigator's assessment of an appropriate distribution.
PK Parameters Assessment: Serum Iron Concentration at 10 Min of First Dosage	2462.67 concentration (ng/mL) Standard Deviation 1006.52	4433.00 concentration (ng/mL) Standard Deviation 2075.13	3123.83 concentration (ng/mL) Standard Deviation 3345.62	1829.50 concentration (ng/mL) Standard Deviation 791.25	13891.00 concentration (ng/mL) Standard Deviation 17933.42

SECONDARY outcome

Timeframe: at 15 min of a time frame of 72 h

Outcome measures

Outcome measures
Measure	CNSI-Fe(II) 30 mg n=3 Participants 30 mg CNSI-Fe(II) 30 mg: The trial comprises a treatment period, including the DLT evaluation period with a duration of 21 days, and a maintenance treatment period. If the subject completes DLT evaluation without intolerable toxicity, an additional dose may be administered based on the investigator's determination of the benefits outweighing the risks. The original protocol planned for three dose groups: 30 mg, 60 mg, and 90 mg. The protocol was amended on March 28, 2024, to add 120 mg and 150 mg dose groups. A single tumor lesion amenable to intratumoral injection will be selected, regardless of tumor size, number, or location. The drug should be administered at the dose specified for the current dose cohort. The injection volume should be adjusted based on the size of the injected lesion.	CNSI-Fe(II) 60 mg n=4 Participants 60 mg CNSI-Fe(II) 60 mg: The trial comprises a treatment period, including the DLT evaluation period with a duration of 21 days, and a maintenance treatment period. If the subject completes DLT evaluation without intolerable toxicity, an additional dose may be administered based on the investigator's determination of the benefits outweighing the risks. The original protocol planned for three dose groups: 30 mg, 60 mg, and 90 mg. The protocol was amended on March 28, 2024, to add 120 mg and 150 mg dose groups. A single tumor lesion amenable to intratumoral injection will be selected, regardless of tumor size, number, or location. The drug should be administered at the dose specified for the current dose cohort. The injection volume should be adjusted based on the size of the injected lesion.	CNSI-Fe(II) 90 mg n=6 Participants 90 mg CNSI-Fe(II) 90 mg: The trial comprises a treatment period, including the DLT evaluation period with a duration of 21 days, and a maintenance treatment period. If the subject completes DLT evaluation without intolerable toxicity, an additional dose may be administered based on the investigator's determination of the benefits outweighing the risks. The original protocol planned for three dose groups: 30 mg, 60 mg, and 90 mg. The protocol was amended on March 28, 2024, to add 120 mg and 150 mg dose groups. A single tumor lesion amenable to intratumoral injection will be selected, regardless of tumor size, number, or location. The drug should be administered at the dose specified for the current dose cohort. The injection volume should be adjusted based on the size of the injected lesion.	CNSI-Fe(II) 120 mg n=3 Participants 120 mg CNSI-Fe(II) 120 mg: The dosing regimen is the same as that for the 30 mg, 60 mg, and 90 mg dose groups. Additionally, if a single lesion cannot accommodate the full corresponding dose of the investigational drug, additional lesions may be selected for simultaneous injection. When multiple lesions are injected, the drug distribution should be allocated proportionally according to the size of each lesion or determined based on the investigator's assessment of an appropriate distribution.	CNSI-Fe(II) 150 mg n=3 Participants 150 mg CNSI-Fe(II) 150 mg: The dosing regimen is the same as that for the 30 mg, 60 mg, and 90 mg dose groups. Additionally, if a single lesion cannot accommodate the full corresponding dose of the investigational drug, additional lesions may be selected for simultaneous injection. When multiple lesions are injected, the drug distribution should be allocated proportionally according to the size of each lesion or determined based on the investigator's assessment of an appropriate distribution.
PK Parameters Assessment: Serum Iron Concentration at 15 Min of First Dosage	6553.00 concentration (ng/mL) Standard Deviation 6514.03	4269.67 concentration (ng/mL) Standard Deviation 1870.56	3076.50 concentration (ng/mL) Standard Deviation 3019.85	8343.67 concentration (ng/mL) Standard Deviation 10921.80	13338.33 concentration (ng/mL) Standard Deviation 16864.40

SECONDARY outcome

Timeframe: at 30 min of a time frame of 72 h

Outcome measures

Outcome measures
Measure	CNSI-Fe(II) 30 mg n=3 Participants 30 mg CNSI-Fe(II) 30 mg: The trial comprises a treatment period, including the DLT evaluation period with a duration of 21 days, and a maintenance treatment period. If the subject completes DLT evaluation without intolerable toxicity, an additional dose may be administered based on the investigator's determination of the benefits outweighing the risks. The original protocol planned for three dose groups: 30 mg, 60 mg, and 90 mg. The protocol was amended on March 28, 2024, to add 120 mg and 150 mg dose groups. A single tumor lesion amenable to intratumoral injection will be selected, regardless of tumor size, number, or location. The drug should be administered at the dose specified for the current dose cohort. The injection volume should be adjusted based on the size of the injected lesion.	CNSI-Fe(II) 60 mg n=4 Participants 60 mg CNSI-Fe(II) 60 mg: The trial comprises a treatment period, including the DLT evaluation period with a duration of 21 days, and a maintenance treatment period. If the subject completes DLT evaluation without intolerable toxicity, an additional dose may be administered based on the investigator's determination of the benefits outweighing the risks. The original protocol planned for three dose groups: 30 mg, 60 mg, and 90 mg. The protocol was amended on March 28, 2024, to add 120 mg and 150 mg dose groups. A single tumor lesion amenable to intratumoral injection will be selected, regardless of tumor size, number, or location. The drug should be administered at the dose specified for the current dose cohort. The injection volume should be adjusted based on the size of the injected lesion.	CNSI-Fe(II) 90 mg n=6 Participants 90 mg CNSI-Fe(II) 90 mg: The trial comprises a treatment period, including the DLT evaluation period with a duration of 21 days, and a maintenance treatment period. If the subject completes DLT evaluation without intolerable toxicity, an additional dose may be administered based on the investigator's determination of the benefits outweighing the risks. The original protocol planned for three dose groups: 30 mg, 60 mg, and 90 mg. The protocol was amended on March 28, 2024, to add 120 mg and 150 mg dose groups. A single tumor lesion amenable to intratumoral injection will be selected, regardless of tumor size, number, or location. The drug should be administered at the dose specified for the current dose cohort. The injection volume should be adjusted based on the size of the injected lesion.	CNSI-Fe(II) 120 mg n=3 Participants 120 mg CNSI-Fe(II) 120 mg: The dosing regimen is the same as that for the 30 mg, 60 mg, and 90 mg dose groups. Additionally, if a single lesion cannot accommodate the full corresponding dose of the investigational drug, additional lesions may be selected for simultaneous injection. When multiple lesions are injected, the drug distribution should be allocated proportionally according to the size of each lesion or determined based on the investigator's assessment of an appropriate distribution.	CNSI-Fe(II) 150 mg n=3 Participants 150 mg CNSI-Fe(II) 150 mg: The dosing regimen is the same as that for the 30 mg, 60 mg, and 90 mg dose groups. Additionally, if a single lesion cannot accommodate the full corresponding dose of the investigational drug, additional lesions may be selected for simultaneous injection. When multiple lesions are injected, the drug distribution should be allocated proportionally according to the size of each lesion or determined based on the investigator's assessment of an appropriate distribution.
PK Parameters Assessment: Serum Iron Concentration at 30 Min of First Dosage	4199.00 concentration (ng/mL) Standard Deviation 2686.34	4959.25 concentration (ng/mL) Standard Deviation 2928.53	2819.17 concentration (ng/mL) Standard Deviation 2760.02	7144.33 concentration (ng/mL) Standard Deviation 9238.01	11807.67 concentration (ng/mL) Standard Deviation 14825.80

SECONDARY outcome

Timeframe: at 1 h of a time frame of 72 h

Outcome measures

Outcome measures
Measure	CNSI-Fe(II) 30 mg n=3 Participants 30 mg CNSI-Fe(II) 30 mg: The trial comprises a treatment period, including the DLT evaluation period with a duration of 21 days, and a maintenance treatment period. If the subject completes DLT evaluation without intolerable toxicity, an additional dose may be administered based on the investigator's determination of the benefits outweighing the risks. The original protocol planned for three dose groups: 30 mg, 60 mg, and 90 mg. The protocol was amended on March 28, 2024, to add 120 mg and 150 mg dose groups. A single tumor lesion amenable to intratumoral injection will be selected, regardless of tumor size, number, or location. The drug should be administered at the dose specified for the current dose cohort. The injection volume should be adjusted based on the size of the injected lesion.	CNSI-Fe(II) 60 mg n=4 Participants 60 mg CNSI-Fe(II) 60 mg: The trial comprises a treatment period, including the DLT evaluation period with a duration of 21 days, and a maintenance treatment period. If the subject completes DLT evaluation without intolerable toxicity, an additional dose may be administered based on the investigator's determination of the benefits outweighing the risks. The original protocol planned for three dose groups: 30 mg, 60 mg, and 90 mg. The protocol was amended on March 28, 2024, to add 120 mg and 150 mg dose groups. A single tumor lesion amenable to intratumoral injection will be selected, regardless of tumor size, number, or location. The drug should be administered at the dose specified for the current dose cohort. The injection volume should be adjusted based on the size of the injected lesion.	CNSI-Fe(II) 90 mg n=6 Participants 90 mg CNSI-Fe(II) 90 mg: The trial comprises a treatment period, including the DLT evaluation period with a duration of 21 days, and a maintenance treatment period. If the subject completes DLT evaluation without intolerable toxicity, an additional dose may be administered based on the investigator's determination of the benefits outweighing the risks. The original protocol planned for three dose groups: 30 mg, 60 mg, and 90 mg. The protocol was amended on March 28, 2024, to add 120 mg and 150 mg dose groups. A single tumor lesion amenable to intratumoral injection will be selected, regardless of tumor size, number, or location. The drug should be administered at the dose specified for the current dose cohort. The injection volume should be adjusted based on the size of the injected lesion.	CNSI-Fe(II) 120 mg n=3 Participants 120 mg CNSI-Fe(II) 120 mg: The dosing regimen is the same as that for the 30 mg, 60 mg, and 90 mg dose groups. Additionally, if a single lesion cannot accommodate the full corresponding dose of the investigational drug, additional lesions may be selected for simultaneous injection. When multiple lesions are injected, the drug distribution should be allocated proportionally according to the size of each lesion or determined based on the investigator's assessment of an appropriate distribution.	CNSI-Fe(II) 150 mg n=3 Participants 150 mg CNSI-Fe(II) 150 mg: The dosing regimen is the same as that for the 30 mg, 60 mg, and 90 mg dose groups. Additionally, if a single lesion cannot accommodate the full corresponding dose of the investigational drug, additional lesions may be selected for simultaneous injection. When multiple lesions are injected, the drug distribution should be allocated proportionally according to the size of each lesion or determined based on the investigator's assessment of an appropriate distribution.
PK Parameters Assessment: Serum Iron Concentration at 1 h of First Dosage	4166.33 concentration (ng/mL) Standard Deviation 3260.77	3968.00 concentration (ng/mL) Standard Deviation 729.60	2432.67 concentration (ng/mL) Standard Deviation 2049.81	6329.67 concentration (ng/mL) Standard Deviation 8156.59	10478.00 concentration (ng/mL) Standard Deviation 12978.06

SECONDARY outcome

Timeframe: at 2 h of a time frame of 72 h

Outcome measures

Outcome measures
Measure	CNSI-Fe(II) 30 mg n=3 Participants 30 mg CNSI-Fe(II) 30 mg: The trial comprises a treatment period, including the DLT evaluation period with a duration of 21 days, and a maintenance treatment period. If the subject completes DLT evaluation without intolerable toxicity, an additional dose may be administered based on the investigator's determination of the benefits outweighing the risks. The original protocol planned for three dose groups: 30 mg, 60 mg, and 90 mg. The protocol was amended on March 28, 2024, to add 120 mg and 150 mg dose groups. A single tumor lesion amenable to intratumoral injection will be selected, regardless of tumor size, number, or location. The drug should be administered at the dose specified for the current dose cohort. The injection volume should be adjusted based on the size of the injected lesion.	CNSI-Fe(II) 60 mg n=4 Participants 60 mg CNSI-Fe(II) 60 mg: The trial comprises a treatment period, including the DLT evaluation period with a duration of 21 days, and a maintenance treatment period. If the subject completes DLT evaluation without intolerable toxicity, an additional dose may be administered based on the investigator's determination of the benefits outweighing the risks. The original protocol planned for three dose groups: 30 mg, 60 mg, and 90 mg. The protocol was amended on March 28, 2024, to add 120 mg and 150 mg dose groups. A single tumor lesion amenable to intratumoral injection will be selected, regardless of tumor size, number, or location. The drug should be administered at the dose specified for the current dose cohort. The injection volume should be adjusted based on the size of the injected lesion.	CNSI-Fe(II) 90 mg n=6 Participants 90 mg CNSI-Fe(II) 90 mg: The trial comprises a treatment period, including the DLT evaluation period with a duration of 21 days, and a maintenance treatment period. If the subject completes DLT evaluation without intolerable toxicity, an additional dose may be administered based on the investigator's determination of the benefits outweighing the risks. The original protocol planned for three dose groups: 30 mg, 60 mg, and 90 mg. The protocol was amended on March 28, 2024, to add 120 mg and 150 mg dose groups. A single tumor lesion amenable to intratumoral injection will be selected, regardless of tumor size, number, or location. The drug should be administered at the dose specified for the current dose cohort. The injection volume should be adjusted based on the size of the injected lesion.	CNSI-Fe(II) 120 mg n=3 Participants 120 mg CNSI-Fe(II) 120 mg: The dosing regimen is the same as that for the 30 mg, 60 mg, and 90 mg dose groups. Additionally, if a single lesion cannot accommodate the full corresponding dose of the investigational drug, additional lesions may be selected for simultaneous injection. When multiple lesions are injected, the drug distribution should be allocated proportionally according to the size of each lesion or determined based on the investigator's assessment of an appropriate distribution.	CNSI-Fe(II) 150 mg n=3 Participants 150 mg CNSI-Fe(II) 150 mg: The dosing regimen is the same as that for the 30 mg, 60 mg, and 90 mg dose groups. Additionally, if a single lesion cannot accommodate the full corresponding dose of the investigational drug, additional lesions may be selected for simultaneous injection. When multiple lesions are injected, the drug distribution should be allocated proportionally according to the size of each lesion or determined based on the investigator's assessment of an appropriate distribution.
PK Parameters Assessment: Serum Iron Concentration at 2 h of First Dosage	1949.33 concentration (ng/mL) Standard Deviation 364.91	3076.25 concentration (ng/mL) Standard Deviation 793.40	1900.00 concentration (ng/mL) Standard Deviation 1572.04	4930.33 concentration (ng/mL) Standard Deviation 5757.17	8106.33 concentration (ng/mL) Standard Deviation 8652.61

SECONDARY outcome

Timeframe: at 4 h of a time frame of 72 h

Outcome measures

Outcome measures
Measure	CNSI-Fe(II) 30 mg n=3 Participants 30 mg CNSI-Fe(II) 30 mg: The trial comprises a treatment period, including the DLT evaluation period with a duration of 21 days, and a maintenance treatment period. If the subject completes DLT evaluation without intolerable toxicity, an additional dose may be administered based on the investigator's determination of the benefits outweighing the risks. The original protocol planned for three dose groups: 30 mg, 60 mg, and 90 mg. The protocol was amended on March 28, 2024, to add 120 mg and 150 mg dose groups. A single tumor lesion amenable to intratumoral injection will be selected, regardless of tumor size, number, or location. The drug should be administered at the dose specified for the current dose cohort. The injection volume should be adjusted based on the size of the injected lesion.	CNSI-Fe(II) 60 mg n=4 Participants 60 mg CNSI-Fe(II) 60 mg: The trial comprises a treatment period, including the DLT evaluation period with a duration of 21 days, and a maintenance treatment period. If the subject completes DLT evaluation without intolerable toxicity, an additional dose may be administered based on the investigator's determination of the benefits outweighing the risks. The original protocol planned for three dose groups: 30 mg, 60 mg, and 90 mg. The protocol was amended on March 28, 2024, to add 120 mg and 150 mg dose groups. A single tumor lesion amenable to intratumoral injection will be selected, regardless of tumor size, number, or location. The drug should be administered at the dose specified for the current dose cohort. The injection volume should be adjusted based on the size of the injected lesion.	CNSI-Fe(II) 90 mg n=6 Participants 90 mg CNSI-Fe(II) 90 mg: The trial comprises a treatment period, including the DLT evaluation period with a duration of 21 days, and a maintenance treatment period. If the subject completes DLT evaluation without intolerable toxicity, an additional dose may be administered based on the investigator's determination of the benefits outweighing the risks. The original protocol planned for three dose groups: 30 mg, 60 mg, and 90 mg. The protocol was amended on March 28, 2024, to add 120 mg and 150 mg dose groups. A single tumor lesion amenable to intratumoral injection will be selected, regardless of tumor size, number, or location. The drug should be administered at the dose specified for the current dose cohort. The injection volume should be adjusted based on the size of the injected lesion.	CNSI-Fe(II) 120 mg n=3 Participants 120 mg CNSI-Fe(II) 120 mg: The dosing regimen is the same as that for the 30 mg, 60 mg, and 90 mg dose groups. Additionally, if a single lesion cannot accommodate the full corresponding dose of the investigational drug, additional lesions may be selected for simultaneous injection. When multiple lesions are injected, the drug distribution should be allocated proportionally according to the size of each lesion or determined based on the investigator's assessment of an appropriate distribution.	CNSI-Fe(II) 150 mg n=3 Participants 150 mg CNSI-Fe(II) 150 mg: The dosing regimen is the same as that for the 30 mg, 60 mg, and 90 mg dose groups. Additionally, if a single lesion cannot accommodate the full corresponding dose of the investigational drug, additional lesions may be selected for simultaneous injection. When multiple lesions are injected, the drug distribution should be allocated proportionally according to the size of each lesion or determined based on the investigator's assessment of an appropriate distribution.
PK Parameters Assessment: Serum Iron Concentration at 4 h of First Dosage	2416.00 concentration (ng/mL) Standard Deviation 1827.83	2555.50 concentration (ng/mL) Standard Deviation 590.25	1337.83 concentration (ng/mL) Standard Deviation 1047.53	2906.00 concentration (ng/mL) Standard Deviation 3068.73	5476.67 concentration (ng/mL) Standard Deviation 5667.68

SECONDARY outcome

Timeframe: at 8 h of a time frame of 72 h

Outcome measures

Outcome measures
Measure	CNSI-Fe(II) 30 mg n=3 Participants 30 mg CNSI-Fe(II) 30 mg: The trial comprises a treatment period, including the DLT evaluation period with a duration of 21 days, and a maintenance treatment period. If the subject completes DLT evaluation without intolerable toxicity, an additional dose may be administered based on the investigator's determination of the benefits outweighing the risks. The original protocol planned for three dose groups: 30 mg, 60 mg, and 90 mg. The protocol was amended on March 28, 2024, to add 120 mg and 150 mg dose groups. A single tumor lesion amenable to intratumoral injection will be selected, regardless of tumor size, number, or location. The drug should be administered at the dose specified for the current dose cohort. The injection volume should be adjusted based on the size of the injected lesion.	CNSI-Fe(II) 60 mg n=4 Participants 60 mg CNSI-Fe(II) 60 mg: The trial comprises a treatment period, including the DLT evaluation period with a duration of 21 days, and a maintenance treatment period. If the subject completes DLT evaluation without intolerable toxicity, an additional dose may be administered based on the investigator's determination of the benefits outweighing the risks. The original protocol planned for three dose groups: 30 mg, 60 mg, and 90 mg. The protocol was amended on March 28, 2024, to add 120 mg and 150 mg dose groups. A single tumor lesion amenable to intratumoral injection will be selected, regardless of tumor size, number, or location. The drug should be administered at the dose specified for the current dose cohort. The injection volume should be adjusted based on the size of the injected lesion.	CNSI-Fe(II) 90 mg n=6 Participants 90 mg CNSI-Fe(II) 90 mg: The trial comprises a treatment period, including the DLT evaluation period with a duration of 21 days, and a maintenance treatment period. If the subject completes DLT evaluation without intolerable toxicity, an additional dose may be administered based on the investigator's determination of the benefits outweighing the risks. The original protocol planned for three dose groups: 30 mg, 60 mg, and 90 mg. The protocol was amended on March 28, 2024, to add 120 mg and 150 mg dose groups. A single tumor lesion amenable to intratumoral injection will be selected, regardless of tumor size, number, or location. The drug should be administered at the dose specified for the current dose cohort. The injection volume should be adjusted based on the size of the injected lesion.	CNSI-Fe(II) 120 mg n=3 Participants 120 mg CNSI-Fe(II) 120 mg: The dosing regimen is the same as that for the 30 mg, 60 mg, and 90 mg dose groups. Additionally, if a single lesion cannot accommodate the full corresponding dose of the investigational drug, additional lesions may be selected for simultaneous injection. When multiple lesions are injected, the drug distribution should be allocated proportionally according to the size of each lesion or determined based on the investigator's assessment of an appropriate distribution.	CNSI-Fe(II) 150 mg n=3 Participants 150 mg CNSI-Fe(II) 150 mg: The dosing regimen is the same as that for the 30 mg, 60 mg, and 90 mg dose groups. Additionally, if a single lesion cannot accommodate the full corresponding dose of the investigational drug, additional lesions may be selected for simultaneous injection. When multiple lesions are injected, the drug distribution should be allocated proportionally according to the size of each lesion or determined based on the investigator's assessment of an appropriate distribution.
PK Parameters Assessment: Serum Iron Concentration at 8 h of First Dosage	292.33 concentration (ng/mL) Standard Deviation 179.53	1324.00 concentration (ng/mL) Standard Deviation 598.48	811.40 concentration (ng/mL) Standard Deviation 999.84	1262.67 concentration (ng/mL) Standard Deviation 1523.64	2613.00 concentration (ng/mL) Standard Deviation 2754.00

SECONDARY outcome

Timeframe: at 12 h of a time frame of 72 h

Outcome measures

Outcome measures
Measure	CNSI-Fe(II) 30 mg n=3 Participants 30 mg CNSI-Fe(II) 30 mg: The trial comprises a treatment period, including the DLT evaluation period with a duration of 21 days, and a maintenance treatment period. If the subject completes DLT evaluation without intolerable toxicity, an additional dose may be administered based on the investigator's determination of the benefits outweighing the risks. The original protocol planned for three dose groups: 30 mg, 60 mg, and 90 mg. The protocol was amended on March 28, 2024, to add 120 mg and 150 mg dose groups. A single tumor lesion amenable to intratumoral injection will be selected, regardless of tumor size, number, or location. The drug should be administered at the dose specified for the current dose cohort. The injection volume should be adjusted based on the size of the injected lesion.	CNSI-Fe(II) 60 mg n=4 Participants 60 mg CNSI-Fe(II) 60 mg: The trial comprises a treatment period, including the DLT evaluation period with a duration of 21 days, and a maintenance treatment period. If the subject completes DLT evaluation without intolerable toxicity, an additional dose may be administered based on the investigator's determination of the benefits outweighing the risks. The original protocol planned for three dose groups: 30 mg, 60 mg, and 90 mg. The protocol was amended on March 28, 2024, to add 120 mg and 150 mg dose groups. A single tumor lesion amenable to intratumoral injection will be selected, regardless of tumor size, number, or location. The drug should be administered at the dose specified for the current dose cohort. The injection volume should be adjusted based on the size of the injected lesion.	CNSI-Fe(II) 90 mg n=6 Participants 90 mg CNSI-Fe(II) 90 mg: The trial comprises a treatment period, including the DLT evaluation period with a duration of 21 days, and a maintenance treatment period. If the subject completes DLT evaluation without intolerable toxicity, an additional dose may be administered based on the investigator's determination of the benefits outweighing the risks. The original protocol planned for three dose groups: 30 mg, 60 mg, and 90 mg. The protocol was amended on March 28, 2024, to add 120 mg and 150 mg dose groups. A single tumor lesion amenable to intratumoral injection will be selected, regardless of tumor size, number, or location. The drug should be administered at the dose specified for the current dose cohort. The injection volume should be adjusted based on the size of the injected lesion.	CNSI-Fe(II) 120 mg n=3 Participants 120 mg CNSI-Fe(II) 120 mg: The dosing regimen is the same as that for the 30 mg, 60 mg, and 90 mg dose groups. Additionally, if a single lesion cannot accommodate the full corresponding dose of the investigational drug, additional lesions may be selected for simultaneous injection. When multiple lesions are injected, the drug distribution should be allocated proportionally according to the size of each lesion or determined based on the investigator's assessment of an appropriate distribution.	CNSI-Fe(II) 150 mg n=3 Participants 150 mg CNSI-Fe(II) 150 mg: The dosing regimen is the same as that for the 30 mg, 60 mg, and 90 mg dose groups. Additionally, if a single lesion cannot accommodate the full corresponding dose of the investigational drug, additional lesions may be selected for simultaneous injection. When multiple lesions are injected, the drug distribution should be allocated proportionally according to the size of each lesion or determined based on the investigator's assessment of an appropriate distribution.
PK Parameters Assessment: Serum Iron Concentration at 12 h of First Dosage	0.00 concentration (ng/mL) Standard Deviation 0.00	677.50 concentration (ng/mL) Standard Deviation 566.56	99.20 concentration (ng/mL) Standard Deviation 133.45	675.67 concentration (ng/mL) Standard Deviation 1170.29	1376.33 concentration (ng/mL) Standard Deviation 1923.36

SECONDARY outcome

Timeframe: at 24 h of a time frame of 72 h

Outcome measures

Outcome measures
Measure	CNSI-Fe(II) 30 mg n=3 Participants 30 mg CNSI-Fe(II) 30 mg: The trial comprises a treatment period, including the DLT evaluation period with a duration of 21 days, and a maintenance treatment period. If the subject completes DLT evaluation without intolerable toxicity, an additional dose may be administered based on the investigator's determination of the benefits outweighing the risks. The original protocol planned for three dose groups: 30 mg, 60 mg, and 90 mg. The protocol was amended on March 28, 2024, to add 120 mg and 150 mg dose groups. A single tumor lesion amenable to intratumoral injection will be selected, regardless of tumor size, number, or location. The drug should be administered at the dose specified for the current dose cohort. The injection volume should be adjusted based on the size of the injected lesion.	CNSI-Fe(II) 60 mg n=4 Participants 60 mg CNSI-Fe(II) 60 mg: The trial comprises a treatment period, including the DLT evaluation period with a duration of 21 days, and a maintenance treatment period. If the subject completes DLT evaluation without intolerable toxicity, an additional dose may be administered based on the investigator's determination of the benefits outweighing the risks. The original protocol planned for three dose groups: 30 mg, 60 mg, and 90 mg. The protocol was amended on March 28, 2024, to add 120 mg and 150 mg dose groups. A single tumor lesion amenable to intratumoral injection will be selected, regardless of tumor size, number, or location. The drug should be administered at the dose specified for the current dose cohort. The injection volume should be adjusted based on the size of the injected lesion.	CNSI-Fe(II) 90 mg n=6 Participants 90 mg CNSI-Fe(II) 90 mg: The trial comprises a treatment period, including the DLT evaluation period with a duration of 21 days, and a maintenance treatment period. If the subject completes DLT evaluation without intolerable toxicity, an additional dose may be administered based on the investigator's determination of the benefits outweighing the risks. The original protocol planned for three dose groups: 30 mg, 60 mg, and 90 mg. The protocol was amended on March 28, 2024, to add 120 mg and 150 mg dose groups. A single tumor lesion amenable to intratumoral injection will be selected, regardless of tumor size, number, or location. The drug should be administered at the dose specified for the current dose cohort. The injection volume should be adjusted based on the size of the injected lesion.	CNSI-Fe(II) 120 mg n=3 Participants 120 mg CNSI-Fe(II) 120 mg: The dosing regimen is the same as that for the 30 mg, 60 mg, and 90 mg dose groups. Additionally, if a single lesion cannot accommodate the full corresponding dose of the investigational drug, additional lesions may be selected for simultaneous injection. When multiple lesions are injected, the drug distribution should be allocated proportionally according to the size of each lesion or determined based on the investigator's assessment of an appropriate distribution.	CNSI-Fe(II) 150 mg n=3 Participants 150 mg CNSI-Fe(II) 150 mg: The dosing regimen is the same as that for the 30 mg, 60 mg, and 90 mg dose groups. Additionally, if a single lesion cannot accommodate the full corresponding dose of the investigational drug, additional lesions may be selected for simultaneous injection. When multiple lesions are injected, the drug distribution should be allocated proportionally according to the size of each lesion or determined based on the investigator's assessment of an appropriate distribution.
PK Parameters Assessment: Serum Iron Concentration at 24 h of First Dosage	0.00 concentration (ng/mL) Standard Deviation 0.00	0.00 concentration (ng/mL) Standard Deviation 0.00	138.33 concentration (ng/mL) Standard Deviation 214.40	214.67 concentration (ng/mL) Standard Deviation 371.81	47.33 concentration (ng/mL) Standard Deviation 81.98

SECONDARY outcome

Timeframe: at 48 h of a time frame of 72 h

Outcome measures

Outcome measures
Measure	CNSI-Fe(II) 30 mg n=3 Participants 30 mg CNSI-Fe(II) 30 mg: The trial comprises a treatment period, including the DLT evaluation period with a duration of 21 days, and a maintenance treatment period. If the subject completes DLT evaluation without intolerable toxicity, an additional dose may be administered based on the investigator's determination of the benefits outweighing the risks. The original protocol planned for three dose groups: 30 mg, 60 mg, and 90 mg. The protocol was amended on March 28, 2024, to add 120 mg and 150 mg dose groups. A single tumor lesion amenable to intratumoral injection will be selected, regardless of tumor size, number, or location. The drug should be administered at the dose specified for the current dose cohort. The injection volume should be adjusted based on the size of the injected lesion.	CNSI-Fe(II) 60 mg n=4 Participants 60 mg CNSI-Fe(II) 60 mg: The trial comprises a treatment period, including the DLT evaluation period with a duration of 21 days, and a maintenance treatment period. If the subject completes DLT evaluation without intolerable toxicity, an additional dose may be administered based on the investigator's determination of the benefits outweighing the risks. The original protocol planned for three dose groups: 30 mg, 60 mg, and 90 mg. The protocol was amended on March 28, 2024, to add 120 mg and 150 mg dose groups. A single tumor lesion amenable to intratumoral injection will be selected, regardless of tumor size, number, or location. The drug should be administered at the dose specified for the current dose cohort. The injection volume should be adjusted based on the size of the injected lesion.	CNSI-Fe(II) 90 mg n=6 Participants 90 mg CNSI-Fe(II) 90 mg: The trial comprises a treatment period, including the DLT evaluation period with a duration of 21 days, and a maintenance treatment period. If the subject completes DLT evaluation without intolerable toxicity, an additional dose may be administered based on the investigator's determination of the benefits outweighing the risks. The original protocol planned for three dose groups: 30 mg, 60 mg, and 90 mg. The protocol was amended on March 28, 2024, to add 120 mg and 150 mg dose groups. A single tumor lesion amenable to intratumoral injection will be selected, regardless of tumor size, number, or location. The drug should be administered at the dose specified for the current dose cohort. The injection volume should be adjusted based on the size of the injected lesion.	CNSI-Fe(II) 120 mg n=3 Participants 120 mg CNSI-Fe(II) 120 mg: The dosing regimen is the same as that for the 30 mg, 60 mg, and 90 mg dose groups. Additionally, if a single lesion cannot accommodate the full corresponding dose of the investigational drug, additional lesions may be selected for simultaneous injection. When multiple lesions are injected, the drug distribution should be allocated proportionally according to the size of each lesion or determined based on the investigator's assessment of an appropriate distribution.	CNSI-Fe(II) 150 mg n=3 Participants 150 mg CNSI-Fe(II) 150 mg: The dosing regimen is the same as that for the 30 mg, 60 mg, and 90 mg dose groups. Additionally, if a single lesion cannot accommodate the full corresponding dose of the investigational drug, additional lesions may be selected for simultaneous injection. When multiple lesions are injected, the drug distribution should be allocated proportionally according to the size of each lesion or determined based on the investigator's assessment of an appropriate distribution.
PK Parameters Assessment: Serum Iron Concentration at 48 h of First Dosage	0.00 concentration (ng/mL) Standard Deviation 0.00	0.00 concentration (ng/mL) Standard Deviation 0.00	0.00 concentration (ng/mL) Standard Deviation 0.00	0.00 concentration (ng/mL) Standard Deviation 0.00	0.00 concentration (ng/mL) Standard Deviation 0.00

SECONDARY outcome

Timeframe: at 72 h of a time frame of 72 h

Outcome measures

Outcome measures
Measure	CNSI-Fe(II) 30 mg n=3 Participants 30 mg CNSI-Fe(II) 30 mg: The trial comprises a treatment period, including the DLT evaluation period with a duration of 21 days, and a maintenance treatment period. If the subject completes DLT evaluation without intolerable toxicity, an additional dose may be administered based on the investigator's determination of the benefits outweighing the risks. The original protocol planned for three dose groups: 30 mg, 60 mg, and 90 mg. The protocol was amended on March 28, 2024, to add 120 mg and 150 mg dose groups. A single tumor lesion amenable to intratumoral injection will be selected, regardless of tumor size, number, or location. The drug should be administered at the dose specified for the current dose cohort. The injection volume should be adjusted based on the size of the injected lesion.	CNSI-Fe(II) 60 mg n=4 Participants 60 mg CNSI-Fe(II) 60 mg: The trial comprises a treatment period, including the DLT evaluation period with a duration of 21 days, and a maintenance treatment period. If the subject completes DLT evaluation without intolerable toxicity, an additional dose may be administered based on the investigator's determination of the benefits outweighing the risks. The original protocol planned for three dose groups: 30 mg, 60 mg, and 90 mg. The protocol was amended on March 28, 2024, to add 120 mg and 150 mg dose groups. A single tumor lesion amenable to intratumoral injection will be selected, regardless of tumor size, number, or location. The drug should be administered at the dose specified for the current dose cohort. The injection volume should be adjusted based on the size of the injected lesion.	CNSI-Fe(II) 90 mg n=6 Participants 90 mg CNSI-Fe(II) 90 mg: The trial comprises a treatment period, including the DLT evaluation period with a duration of 21 days, and a maintenance treatment period. If the subject completes DLT evaluation without intolerable toxicity, an additional dose may be administered based on the investigator's determination of the benefits outweighing the risks. The original protocol planned for three dose groups: 30 mg, 60 mg, and 90 mg. The protocol was amended on March 28, 2024, to add 120 mg and 150 mg dose groups. A single tumor lesion amenable to intratumoral injection will be selected, regardless of tumor size, number, or location. The drug should be administered at the dose specified for the current dose cohort. The injection volume should be adjusted based on the size of the injected lesion.	CNSI-Fe(II) 120 mg n=3 Participants 120 mg CNSI-Fe(II) 120 mg: The dosing regimen is the same as that for the 30 mg, 60 mg, and 90 mg dose groups. Additionally, if a single lesion cannot accommodate the full corresponding dose of the investigational drug, additional lesions may be selected for simultaneous injection. When multiple lesions are injected, the drug distribution should be allocated proportionally according to the size of each lesion or determined based on the investigator's assessment of an appropriate distribution.	CNSI-Fe(II) 150 mg n=3 Participants 150 mg CNSI-Fe(II) 150 mg: The dosing regimen is the same as that for the 30 mg, 60 mg, and 90 mg dose groups. Additionally, if a single lesion cannot accommodate the full corresponding dose of the investigational drug, additional lesions may be selected for simultaneous injection. When multiple lesions are injected, the drug distribution should be allocated proportionally according to the size of each lesion or determined based on the investigator's assessment of an appropriate distribution.
PK Parameters Assessment: Serum Iron Concentration at 72 h of First Dosage	0.00 concentration (ng/mL) Standard Deviation 0.00	0.00 concentration (ng/mL) Standard Deviation 0.00	0.00 concentration (ng/mL) Standard Deviation 0.00	0.00 concentration (ng/mL) Standard Deviation 0.00	0.00 concentration (ng/mL) Standard Deviation 0.00

SECONDARY outcome

Timeframe: 1 h (of a time frame of 72 h) before second dosage (22~35 days after first dosing. For patient in 30 mg group, 23 days; for patients in 60 mg group, 26 and 22 days; for patients in 90 mg group, 23, 35 and 28 days; for patient in 120 mg group, 28 days.)

Population: The number of patients receiving the second dose in the 30 mg, 60 mg, 90 mg, 120 mg, and 150 mg dose groups was: 1, 2, 3, 1, and 0, respectively.

This secondary outcome measure focuses on assessing the pharmacokinetic (PK) profile of CNSI-Fe(II) in patients with advanced solid tumors. Assessment Details: PK Parameters Assessment: This assessment involves the analysis of the drug's absorption, distribution, metabolism, and excretion (ADME) in patients. It will provide insights into how CNSI-Fe(II) behaves in the human body. The fifth assessed parameter is serum iron concentration. Serum iron concentration at -1 h of second dosage: The number of patients receiving the second dose in the 30 mg, 60 mg, 90 mg, 120 mg, and 150 mg dose groups was: 1, 2, 3, 1, and 0, respectively. Due to the requirement for mean ± SD data presentation, the number of evaluable subjects in 30 mg, 120 mg, 150 mg groups was fewer than two, making SD calculation impossible. Units of Measure: Nanograms per milliliter (ng/mL) (serum iron ion concentrations changes from baseline)

Outcome measures

Outcome measures
Measure	CNSI-Fe(II) 30 mg n=2 Participants 30 mg CNSI-Fe(II) 30 mg: The trial comprises a treatment period, including the DLT evaluation period with a duration of 21 days, and a maintenance treatment period. If the subject completes DLT evaluation without intolerable toxicity, an additional dose may be administered based on the investigator's determination of the benefits outweighing the risks. The original protocol planned for three dose groups: 30 mg, 60 mg, and 90 mg. The protocol was amended on March 28, 2024, to add 120 mg and 150 mg dose groups. A single tumor lesion amenable to intratumoral injection will be selected, regardless of tumor size, number, or location. The drug should be administered at the dose specified for the current dose cohort. The injection volume should be adjusted based on the size of the injected lesion.	CNSI-Fe(II) 60 mg n=3 Participants 60 mg CNSI-Fe(II) 60 mg: The trial comprises a treatment period, including the DLT evaluation period with a duration of 21 days, and a maintenance treatment period. If the subject completes DLT evaluation without intolerable toxicity, an additional dose may be administered based on the investigator's determination of the benefits outweighing the risks. The original protocol planned for three dose groups: 30 mg, 60 mg, and 90 mg. The protocol was amended on March 28, 2024, to add 120 mg and 150 mg dose groups. A single tumor lesion amenable to intratumoral injection will be selected, regardless of tumor size, number, or location. The drug should be administered at the dose specified for the current dose cohort. The injection volume should be adjusted based on the size of the injected lesion.	CNSI-Fe(II) 90 mg 90 mg CNSI-Fe(II) 90 mg: The trial comprises a treatment period, including the DLT evaluation period with a duration of 21 days, and a maintenance treatment period. If the subject completes DLT evaluation without intolerable toxicity, an additional dose may be administered based on the investigator's determination of the benefits outweighing the risks. The original protocol planned for three dose groups: 30 mg, 60 mg, and 90 mg. The protocol was amended on March 28, 2024, to add 120 mg and 150 mg dose groups. A single tumor lesion amenable to intratumoral injection will be selected, regardless of tumor size, number, or location. The drug should be administered at the dose specified for the current dose cohort. The injection volume should be adjusted based on the size of the injected lesion.	CNSI-Fe(II) 120 mg 120 mg CNSI-Fe(II) 120 mg: The dosing regimen is the same as that for the 30 mg, 60 mg, and 90 mg dose groups. Additionally, if a single lesion cannot accommodate the full corresponding dose of the investigational drug, additional lesions may be selected for simultaneous injection. When multiple lesions are injected, the drug distribution should be allocated proportionally according to the size of each lesion or determined based on the investigator's assessment of an appropriate distribution.	CNSI-Fe(II) 150 mg 150 mg CNSI-Fe(II) 150 mg: The dosing regimen is the same as that for the 30 mg, 60 mg, and 90 mg dose groups. Additionally, if a single lesion cannot accommodate the full corresponding dose of the investigational drug, additional lesions may be selected for simultaneous injection. When multiple lesions are injected, the drug distribution should be allocated proportionally according to the size of each lesion or determined based on the investigator's assessment of an appropriate distribution.
PK Parameters Assessment: Serum Iron Concentration at 1 h Before Second Dosage	0.00 concentration (ng/mL) Standard Deviation 0.00	0.00 concentration (ng/mL) Standard Deviation 0.00	—	—	—

SECONDARY outcome

Timeframe: at 5 min (of a time frame of 72 h) of second dosage (22~35 days after first dosing. For patient in 30 mg group, 23 days; for patients in 60 mg group, 26 and 22 days; for patients in 90 mg group, 23, 35 and 28 days; for patient in 120 mg group, 28 days.)

Population: The number of patients receiving the second dose in the 30 mg, 60 mg, 90 mg, 120 mg, and 150 mg dose groups was: 1, 2, 3, 1, and 0, respectively.

This secondary outcome measure focuses on assessing the pharmacokinetic (PK) profile of CNSI-Fe(II) in patients with advanced solid tumors. Assessment Details: PK Parameters Assessment: This assessment involves the analysis of the drug's absorption, distribution, metabolism, and excretion (ADME) in patients. It will provide insights into how CNSI-Fe(II) behaves in the human body. The fifth assessed parameter is serum iron concentration. Serum iron concentration at 5 min of first dosage: The number of patients receiving the second dose in the 30 mg, 60 mg, 90 mg, 120 mg, and 150 mg dose groups was: 1, 2, 3, 1, and 0, respectively. Due to the requirement for mean ± SD data presentation, the number of evaluable subjects in 30 mg, 120 mg, 150 mg groups was fewer than two, making SD calculation impossible. Units of Measure: Nanograms per milliliter (ng/mL) (serum iron ion concentrations changes from baseline)

Outcome measures

Outcome measures
Measure	CNSI-Fe(II) 30 mg n=2 Participants 30 mg CNSI-Fe(II) 30 mg: The trial comprises a treatment period, including the DLT evaluation period with a duration of 21 days, and a maintenance treatment period. If the subject completes DLT evaluation without intolerable toxicity, an additional dose may be administered based on the investigator's determination of the benefits outweighing the risks. The original protocol planned for three dose groups: 30 mg, 60 mg, and 90 mg. The protocol was amended on March 28, 2024, to add 120 mg and 150 mg dose groups. A single tumor lesion amenable to intratumoral injection will be selected, regardless of tumor size, number, or location. The drug should be administered at the dose specified for the current dose cohort. The injection volume should be adjusted based on the size of the injected lesion.	CNSI-Fe(II) 60 mg n=3 Participants 60 mg CNSI-Fe(II) 60 mg: The trial comprises a treatment period, including the DLT evaluation period with a duration of 21 days, and a maintenance treatment period. If the subject completes DLT evaluation without intolerable toxicity, an additional dose may be administered based on the investigator's determination of the benefits outweighing the risks. The original protocol planned for three dose groups: 30 mg, 60 mg, and 90 mg. The protocol was amended on March 28, 2024, to add 120 mg and 150 mg dose groups. A single tumor lesion amenable to intratumoral injection will be selected, regardless of tumor size, number, or location. The drug should be administered at the dose specified for the current dose cohort. The injection volume should be adjusted based on the size of the injected lesion.	CNSI-Fe(II) 90 mg 90 mg CNSI-Fe(II) 90 mg: The trial comprises a treatment period, including the DLT evaluation period with a duration of 21 days, and a maintenance treatment period. If the subject completes DLT evaluation without intolerable toxicity, an additional dose may be administered based on the investigator's determination of the benefits outweighing the risks. The original protocol planned for three dose groups: 30 mg, 60 mg, and 90 mg. The protocol was amended on March 28, 2024, to add 120 mg and 150 mg dose groups. A single tumor lesion amenable to intratumoral injection will be selected, regardless of tumor size, number, or location. The drug should be administered at the dose specified for the current dose cohort. The injection volume should be adjusted based on the size of the injected lesion.	CNSI-Fe(II) 120 mg 120 mg CNSI-Fe(II) 120 mg: The dosing regimen is the same as that for the 30 mg, 60 mg, and 90 mg dose groups. Additionally, if a single lesion cannot accommodate the full corresponding dose of the investigational drug, additional lesions may be selected for simultaneous injection. When multiple lesions are injected, the drug distribution should be allocated proportionally according to the size of each lesion or determined based on the investigator's assessment of an appropriate distribution.	CNSI-Fe(II) 150 mg 150 mg CNSI-Fe(II) 150 mg: The dosing regimen is the same as that for the 30 mg, 60 mg, and 90 mg dose groups. Additionally, if a single lesion cannot accommodate the full corresponding dose of the investigational drug, additional lesions may be selected for simultaneous injection. When multiple lesions are injected, the drug distribution should be allocated proportionally according to the size of each lesion or determined based on the investigator's assessment of an appropriate distribution.
PK Parameters Assessment: Serum Iron Concentration at 5 Min of Second Dosage	3371.50 concentration (ng/mL) Standard Deviation 296.28	8478.67 concentration (ng/mL) Standard Deviation 8787.13	—	—	—

SECONDARY outcome

Timeframe: at 10 min (of a time frame of 72 h) of second dosage (22~35 days after first dosing. For patient in 30 mg group, 23 days; for patients in 60 mg group, 26 and 22 days; for patients in 90 mg group, 23, 35 and 28 days; for patient in 120 mg group, 28 days.)

Population: The number of patients receiving the second dose in the 30 mg, 60 mg, 90 mg, 120 mg, and 150 mg dose groups was: 1, 2, 3, 1, and 0, respectively.

This secondary outcome measure focuses on assessing the pharmacokinetic (PK) profile of CNSI-Fe(II) in patients with advanced solid tumors. Assessment Details: PK Parameters Assessment: This assessment involves the analysis of the drug's absorption, distribution, metabolism, and excretion (ADME) in patients. It will provide insights into how CNSI-Fe(II) behaves in the human body. The fifth assessed parameter is serum iron concentration. Serum iron concentration at 10 min of first dosage: The number of patients receiving the second dose in the 30 mg, 60 mg, 90 mg, 120 mg, and 150 mg dose groups was: 1, 2, 3, 1, and 0, respectively. Due to the requirement for mean ± SD data presentation, the number of evaluable subjects in 30 mg, 120 mg, 150 mg groups was fewer than two, making SD calculation impossible. Units of Measure: Nanograms per milliliter (ng/mL) (serum iron ion concentrations changes from baseline)

Outcome measures

Outcome measures
Measure	CNSI-Fe(II) 30 mg n=2 Participants 30 mg CNSI-Fe(II) 30 mg: The trial comprises a treatment period, including the DLT evaluation period with a duration of 21 days, and a maintenance treatment period. If the subject completes DLT evaluation without intolerable toxicity, an additional dose may be administered based on the investigator's determination of the benefits outweighing the risks. The original protocol planned for three dose groups: 30 mg, 60 mg, and 90 mg. The protocol was amended on March 28, 2024, to add 120 mg and 150 mg dose groups. A single tumor lesion amenable to intratumoral injection will be selected, regardless of tumor size, number, or location. The drug should be administered at the dose specified for the current dose cohort. The injection volume should be adjusted based on the size of the injected lesion.	CNSI-Fe(II) 60 mg n=3 Participants 60 mg CNSI-Fe(II) 60 mg: The trial comprises a treatment period, including the DLT evaluation period with a duration of 21 days, and a maintenance treatment period. If the subject completes DLT evaluation without intolerable toxicity, an additional dose may be administered based on the investigator's determination of the benefits outweighing the risks. The original protocol planned for three dose groups: 30 mg, 60 mg, and 90 mg. The protocol was amended on March 28, 2024, to add 120 mg and 150 mg dose groups. A single tumor lesion amenable to intratumoral injection will be selected, regardless of tumor size, number, or location. The drug should be administered at the dose specified for the current dose cohort. The injection volume should be adjusted based on the size of the injected lesion.	CNSI-Fe(II) 90 mg 90 mg CNSI-Fe(II) 90 mg: The trial comprises a treatment period, including the DLT evaluation period with a duration of 21 days, and a maintenance treatment period. If the subject completes DLT evaluation without intolerable toxicity, an additional dose may be administered based on the investigator's determination of the benefits outweighing the risks. The original protocol planned for three dose groups: 30 mg, 60 mg, and 90 mg. The protocol was amended on March 28, 2024, to add 120 mg and 150 mg dose groups. A single tumor lesion amenable to intratumoral injection will be selected, regardless of tumor size, number, or location. The drug should be administered at the dose specified for the current dose cohort. The injection volume should be adjusted based on the size of the injected lesion.	CNSI-Fe(II) 120 mg 120 mg CNSI-Fe(II) 120 mg: The dosing regimen is the same as that for the 30 mg, 60 mg, and 90 mg dose groups. Additionally, if a single lesion cannot accommodate the full corresponding dose of the investigational drug, additional lesions may be selected for simultaneous injection. When multiple lesions are injected, the drug distribution should be allocated proportionally according to the size of each lesion or determined based on the investigator's assessment of an appropriate distribution.	CNSI-Fe(II) 150 mg 150 mg CNSI-Fe(II) 150 mg: The dosing regimen is the same as that for the 30 mg, 60 mg, and 90 mg dose groups. Additionally, if a single lesion cannot accommodate the full corresponding dose of the investigational drug, additional lesions may be selected for simultaneous injection. When multiple lesions are injected, the drug distribution should be allocated proportionally according to the size of each lesion or determined based on the investigator's assessment of an appropriate distribution.
PK Parameters Assessment: Serum Iron Concentration at 10 Min of Second Dosage	3060.00 concentration (ng/mL) Standard Deviation 93.34	7695.67 concentration (ng/mL) Standard Deviation 8297.76	—	—	—

SECONDARY outcome

Timeframe: at 15 min (of a time frame of 72 h) of second dosage (22~35 days after first dosing. For patient in 30 mg group, 23 days; for patients in 60 mg group, 26 and 22 days; for patients in 90 mg group, 23, 35 and 28 days; for patient in 120 mg group, 28 days.)

Population: The number of patients receiving the second dose in the 30 mg, 60 mg, 90 mg, 120 mg, and 150 mg dose groups was: 1, 2, 3, 1, and 0, respectively.

This secondary outcome measure focuses on assessing the pharmacokinetic (PK) profile of CNSI-Fe(II) in patients with advanced solid tumors. Assessment Details: PK Parameters Assessment: This assessment involves the analysis of the drug's absorption, distribution, metabolism, and excretion (ADME) in patients. It will provide insights into how CNSI-Fe(II) behaves in the human body. The fifth assessed parameter is serum iron concentration. Serum iron concentration at 15 min of first dosage: The number of patients receiving the second dose in the 30 mg, 60 mg, 90 mg, 120 mg, and 150 mg dose groups was: 1, 2, 3, 1, and 0, respectively. Due to the requirement for mean ± SD data presentation, the number of evaluable subjects in 30 mg, 120 mg, 150 mg groups was fewer than two, making SD calculation impossible. Units of Measure: Nanograms per milliliter (ng/mL) (serum iron ion concentrations changes from baseline)

Outcome measures

Outcome measures
Measure	CNSI-Fe(II) 30 mg n=2 Participants 30 mg CNSI-Fe(II) 30 mg: The trial comprises a treatment period, including the DLT evaluation period with a duration of 21 days, and a maintenance treatment period. If the subject completes DLT evaluation without intolerable toxicity, an additional dose may be administered based on the investigator's determination of the benefits outweighing the risks. The original protocol planned for three dose groups: 30 mg, 60 mg, and 90 mg. The protocol was amended on March 28, 2024, to add 120 mg and 150 mg dose groups. A single tumor lesion amenable to intratumoral injection will be selected, regardless of tumor size, number, or location. The drug should be administered at the dose specified for the current dose cohort. The injection volume should be adjusted based on the size of the injected lesion.	CNSI-Fe(II) 60 mg n=3 Participants 60 mg CNSI-Fe(II) 60 mg: The trial comprises a treatment period, including the DLT evaluation period with a duration of 21 days, and a maintenance treatment period. If the subject completes DLT evaluation without intolerable toxicity, an additional dose may be administered based on the investigator's determination of the benefits outweighing the risks. The original protocol planned for three dose groups: 30 mg, 60 mg, and 90 mg. The protocol was amended on March 28, 2024, to add 120 mg and 150 mg dose groups. A single tumor lesion amenable to intratumoral injection will be selected, regardless of tumor size, number, or location. The drug should be administered at the dose specified for the current dose cohort. The injection volume should be adjusted based on the size of the injected lesion.	CNSI-Fe(II) 90 mg 90 mg CNSI-Fe(II) 90 mg: The trial comprises a treatment period, including the DLT evaluation period with a duration of 21 days, and a maintenance treatment period. If the subject completes DLT evaluation without intolerable toxicity, an additional dose may be administered based on the investigator's determination of the benefits outweighing the risks. The original protocol planned for three dose groups: 30 mg, 60 mg, and 90 mg. The protocol was amended on March 28, 2024, to add 120 mg and 150 mg dose groups. A single tumor lesion amenable to intratumoral injection will be selected, regardless of tumor size, number, or location. The drug should be administered at the dose specified for the current dose cohort. The injection volume should be adjusted based on the size of the injected lesion.	CNSI-Fe(II) 120 mg 120 mg CNSI-Fe(II) 120 mg: The dosing regimen is the same as that for the 30 mg, 60 mg, and 90 mg dose groups. Additionally, if a single lesion cannot accommodate the full corresponding dose of the investigational drug, additional lesions may be selected for simultaneous injection. When multiple lesions are injected, the drug distribution should be allocated proportionally according to the size of each lesion or determined based on the investigator's assessment of an appropriate distribution.	CNSI-Fe(II) 150 mg 150 mg CNSI-Fe(II) 150 mg: The dosing regimen is the same as that for the 30 mg, 60 mg, and 90 mg dose groups. Additionally, if a single lesion cannot accommodate the full corresponding dose of the investigational drug, additional lesions may be selected for simultaneous injection. When multiple lesions are injected, the drug distribution should be allocated proportionally according to the size of each lesion or determined based on the investigator's assessment of an appropriate distribution.
PK Parameters Assessment: Serum Iron Concentration at 15 Min of Second Dosage	2869.50 concentration (ng/mL) Standard Deviation 91.22	7485.00 concentration (ng/mL) Standard Deviation 7915.82	—	—	—

SECONDARY outcome

Timeframe: at 30 min (of a time frame of 72 h) of second dosage (22~35 days after first dosing. For patient in 30 mg group, 23 days; for patients in 60 mg group, 26 and 22 days; for patients in 90 mg group, 23, 35 and 28 days; for patient in 120 mg group, 28 days.)

Population: The number of patients receiving the second dose in the 30 mg, 60 mg, 90 mg, 120 mg, and 150 mg dose groups was: 1, 2, 3, 1, and 0, respectively.

This secondary outcome measure focuses on assessing the pharmacokinetic (PK) profile of CNSI-Fe(II) in patients with advanced solid tumors. Assessment Details: PK Parameters Assessment: This assessment involves the analysis of the drug's absorption, distribution, metabolism, and excretion (ADME) in patients. It will provide insights into how CNSI-Fe(II) behaves in the human body. The fifth assessed parameter is serum iron concentration. Serum iron concentration at 30 min of first dosage: The number of patients receiving the second dose in the 30 mg, 60 mg, 90 mg, 120 mg, and 150 mg dose groups was: 1, 2, 3, 1, and 0, respectively. Due to the requirement for mean ± SD data presentation, the number of evaluable subjects in 30 mg, 120 mg, 150 mg groups was fewer than two, making SD calculation impossible. Units of Measure: Nanograms per milliliter (ng/mL) (serum iron ion concentrations changes from baseline)

Outcome measures

Outcome measures
Measure	CNSI-Fe(II) 30 mg n=2 Participants 30 mg CNSI-Fe(II) 30 mg: The trial comprises a treatment period, including the DLT evaluation period with a duration of 21 days, and a maintenance treatment period. If the subject completes DLT evaluation without intolerable toxicity, an additional dose may be administered based on the investigator's determination of the benefits outweighing the risks. The original protocol planned for three dose groups: 30 mg, 60 mg, and 90 mg. The protocol was amended on March 28, 2024, to add 120 mg and 150 mg dose groups. A single tumor lesion amenable to intratumoral injection will be selected, regardless of tumor size, number, or location. The drug should be administered at the dose specified for the current dose cohort. The injection volume should be adjusted based on the size of the injected lesion.	CNSI-Fe(II) 60 mg n=3 Participants 60 mg CNSI-Fe(II) 60 mg: The trial comprises a treatment period, including the DLT evaluation period with a duration of 21 days, and a maintenance treatment period. If the subject completes DLT evaluation without intolerable toxicity, an additional dose may be administered based on the investigator's determination of the benefits outweighing the risks. The original protocol planned for three dose groups: 30 mg, 60 mg, and 90 mg. The protocol was amended on March 28, 2024, to add 120 mg and 150 mg dose groups. A single tumor lesion amenable to intratumoral injection will be selected, regardless of tumor size, number, or location. The drug should be administered at the dose specified for the current dose cohort. The injection volume should be adjusted based on the size of the injected lesion.	CNSI-Fe(II) 90 mg 90 mg CNSI-Fe(II) 90 mg: The trial comprises a treatment period, including the DLT evaluation period with a duration of 21 days, and a maintenance treatment period. If the subject completes DLT evaluation without intolerable toxicity, an additional dose may be administered based on the investigator's determination of the benefits outweighing the risks. The original protocol planned for three dose groups: 30 mg, 60 mg, and 90 mg. The protocol was amended on March 28, 2024, to add 120 mg and 150 mg dose groups. A single tumor lesion amenable to intratumoral injection will be selected, regardless of tumor size, number, or location. The drug should be administered at the dose specified for the current dose cohort. The injection volume should be adjusted based on the size of the injected lesion.	CNSI-Fe(II) 120 mg 120 mg CNSI-Fe(II) 120 mg: The dosing regimen is the same as that for the 30 mg, 60 mg, and 90 mg dose groups. Additionally, if a single lesion cannot accommodate the full corresponding dose of the investigational drug, additional lesions may be selected for simultaneous injection. When multiple lesions are injected, the drug distribution should be allocated proportionally according to the size of each lesion or determined based on the investigator's assessment of an appropriate distribution.	CNSI-Fe(II) 150 mg 150 mg CNSI-Fe(II) 150 mg: The dosing regimen is the same as that for the 30 mg, 60 mg, and 90 mg dose groups. Additionally, if a single lesion cannot accommodate the full corresponding dose of the investigational drug, additional lesions may be selected for simultaneous injection. When multiple lesions are injected, the drug distribution should be allocated proportionally according to the size of each lesion or determined based on the investigator's assessment of an appropriate distribution.
PK Parameters Assessment: Serum Iron Concentration at 30 Min of Second Dosage	2724.00 concentration (ng/mL) Standard Deviation 209.30	6082.33 concentration (ng/mL) Standard Deviation 6471.97	—	—	—

SECONDARY outcome

Timeframe: at 1 h (of a time frame of 72 h) of second dosage (22~35 days after first dosing. For patient in 30 mg group, 23 days; for patients in 60 mg group, 26 and 22 days; for patients in 90 mg group, 23, 35 and 28 days; for patient in 120 mg group, 28 days.)

Population: The number of patients receiving the second dose in the 30 mg, 60 mg, 90 mg, 120 mg, and 150 mg dose groups was: 1, 2, 3, 1, and 0, respectively.

This secondary outcome measure focuses on assessing the pharmacokinetic (PK) profile of CNSI-Fe(II) in patients with advanced solid tumors. Assessment Details: PK Parameters Assessment: This assessment involves the analysis of the drug's absorption, distribution, metabolism, and excretion (ADME) in patients. It will provide insights into how CNSI-Fe(II) behaves in the human body. The fifth assessed parameter is serum iron concentration. Serum iron concentration at 1 h of first dosage: The number of patients receiving the second dose in the 30 mg, 60 mg, 90 mg, 120 mg, and 150 mg dose groups was: 1, 2, 3, 1, and 0, respectively. Due to the requirement for mean ± SD data presentation, the number of evaluable subjects in 30 mg, 120 mg, 150 mg groups was fewer than two, making SD calculation impossible. Units of Measure: Nanograms per milliliter (ng/mL) (serum iron ion concentrations changes from baseline)

Outcome measures

Outcome measures
Measure	CNSI-Fe(II) 30 mg n=2 Participants 30 mg CNSI-Fe(II) 30 mg: The trial comprises a treatment period, including the DLT evaluation period with a duration of 21 days, and a maintenance treatment period. If the subject completes DLT evaluation without intolerable toxicity, an additional dose may be administered based on the investigator's determination of the benefits outweighing the risks. The original protocol planned for three dose groups: 30 mg, 60 mg, and 90 mg. The protocol was amended on March 28, 2024, to add 120 mg and 150 mg dose groups. A single tumor lesion amenable to intratumoral injection will be selected, regardless of tumor size, number, or location. The drug should be administered at the dose specified for the current dose cohort. The injection volume should be adjusted based on the size of the injected lesion.	CNSI-Fe(II) 60 mg n=3 Participants 60 mg CNSI-Fe(II) 60 mg: The trial comprises a treatment period, including the DLT evaluation period with a duration of 21 days, and a maintenance treatment period. If the subject completes DLT evaluation without intolerable toxicity, an additional dose may be administered based on the investigator's determination of the benefits outweighing the risks. The original protocol planned for three dose groups: 30 mg, 60 mg, and 90 mg. The protocol was amended on March 28, 2024, to add 120 mg and 150 mg dose groups. A single tumor lesion amenable to intratumoral injection will be selected, regardless of tumor size, number, or location. The drug should be administered at the dose specified for the current dose cohort. The injection volume should be adjusted based on the size of the injected lesion.	CNSI-Fe(II) 90 mg 90 mg CNSI-Fe(II) 90 mg: The trial comprises a treatment period, including the DLT evaluation period with a duration of 21 days, and a maintenance treatment period. If the subject completes DLT evaluation without intolerable toxicity, an additional dose may be administered based on the investigator's determination of the benefits outweighing the risks. The original protocol planned for three dose groups: 30 mg, 60 mg, and 90 mg. The protocol was amended on March 28, 2024, to add 120 mg and 150 mg dose groups. A single tumor lesion amenable to intratumoral injection will be selected, regardless of tumor size, number, or location. The drug should be administered at the dose specified for the current dose cohort. The injection volume should be adjusted based on the size of the injected lesion.	CNSI-Fe(II) 120 mg 120 mg CNSI-Fe(II) 120 mg: The dosing regimen is the same as that for the 30 mg, 60 mg, and 90 mg dose groups. Additionally, if a single lesion cannot accommodate the full corresponding dose of the investigational drug, additional lesions may be selected for simultaneous injection. When multiple lesions are injected, the drug distribution should be allocated proportionally according to the size of each lesion or determined based on the investigator's assessment of an appropriate distribution.	CNSI-Fe(II) 150 mg 150 mg CNSI-Fe(II) 150 mg: The dosing regimen is the same as that for the 30 mg, 60 mg, and 90 mg dose groups. Additionally, if a single lesion cannot accommodate the full corresponding dose of the investigational drug, additional lesions may be selected for simultaneous injection. When multiple lesions are injected, the drug distribution should be allocated proportionally according to the size of each lesion or determined based on the investigator's assessment of an appropriate distribution.
PK Parameters Assessment: Serum Iron Concentration at 1 h of Second Dosage	2140.50 concentration (ng/mL) Standard Deviation 156.27	4873.67 concentration (ng/mL) Standard Deviation 4808.39	—	—	—

SECONDARY outcome

Timeframe: at 2 h (of a time frame of 72 h) of second dosage (22~35 days after first dosing. For patient in 30 mg group, 23 days; for patients in 60 mg group, 26 and 22 days; for patients in 90 mg group, 23, 35 and 28 days; for patient in 120 mg group, 28 days.)

Population: The number of patients receiving the second dose in the 30 mg, 60 mg, 90 mg, 120 mg, and 150 mg dose groups was: 1, 2, 3, 1, and 0, respectively.

This secondary outcome measure focuses on assessing the pharmacokinetic (PK) profile of CNSI-Fe(II) in patients with advanced solid tumors. Assessment Details: PK Parameters Assessment: This assessment involves the analysis of the drug's absorption, distribution, metabolism, and excretion (ADME) in patients. It will provide insights into how CNSI-Fe(II) behaves in the human body. The fifth assessed parameter is serum iron concentration. Serum iron concentration at 2 h of first dosage: The number of patients receiving the second dose in the 30 mg, 60 mg, 90 mg, 120 mg, and 150 mg dose groups was: 1, 2, 3, 1, and 0, respectively. Due to the requirement for mean ± SD data presentation, the number of evaluable subjects in 30 mg, 120 mg, 150 mg groups was fewer than two, making SD calculation impossible. Units of Measure: Nanograms per milliliter (ng/mL) (serum iron ion concentrations changes from baseline)

Outcome measures

Outcome measures
Measure	CNSI-Fe(II) 30 mg n=2 Participants 30 mg CNSI-Fe(II) 30 mg: The trial comprises a treatment period, including the DLT evaluation period with a duration of 21 days, and a maintenance treatment period. If the subject completes DLT evaluation without intolerable toxicity, an additional dose may be administered based on the investigator's determination of the benefits outweighing the risks. The original protocol planned for three dose groups: 30 mg, 60 mg, and 90 mg. The protocol was amended on March 28, 2024, to add 120 mg and 150 mg dose groups. A single tumor lesion amenable to intratumoral injection will be selected, regardless of tumor size, number, or location. The drug should be administered at the dose specified for the current dose cohort. The injection volume should be adjusted based on the size of the injected lesion.	CNSI-Fe(II) 60 mg n=3 Participants 60 mg CNSI-Fe(II) 60 mg: The trial comprises a treatment period, including the DLT evaluation period with a duration of 21 days, and a maintenance treatment period. If the subject completes DLT evaluation without intolerable toxicity, an additional dose may be administered based on the investigator's determination of the benefits outweighing the risks. The original protocol planned for three dose groups: 30 mg, 60 mg, and 90 mg. The protocol was amended on March 28, 2024, to add 120 mg and 150 mg dose groups. A single tumor lesion amenable to intratumoral injection will be selected, regardless of tumor size, number, or location. The drug should be administered at the dose specified for the current dose cohort. The injection volume should be adjusted based on the size of the injected lesion.	CNSI-Fe(II) 90 mg 90 mg CNSI-Fe(II) 90 mg: The trial comprises a treatment period, including the DLT evaluation period with a duration of 21 days, and a maintenance treatment period. If the subject completes DLT evaluation without intolerable toxicity, an additional dose may be administered based on the investigator's determination of the benefits outweighing the risks. The original protocol planned for three dose groups: 30 mg, 60 mg, and 90 mg. The protocol was amended on March 28, 2024, to add 120 mg and 150 mg dose groups. A single tumor lesion amenable to intratumoral injection will be selected, regardless of tumor size, number, or location. The drug should be administered at the dose specified for the current dose cohort. The injection volume should be adjusted based on the size of the injected lesion.	CNSI-Fe(II) 120 mg 120 mg CNSI-Fe(II) 120 mg: The dosing regimen is the same as that for the 30 mg, 60 mg, and 90 mg dose groups. Additionally, if a single lesion cannot accommodate the full corresponding dose of the investigational drug, additional lesions may be selected for simultaneous injection. When multiple lesions are injected, the drug distribution should be allocated proportionally according to the size of each lesion or determined based on the investigator's assessment of an appropriate distribution.	CNSI-Fe(II) 150 mg 150 mg CNSI-Fe(II) 150 mg: The dosing regimen is the same as that for the 30 mg, 60 mg, and 90 mg dose groups. Additionally, if a single lesion cannot accommodate the full corresponding dose of the investigational drug, additional lesions may be selected for simultaneous injection. When multiple lesions are injected, the drug distribution should be allocated proportionally according to the size of each lesion or determined based on the investigator's assessment of an appropriate distribution.
PK Parameters Assessment: Serum Iron Concentration at 2 h of Second Dosage	2299.00 concentration (ng/mL) Standard Deviation 748.12	3637.67 concentration (ng/mL) Standard Deviation 3637.67	—	—	—

SECONDARY outcome

Timeframe: at 4 h (of a time frame of 72 h) of second dosage (22~35 days after first dosing. For patient in 30 mg group, 23 days; for patients in 60 mg group, 26 and 22 days; for patients in 90 mg group, 23, 35 and 28 days; for patient in 120 mg group, 28 days.)

Population: The number of patients receiving the second dose in the 30 mg, 60 mg, 90 mg, 120 mg, and 150 mg dose groups was: 1, 2, 3, 1, and 0, respectively.

This secondary outcome measure focuses on assessing the pharmacokinetic (PK) profile of CNSI-Fe(II) in patients with advanced solid tumors. Assessment Details: PK Parameters Assessment: This assessment involves the analysis of the drug's absorption, distribution, metabolism, and excretion (ADME) in patients. It will provide insights into how CNSI-Fe(II) behaves in the human body. The fifth assessed parameter is serum iron concentration. Serum iron concentration at 4 h of first dosage: The number of patients receiving the second dose in the 30 mg, 60 mg, 90 mg, 120 mg, and 150 mg dose groups was: 1, 2, 3, 1, and 0, respectively. Due to the requirement for mean ± SD data presentation, the number of evaluable subjects in 30 mg, 120 mg, 150 mg groups was fewer than two, making SD calculation impossible. Units of Measure: Nanograms per milliliter (ng/mL) (serum iron ion concentrations changes from baseline)

Outcome measures

Outcome measures
Measure	CNSI-Fe(II) 30 mg n=2 Participants 30 mg CNSI-Fe(II) 30 mg: The trial comprises a treatment period, including the DLT evaluation period with a duration of 21 days, and a maintenance treatment period. If the subject completes DLT evaluation without intolerable toxicity, an additional dose may be administered based on the investigator's determination of the benefits outweighing the risks. The original protocol planned for three dose groups: 30 mg, 60 mg, and 90 mg. The protocol was amended on March 28, 2024, to add 120 mg and 150 mg dose groups. A single tumor lesion amenable to intratumoral injection will be selected, regardless of tumor size, number, or location. The drug should be administered at the dose specified for the current dose cohort. The injection volume should be adjusted based on the size of the injected lesion.	CNSI-Fe(II) 60 mg n=3 Participants 60 mg CNSI-Fe(II) 60 mg: The trial comprises a treatment period, including the DLT evaluation period with a duration of 21 days, and a maintenance treatment period. If the subject completes DLT evaluation without intolerable toxicity, an additional dose may be administered based on the investigator's determination of the benefits outweighing the risks. The original protocol planned for three dose groups: 30 mg, 60 mg, and 90 mg. The protocol was amended on March 28, 2024, to add 120 mg and 150 mg dose groups. A single tumor lesion amenable to intratumoral injection will be selected, regardless of tumor size, number, or location. The drug should be administered at the dose specified for the current dose cohort. The injection volume should be adjusted based on the size of the injected lesion.	CNSI-Fe(II) 90 mg 90 mg CNSI-Fe(II) 90 mg: The trial comprises a treatment period, including the DLT evaluation period with a duration of 21 days, and a maintenance treatment period. If the subject completes DLT evaluation without intolerable toxicity, an additional dose may be administered based on the investigator's determination of the benefits outweighing the risks. The original protocol planned for three dose groups: 30 mg, 60 mg, and 90 mg. The protocol was amended on March 28, 2024, to add 120 mg and 150 mg dose groups. A single tumor lesion amenable to intratumoral injection will be selected, regardless of tumor size, number, or location. The drug should be administered at the dose specified for the current dose cohort. The injection volume should be adjusted based on the size of the injected lesion.	CNSI-Fe(II) 120 mg 120 mg CNSI-Fe(II) 120 mg: The dosing regimen is the same as that for the 30 mg, 60 mg, and 90 mg dose groups. Additionally, if a single lesion cannot accommodate the full corresponding dose of the investigational drug, additional lesions may be selected for simultaneous injection. When multiple lesions are injected, the drug distribution should be allocated proportionally according to the size of each lesion or determined based on the investigator's assessment of an appropriate distribution.	CNSI-Fe(II) 150 mg 150 mg CNSI-Fe(II) 150 mg: The dosing regimen is the same as that for the 30 mg, 60 mg, and 90 mg dose groups. Additionally, if a single lesion cannot accommodate the full corresponding dose of the investigational drug, additional lesions may be selected for simultaneous injection. When multiple lesions are injected, the drug distribution should be allocated proportionally according to the size of each lesion or determined based on the investigator's assessment of an appropriate distribution.
PK Parameters Assessment: Serum Iron Concentration at 4 h of Second Dosage	988.50 concentration (ng/mL) Standard Deviation 314.66	2246.67 concentration (ng/mL) Standard Deviation 2175.61	—	—	—

SECONDARY outcome

Timeframe: at 8 h (of a time frame of 72 h) of second dosage (22~35 days after first dosing. For patient in 30 mg group, 23 days; for patients in 60 mg group, 26 and 22 days; for patients in 90 mg group, 23, 35 and 28 days; for patient in 120 mg group, 28 days.)

Population: The number of patients receiving the second dose in the 30 mg, 60 mg, 90 mg, 120 mg, and 150 mg dose groups was: 1, 2, 3, 1, and 0, respectively.

This secondary outcome measure focuses on assessing the pharmacokinetic (PK) profile of CNSI-Fe(II) in patients with advanced solid tumors. Assessment Details: PK Parameters Assessment: This assessment involves the analysis of the drug's absorption, distribution, metabolism, and excretion (ADME) in patients. It will provide insights into how CNSI-Fe(II) behaves in the human body. The fifth assessed parameter is serum iron concentration. Serum iron concentration at 8 h of first dosage: The number of patients receiving the second dose in the 30 mg, 60 mg, 90 mg, 120 mg, and 150 mg dose groups was: 1, 2, 3, 1, and 0, respectively. Due to the requirement for mean ± SD data presentation, the number of evaluable subjects in 30 mg, 120 mg, 150 mg groups was fewer than two, making SD calculation impossible. Units of Measure: Nanograms per milliliter (ng/mL) (serum iron ion concentrations changes from baseline)

Outcome measures

Outcome measures
Measure	CNSI-Fe(II) 30 mg n=2 Participants 30 mg CNSI-Fe(II) 30 mg: The trial comprises a treatment period, including the DLT evaluation period with a duration of 21 days, and a maintenance treatment period. If the subject completes DLT evaluation without intolerable toxicity, an additional dose may be administered based on the investigator's determination of the benefits outweighing the risks. The original protocol planned for three dose groups: 30 mg, 60 mg, and 90 mg. The protocol was amended on March 28, 2024, to add 120 mg and 150 mg dose groups. A single tumor lesion amenable to intratumoral injection will be selected, regardless of tumor size, number, or location. The drug should be administered at the dose specified for the current dose cohort. The injection volume should be adjusted based on the size of the injected lesion.	CNSI-Fe(II) 60 mg n=3 Participants 60 mg CNSI-Fe(II) 60 mg: The trial comprises a treatment period, including the DLT evaluation period with a duration of 21 days, and a maintenance treatment period. If the subject completes DLT evaluation without intolerable toxicity, an additional dose may be administered based on the investigator's determination of the benefits outweighing the risks. The original protocol planned for three dose groups: 30 mg, 60 mg, and 90 mg. The protocol was amended on March 28, 2024, to add 120 mg and 150 mg dose groups. A single tumor lesion amenable to intratumoral injection will be selected, regardless of tumor size, number, or location. The drug should be administered at the dose specified for the current dose cohort. The injection volume should be adjusted based on the size of the injected lesion.	CNSI-Fe(II) 90 mg 90 mg CNSI-Fe(II) 90 mg: The trial comprises a treatment period, including the DLT evaluation period with a duration of 21 days, and a maintenance treatment period. If the subject completes DLT evaluation without intolerable toxicity, an additional dose may be administered based on the investigator's determination of the benefits outweighing the risks. The original protocol planned for three dose groups: 30 mg, 60 mg, and 90 mg. The protocol was amended on March 28, 2024, to add 120 mg and 150 mg dose groups. A single tumor lesion amenable to intratumoral injection will be selected, regardless of tumor size, number, or location. The drug should be administered at the dose specified for the current dose cohort. The injection volume should be adjusted based on the size of the injected lesion.	CNSI-Fe(II) 120 mg 120 mg CNSI-Fe(II) 120 mg: The dosing regimen is the same as that for the 30 mg, 60 mg, and 90 mg dose groups. Additionally, if a single lesion cannot accommodate the full corresponding dose of the investigational drug, additional lesions may be selected for simultaneous injection. When multiple lesions are injected, the drug distribution should be allocated proportionally according to the size of each lesion or determined based on the investigator's assessment of an appropriate distribution.	CNSI-Fe(II) 150 mg 150 mg CNSI-Fe(II) 150 mg: The dosing regimen is the same as that for the 30 mg, 60 mg, and 90 mg dose groups. Additionally, if a single lesion cannot accommodate the full corresponding dose of the investigational drug, additional lesions may be selected for simultaneous injection. When multiple lesions are injected, the drug distribution should be allocated proportionally according to the size of each lesion or determined based on the investigator's assessment of an appropriate distribution.
PK Parameters Assessment: Serum Iron Concentration at 8 h of Second Dosage	579.50 concentration (ng/mL) Standard Deviation 532.45	1637.33 concentration (ng/mL) Standard Deviation 1640.51	—	—	—

SECONDARY outcome

Timeframe: at 12 h (of a time frame of 72 h) of second dosage (22~35 days after first dosing. For patient in 30 mg group, 23 days; for patients in 60 mg group, 26 and 22 days; for patients in 90 mg group, 23, 35 and 28 days; for patient in 120 mg group, 28 days.)

Population: The number of patients receiving the second dose in the 30 mg, 60 mg, 90 mg, 120 mg, and 150 mg dose groups was: 1, 2, 3, 1, and 0, respectively.

This secondary outcome measure focuses on assessing the pharmacokinetic (PK) profile of CNSI-Fe(II) in patients with advanced solid tumors. Assessment Details: PK Parameters Assessment: This assessment involves the analysis of the drug's absorption, distribution, metabolism, and excretion (ADME) in patients. It will provide insights into how CNSI-Fe(II) behaves in the human body. The fifth assessed parameter is serum iron concentration. Serum iron concentration at 12 h of first dosage: The number of patients receiving the second dose in the 30 mg, 60 mg, 90 mg, 120 mg, and 150 mg dose groups was: 1, 2, 3, 1, and 0, respectively. Due to the requirement for mean ± SD data presentation, the number of evaluable subjects in 30 mg, 120 mg, 150 mg groups was fewer than two, making SD calculation impossible. Units of Measure: Nanograms per milliliter (ng/mL) (serum iron ion concentrations changes from baseline)

Outcome measures

Outcome measures
Measure	CNSI-Fe(II) 30 mg n=2 Participants 30 mg CNSI-Fe(II) 30 mg: The trial comprises a treatment period, including the DLT evaluation period with a duration of 21 days, and a maintenance treatment period. If the subject completes DLT evaluation without intolerable toxicity, an additional dose may be administered based on the investigator's determination of the benefits outweighing the risks. The original protocol planned for three dose groups: 30 mg, 60 mg, and 90 mg. The protocol was amended on March 28, 2024, to add 120 mg and 150 mg dose groups. A single tumor lesion amenable to intratumoral injection will be selected, regardless of tumor size, number, or location. The drug should be administered at the dose specified for the current dose cohort. The injection volume should be adjusted based on the size of the injected lesion.	CNSI-Fe(II) 60 mg n=3 Participants 60 mg CNSI-Fe(II) 60 mg: The trial comprises a treatment period, including the DLT evaluation period with a duration of 21 days, and a maintenance treatment period. If the subject completes DLT evaluation without intolerable toxicity, an additional dose may be administered based on the investigator's determination of the benefits outweighing the risks. The original protocol planned for three dose groups: 30 mg, 60 mg, and 90 mg. The protocol was amended on March 28, 2024, to add 120 mg and 150 mg dose groups. A single tumor lesion amenable to intratumoral injection will be selected, regardless of tumor size, number, or location. The drug should be administered at the dose specified for the current dose cohort. The injection volume should be adjusted based on the size of the injected lesion.	CNSI-Fe(II) 90 mg 90 mg CNSI-Fe(II) 90 mg: The trial comprises a treatment period, including the DLT evaluation period with a duration of 21 days, and a maintenance treatment period. If the subject completes DLT evaluation without intolerable toxicity, an additional dose may be administered based on the investigator's determination of the benefits outweighing the risks. The original protocol planned for three dose groups: 30 mg, 60 mg, and 90 mg. The protocol was amended on March 28, 2024, to add 120 mg and 150 mg dose groups. A single tumor lesion amenable to intratumoral injection will be selected, regardless of tumor size, number, or location. The drug should be administered at the dose specified for the current dose cohort. The injection volume should be adjusted based on the size of the injected lesion.	CNSI-Fe(II) 120 mg 120 mg CNSI-Fe(II) 120 mg: The dosing regimen is the same as that for the 30 mg, 60 mg, and 90 mg dose groups. Additionally, if a single lesion cannot accommodate the full corresponding dose of the investigational drug, additional lesions may be selected for simultaneous injection. When multiple lesions are injected, the drug distribution should be allocated proportionally according to the size of each lesion or determined based on the investigator's assessment of an appropriate distribution.	CNSI-Fe(II) 150 mg 150 mg CNSI-Fe(II) 150 mg: The dosing regimen is the same as that for the 30 mg, 60 mg, and 90 mg dose groups. Additionally, if a single lesion cannot accommodate the full corresponding dose of the investigational drug, additional lesions may be selected for simultaneous injection. When multiple lesions are injected, the drug distribution should be allocated proportionally according to the size of each lesion or determined based on the investigator's assessment of an appropriate distribution.
PK Parameters Assessment: Serum Iron Concentration at 12 h of Second Dosage	369.50 concentration (ng/mL) Standard Deviation 328.80	674.67 concentration (ng/mL) Standard Deviation 681.60	—	—	—

SECONDARY outcome

Timeframe: at 24 h (of a time frame of 72 h) of second dosage (22~35 days after first dosing. For patient in 30 mg group, 23 days; for patients in 60 mg group, 26 and 22 days; for patients in 90 mg group, 23, 35 and 28 days; for patient in 120 mg group, 28 days.)

Population: The number of patients receiving the second dose in the 30 mg, 60 mg, 90 mg, 120 mg, and 150 mg dose groups was: 1, 2, 3, 1, and 0, respectively.

This secondary outcome measure focuses on assessing the pharmacokinetic (PK) profile of CNSI-Fe(II) in patients with advanced solid tumors. Assessment Details: PK Parameters Assessment: This assessment involves the analysis of the drug's absorption, distribution, metabolism, and excretion (ADME) in patients. It will provide insights into how CNSI-Fe(II) behaves in the human body. The fifth assessed parameter is serum iron concentration. Serum iron concentration at 24 h of first dosage: The number of patients receiving the second dose in the 30 mg, 60 mg, 90 mg, 120 mg, and 150 mg dose groups was: 1, 2, 3, 1, and 0, respectively. Due to the requirement for mean ± SD data presentation, the number of evaluable subjects in 30 mg, 120 mg, 150 mg groups was fewer than two, making SD calculation impossible. Units of Measure: Nanograms per milliliter (ng/mL) (serum iron ion concentrations changes from baseline)

Outcome measures

Outcome measures
Measure	CNSI-Fe(II) 30 mg n=2 Participants 30 mg CNSI-Fe(II) 30 mg: The trial comprises a treatment period, including the DLT evaluation period with a duration of 21 days, and a maintenance treatment period. If the subject completes DLT evaluation without intolerable toxicity, an additional dose may be administered based on the investigator's determination of the benefits outweighing the risks. The original protocol planned for three dose groups: 30 mg, 60 mg, and 90 mg. The protocol was amended on March 28, 2024, to add 120 mg and 150 mg dose groups. A single tumor lesion amenable to intratumoral injection will be selected, regardless of tumor size, number, or location. The drug should be administered at the dose specified for the current dose cohort. The injection volume should be adjusted based on the size of the injected lesion.	CNSI-Fe(II) 60 mg n=3 Participants 60 mg CNSI-Fe(II) 60 mg: The trial comprises a treatment period, including the DLT evaluation period with a duration of 21 days, and a maintenance treatment period. If the subject completes DLT evaluation without intolerable toxicity, an additional dose may be administered based on the investigator's determination of the benefits outweighing the risks. The original protocol planned for three dose groups: 30 mg, 60 mg, and 90 mg. The protocol was amended on March 28, 2024, to add 120 mg and 150 mg dose groups. A single tumor lesion amenable to intratumoral injection will be selected, regardless of tumor size, number, or location. The drug should be administered at the dose specified for the current dose cohort. The injection volume should be adjusted based on the size of the injected lesion.	CNSI-Fe(II) 90 mg 90 mg CNSI-Fe(II) 90 mg: The trial comprises a treatment period, including the DLT evaluation period with a duration of 21 days, and a maintenance treatment period. If the subject completes DLT evaluation without intolerable toxicity, an additional dose may be administered based on the investigator's determination of the benefits outweighing the risks. The original protocol planned for three dose groups: 30 mg, 60 mg, and 90 mg. The protocol was amended on March 28, 2024, to add 120 mg and 150 mg dose groups. A single tumor lesion amenable to intratumoral injection will be selected, regardless of tumor size, number, or location. The drug should be administered at the dose specified for the current dose cohort. The injection volume should be adjusted based on the size of the injected lesion.	CNSI-Fe(II) 120 mg 120 mg CNSI-Fe(II) 120 mg: The dosing regimen is the same as that for the 30 mg, 60 mg, and 90 mg dose groups. Additionally, if a single lesion cannot accommodate the full corresponding dose of the investigational drug, additional lesions may be selected for simultaneous injection. When multiple lesions are injected, the drug distribution should be allocated proportionally according to the size of each lesion or determined based on the investigator's assessment of an appropriate distribution.	CNSI-Fe(II) 150 mg 150 mg CNSI-Fe(II) 150 mg: The dosing regimen is the same as that for the 30 mg, 60 mg, and 90 mg dose groups. Additionally, if a single lesion cannot accommodate the full corresponding dose of the investigational drug, additional lesions may be selected for simultaneous injection. When multiple lesions are injected, the drug distribution should be allocated proportionally according to the size of each lesion or determined based on the investigator's assessment of an appropriate distribution.
PK Parameters Assessment: Serum Iron Concentration at 24 h of Second Dosage	0.00 concentration (ng/mL) Standard Deviation 0.00	27.00 concentration (ng/mL) Standard Deviation 46.77	—	—	—

SECONDARY outcome

Timeframe: at 48 h (of a time frame of 72 h) of second dosage (22~35 days after first dosing. For patient in 30 mg group, 23 days; for patients in 60 mg group, 26 and 22 days; for patients in 90 mg group, 23, 35 and 28 days; for patient in 120 mg group, 28 days.)

Population: The number of patients receiving the second dose in the 30 mg, 60 mg, 90 mg, 120 mg, and 150 mg dose groups was: 1, 2, 3, 1, and 0, respectively.

This secondary outcome measure focuses on assessing the pharmacokinetic (PK) profile of CNSI-Fe(II) in patients with advanced solid tumors. Assessment Details: PK Parameters Assessment: This assessment involves the analysis of the drug's absorption, distribution, metabolism, and excretion (ADME) in patients. It will provide insights into how CNSI-Fe(II) behaves in the human body. The fifth assessed parameter is serum iron concentration. Serum iron concentration at 48 h of first dosage: The number of patients receiving the second dose in the 30 mg, 60 mg, 90 mg, 120 mg, and 150 mg dose groups was: 1, 2, 3, 1, and 0, respectively. Due to the requirement for mean ± SD data presentation, the number of evaluable subjects in 30 mg, 120 mg, 150 mg groups was fewer than two, making SD calculation impossible. Units of Measure: Nanograms per milliliter (ng/mL) (serum iron ion concentrations changes from baseline)

Outcome measures

Outcome measures
Measure	CNSI-Fe(II) 30 mg n=2 Participants 30 mg CNSI-Fe(II) 30 mg: The trial comprises a treatment period, including the DLT evaluation period with a duration of 21 days, and a maintenance treatment period. If the subject completes DLT evaluation without intolerable toxicity, an additional dose may be administered based on the investigator's determination of the benefits outweighing the risks. The original protocol planned for three dose groups: 30 mg, 60 mg, and 90 mg. The protocol was amended on March 28, 2024, to add 120 mg and 150 mg dose groups. A single tumor lesion amenable to intratumoral injection will be selected, regardless of tumor size, number, or location. The drug should be administered at the dose specified for the current dose cohort. The injection volume should be adjusted based on the size of the injected lesion.	CNSI-Fe(II) 60 mg n=3 Participants 60 mg CNSI-Fe(II) 60 mg: The trial comprises a treatment period, including the DLT evaluation period with a duration of 21 days, and a maintenance treatment period. If the subject completes DLT evaluation without intolerable toxicity, an additional dose may be administered based on the investigator's determination of the benefits outweighing the risks. The original protocol planned for three dose groups: 30 mg, 60 mg, and 90 mg. The protocol was amended on March 28, 2024, to add 120 mg and 150 mg dose groups. A single tumor lesion amenable to intratumoral injection will be selected, regardless of tumor size, number, or location. The drug should be administered at the dose specified for the current dose cohort. The injection volume should be adjusted based on the size of the injected lesion.	CNSI-Fe(II) 90 mg 90 mg CNSI-Fe(II) 90 mg: The trial comprises a treatment period, including the DLT evaluation period with a duration of 21 days, and a maintenance treatment period. If the subject completes DLT evaluation without intolerable toxicity, an additional dose may be administered based on the investigator's determination of the benefits outweighing the risks. The original protocol planned for three dose groups: 30 mg, 60 mg, and 90 mg. The protocol was amended on March 28, 2024, to add 120 mg and 150 mg dose groups. A single tumor lesion amenable to intratumoral injection will be selected, regardless of tumor size, number, or location. The drug should be administered at the dose specified for the current dose cohort. The injection volume should be adjusted based on the size of the injected lesion.	CNSI-Fe(II) 120 mg 120 mg CNSI-Fe(II) 120 mg: The dosing regimen is the same as that for the 30 mg, 60 mg, and 90 mg dose groups. Additionally, if a single lesion cannot accommodate the full corresponding dose of the investigational drug, additional lesions may be selected for simultaneous injection. When multiple lesions are injected, the drug distribution should be allocated proportionally according to the size of each lesion or determined based on the investigator's assessment of an appropriate distribution.	CNSI-Fe(II) 150 mg 150 mg CNSI-Fe(II) 150 mg: The dosing regimen is the same as that for the 30 mg, 60 mg, and 90 mg dose groups. Additionally, if a single lesion cannot accommodate the full corresponding dose of the investigational drug, additional lesions may be selected for simultaneous injection. When multiple lesions are injected, the drug distribution should be allocated proportionally according to the size of each lesion or determined based on the investigator's assessment of an appropriate distribution.
PK Parameters Assessment: Serum Iron Concentration at 48 h of Second Dosage	0.00 concentration (ng/mL) Standard Deviation 0.00	24.33 concentration (ng/mL) Standard Deviation 42.15	—	—	—

SECONDARY outcome

Timeframe: at 72 h (of a time frame of 72 h) of second dosage (22~35 days after first dosing. For patient in 30 mg group, 23 days; for patients in 60 mg group, 26 and 22 days; for patients in 90 mg group, 23, 35 and 28 days; for patient in 120 mg group, 28 days.)

Population: The number of patients receiving the second dose in the 30 mg, 60 mg, 90 mg, 120 mg, and 150 mg dose groups was: 1, 2, 3, 1, and 0, respectively.

This secondary outcome measure focuses on assessing the pharmacokinetic (PK) profile of CNSI-Fe(II) in patients with advanced solid tumors. Assessment Details: PK Parameters Assessment: This assessment involves the analysis of the drug's absorption, distribution, metabolism, and excretion (ADME) in patients. It will provide insights into how CNSI-Fe(II) behaves in the human body. The fifth assessed parameter is serum iron concentration. Serum iron concentration at 72 h of first dosage: The number of patients receiving the second dose in the 30 mg, 60 mg, 90 mg, 120 mg, and 150 mg dose groups was: 1, 2, 3, 1, and 0, respectively. Due to the requirement for mean ± SD data presentation, the number of evaluable subjects in 30 mg, 120 mg, 150 mg groups was fewer than two, making SD calculation impossible. Units of Measure: Nanograms per milliliter (ng/mL) (serum iron ion concentrations changes from baseline)

Outcome measures

Outcome measures
Measure	CNSI-Fe(II) 30 mg n=2 Participants 30 mg CNSI-Fe(II) 30 mg: The trial comprises a treatment period, including the DLT evaluation period with a duration of 21 days, and a maintenance treatment period. If the subject completes DLT evaluation without intolerable toxicity, an additional dose may be administered based on the investigator's determination of the benefits outweighing the risks. The original protocol planned for three dose groups: 30 mg, 60 mg, and 90 mg. The protocol was amended on March 28, 2024, to add 120 mg and 150 mg dose groups. A single tumor lesion amenable to intratumoral injection will be selected, regardless of tumor size, number, or location. The drug should be administered at the dose specified for the current dose cohort. The injection volume should be adjusted based on the size of the injected lesion.	CNSI-Fe(II) 60 mg n=3 Participants 60 mg CNSI-Fe(II) 60 mg: The trial comprises a treatment period, including the DLT evaluation period with a duration of 21 days, and a maintenance treatment period. If the subject completes DLT evaluation without intolerable toxicity, an additional dose may be administered based on the investigator's determination of the benefits outweighing the risks. The original protocol planned for three dose groups: 30 mg, 60 mg, and 90 mg. The protocol was amended on March 28, 2024, to add 120 mg and 150 mg dose groups. A single tumor lesion amenable to intratumoral injection will be selected, regardless of tumor size, number, or location. The drug should be administered at the dose specified for the current dose cohort. The injection volume should be adjusted based on the size of the injected lesion.	CNSI-Fe(II) 90 mg 90 mg CNSI-Fe(II) 90 mg: The trial comprises a treatment period, including the DLT evaluation period with a duration of 21 days, and a maintenance treatment period. If the subject completes DLT evaluation without intolerable toxicity, an additional dose may be administered based on the investigator's determination of the benefits outweighing the risks. The original protocol planned for three dose groups: 30 mg, 60 mg, and 90 mg. The protocol was amended on March 28, 2024, to add 120 mg and 150 mg dose groups. A single tumor lesion amenable to intratumoral injection will be selected, regardless of tumor size, number, or location. The drug should be administered at the dose specified for the current dose cohort. The injection volume should be adjusted based on the size of the injected lesion.	CNSI-Fe(II) 120 mg 120 mg CNSI-Fe(II) 120 mg: The dosing regimen is the same as that for the 30 mg, 60 mg, and 90 mg dose groups. Additionally, if a single lesion cannot accommodate the full corresponding dose of the investigational drug, additional lesions may be selected for simultaneous injection. When multiple lesions are injected, the drug distribution should be allocated proportionally according to the size of each lesion or determined based on the investigator's assessment of an appropriate distribution.	CNSI-Fe(II) 150 mg 150 mg CNSI-Fe(II) 150 mg: The dosing regimen is the same as that for the 30 mg, 60 mg, and 90 mg dose groups. Additionally, if a single lesion cannot accommodate the full corresponding dose of the investigational drug, additional lesions may be selected for simultaneous injection. When multiple lesions are injected, the drug distribution should be allocated proportionally according to the size of each lesion or determined based on the investigator's assessment of an appropriate distribution.
PK Parameters Assessment: Serum Iron Concentration at 72 h of Second Dosage	0.00 concentration (ng/mL) Standard Deviation 0.00	13.00 concentration (ng/mL) Standard Deviation 22.52	—	—	—

Adverse Events

CNSI-Fe(II) 30 mg

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

CNSI-Fe(II) 60 mg

Serious events: 1 serious events

Other events: 4 other events

Deaths: 0 deaths

CNSI-Fe(II) 90 mg

Serious events: 5 serious events

Other events: 6 other events

Deaths: 2 deaths

CNSI-Fe(II) 120 mg

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

CNSI-Fe(II) 150 mg

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	CNSI-Fe(II) 30 mg n=3 participants at risk 30 mg CNSI-Fe(II) 30 mg: The trial comprises a treatment period, including the DLT evaluation period with a duration of 21 days, and a maintenance treatment period. If the subject completes DLT evaluation without intolerable toxicity, an additional dose may be administered based on the investigator's determination of the benefits outweighing the risks. Five dose groups are planned \[based on Fe(II)\]: 30 mg, 60 mg, 90 mg, 120 mg and 150 mg. A single tumor lesion amenable to intratumoral injection will be selected, regardless of tumor size, number, or location. The corresponding dose will be administered by intratumoral injection, with the injection volume determined according to the size of the injection lesion.	CNSI-Fe(II) 60 mg n=4 participants at risk 60 mg CNSI-Fe(II) 60 mg: The trial comprises a treatment period, including the DLT evaluation period with a duration of 21 days, and a maintenance treatment period. If the subject completes DLT evaluation without intolerable toxicity, an additional dose may be administered based on the investigator's determination of the benefits outweighing the risks. Five dose groups are planned \[based on Fe(II)\]: 30 mg, 60 mg, 90 mg, 120 mg and 150 mg. A single tumor lesion amenable to intratumoral injection will be selected, regardless of tumor size, number, or location. The corresponding dose will be administered by intratumoral injection, with the injection volume determined according to the size of the injection lesion.	CNSI-Fe(II) 90 mg n=6 participants at risk 90 mg CNSI-Fe(II) 90 mg: The trial comprises a treatment period, including the DLT evaluation period with a duration of 21 days, and a maintenance treatment period. If the subject completes DLT evaluation without intolerable toxicity, an additional dose may be administered based on the investigator's determination of the benefits outweighing the risks. Five dose groups are planned \[based on Fe(II)\]: 30 mg, 60 mg, 90 mg, 120 mg and 150 mg. A single tumor lesion amenable to intratumoral injection will be selected, regardless of tumor size, number, or location. The corresponding dose will be administered by intratumoral injection, with the injection volume determined according to the size of the injection lesion.	CNSI-Fe(II) 120 mg n=3 participants at risk 120 mg CNSI-Fe(II) 120 mg: The trial comprises a treatment period, including the DLT evaluation period with a duration of 21 days, and a maintenance treatment period. If the subject completes DLT evaluation without intolerable toxicity, an additional dose may be administered based on the investigator's determination of the benefits outweighing the risks. Five dose groups are planned \[based on Fe(II)\]: 30 mg, 60 mg, 90 mg, 120 mg and 150 mg. A single tumor lesion amenable to intratumoral injection will be selected, regardless of tumor size, number, or location. The corresponding dose will be administered by intratumoral injection, with the injection volume determined according to the size of the injection lesion.	CNSI-Fe(II) 150 mg n=3 participants at risk 150 mg CNSI-Fe(II) 150 mg: The trial comprises a treatment period, including the DLT evaluation period with a duration of 21 days, and a maintenance treatment period. If the subject completes DLT evaluation without intolerable toxicity, an additional dose may be administered based on the investigator's determination of the benefits outweighing the risks. Five dose groups are planned \[based on Fe(II)\]: 30 mg, 60 mg, 90 mg, 120 mg and 150 mg. A single tumor lesion amenable to intratumoral injection will be selected, regardless of tumor size, number, or location. The corresponding dose will be administered by intratumoral injection, with the injection volume determined according to the size of the injection lesion.
Infections and infestations abdominal wall abscess	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/4 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	16.7% 1/6 • Number of events 1 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.
Infections and infestations pneumonia	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/4 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/6 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	33.3% 1/3 • Number of events 1 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.
Infections and infestations focal peritonitis	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/4 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	16.7% 1/6 • Number of events 1 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.
Infections and infestations oral infection	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/4 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	16.7% 1/6 • Number of events 1 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) malignant tumor progression	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/4 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	50.0% 3/6 • Number of events 3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) cancer pain	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/4 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	33.3% 2/6 • Number of events 2 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.
General disorders pain	33.3% 1/3 • Number of events 1 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/4 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/6 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.
General disorders weakness	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/4 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	16.7% 1/6 • Number of events 1 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.
General disorders injection site reaction	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/4 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	16.7% 1/6 • Number of events 1 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.
General disorders injection site pain	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/4 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	16.7% 1/6 • Number of events 1 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.
Gastrointestinal disorders colonic fistula	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/4 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	16.7% 1/6 • Number of events 1 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.
Gastrointestinal disorders emesis	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/4 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	16.7% 1/6 • Number of events 1 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.
Gastrointestinal disorders upper gastrointestinal bleeding	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/4 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	16.7% 1/6 • Number of events 1 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.
Injury, poisoning and procedural complications prescription drug overdose	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/4 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	16.7% 1/6 • Number of events 1 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.
Respiratory, thoracic and mediastinal disorders dyspnea	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/4 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	16.7% 1/6 • Number of events 1 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.
Immune system disorders hypersensitivity reaction	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	25.0% 1/4 • Number of events 1 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/6 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.

Other adverse events

Other adverse events
Measure	CNSI-Fe(II) 30 mg n=3 participants at risk 30 mg CNSI-Fe(II) 30 mg: The trial comprises a treatment period, including the DLT evaluation period with a duration of 21 days, and a maintenance treatment period. If the subject completes DLT evaluation without intolerable toxicity, an additional dose may be administered based on the investigator's determination of the benefits outweighing the risks. Five dose groups are planned \[based on Fe(II)\]: 30 mg, 60 mg, 90 mg, 120 mg and 150 mg. A single tumor lesion amenable to intratumoral injection will be selected, regardless of tumor size, number, or location. The corresponding dose will be administered by intratumoral injection, with the injection volume determined according to the size of the injection lesion.	CNSI-Fe(II) 60 mg n=4 participants at risk 60 mg CNSI-Fe(II) 60 mg: The trial comprises a treatment period, including the DLT evaluation period with a duration of 21 days, and a maintenance treatment period. If the subject completes DLT evaluation without intolerable toxicity, an additional dose may be administered based on the investigator's determination of the benefits outweighing the risks. Five dose groups are planned \[based on Fe(II)\]: 30 mg, 60 mg, 90 mg, 120 mg and 150 mg. A single tumor lesion amenable to intratumoral injection will be selected, regardless of tumor size, number, or location. The corresponding dose will be administered by intratumoral injection, with the injection volume determined according to the size of the injection lesion.	CNSI-Fe(II) 90 mg n=6 participants at risk 90 mg CNSI-Fe(II) 90 mg: The trial comprises a treatment period, including the DLT evaluation period with a duration of 21 days, and a maintenance treatment period. If the subject completes DLT evaluation without intolerable toxicity, an additional dose may be administered based on the investigator's determination of the benefits outweighing the risks. Five dose groups are planned \[based on Fe(II)\]: 30 mg, 60 mg, 90 mg, 120 mg and 150 mg. A single tumor lesion amenable to intratumoral injection will be selected, regardless of tumor size, number, or location. The corresponding dose will be administered by intratumoral injection, with the injection volume determined according to the size of the injection lesion.	CNSI-Fe(II) 120 mg n=3 participants at risk 120 mg CNSI-Fe(II) 120 mg: The trial comprises a treatment period, including the DLT evaluation period with a duration of 21 days, and a maintenance treatment period. If the subject completes DLT evaluation without intolerable toxicity, an additional dose may be administered based on the investigator's determination of the benefits outweighing the risks. Five dose groups are planned \[based on Fe(II)\]: 30 mg, 60 mg, 90 mg, 120 mg and 150 mg. A single tumor lesion amenable to intratumoral injection will be selected, regardless of tumor size, number, or location. The corresponding dose will be administered by intratumoral injection, with the injection volume determined according to the size of the injection lesion.	CNSI-Fe(II) 150 mg n=3 participants at risk 150 mg CNSI-Fe(II) 150 mg: The trial comprises a treatment period, including the DLT evaluation period with a duration of 21 days, and a maintenance treatment period. If the subject completes DLT evaluation without intolerable toxicity, an additional dose may be administered based on the investigator's determination of the benefits outweighing the risks. Five dose groups are planned \[based on Fe(II)\]: 30 mg, 60 mg, 90 mg, 120 mg and 150 mg. A single tumor lesion amenable to intratumoral injection will be selected, regardless of tumor size, number, or location. The corresponding dose will be administered by intratumoral injection, with the injection volume determined according to the size of the injection lesion.
Nervous system disorders Headache	33.3% 1/3 • Number of events 2 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/4 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	16.7% 1/6 • Number of events 1 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.
Nervous system disorders Hypoesthesia	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	25.0% 1/4 • Number of events 1 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/6 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.
Nervous system disorders Parageusia	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/4 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/6 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	33.3% 1/3 • Number of events 1 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/4 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	16.7% 1/6 • Number of events 1 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	33.3% 1/3 • Number of events 1 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.
Musculoskeletal and connective tissue disorders Limb pain	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	25.0% 1/4 • Number of events 1 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/6 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	33.3% 1/3 • Number of events 1 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.
Infections and infestations Abdominal wall abscess	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/4 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	16.7% 1/6 • Number of events 1 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.
Infections and infestations pneumonia	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/4 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/6 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	33.3% 1/3 • Number of events 1 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.
Infections and infestations Focal peritonitis	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/4 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	16.7% 1/6 • Number of events 1 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.
Infections and infestations Oral infection	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/4 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	16.7% 1/6 • Number of events 1 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.
Infections and infestations Urinary tract infection	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/4 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	16.7% 1/6 • Number of events 1 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.
Infections and infestations Upper respiratory tract infection	33.3% 1/3 • Number of events 1 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/4 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/6 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.
Infections and infestations Infectious exacerbation of bronchiectasis	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/4 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	16.7% 1/6 • Number of events 1 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.
Nervous system disorders Dizziness	33.3% 1/3 • Number of events 3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	25.0% 1/4 • Number of events 2 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	33.3% 2/6 • Number of events 2 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	33.3% 1/3 • Number of events 1 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.
Surgical and medical procedures injection site pain	100.0% 3/3 • Number of events 3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	100.0% 4/4 • Number of events 5 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	83.3% 5/6 • Number of events 6 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	100.0% 3/3 • Number of events 3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	66.7% 2/3 • Number of events 2 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.
General disorders weak	33.3% 1/3 • Number of events 1 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	50.0% 2/4 • Number of events 4 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	50.0% 3/6 • Number of events 4 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	33.3% 1/3 • Number of events 1 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.
General disorders fever	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/4 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	50.0% 3/6 • Number of events 4 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	66.7% 2/3 • Number of events 3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	33.3% 1/3 • Number of events 3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.
General disorders pain	33.3% 1/3 • Number of events 1 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/4 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/6 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	33.3% 1/3 • Number of events 1 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.
Surgical and medical procedures injection site swelling	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	50.0% 2/4 • Number of events 2 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/6 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.
Surgical and medical procedures injection site reaction	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/4 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	33.3% 2/6 • Number of events 2 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.
Skin and subcutaneous tissue disorders Facial edema	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/4 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	33.3% 2/6 • Number of events 2 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.
General disorders Peripheral edema	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/4 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/6 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	33.3% 1/3 • Number of events 1 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.
General disorders stethalgia	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/4 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	16.7% 1/6 • Number of events 1 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.
General disorders foreign body sensation	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/4 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/6 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	33.3% 1/3 • Number of events 1 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.
Surgical and medical procedures Injection site warmth	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	25.0% 1/4 • Number of events 1 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/6 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.
Vascular disorders elevation of blood pressure	33.3% 1/3 • Number of events 3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	50.0% 2/4 • Number of events 3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	33.3% 2/6 • Number of events 3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	66.7% 2/3 • Number of events 2 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	100.0% 3/3 • Number of events 3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.
Investigations Elevated serum iron	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	50.0% 2/4 • Number of events 2 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	66.7% 4/6 • Number of events 5 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	33.3% 1/3 • Number of events 1 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	66.7% 2/3 • Number of events 2 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.
Investigations Lymphocyte count decreased	33.3% 1/3 • Number of events 3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	50.0% 2/4 • Number of events 2 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	50.0% 3/6 • Number of events 3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.
Investigations decreased white blood cell count	66.7% 2/3 • Number of events 2 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/4 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/6 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	66.7% 2/3 • Number of events 2 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.
Investigations Alanine aminotransferase elevation	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	50.0% 2/4 • Number of events 3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	33.3% 2/6 • Number of events 2 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.
Investigations Elevated platelet count	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	25.0% 1/4 • Number of events 1 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	50.0% 3/6 • Number of events 3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.
Investigations neutrophil count decrease	66.7% 2/3 • Number of events 3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/4 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/6 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	33.3% 1/3 • Number of events 1 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.
Investigations Elevated white blood cell count	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	25.0% 1/4 • Number of events 1 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	16.7% 1/6 • Number of events 1 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.
Investigations Urine leukocyte positive	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/4 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	16.7% 1/6 • Number of events 1 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	33.3% 1/3 • Number of events 1 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.
Investigations Abnormal T wave of ECG	33.3% 1/3 • Number of events 1 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	25.0% 1/4 • Number of events 1 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/6 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.
Investigations Elevated heart rate	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/4 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	33.3% 2/6 • Number of events 2 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.
Investigations hypoalbuminia	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/4 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/6 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	33.3% 1/3 • Number of events 2 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	33.3% 1/3 • Number of events 1 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.
Investigations Elevated neutrophil count	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	25.0% 1/4 • Number of events 1 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	16.7% 1/6 • Number of events 1 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.
Investigations elevated C-reactive protein	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/4 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	16.7% 1/6 • Number of events 1 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.
Investigations Alpha-Hydroxybutyrate Dehydrogenase (α-HBDH) Elevation	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/4 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	16.7% 1/6 • Number of events 1 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.
Investigations decrease of binding capacity of unsaturated iron	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/4 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	16.7% 1/6 • Number of events 1 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.
Investigations Elevated Amylase	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/4 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	16.7% 1/6 • Number of events 1 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.
Investigations Increased Respiratory Rate	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/4 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	16.7% 1/6 • Number of events 1 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.
Investigations Elevated Procalcitonin	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/4 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	16.7% 1/6 • Number of events 1 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.
Investigations Decreased Lymphocyte Percentage	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	25.0% 1/4 • Number of events 1 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/6 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.
Investigations Positive Urine Occult Blood	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/4 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/6 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	33.3% 1/3 • Number of events 2 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.
Investigations Presence of Urine Ketones	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/4 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	16.7% 1/6 • Number of events 1 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.
Investigations Decreased Eosinophil Percentage	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	25.0% 1/4 • Number of events 1 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/6 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.
Investigations Weight Loss	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/4 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	16.7% 1/6 • Number of events 1 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.
Investigations Elevated Aspartate Aminotransferase	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/4 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	16.7% 1/6 • Number of events 1 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.
Investigations Abnormal ST ESG	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/4 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/6 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	33.3% 1/3 • Number of events 1 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.
Investigations Increased Cardiac Necrosis Markers	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/4 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/6 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	33.3% 1/3 • Number of events 1 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.
Investigations Elevated Blood Bilirubin	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/4 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	16.7% 1/6 • Number of events 1 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.
Investigations Elevated Blood Creatinine	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/4 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/6 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	33.3% 1/3 • Number of events 1 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.
Investigations Elevated Alkaline Phosphatase	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/4 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/6 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	33.3% 1/3 • Number of events 1 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.
Investigations Elevated Blood Glucose	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/4 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	16.7% 1/6 • Number of events 1 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.
Investigations Elevated serum ferritin	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/4 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	16.7% 1/6 • Number of events 1 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.
Investigations Elevated blood lactate	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/4 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	16.7% 1/6 • Number of events 1 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.
Investigations Elevated lactate dehydrogenase	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/4 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	16.7% 1/6 • Number of events 1 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.
Investigations Platelet count decreased	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/4 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	16.7% 1/6 • Number of events 1 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.
Investigations Blood pressure decreased	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/4 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/6 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	33.3% 1/3 • Number of events 3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.
Investigations Lipase elevated	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/4 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	16.7% 1/6 • Number of events 2 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.
Investigations Neutrophil percentage increased	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	25.0% 1/4 • Number of events 1 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/6 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.
Investigations Transferrin saturation abnormal	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/4 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	16.7% 1/6 • Number of events 1 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.
Investigations Total protein decreased	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/4 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/6 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	33.3% 1/3 • Number of events 1 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.
Investigations Total iron-binding capacity increased	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/4 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	16.7% 1/6 • Number of events 1 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.
Metabolism and nutrition disorders Hyponatremia	33.3% 1/3 • Number of events 1 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/4 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	33.3% 2/6 • Number of events 3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	66.7% 2/3 • Number of events 3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	66.7% 2/3 • Number of events 3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.
Metabolism and nutrition disorders Hypoalbuminemia	33.3% 1/3 • Number of events 1 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/4 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	50.0% 3/6 • Number of events 3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	33.3% 1/3 • Number of events 1 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.
Metabolism and nutrition disorders Reduced food intake	66.7% 2/3 • Number of events 2 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	25.0% 1/4 • Number of events 1 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	33.3% 2/6 • Number of events 2 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.
Metabolism and nutrition disorders Hypertriglyceridemia	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	50.0% 2/4 • Number of events 2 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	33.3% 2/6 • Number of events 3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	25.0% 1/4 • Number of events 1 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/6 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	66.7% 2/3 • Number of events 2 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	33.3% 1/3 • Number of events 1 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.
Metabolism and nutrition disorders Hypokalemia	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	25.0% 1/4 • Number of events 2 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	16.7% 1/6 • Number of events 1 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.
Metabolism and nutrition disorders Hypocalcemia	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/4 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	16.7% 1/6 • Number of events 2 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.
Metabolism and nutrition disorders Hypomagnesemia	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/4 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/6 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	33.3% 1/3 • Number of events 2 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.
Metabolism and nutrition disorders Hyperglycemia	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/4 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	16.7% 1/6 • Number of events 1 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.
Metabolism and nutrition disorders Iron overload	33.3% 1/3 • Number of events 1 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/4 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/6 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.
Respiratory, thoracic and mediastinal disorders Difficulty breathing	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/4 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	33.3% 2/6 • Number of events 2 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	33.3% 1/3 • Number of events 1 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	33.3% 1/3 • Number of events 1 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.
Respiratory, thoracic and mediastinal disorders Hemoptysis	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/4 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/6 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	66.7% 2/3 • Number of events 2 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/4 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/6 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	66.7% 2/3 • Number of events 2 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/4 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/6 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	66.7% 2/3 • Number of events 3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.
Respiratory, thoracic and mediastinal disorders Paranasal sinus inflammation	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/4 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	16.7% 1/6 • Number of events 1 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.
Respiratory, thoracic and mediastinal disorders Dysphonia	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/4 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	16.7% 1/6 • Number of events 1 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	33.3% 1/3 • Number of events 1 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/4 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/6 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.
Respiratory, thoracic and mediastinal disorders Productive cough	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/4 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/6 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	33.3% 1/3 • Number of events 1 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.
Blood and lymphatic system disorders anemia	33.3% 1/3 • Number of events 1 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	50.0% 2/4 • Number of events 2 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	50.0% 3/6 • Number of events 5 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	33.3% 1/3 • Number of events 1 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	66.7% 2/3 • Number of events 2 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.
Infections and infestations COVID-19	33.3% 1/3 • Number of events 1 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/4 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/6 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.
Musculoskeletal and connective tissue disorders Muscle twitching	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/4 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	16.7% 1/6 • Number of events 1 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.
Musculoskeletal and connective tissue disorders Disc disease	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/4 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/6 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	33.3% 1/3 • Number of events 1 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer pain	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/4 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	33.3% 2/6 • Number of events 3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	33.3% 1/3 • Number of events 1 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant tumor progression	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/4 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	50.0% 3/6 • Number of events 3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/4 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/6 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	33.3% 1/3 • Number of events 1 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.
Skin and subcutaneous tissue disorders Rash	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/4 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/6 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	33.3% 1/3 • Number of events 1 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.
Skin and subcutaneous tissue disorders Pruritus	33.3% 1/3 • Number of events 3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/4 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/6 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.
Blood and lymphatic system disorders Hypotension	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/4 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	16.7% 1/6 • Number of events 1 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	33.3% 1/3 • Number of events 1 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.
Blood and lymphatic system disorders Pallor	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/4 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/6 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	33.3% 1/3 • Number of events 1 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.
Blood and lymphatic system disorders Superficial vein thrombosis	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/4 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/6 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	33.3% 1/3 • Number of events 1 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.
Hepatobiliary disorders Abnormal liver function	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/4 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/6 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	33.3% 1/3 • Number of events 1 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.
Hepatobiliary disorders Chronic cholecystitis	33.3% 1/3 • Number of events 1 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/4 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/6 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.
Renal and urinary disorders Dysuria	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/4 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	33.3% 2/6 • Number of events 2 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.
Cardiac disorders palpitation	33.3% 1/3 • Number of events 1 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/4 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/6 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	33.3% 1/3 • Number of events 1 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.
Eye disorders Blurred vision	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/4 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/6 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	33.3% 1/3 • Number of events 1 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.
Eye disorders Eye congestion	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/4 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/6 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	33.3% 1/3 • Number of events 1 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.
Eye disorders Periorbital edema	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/4 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	16.7% 1/6 • Number of events 1 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.
Injury, poisoning and procedural complications Prescription drug overdose	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/4 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	16.7% 1/6 • Number of events 1 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.
Immune system disorders Hypersensitivity reaction	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	25.0% 1/4 • Number of events 1 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/6 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.
Gastrointestinal disorders Nausea	66.7% 2/3 • Number of events 4 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/4 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	16.7% 1/6 • Number of events 2 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	66.7% 2/3 • Number of events 3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	66.7% 2/3 • Number of events 2 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.
Gastrointestinal disorders Vomiting	33.3% 1/3 • Number of events 2 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	25.0% 1/4 • Number of events 1 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	50.0% 3/6 • Number of events 4 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	33.3% 1/3 • Number of events 2 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	33.3% 1/3 • Number of events 1 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.
Gastrointestinal disorders Constipation	33.3% 1/3 • Number of events 1 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	25.0% 1/4 • Number of events 1 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/6 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.
Gastrointestinal disorders Abdominal discomfort	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/4 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	16.7% 1/6 • Number of events 1 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	33.3% 1/3 • Number of events 1 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.
Gastrointestinal disorders Abdominal distension	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/4 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	16.7% 1/6 • Number of events 3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	33.3% 1/3 • Number of events 1 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.
Gastrointestinal disorders Reduced oral sensation	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	25.0% 1/4 • Number of events 1 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	16.7% 1/6 • Number of events 2 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.
Gastrointestinal disorders Abdominal tenderness	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/4 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	16.7% 1/6 • Number of events 1 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.
Gastrointestinal disorders Abdominal pain	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/4 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/6 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	33.3% 1/3 • Number of events 1 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.
Gastrointestinal disorders Diarrhea	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/4 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/6 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	33.3% 1/3 • Number of events 1 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.
Gastrointestinal disorders Retching	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/4 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/6 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	33.3% 1/3 • Number of events 1 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.
Gastrointestinal disorders Colonic fistula	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/4 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	16.7% 1/6 • Number of events 1 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.
Gastrointestinal disorders Oral bleeding	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/4 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	16.7% 1/6 • Number of events 3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.
Gastrointestinal disorders Upper gastrointestinal bleeding	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/4 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	16.7% 1/6 • Number of events 1 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.
Gastrointestinal disorders Toothache	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/4 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	16.7% 1/6 • Number of events 1 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.
Gastrointestinal disorders Hemorrhoidal bleeding	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	25.0% 1/4 • Number of events 1 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/6 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.	0.00% 0/3 • From ICF signing until the first study drug administration, adverse clinical events are generally recorded as medical history/concomitant conditions in the eCRF, with only protocol-related SAEs reported. All AEs occurring from treatment initiation until 28 days post-last dose or new anti-tumor therapy start (whichever comes first) must be fully documented in the eCRF.

Additional Information

Professor. Yongsheng Wang

West China Hospital of Sichuan University

Phone: 18980602258

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place