Trial Outcomes & Findings for Study of Intratumorally Administered Stimulator of Interferon Genes (STING) Agonist E7766 in Participants With Advanced Solid Tumors or Lymphomas - INSTAL-101 (NCT NCT04144140)

Last Updated: 2024-03-07

Results Overview

DLTs were predefined as any of the following toxicities occurring during Cycle 1 and were assessed by the investigator according to National Cancer Institute \[NCI\] Common Terminology Criteria for Adverse Events \[CTCAE\] version (v) 5.0. as related to E7766. Nonhematologic toxicity greater than or equal to (\>=) Grade 3 (NCI CTCAE v. 5.0), except Grade 3 fatigue less than (\<) 5 days. Asymptomatic Grade 3 or 4 laboratory abnormalities that were corrected within 72 hours. \>=Grade 3 nausea, vomiting, and diarrhea unless lasting greater than (\>) 48 hours despite optimal supportive care. Hematologic toxicity: Grade 4 neutropenia for \>=5 days, or febrile neutropenia. Grade 4 thrombocytopenia, or Grade 3 thrombocytopenia with hemorrhage. A DLT may have continued treatment at a reduced dose if the DLT had resolved and in the opinion of the investigator the participant was benefiting from treatment. In case of recurrence of the DLT at a lower dose, E7766 treatment was discontinued.

Recruitment status

TERMINATED

Study phase

PHASE1

Target enrollment

24 participants

Primary outcome timeframe

Cycle 1 (Cycle length= 21 days)

Results posted on

2024-03-07

Participant Flow

Participants took part in the study at 8 investigative sites in the United States, France, and United Kingdom from 24 February 2020 to 26 July 2022.

A total of 31 participants were screened, of which 7 were screen failures and 24 were enrolled to receive study treatment in the Dose Escalation Part of this study. The study was terminated due to sponsor's strategic decision, which is unrelated to safety, therefore no participants were enrolled in the Dose Expansion part. Hence, no data collection and analysis were done during Dose Expansion part of this study.

Participant milestones

Participant milestones
Measure	Dose Escalation Part: E7766 75 mcg Participants received E7766 75 microgram (mcg), injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until progressive disease (PD) or until other discontinuation criteria whichever occurred first.	Dose Escalation Part: E7766 150 mcg Participants received E7766 150 mcg injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.	Dose Escalation Part: E7766 300 mcg Participants received E7766 300 mcg injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.	Dose Escalation Part: E7766 600 mcg Participants received E7766 600 mcg injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.	Dose Escalation Part: E7766 780 mcg Participants received E7766 780 mcg injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.	Dose Escalation Part: E7766 1000 mcg Participants received E7766 1000 mcg injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.
Overall Study STARTED	2	2	2	11	6	1
Overall Study COMPLETED	2	2	2	11	6	0
Overall Study NOT COMPLETED	0	0	0	0	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Dose Escalation Part: E7766 75 mcg Participants received E7766 75 microgram (mcg), injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until progressive disease (PD) or until other discontinuation criteria whichever occurred first.	Dose Escalation Part: E7766 150 mcg Participants received E7766 150 mcg injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.	Dose Escalation Part: E7766 300 mcg Participants received E7766 300 mcg injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.	Dose Escalation Part: E7766 600 mcg Participants received E7766 600 mcg injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.	Dose Escalation Part: E7766 780 mcg Participants received E7766 780 mcg injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.	Dose Escalation Part: E7766 1000 mcg Participants received E7766 1000 mcg injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.	Dose Expansion Part Participants were planned to receive the dose identified from dose escalation part for E7766 in dose expansion part. Since no participants were enrolled in the Dose Expansion part of E7766. Hence, no data collection and analysis were done during Dose Expansion part of this study.
Overall Study Other	0	0	0	0	0	1	0

Baseline Characteristics

Study of Intratumorally Administered Stimulator of Interferon Genes (STING) Agonist E7766 in Participants With Advanced Solid Tumors or Lymphomas - INSTAL-101

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Dose Escalation Part: E7766 75 mcg n=2 Participants Participants received E7766 75 mcg, injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.	Dose Escalation Part: E7766 150 mcg n=2 Participants Participants received E7766 150 mcg injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.	Dose Escalation Part: E7766 300 mcg n=2 Participants Participants received E7766 300 mcg injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.	Dose Escalation Part: E7766 600 mcg n=11 Participants Participants received E7766 600 mcg injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.	Dose Escalation Part: E7766 780 mcg n=6 Participants Participants received E7766 780 mcg injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.	Dose Escalation Part: E7766 1000 mcg n=1 Participants Participants received E7766 1000 mcg injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.	Total n=24 Participants Total of all reporting groups
Age, Continuous	72.0 years STANDARD_DEVIATION 4.24 • n=5 Participants	53.5 years STANDARD_DEVIATION 13.44 • n=7 Participants	49.5 years STANDARD_DEVIATION 12.02 • n=5 Participants	57.4 years STANDARD_DEVIATION 12.95 • n=4 Participants	60.5 years STANDARD_DEVIATION 17.39 • n=21 Participants	61.0 years STANDARD_DEVIATION NA • n=10 Participants	58.5 years STANDARD_DEVIATION 13.44 • n=115 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	4 Participants n=4 Participants	3 Participants n=21 Participants	0 Participants n=10 Participants	10 Participants n=115 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	7 Participants n=4 Participants	3 Participants n=21 Participants	1 Participants n=10 Participants	14 Participants n=115 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	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	0 Participants n=115 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	2 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	10 Participants n=4 Participants	5 Participants n=21 Participants	1 Participants n=10 Participants	22 Participants n=115 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=10 Participants	2 Participants n=115 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	0 Participants n=115 Participants
Race (NIH/OMB) Asian	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	0 Participants n=115 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	0 Participants n=115 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	1 Participants n=115 Participants
Race (NIH/OMB) White	2 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	10 Participants n=4 Participants	6 Participants n=21 Participants	1 Participants n=10 Participants	23 Participants n=115 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	0 Participants n=115 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	0 Participants n=115 Participants

PRIMARY outcome

Timeframe: Cycle 1 (Cycle length= 21 days)

Population: The DLT analysis set included all participants in the Dose Escalation part who completed Cycle 1 without incurring certain major protocol deviations (for instance those related to dosing or others identified before database lock) with at least 2 E7766 injections during Cycle 1 and were evaluable for DLT, or participants who experienced DLT during Cycle 1.

Outcome measures

Outcome measures
Measure	Dose Escalation Part: E7766 75 mcg n=2 Participants Participants received E7766 75 mcg, injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.	Dose Escalation Part: E7766 150 mcg n=2 Participants Participants received E7766 150 mcg injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.	Dose Escalation Part: E7766 300 mcg n=2 Participants Participants received E7766 300 mcg injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.	Dose Escalation Part: E7766 600 mcg n=11 Participants Participants received E7766 600 mcg injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.	Dose Escalation Part: E7766 780 mcg n=6 Participants Participants received E7766 780 mcg injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.	Dose Escalation Part: E7766 1000 mcg Participants received E7766 1000 mcg injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.	Dose Expansion Part Participants were planned to receive the dose identified from dose escalation part for E7766 in dose expansion part. Since no participants were enrolled in the Dose Expansion part. Hence, no data collection and analysis were done during Dose Expansion part of this study.
Dose Escalation Part: Number of Participants With Dose-limiting Toxicities (DLTs)	0 Participants	0 Participants	0 Participants	2 Participants	1 Participants	—	—

PRIMARY outcome

Timeframe: From the first dose of the study drug up to 90 days after the last dose (up to 9 months and 14 days)

Population: The safety analysis set included all participants who received at least 1 dose of study drug. No participants were enrolled in the Dose Expansion part. Hence, no data collection and analysis were done during Dose Expansion part.

A TEAE was defined as an adverse event (AE) that emerges during treatment (on or after the first dose of study drug up to 90 days after the participant's last dose) or start day of another anticancer therapy, whichever is earlier; or in case participant has initiated new anticancer therapy within 30 days, then AEs occurring for 30 days following the last dose of E7766, having been absent at pretreatment (Baseline) or reemerges during treatment, having been present at pretreatment (Baseline) but stopped before treatment, or worsens in severity during treatment relative to the pretreatment state, when the AE is continuous.

Outcome measures

Outcome measures
Measure	Dose Escalation Part: E7766 75 mcg n=2 Participants Participants received E7766 75 mcg, injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.	Dose Escalation Part: E7766 150 mcg n=2 Participants Participants received E7766 150 mcg injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.	Dose Escalation Part: E7766 300 mcg n=2 Participants Participants received E7766 300 mcg injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.	Dose Escalation Part: E7766 600 mcg n=11 Participants Participants received E7766 600 mcg injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.	Dose Escalation Part: E7766 780 mcg n=6 Participants Participants received E7766 780 mcg injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.	Dose Escalation Part: E7766 1000 mcg n=1 Participants Participants received E7766 1000 mcg injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.	Dose Expansion Part Participants were planned to receive the dose identified from dose escalation part for E7766 in dose expansion part. Since no participants were enrolled in the Dose Expansion part. Hence, no data collection and analysis were done during Dose Expansion part of this study.
Number of Participants With Any Treatment-emergent Adverse Events (TEAEs)	2 Participants	2 Participants	2 Participants	11 Participants	6 Participants	1 Participants	—

PRIMARY outcome

Timeframe: From date of first dose of study drug until confirmed CR or PR (up to 29 months)

Population: The full analysis set included all participants who received at least 1 dose of study drug. No participants were enrolled in the Dose Expansion part. Hence, no data collection and analysis were done during Dose Expansion part.

ORR was defined as the percentage of participants with a best overall response (BOR) of complete response (CR) or partial response (PR) for target and non-target lesions. CR was defined as the disappearance of all target lesions and non-target lesions. Any pathological lymph nodes (target or non-target) had to be reduced in the short axis to less than 10 millimeter (mm). PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. The tumor assessment was done using number of lesions based on modified RECIST 1.1 as per investigator assessment for assessing tumor burden up to 10 target lesions with up to 5 target lesions per organ.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: From date of first dose of study drug until confirmed iCR or iPR (up to 29 months)

ORR was defined as the percentage of participants whose BOR was iCR or iPR according to iRECIST as per investigator assessment. iCR: immune complete response achieved with disappearance of all target lesions iCPD: immune confirmed progressive disease when there is either 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions iSD: immune stable disease in the absence of iCR or iPD. iUPD: immune unconfirmed progressive disease when iPD is unconfirmed NE: not evaluable.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: From first documented confirmed CR or PR until first documentation of PD or death (up to 29 months)

DOR was defined as time from the first documented of CR or PR to the date of first documentation of PD based on modified RECIST 1.1 as per investigator assessment or death (whichever occurs first). CR was defined as the disappearance of all target lesions and non-target lesions. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. PD for target lesion, was defined as a minimum 20% increase and a minimum 5 mm absolute increase in sum of diameters compared to nadir, or PD for non-target lesion(s) or unequivocal new lesion(s). Nadir was defined as lowest measure sum of diameters of target lesions at any time point from baseline onward. The tumor assessment was done using number of lesions based on modified RECIST 1.1 for assessing tumor burden up to 10 target lesions with up to 5 target lesions per organ.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: From first documented confirmed iCR or iPR until first documentation of iPD or death (up to 29 months)

DOR: time from date of first observation of response (iPR or iCR) to date of the first observation of progression based on iRECIST 1.1 as per investigator assessment, or date of death, whatever the cause. iCR: immune complete response achieved with disappearance of all target lesions iCPD: immune confirmed progressive disease when there is either 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: From first dose of study drug until confirmed CR or PR or >=5 weeks after first dose for SD (up to 29 months)

DCR was defined as the percentage of participants with a best overall response of CR or PR, or stable disease (SD) based on mRECIST 1.1 as per investigator assessment. Best overall response of SD must have been \>=5 weeks after randomization. CR was defined as disappearance of any intratumoral arterial enhancement in all target lesions. PR was defined as at least a 30% decrease in the sum of diameters of viable (enhancement of arterial phase) target lesions taking as reference the baseline sum of the diameters of target lesions. SD was when a case does not qualify for either PR or PD and was new non-target lesions. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the baseline sum of diameters of target lesions.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: From first dose of study drug until confirmed iCR or iPR or >=5 weeks after first dose for iSD (up to 29 months)

DCR: percentage of participants with a confirmed iCR, iPR, or i-SD (duration of iSD \>=5 weeks). DCR was assessed on iRECIST v1.1 as per investigator assessment. iCR: immune complete response achieved with disappearance of all target lesions iCPD: immune confirmed progressive disease when there is either 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions iSD: immune stable disease in the absence of iCR or iPD. iUPD: immune unconfirmed progressive disease when iPD is unconfirmed NE: not evaluable.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From date of first dose of study drug until confirmed iCR or iPR (up to 6 months and 18 days)

Population: The full analysis set included all participants who received at least 1 dose of study drug.

ORR was defined as the percentage of participants whose BOR was iCR or iPR according to iRECIST as per investigator assessment. iCR: immune complete response achieved with disappearance of all target lesions iCPD: immune confirmed progressive disease when there is either 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions iSD: immune stable disease in the absence of iCR or iPD iUPD: immune unconfirmed progressive disease when iPD is unconfirmed NE: not evaluable.

Outcome measures

Outcome measures
Measure	Dose Escalation Part: E7766 75 mcg n=2 Participants Participants received E7766 75 mcg, injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.	Dose Escalation Part: E7766 150 mcg n=2 Participants Participants received E7766 150 mcg injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.	Dose Escalation Part: E7766 300 mcg n=2 Participants Participants received E7766 300 mcg injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.	Dose Escalation Part: E7766 600 mcg n=11 Participants Participants received E7766 600 mcg injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.	Dose Escalation Part: E7766 780 mcg n=6 Participants Participants received E7766 780 mcg injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.	Dose Escalation Part: E7766 1000 mcg n=1 Participants Participants received E7766 1000 mcg injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.	Dose Expansion Part Participants were planned to receive the dose identified from dose escalation part for E7766 in dose expansion part. Since no participants were enrolled in the Dose Expansion part. Hence, no data collection and analysis were done during Dose Expansion part of this study.
Dose Escalation Part: ORR Based on iRECIST	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	—

SECONDARY outcome

Timeframe: From date of first dose of study drug until confirmed CR or PR (up to 6 months and 18 days)

Population: The full analysis set included all participants who received at least 1 dose of study drug.

ORR was defined as the percentage of participants with a BOR of CR or PR for target and non-target lesions. CR was defined as the disappearance of all target lesions and non-target lesions. Any pathological lymph nodes (target or non-target) had to be reduced in the short axis to less than 10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. The tumor assessment was done using number of lesions based on modified RECIST 1.1 as per investigator assessment for assessing tumor burden up to 10 target lesions with up to 5 target lesions per organ.

Outcome measures

Outcome measures
Measure	Dose Escalation Part: E7766 75 mcg n=2 Participants Participants received E7766 75 mcg, injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.	Dose Escalation Part: E7766 150 mcg n=2 Participants Participants received E7766 150 mcg injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.	Dose Escalation Part: E7766 300 mcg n=2 Participants Participants received E7766 300 mcg injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.	Dose Escalation Part: E7766 600 mcg n=11 Participants Participants received E7766 600 mcg injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.	Dose Escalation Part: E7766 780 mcg n=6 Participants Participants received E7766 780 mcg injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.	Dose Escalation Part: E7766 1000 mcg n=1 Participants Participants received E7766 1000 mcg injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.	Dose Expansion Part Participants were planned to receive the dose identified from dose escalation part for E7766 in dose expansion part. Since no participants were enrolled in the Dose Expansion part. Hence, no data collection and analysis were done during Dose Expansion part of this study.
Dose Escalation Part: ORR Based on mRECIST v1.1	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	—

SECONDARY outcome

Timeframe: From first documented confirmed iCR or iPR until first documentation of iPD or death (up to 6 months and 18 days)

Population: The full analysis set included all participants who received at least 1 dose of study drug. Here, Overall number of participants analyzed signifies participants who had overall response (OR) (CR or PR) as per Investigator Assessment.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From first documented confirmed CR or PR until first documentation of PD or death (up to 6 months and 18 days)

DOR was defined as time from the first documented of CR or PR to the date of first documentation of PD based on modified RECIST 1.1as per investigator assessment or death (whichever occurs first). CR was defined as the disappearance of all target lesions and non-target lesions. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. PD for target lesion, was defined as a minimum 20% increase and a minimum 5 mm absolute increase in sum of diameters compared to nadir, or PD for non-target lesion(s) or unequivocal new lesion(s). Nadir was defined as lowest measure sum of diameters of target lesions at any time point from baseline onward. The tumor assessment was done using number of lesions based on modified RECIST 1.1 for assessing tumor burden up to 10 target lesions with up to 5 target lesions per organ.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From first dose of study drug until confirmed iCR or iPR or >=5 weeks after first dose for iSD (up to 6 months and 18 days)

Population: The full analysis set included all participants who received at least 1 dose of study drug.

DCR: percentage of participants with a confirmed iCR, iPR, or i-SD (duration of iSD \>=5 weeks). DCR was assessed on iRECIST v1.1 as per investigator assessment. iCR: immune complete response achieved with disappearance of all target lesions iCPD: immune confirmed progressive disease when there is either 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions iSD: immune stable disease in the absence of iCR or iPD iUPD: immune unconfirmed progressive disease when iPD is unconfirmed NE: not evaluable.

Outcome measures

Outcome measures
Measure	Dose Escalation Part: E7766 75 mcg n=2 Participants Participants received E7766 75 mcg, injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.	Dose Escalation Part: E7766 150 mcg n=2 Participants Participants received E7766 150 mcg injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.	Dose Escalation Part: E7766 300 mcg n=2 Participants Participants received E7766 300 mcg injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.	Dose Escalation Part: E7766 600 mcg n=11 Participants Participants received E7766 600 mcg injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.	Dose Escalation Part: E7766 780 mcg n=6 Participants Participants received E7766 780 mcg injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.	Dose Escalation Part: E7766 1000 mcg n=1 Participants Participants received E7766 1000 mcg injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.	Dose Expansion Part Participants were planned to receive the dose identified from dose escalation part for E7766 in dose expansion part. Since no participants were enrolled in the Dose Expansion part. Hence, no data collection and analysis were done during Dose Expansion part of this study.
Dose Escalation Part: DCR Based on iRECIST	100.0 percentage of participants	0.0 percentage of participants	50.0 percentage of participants	36.4 percentage of participants	16.7 percentage of participants	0.0 percentage of participants	—

SECONDARY outcome

Timeframe: From first dose of study drug until confirmed CR or PR or >=5 weeks after first dose for SD (up to 6 months and 18 days)

Population: The full analysis set included all participants who received at least 1 dose of study drug.

DCR was defined as the percentage of participants with a best overall response of CR or PR, or SD based on mRECIST 1.1 as per investigator assessment. Best overall response of SD must have been \>=7 weeks after randomization. CR was defined as disappearance of any intratumoral arterial enhancement in all target lesions. PR was defined as at least a 30% decrease in the sum of diameters of viable (enhancement of arterial phase) target lesions taking as reference the baseline sum of the diameters of target lesions. SD was when a case does not qualify for either PR or PD and was new non-target lesions. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the baseline sum of diameters of target lesions.

Outcome measures

Outcome measures
Measure	Dose Escalation Part: E7766 75 mcg n=2 Participants Participants received E7766 75 mcg, injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.	Dose Escalation Part: E7766 150 mcg n=2 Participants Participants received E7766 150 mcg injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.	Dose Escalation Part: E7766 300 mcg n=2 Participants Participants received E7766 300 mcg injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.	Dose Escalation Part: E7766 600 mcg n=11 Participants Participants received E7766 600 mcg injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.	Dose Escalation Part: E7766 780 mcg n=6 Participants Participants received E7766 780 mcg injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.	Dose Escalation Part: E7766 1000 mcg n=1 Participants Participants received E7766 1000 mcg injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.	Dose Expansion Part Participants were planned to receive the dose identified from dose escalation part for E7766 in dose expansion part. Since no participants were enrolled in the Dose Expansion part. Hence, no data collection and analysis were done during Dose Expansion part of this study.
Dose Escalation Part: DCR Based on mRECIST v1.1	100.0 percentage of participants	0.0 percentage of participants	50.0 percentage of participants	36.4 percentage of participants	16.7 percentage of participants	0.0 percentage of participants	—

SECONDARY outcome

Timeframe: Dose Escalation: Cycle 1 Days 1 and 15: predose and up to 24 hours postdose; Dose Expansion: Cycle 1 Days 1 and 15: predose up to 2 hours postdose (Cycle length=21 days)

Population: The Pharmacokinetic (PK) analysis set included the group of participants who have received at least 1 dose of study drug and have at least 1 evaluable plasma concentration. No participants were enrolled in the Dose Expansion part. Hence, no data collection and analysis were done during Dose Expansion part. Here number analyzed "n" are the participants who were evaluable for this outcome measure for given timepoints.

Cmax was quantified using liquid chromatography tandem mass spectrometry (LC-MS/MS) methods.

Outcome measures

Outcome measures
Measure	Dose Escalation Part: E7766 75 mcg n=2 Participants Participants received E7766 75 mcg, injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.	Dose Escalation Part: E7766 150 mcg n=2 Participants Participants received E7766 150 mcg injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.	Dose Escalation Part: E7766 300 mcg n=2 Participants Participants received E7766 300 mcg injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.	Dose Escalation Part: E7766 600 mcg n=11 Participants Participants received E7766 600 mcg injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.	Dose Escalation Part: E7766 780 mcg n=6 Participants Participants received E7766 780 mcg injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.	Dose Escalation Part: E7766 1000 mcg n=1 Participants Participants received E7766 1000 mcg injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.	Dose Expansion Part Participants were planned to receive the dose identified from dose escalation part for E7766 in dose expansion part. Since no participants were enrolled in the Dose Expansion part. Hence, no data collection and analysis were done during Dose Expansion part of this study.
Cmax: Maximum Observed Plasma Concentration for E7766 Cycle 1 Day 1	4.23 nanogram per milliliter (ng/mL) Geometric Coefficient of Variation 87.4	2.77 nanogram per milliliter (ng/mL) Geometric Coefficient of Variation 7.16	2.95 nanogram per milliliter (ng/mL) Geometric Coefficient of Variation 9.85	8.03 nanogram per milliliter (ng/mL) Geometric Coefficient of Variation 95.8	11.3 nanogram per milliliter (ng/mL) Geometric Coefficient of Variation 30.6	9.99 nanogram per milliliter (ng/mL) Geometric Coefficient of Variation NA Geometric Coefficient of Variation for this arm was not determined due to insufficient number of participants.	—
Cmax: Maximum Observed Plasma Concentration for E7766 Cycle 1 Day 15	1.29 nanogram per milliliter (ng/mL) Geometric Coefficient of Variation 22.7	2.23 nanogram per milliliter (ng/mL) Geometric Coefficient of Variation 58.1	4.53 nanogram per milliliter (ng/mL) Geometric Coefficient of Variation NA Geometric Coefficient of Variation for this arm was not determined due to insufficient number of participants.	2.72 nanogram per milliliter (ng/mL) Geometric Coefficient of Variation 168	9.33 nanogram per milliliter (ng/mL) Geometric Coefficient of Variation 34.8	—	—

SECONDARY outcome

Timeframe: Dose Escalation: Cycle 1 Days 1 and 15: predose and up to 24 hours postdose; Dose Expansion: Cycle 1 Days 1 and 15: predose up to 2 hours postdose (Cycle length=21 days)

Population: The PK analysis set included the group of participants who have received at least 1 dose of study drug and have at least 1 evaluable plasma concentration. No participants were enrolled in the Dose Expansion part. Hence, no data collection and analysis were done during Dose Expansion part.Here number analyzed "n" are the participants who were evaluable for this outcome measure for given timepoints.

Tmax was quantified using validated liquid LC-MS/MS methods.

Outcome measures

Outcome measures
Measure	Dose Escalation Part: E7766 75 mcg n=2 Participants Participants received E7766 75 mcg, injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.	Dose Escalation Part: E7766 150 mcg n=2 Participants Participants received E7766 150 mcg injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.	Dose Escalation Part: E7766 300 mcg n=2 Participants Participants received E7766 300 mcg injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.	Dose Escalation Part: E7766 600 mcg n=11 Participants Participants received E7766 600 mcg injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.	Dose Escalation Part: E7766 780 mcg n=6 Participants Participants received E7766 780 mcg injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.	Dose Escalation Part: E7766 1000 mcg n=1 Participants Participants received E7766 1000 mcg injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.	Dose Expansion Part Participants were planned to receive the dose identified from dose escalation part for E7766 in dose expansion part. Since no participants were enrolled in the Dose Expansion part. Hence, no data collection and analysis were done during Dose Expansion part of this study.
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for E7766 Cycle 1 Day 15	0.215 hours Interval 0.18 to 0.25	0.385 hours Interval 0.27 to 0.5	0.25 hours Interval 0.25 to 0.25	0.25 hours Interval 0.17 to 23.4	0.21 hours Interval 0.2 to 0.25	—	—
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for E7766 Cycle 1 Day 1	0.275 hours Interval 0.25 to 0.3	0.31 hours Interval 0.27 to 0.35	0.275 hours Interval 0.25 to 0.3	0.25 hours Interval 0.2 to 0.52	0.25 hours Interval 0.2 to 0.28	0.28 hours Interval 0.28 to 0.28	—

SECONDARY outcome

Timeframe: Dose Escalation: Cycle 1 Days 1 and 15: predose and up to 24 hours postdose; Dose Expansion: Cycle 1 Days 1 and 15: predose up to 2 hours postdose (Cycle length=21 days)

Population: The PK analysis set included the group of participants who have received at least 1 dose of study drug and have at least 1 evaluable plasma concentration. No participants were enrolled in the Dose Expansion part. Hence, no data collection and analysis were done during Dose Expansion part. Here number analyzed "n" are the participants who were evaluable for this outcome measure for given timepoints.

AUC was quantified using validated liquid LC-MS/MS methods.

Outcome measures

Outcome measures
Measure	Dose Escalation Part: E7766 75 mcg n=2 Participants Participants received E7766 75 mcg, injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.	Dose Escalation Part: E7766 150 mcg n=2 Participants Participants received E7766 150 mcg injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.	Dose Escalation Part: E7766 300 mcg n=2 Participants Participants received E7766 300 mcg injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.	Dose Escalation Part: E7766 600 mcg n=11 Participants Participants received E7766 600 mcg injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.	Dose Escalation Part: E7766 780 mcg n=6 Participants Participants received E7766 780 mcg injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.	Dose Escalation Part: E7766 1000 mcg n=1 Participants Participants received E7766 1000 mcg injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.	Dose Expansion Part Participants were planned to receive the dose identified from dose escalation part for E7766 in dose expansion part. Since no participants were enrolled in the Dose Expansion part. Hence, no data collection and analysis were done during Dose Expansion part of this study.
Part: AUC(0-t): Area Under the Plasma Concentration From Time Zero to Last Curve for E7766 Cycle 1 Day 1	2.71 hournanograms per milliliter (hng/mL) Geometric Coefficient of Variation 114.0	3.42 hournanograms per milliliter (hng/mL) Geometric Coefficient of Variation 64.7	4.25 hournanograms per milliliter (hng/mL) Geometric Coefficient of Variation 26.6	7.7 hournanograms per milliliter (hng/mL) Geometric Coefficient of Variation 35.9	8.29 hournanograms per milliliter (hng/mL) Geometric Coefficient of Variation 44.2	10.3 hournanograms per milliliter (hng/mL) Geometric Coefficient of Variation NA Geometric Coefficient of Variation for this arm was not determined due to insufficient number of participants.	—
Part: AUC(0-t): Area Under the Plasma Concentration From Time Zero to Last Curve for E7766 Cycle 1 Day 15	0.536 hournanograms per milliliter (hng/mL) Geometric Coefficient of Variation 17.0	1.95 hournanograms per milliliter (hng/mL) Geometric Coefficient of Variation 29.4	5.51 hournanograms per milliliter (hng/mL) Geometric Coefficient of Variation NA Geometric Coefficient of Variation for this arm was not determined due to insufficient number of participants.	4.06 hournanograms per milliliter (hng/mL) Geometric Coefficient of Variation 101.0	6.89 hournanograms per milliliter (hng/mL) Geometric Coefficient of Variation 76.9	—	—

SECONDARY outcome

Timeframe: Dose Escalation: Cycle 1 Days 1 and 15: predose and up to 24 hours postdose; Dose Expansion: Cycle 1 Days 1 and 15: predose up to 2 hours postdose (Cycle length=21 days)

Population: The PK analysis set included the group of participants who have received at least 1 dose of study drug and have at least 1 evaluable plasma concentration. No participants were enrolled in the Dose Expansion part. Hence, no data collection and analysis were done during Dose Expansion part. Here overall number analyzed "N" were the participants who were evaluable for the outcome measure and number analyzed "n" are the participants who were evaluable for given timepoints.

AUC(0-inf) was quantified using liquid chromatography tandem mass spectrometry (LC-MS/MS) methods.

Outcome measures

Outcome measures
Measure	Dose Escalation Part: E7766 75 mcg Participants received E7766 75 mcg, injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.	Dose Escalation Part: E7766 150 mcg n=2 Participants Participants received E7766 150 mcg injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.	Dose Escalation Part: E7766 300 mcg n=2 Participants Participants received E7766 300 mcg injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.	Dose Escalation Part: E7766 600 mcg n=9 Participants Participants received E7766 600 mcg injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.	Dose Escalation Part: E7766 780 mcg n=4 Participants Participants received E7766 780 mcg injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.	Dose Escalation Part: E7766 1000 mcg n=1 Participants Participants received E7766 1000 mcg injection, intratumorally on Days 1, 8, and 15 in the first cycle of 21 days and then on Day 1 of each subsequent 21-days cycle, once every 3 weeks until PD or until other discontinuation criteria whichever occurred first.	Dose Expansion Part Participants were planned to receive the dose identified from dose escalation part for E7766 in dose expansion part. Since no participants were enrolled in the Dose Expansion part. Hence, no data collection and analysis were done during Dose Expansion part of this study.
AUC(0-inf): Area Under the Plasma Concentration From Time Zero to Infinity Curve for E7766 Cycle 1 Day 1	—	5.58 h*ng/mL Geometric Coefficient of Variation NA Geometric Coefficient of Variation for this arm was not determined due to insufficient number of participants.	4.64 h*ng/mL Geometric Coefficient of Variation 25.1	8.07 h*ng/mL Geometric Coefficient of Variation 38.5	8.93 h*ng/mL Geometric Coefficient of Variation 54.9	10.4 h*ng/mL Geometric Coefficient of Variation NA Geometric Coefficient of Variation for this arm was not determined due to insufficient number of participants.	—
AUC(0-inf): Area Under the Plasma Concentration From Time Zero to Infinity Curve for E7766 Cycle 1 Day 15	—	2.18 h*ng/mL Geometric Coefficient of Variation 35.4	5.79 h*ng/mL Geometric Coefficient of Variation NA Geometric Coefficient of Variation for this arm was not determined due to insufficient number of participants.	5.16 h*ng/mL Geometric Coefficient of Variation 83.6	7.07 h*ng/mL Geometric Coefficient of Variation 75.7	—	—

SECONDARY outcome

Timeframe: Dose Escalation: Cycle 1 Days 1 and 15: predose and up to 24 hours postdose; Dose Expansion: Cycle 1 Days 1 and 15: predose up to 2 hours postdose (Cycle length=21 days)

Population: The PK analysis set included the group of participants who have received at least 1 dose of study drug and have at least 1 evaluable plasma concentration. No participants were enrolled in the Dose Expansion part. Hence, no data collection and analysis were done during Dose Expansion part. Here overall number analyzed "N" were the participants who were evaluable for the outcome measure and number analyzed "n" are the participants who were evaluable for given timepoints.

t1/2 was quantified using validated liquid LC-MS/MS methods.