Trial Outcomes & Findings for Alisertib and Pembrolizumab for the Treatment of Patients With Rb-deficient Head and Neck Squamous Cell Cancer (NCT NCT04555837)

NCT ID: NCT04555837

Last Updated: 2025-05-20

Results Overview

Phase I: To determine the recommend phase II dose of the combination of alisertib and pembrolizumab

• Recruitment status: COMPLETED
• Study phase: PHASE1/PHASE2
• Target enrollment: 24 participants
• Primary outcome timeframe: Approximately 33 months
• Results posted on: 2025-05-20

Participant Flow

Patient with Rb-deficient head and neck squamous cell carcinomas. 28 patient were screened for the study. 4 patients were screen failed.

Participant milestones

Measure	Phase I Pembrolizumab 200mg IV every 3 weeks + Alisertib 40mg PO BID x 7 days every 21 days	Phase II Pembrolizumab 200mg IV every 3 weeks + Alisertib 40mg po BID x 7 days every 21 days
Overall Study STARTED	10	14
Overall Study COMPLETED	10	12
Overall Study NOT COMPLETED	0	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Phase I n=10 Participants Pembrolizumab 200mg IV every 3 weeks + Alisertib 40mg PO BID x 7 days every 21 days	Phase II n=14 Participants Pembrolizumab 200mg IV every 3 weeks + Alisertib 40mg po BID x 7 days every 21 days	Total n=24 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=10 Participants	0 Participants n=14 Participants	0 Participants n=24 Participants
Age, Categorical Between 18 and 65 years	7 Participants n=10 Participants	7 Participants n=14 Participants	14 Participants n=24 Participants
Age, Categorical >=65 years	3 Participants n=10 Participants	7 Participants n=14 Participants	10 Participants n=24 Participants
Sex: Female, Male Female	4 Participants n=10 Participants	0 Participants n=14 Participants	4 Participants n=24 Participants
Sex: Female, Male Male	6 Participants n=10 Participants	14 Participants n=14 Participants	20 Participants n=24 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=10 Participants	0 Participants n=14 Participants	1 Participants n=24 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	9 Participants n=10 Participants	14 Participants n=14 Participants	23 Participants n=24 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=10 Participants	0 Participants n=14 Participants	0 Participants n=24 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=10 Participants	0 Participants n=14 Participants	0 Participants n=24 Participants
Race (NIH/OMB) Asian	0 Participants n=10 Participants	1 Participants n=14 Participants	1 Participants n=24 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=10 Participants	0 Participants n=14 Participants	0 Participants n=24 Participants
Race (NIH/OMB) Black or African American	2 Participants n=10 Participants	0 Participants n=14 Participants	2 Participants n=24 Participants
Race (NIH/OMB) White	7 Participants n=10 Participants	13 Participants n=14 Participants	20 Participants n=24 Participants
Race (NIH/OMB) More than one race	0 Participants n=10 Participants	0 Participants n=14 Participants	0 Participants n=24 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=10 Participants	0 Participants n=14 Participants	1 Participants n=24 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: Approximately 33 months

Population: Phase I: To determine the recommend phase II dose of the combination of alisertib and pembrolizumab

Phase I: To determine the recommend phase II dose of the combination of alisertib and pembrolizumab

Outcome measures

Measure	Phase I n=10 Participants Pembrolizumab 200mg IV every 3 weeks + Alisertib 40mg PO BID x 7 days every 21 days	Phase II Pembrolizumab 200mg IV every 3 weeks + Alisertib 50mg po BID x 7 days every 21 days
Phase I: The Recommended Phase II Dose Determenation. Phase II: Overall Response Rate (ORR) and Progression Free Survival (PFS)	40 mg	—

PRIMARY outcome

Timeframe: Approximately 33 months

Population: Insufficient number of participants with events

Phase II: To determine the overall response rate (ORR) of patients with recurrent or metastatic Rb-deficient head and neck squamous cell carcinoma (HNSCC) treated with the combination of pembrolizumab and alisertib.

Outcome measures

Measure	Phase I n=14 Participants Pembrolizumab 200mg IV every 3 weeks + Alisertib 40mg PO BID x 7 days every 21 days	Phase II Pembrolizumab 200mg IV every 3 weeks + Alisertib 50mg po BID x 7 days every 21 days
Phase II: Overall Response Rate (ORR)	0 Participants	—

PRIMARY outcome

Timeframe: Approximately 33 months

Phase II: To determine the progression free survival (PFS) of patients with recurrent or metastatic Rb-deficient head and neck squamous cell carcinoma (HNSCC) treated with the combination of pembrolizumab and alisertib.

Outcome measures

Measure	Phase I n=14 Participants Pembrolizumab 200mg IV every 3 weeks + Alisertib 40mg PO BID x 7 days every 21 days	Phase II Pembrolizumab 200mg IV every 3 weeks + Alisertib 50mg po BID x 7 days every 21 days
Phase II: Progression Free Survival (PFS)	1.4 months Insufficient number of participants with events	—

SECONDARY outcome

Timeframe: Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months.

Population: 28 patients (4 patients were screen failures) enrolled from September 2020 to June 2023, 24 were treated and evaluable for safety.

To evaluate the safety of the combination of pembrolizumab and alisertib in patients with solid tumors.

Outcome measures

Measure	Phase I n=10 Participants Pembrolizumab 200mg IV every 3 weeks + Alisertib 40mg PO BID x 7 days every 21 days	Phase II n=14 Participants Pembrolizumab 200mg IV every 3 weeks + Alisertib 50mg po BID x 7 days every 21 days
The Safety of the Combination of Pembrolizumab and Alisertib AE	10 Participants	13 Participants
The Safety of the Combination of Pembrolizumab and Alisertib SAE	2 Participants	2 Participants
The Safety of the Combination of Pembrolizumab and Alisertib Death	2 Participants	0 Participants

SECONDARY outcome

Timeframe: 28 patients (4 patients were screen failures) enrolled from September 2020 to June 2023, 24 were treated and evaluable for response. Patients were followed for overall survial for approximately 33 months

Population: To determine the overall survival in HNSCC patients treated with the combination of pembrolizumab and alisertib in Phase II only.

To determine the overall survival in HNSCC patients treated with the combination of pembrolizumab and alisertib in Phase II only.

Outcome measures

Measure	Phase I Pembrolizumab 200mg IV every 3 weeks + Alisertib 40mg PO BID x 7 days every 21 days	Phase II n=14 Participants Pembrolizumab 200mg IV every 3 weeks + Alisertib 50mg po BID x 7 days every 21 days
The Overall Survival in HNSCC Patients	—	16.8 Months Insufficient number of participants with events

SECONDARY outcome

Timeframe: The trial design dictated that if there were no objective responses in thefirst cohort of the phase II study, the trial would close after the first cohort.

Population: Data are not collected

To determine the relationship between pharmacokinetics, pharmacodynamics, baseline immune and tumor biomarkers and clinical responses in patients treated with alisertib and pembrolizumab in phase II only.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: The trial design dictated that if there were no objective responses in the first cohort of the phase II study, the trial would close after the first cohort.

Population: The trial design dictated that if there were no objective responses in the first cohort of the phase II study, the trial would close after the first cohort. Biopsies were not performed in the first cohort, per study design, and HPV-reactive T cells could not be measured.

To determine correlations between clinical responses and the effect of the treatment on human papilloma virus (HPV)-reactive T cells in HPV+ cancers in phase II only.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: The trial design dictated that if there were no objective responses in the first cohort of the phase II study, the trial would close after the first cohort.

Population: The trial design dictated that if there were no objective responses in the first cohort of the phase II study, the trial would close after the first cohort. Biopsies were not performed in the first cohort, per study design, and tumor infiltrating lymphocyte function and T cell repertoire could not be measured.

To determine correlations between clinical responses and tumor infiltrating lymphocyte function and T cell repertoire in phase II only.

Outcome measures

Outcome data not reported

Adverse Events

Phase I

Serious events: 2 serious events

Other events: 10 other events

Deaths: 2 deaths

Phase II

Serious events: 2 serious events

Other events: 13 other events

Deaths: 0 deaths

Serious adverse events

Measure	Phase I n=10 participants at risk Pembrolizumab 200mg IV every 3 weeks + Alisertib 40mg PO BID x 7 days every 21 days	Phase II n=14 participants at risk Pembrolizumab 200mg IV every 3 weeks + Alisertib 40mg po BID x 7 days every 21 days
Blood and lymphatic system disorders Anemia	0.00% 0/10 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.	7.1% 1/14 • Number of events 3 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.
Gastrointestinal disorders Diarrhea	10.0% 1/10 • Number of events 1 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.	0.00% 0/14 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.
Blood and lymphatic system disorders Febrile neutropenia	10.0% 1/10 • Number of events 1 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.	7.1% 1/14 • Number of events 1 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.
Vascular disorders Hypotension	0.00% 0/10 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.	7.1% 1/14 • Number of events 1 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/10 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.	7.1% 1/14 • Number of events 1 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.
Infections and infestations Lung infection	0.00% 0/10 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.	7.1% 1/14 • Number of events 1 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.
Gastrointestinal disorders Mucositis oral	10.0% 1/10 • Number of events 1 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.	0.00% 0/14 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.
Gastrointestinal disorders Nausea	10.0% 1/10 • Number of events 1 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.	0.00% 0/14 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.
Skin and subcutaneous tissue disorders Rash acneiform	10.0% 1/10 • Number of events 1 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.	0.00% 0/14 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/10 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.	7.1% 1/14 • Number of events 1 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.
Infections and infestations Sepsis	0.00% 0/10 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.	7.1% 1/14 • Number of events 1 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.
Infections and infestations Tracheitis	0.00% 0/10 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.	7.1% 1/14 • Number of events 1 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.
Investigations White blood cell decreased	0.00% 0/10 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.	7.1% 1/14 • Number of events 2 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.

Other adverse events

Measure	Phase I n=10 participants at risk Pembrolizumab 200mg IV every 3 weeks + Alisertib 40mg PO BID x 7 days every 21 days	Phase II n=14 participants at risk Pembrolizumab 200mg IV every 3 weeks + Alisertib 40mg po BID x 7 days every 21 days
Gastrointestinal disorders Abdominal distension	10.0% 1/10 • Number of events 1 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.	7.1% 1/14 • Number of events 1 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.
Gastrointestinal disorders Abdominal pain	10.0% 1/10 • Number of events 1 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.	0.00% 0/14 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.
Investigations Activated partial thromboplastin time prolonged	10.0% 1/10 • Number of events 1 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.	0.00% 0/14 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.
Investigations Alanine aminotransferase increased	40.0% 4/10 • Number of events 11 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.	14.3% 2/14 • Number of events 2 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.
Investigations Alkaline phosphatase increased	30.0% 3/10 • Number of events 10 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.	21.4% 3/14 • Number of events 3 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.
Respiratory, thoracic and mediastinal disorders Allergic rhinitis	10.0% 1/10 • Number of events 1 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.	0.00% 0/14 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.
Skin and subcutaneous tissue disorders Alopecia	50.0% 5/10 • Number of events 6 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.	7.1% 1/14 • Number of events 1 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.
Blood and lymphatic system disorders Anemia	90.0% 9/10 • Number of events 35 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.	71.4% 10/14 • Number of events 22 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.
Metabolism and nutrition disorders Anorexia	20.0% 2/10 • Number of events 2 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.	21.4% 3/14 • Number of events 3 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.
Psychiatric disorders Anxiety	10.0% 1/10 • Number of events 1 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.	0.00% 0/14 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.
Investigations Aspartate aminotransferase increased	30.0% 3/10 • Number of events 9 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.	14.3% 2/14 • Number of events 2 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.
Respiratory, thoracic and mediastinal disorders Aspiration	10.0% 1/10 • Number of events 1 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.	0.00% 0/14 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.
Musculoskeletal and connective tissue disorders Back pain	30.0% 3/10 • Number of events 3 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.	7.1% 1/14 • Number of events 1 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.
Investigations Blood bilirubin increased	10.0% 1/10 • Number of events 3 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.	7.1% 1/14 • Number of events 1 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.
Investigations Blood lactate dehydrogenase increased	20.0% 2/10 • Number of events 2 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.	28.6% 4/14 • Number of events 4 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.
Eye disorders Blurred vision	0.00% 0/10 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.	7.1% 1/14 • Number of events 1 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.
Gastrointestinal disorders Cheilitis	0.00% 0/10 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.	7.1% 1/14 • Number of events 1 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.
Musculoskeletal and connective tissue disorders Chest wall pain	10.0% 1/10 • Number of events 1 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.	0.00% 0/14 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.
General disorders Chills	10.0% 1/10 • Number of events 1 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.	0.00% 0/14 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.
Musculoskeletal and connective tissue disorders Chronic kidney disease	0.00% 0/10 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.	7.1% 1/14 • Number of events 1 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.
Nervous system disorders Concentration impairment	10.0% 1/10 • Number of events 1 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.	0.00% 0/14 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.
Psychiatric disorders Confusion	10.0% 1/10 • Number of events 1 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.	0.00% 0/14 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.
Gastrointestinal disorders Constipation	30.0% 3/10 • Number of events 4 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.	7.1% 1/14 • Number of events 2 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.
Respiratory, thoracic and mediastinal disorders Cough	40.0% 4/10 • Number of events 4 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.	7.1% 1/14 • Number of events 1 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.
Investigations Creatinine increased	20.0% 2/10 • Number of events 2 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.	21.4% 3/14 • Number of events 4 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.
Psychiatric disorders Delirium	10.0% 1/10 • Number of events 1 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.	0.00% 0/14 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.
Gastrointestinal disorders Dental caries	10.0% 1/10 • Number of events 1 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.	0.00% 0/14 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.
Gastrointestinal disorders Depression	10.0% 1/10 • Number of events 1 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.	7.1% 1/14 • Number of events 1 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.
Gastrointestinal disorders Diarrhea	40.0% 4/10 • Number of events 8 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.	0.00% 0/14 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.
Nervous system disorders Dizziness	30.0% 3/10 • Number of events 3 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.	0.00% 0/14 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.
Gastrointestinal disorders Dry mouth	0.00% 0/10 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.	7.1% 1/14 • Number of events 1 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.
Gastrointestinal disorders Dry skin	10.0% 1/10 • Number of events 1 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.	0.00% 0/14 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.
Nervous system disorders Dysgeusia	20.0% 2/10 • Number of events 2 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.	7.1% 1/14 • Number of events 1 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.
Gastrointestinal disorders Dyspepsia	10.0% 1/10 • Number of events 1 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.	0.00% 0/14 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.
Gastrointestinal disorders Dysphagia	20.0% 2/10 • Number of events 3 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.	0.00% 0/14 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.
Respiratory, thoracic and mediastinal disorders Dyspnea	30.0% 3/10 • Number of events 4 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.	7.1% 1/14 • Number of events 1 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.
Investigations Ejection fraction decreased	0.00% 0/10 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.	7.1% 1/14 • Number of events 1 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.
Investigations Electrocardiogram QT corrected interval prolonged	10.0% 1/10 • Number of events 1 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.	0.00% 0/14 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.
Skin and subcutaneous tissue disorders Erythema multiforme	0.00% 0/10 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.	7.1% 1/14 • Number of events 1 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.
Eye disorders Eye disorders - Other, specify (redness)	10.0% 1/10 • Number of events 1 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.	0.00% 0/14 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.
Eye disorders Eye disorders - Other, specify (L upper eye field defects)	0.00% 0/10 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.	7.1% 1/14 • Number of events 1 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.
General disorders Fatigue	90.0% 9/10 • Number of events 13 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.	35.7% 5/14 • Number of events 7 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.
General disorders Febrile neutropenia	10.0% 1/10 • Number of events 1 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.	7.1% 1/14 • Number of events 1 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.
General disorders Fever	10.0% 1/10 • Number of events 1 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.	14.3% 2/14 • Number of events 2 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.
General disorders Gait disturbance	10.0% 1/10 • Number of events 1 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.	0.00% 0/14 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.
Gastrointestinal disorders Gastroesophageal reflux disease	10.0% 1/10 • Number of events 1 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.	7.1% 1/14 • Number of events 1 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.
Gastrointestinal disorders Gastrointestinal disorders - Other, specify (complication of Gastric Tube. Replaced at ACCC)	10.0% 1/10 • Number of events 1 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.	0.00% 0/14 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.
General disorders General disorders and administration site conditions - Other, specify (Stomach ache)	10.0% 1/10 • Number of events 1 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.	0.00% 0/14 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.
General disorders General disorders and administration site conditions - Other, specify (facial cellulitis)	10.0% 1/10 • Number of events 1 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.	0.00% 0/14 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.
General disorders General disorders and administration site conditions - Other, specify (Oral Thrush)	10.0% 1/10 • Number of events 1 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.	0.00% 0/14 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	40.0% 4/10 • Number of events 4 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.	7.1% 1/14 • Number of events 1 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.
Skin and subcutaneous tissue disorders Hair texture abnormal	40.0% 4/10 • Number of events 4 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.	7.1% 1/14 • Number of events 1 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.
Nervous system disorders Headache	30.0% 3/10 • Number of events 3 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.	0.00% 0/14 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.
Metabolism and nutrition disorders Hypercalcemia	20.0% 2/10 • Number of events 2 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.	21.4% 3/14 • Number of events 3 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.
Metabolism and nutrition disorders Hyperglycemia	80.0% 8/10 • Number of events 15 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.	57.1% 8/14 • Number of events 9 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.
Metabolism and nutrition disorders Hyperkalemia	20.0% 2/10 • Number of events 2 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.	7.1% 1/14 • Number of events 2 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.
Metabolism and nutrition disorders Hypernatremia	10.0% 1/10 • Number of events 4 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.	7.1% 1/14 • Number of events 1 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.
Musculoskeletal and connective tissue disorders Hyperphosphatemia	0.00% 0/10 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.	7.1% 1/14 • Number of events 1 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.
Vascular disorders Hypertension	10.0% 1/10 • Number of events 1 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.	14.3% 2/14 • Number of events 2 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.
Metabolism and nutrition disorders Hypoalbuminemia	20.0% 2/10 • Number of events 6 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.	0.00% 0/14 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.
Metabolism and nutrition disorders Hypocalcemia	10.0% 1/10 • Number of events 1 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.	7.1% 1/14 • Number of events 3 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.
Metabolism and nutrition disorders Hypoglycemia	10.0% 1/10 • Number of events 1 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.	0.00% 0/14 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.
Metabolism and nutrition disorders Hypokalemia	10.0% 1/10 • Number of events 8 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.	14.3% 2/14 • Number of events 4 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.
Metabolism and nutrition disorders Hypomagnesemia	10.0% 1/10 • Number of events 4 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.	7.1% 1/14 • Number of events 1 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.
Metabolism and nutrition disorders Hyponatremia	50.0% 5/10 • Number of events 9 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.	42.9% 6/14 • Number of events 10 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.
Metabolism and nutrition disorders Hypophosphatemia	20.0% 2/10 • Number of events 4 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.	14.3% 2/14 • Number of events 2 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.
Investigations INR increased	30.0% 3/10 • Number of events 3 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.	0.00% 0/14 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.
Psychiatric disorders Insomnia	10.0% 1/10 • Number of events 1 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.	7.1% 1/14 • Number of events 1 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.
Investigations Investigations - Other, specify	10.0% 1/10 • Number of events 1 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.	0.00% 0/14 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.
Investigations Investigations - Other, specify (Right Shoulder Discomfort)	10.0% 1/10 • Number of events 1 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.	0.00% 0/14 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.
Vascular disorders Lymphedema	0.00% 0/10 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.	7.1% 1/14 • Number of events 1 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.
Investigations Lymphocyte count decreased	80.0% 8/10 • Number of events 34 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.	71.4% 10/14 • Number of events 28 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.
Metabolism and nutrition disorders Metabolism and nutrition disorders - Other, specify (Vitamin D Deficiency)	0.00% 0/10 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.	7.1% 1/14 • Number of events 1 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.
Gastrointestinal disorders Mucositis Oral	30.0% 3/10 • Number of events 6 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.	28.6% 4/14 • Number of events 6 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.
Musculoskeletal and connective tissue disorders Myalgia	10.0% 1/10 • Number of events 1 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.	0.00% 0/14 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.
Respiratory, thoracic and mediastinal disorders Nasal congestion	30.0% 3/10 • Number of events 3 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.	0.00% 0/14 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.
Gastrointestinal disorders Nausea	40.0% 4/10 • Number of events 5 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.	7.1% 1/14 • Number of events 2 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.
Musculoskeletal and connective tissue disorders Neck pain	20.0% 2/10 • Number of events 2 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.	0.00% 0/14 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.
Investigations Neutrophil count decreased	60.0% 6/10 • Number of events 21 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.	28.6% 4/14 • Number of events 5 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.
General disorders Non-cardiac chest pain	0.00% 0/10 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.	7.1% 1/14 • Number of events 1 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.
Gastrointestinal disorders Oral pain	10.0% 1/10 • Number of events 1 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.	0.00% 0/14 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.
General disorders Pain	30.0% 3/10 • Number of events 3 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.	7.1% 1/14 • Number of events 1 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.
Musculoskeletal and connective tissue disorders Pain in extremity	10.0% 1/10 • Number of events 1 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.	0.00% 0/14 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.
Nervous system disorders Peripheral sensory neuropathy	10.0% 1/10 • Number of events 1 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.	0.00% 0/14 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.
Investigations Platelet count decreased	30.0% 3/10 • Number of events 8 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.	14.3% 2/14 • Number of events 7 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.
Respiratory, thoracic and mediastinal disorders Pleural effusion	10.0% 1/10 • Number of events 1 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.	0.00% 0/14 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.
Respiratory, thoracic and mediastinal disorders Pneumothorax	10.0% 1/10 • Number of events 1 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.	0.00% 0/14 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.
Respiratory, thoracic and mediastinal disorders Productive cough	0.00% 0/10 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.	7.1% 1/14 • Number of events 1 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.
Skin and subcutaneous tissue disorders Pruritus	40.0% 4/10 • Number of events 5 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.	7.1% 1/14 • Number of events 1 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.
Skin and subcutaneous tissue disorders Rash acneiform	10.0% 1/10 • Number of events 2 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.	7.1% 1/14 • Number of events 1 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.
Skin and subcutaneous tissue disorders Rash maculo-papular	10.0% 1/10 • Number of events 1 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.	0.00% 0/14 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.
Nervous system disorders Seizure	10.0% 1/10 • Number of events 1 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.	0.00% 0/14 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.
Cardiac disorders Sinus bradycardia	0.00% 0/10 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.	7.1% 1/14 • Number of events 1 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.
Cardiac disorders Sinus tachycardia	10.0% 1/10 • Number of events 1 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.	7.1% 1/14 • Number of events 1 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, specify (skin peeling)	10.0% 1/10 • Number of events 1 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.	0.00% 0/14 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, specify (Serpentine rash to bilateral forearms)	0.00% 0/10 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.	7.1% 1/14 • Number of events 1 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.
Skin and subcutaneous tissue disorders Skin hyperpigmentation	10.0% 1/10 • Number of events 1 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.	0.00% 0/14 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.
Respiratory, thoracic and mediastinal disorders Sore throat	10.0% 1/10 • Number of events 1 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.	14.3% 2/14 • Number of events 2 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.
Blood and lymphatic system disorders Thrombotic thrombocytopenic purpura	10.0% 1/10 • Number of events 1 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.	0.00% 0/14 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.
Renal and urinary disorders Urinary retention	10.0% 1/10 • Number of events 1 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.	0.00% 0/14 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.
Reproductive system and breast disorders Vaginal pain	10.0% 1/10 • Number of events 1 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.	0.00% 0/14 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.
Gastrointestinal disorders Vomiting	10.0% 1/10 • Number of events 1 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.	7.1% 1/14 • Number of events 1 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.
Eye disorders Watering eyes	10.0% 1/10 • Number of events 1 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.	0.00% 0/14 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.
Investigations Weight loss	30.0% 3/10 • Number of events 4 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.	21.4% 3/14 • Number of events 4 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.
Respiratory, thoracic and mediastinal disorders Wheezing	20.0% 2/10 • Number of events 2 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.	0.00% 0/14 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.
Investigations White blood cell decreased	70.0% 7/10 • Number of events 35 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.	21.4% 3/14 • Number of events 6 • 28 patients enrolled from September 2020 to June 2023 (4 patients were screen failures), 24 were treated and evaluable for safety. Adverse events were monitored until off study due to disease progression, death, unacceptable toxicity, consent withdrawal, or physician's discretion, approximately 33 months. All eligible patients who received at least one cycle of treatment were considered evaluable for safety analyses. AEs (realted and unrelated) were graded according to Common Terminology Criteria for AEs version 5.0.

Additional Information

Faye Johnson, MD

The University of Texas MD Anderson Cancer Center

Phone: (713) 792-6363

Email: fmjohns@mdanderson.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place