Trial Outcomes & Findings for An Open Label Study of Bavituximab and Pembrolizumab in Advanced Gastric and GEJ Cancer Patients (NCT NCT04099641)

NCT ID: NCT04099641

Last Updated: 2023-02-08

Results Overview

Incidence of TEAEs graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0, including changes in clinical laboratory parameters. TEAEs: any AE that emerged on or after first dose, and within 30 days of the last dose.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 80 participants
• Primary outcome timeframe: From first dose through 30 days after last dose. Maximum exposure: 567 days.
• Results posted on: 2023-02-08

Participant Flow

The study was conducted at 25 centers located in 4 countries. A total of 107 participants were screened between 11 September 2019 and 03 June 2021, out of which 80 participants enrolled in the study.

A total of 80 participants received treatment: 61 participants had progressed on standard chemotherapy and were naïve to checkpoint inhibitor (CPI) therapy (CPI Naïve; Group 1) and 19 participants had achieved stable disease (SD) or better and then subsequently progressed following treatment with CPI either alone or in combination with chemotherapy (CPI Relapse; Group 2). Data are reported based on the date of 20 December 2021.

Participant milestones

Measure	Group 1 (CPI Naïve) Group 1 participants had progressed on standard chemotherapy and were naïve to CPI therapy. Participants received bavituximab at 3 mg/kg on Days 1, 8, and 15 of a 3-week cycle through IV infusion. Participants received pembrolizumab at 200 mg on Day 1 of a 3-week cycle through IV infusion.	Group 2 (CPI Relapse) Group 2 participants had achieved SD or better and then subsequently progressed following treatment with CPI either alone or in combination with chemotherapy. Participants received bavituximab at 3 mg/kg on Days 1, 8, and 15 of a 3-week cycle through IV infusion. Participants received pembrolizumab at 200 mg on Day 1 of a 3-week cycle through IV infusion.
Overall Study STARTED	61	19
Overall Study Safety Population	61	19
Overall Study DLT-evaluable Population	3	0
Overall Study Efficacy Population	61	19
Overall Study COMPLETED	12	7
Overall Study NOT COMPLETED	49	12

Reasons for withdrawal

Measure	Group 1 (CPI Naïve) Group 1 participants had progressed on standard chemotherapy and were naïve to CPI therapy. Participants received bavituximab at 3 mg/kg on Days 1, 8, and 15 of a 3-week cycle through IV infusion. Participants received pembrolizumab at 200 mg on Day 1 of a 3-week cycle through IV infusion.	Group 2 (CPI Relapse) Group 2 participants had achieved SD or better and then subsequently progressed following treatment with CPI either alone or in combination with chemotherapy. Participants received bavituximab at 3 mg/kg on Days 1, 8, and 15 of a 3-week cycle through IV infusion. Participants received pembrolizumab at 200 mg on Day 1 of a 3-week cycle through IV infusion.
Overall Study Death	46	12
Overall Study Lost to Follow-up	1	0
Overall Study Withdrawal by Subject	2	0

Baseline Characteristics

An Open Label Study of Bavituximab and Pembrolizumab in Advanced Gastric and GEJ Cancer Patients

Baseline characteristics by cohort

Measure	Group 1 (CPI Naïve) n=61 Participants Group 1 participants had progressed on standard chemotherapy and were naïve to CPI therapy. Participants received bavituximab at 3 mg/kg on Days 1, 8, and 15 of a 3-week cycle through IV infusion. Participants received pembrolizumab at 200 mg on Day 1 of a 3-week cycle through IV infusion.	Group 2 (CPI Relapse) n=19 Participants Group 2 participants had achieved SD or better and then subsequently progressed following treatment with CPI either alone or in combination with chemotherapy. Participants received bavituximab at 3 mg/kg on Days 1, 8, and 15 of a 3-week cycle through IV infusion. Participants received pembrolizumab at 200 mg on Day 1 of a 3-week cycle through IV infusion.	Total n=80 Participants Total of all reporting groups
Age, Continuous	60.2 years STANDARD_DEVIATION 12.82 • n=5 Participants	61.2 years STANDARD_DEVIATION 11.68 • n=7 Participants	60.4 years STANDARD_DEVIATION 12.49 • n=5 Participants
Sex: Female, Male Female	16 Participants n=5 Participants	4 Participants n=7 Participants	20 Participants n=5 Participants
Sex: Female, Male Male	45 Participants n=5 Participants	15 Participants n=7 Participants	60 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	55 Participants n=5 Participants	16 Participants n=7 Participants	71 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	33 Participants n=5 Participants	12 Participants n=7 Participants	45 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) White	21 Participants n=5 Participants	4 Participants n=7 Participants	25 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants
Region of Enrollment South Korea	21 Participants n=5 Participants	12 Participants n=7 Participants	33 Participants n=5 Participants
Region of Enrollment United States	27 Participants n=5 Participants	4 Participants n=7 Participants	31 Participants n=5 Participants
Region of Enrollment Taiwan	11 Participants n=5 Participants	0 Participants n=7 Participants	11 Participants n=5 Participants
Region of Enrollment United Kingdom	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Central PD-L1 Combined Positive Score <1	17 Participants n=5 Participants	7 Participants n=7 Participants	24 Participants n=5 Participants
Central PD-L1 Combined Positive Score ≥1 and <10	22 Participants n=5 Participants	4 Participants n=7 Participants	26 Participants n=5 Participants
Central PD-L1 Combined Positive Score ≥10	18 Participants n=5 Participants	5 Participants n=7 Participants	23 Participants n=5 Participants
Central PD-L1 Combined Positive Score Missing	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants

PRIMARY outcome

Timeframe: From first dose through 30 days after last dose. Maximum exposure: 567 days.

Population: Analysis was performed on the safety population.

Incidence of TEAEs graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0, including changes in clinical laboratory parameters. TEAEs: any AE that emerged on or after first dose, and within 30 days of the last dose.

Outcome measures

Measure	Group 1 (CPI Naïve) n=61 Participants Group 1 participants had progressed on standard chemotherapy and were naïve to CPI therapy. Participants received bavituximab at 3 mg/kg on Days 1, 8, and 15 of a 3-week cycle through IV infusion. Participants received pembrolizumab at 200 mg on Day 1 of a 3-week cycle through IV infusion.	Group 2 (CPI Relapse) n=19 Participants Group 2 participants had achieved SD or better and then subsequently progressed following treatment with CPI either alone or in combination with chemotherapy. Participants received bavituximab at 3 mg/kg on Days 1, 8, and 15 of a 3-week cycle through IV infusion. Participants received pembrolizumab at 200 mg on Day 1 of a 3-week cycle through IV infusion.
Number of Patients With Treatment Emergent Adverse Events (TEAE)	61 Participants	19 Participants

PRIMARY outcome

Timeframe: From first dose through 30 days after last dose. Maximum exposure: 567 days.

Population: Analysis was performed on the safety population.

Severity of TEAEs graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0, including changes in clinical laboratory parameters. TEAEs: any AE that emerged on or after first dose, and within 30 days of the last dose.

Outcome measures

Measure	Group 1 (CPI Naïve) n=61 Participants Group 1 participants had progressed on standard chemotherapy and were naïve to CPI therapy. Participants received bavituximab at 3 mg/kg on Days 1, 8, and 15 of a 3-week cycle through IV infusion. Participants received pembrolizumab at 200 mg on Day 1 of a 3-week cycle through IV infusion.	Group 2 (CPI Relapse) n=19 Participants Group 2 participants had achieved SD or better and then subsequently progressed following treatment with CPI either alone or in combination with chemotherapy. Participants received bavituximab at 3 mg/kg on Days 1, 8, and 15 of a 3-week cycle through IV infusion. Participants received pembrolizumab at 200 mg on Day 1 of a 3-week cycle through IV infusion.
Severity of Treatment Emergent Adverse Events (TEAE) At least one Grade 1 TEAE	3 Participants	4 Participants
Severity of Treatment Emergent Adverse Events (TEAE) At least one Grade 2 TEAE	19 Participants	2 Participants
Severity of Treatment Emergent Adverse Events (TEAE) At least one Grade 3 TEAE	21 Participants	8 Participants
Severity of Treatment Emergent Adverse Events (TEAE) At least one Grade 4 TEAE	1 Participants	0 Participants
Severity of Treatment Emergent Adverse Events (TEAE) At least one Grade 5 TEAE	17 Participants	5 Participants

PRIMARY outcome

Timeframe: From date of first dose until the date of CR, PR, first documented progression or date of death from any cause, whichever came first. Maximum exposure: 567 days.

Population: The efficacy population include all participants enrolled in the study.

ORR was based on RECIST version 1.1 criteria for target lesions, where a patient may achieve as best overall response (BOR) either complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PD). CR was defined as the disappearance of all target lesions. PR was defined as at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline summary of diameters. ORR is calculated as the number of patients achieving a CR or PR (objective response) divided by the number of efficacy patients.

Outcome measures

Measure	Group 1 (CPI Naïve) n=61 Participants Group 1 participants had progressed on standard chemotherapy and were naïve to CPI therapy. Participants received bavituximab at 3 mg/kg on Days 1, 8, and 15 of a 3-week cycle through IV infusion. Participants received pembrolizumab at 200 mg on Day 1 of a 3-week cycle through IV infusion.	Group 2 (CPI Relapse) n=19 Participants Group 2 participants had achieved SD or better and then subsequently progressed following treatment with CPI either alone or in combination with chemotherapy. Participants received bavituximab at 3 mg/kg on Days 1, 8, and 15 of a 3-week cycle through IV infusion. Participants received pembrolizumab at 200 mg on Day 1 of a 3-week cycle through IV infusion.
Objective Response Rate (ORR) Complete Response	2 Participants	0 Participants
Objective Response Rate (ORR) Partial Response	6 Participants	1 Participants
Objective Response Rate (ORR) Stable Disease	16 Participants	9 Participants
Objective Response Rate (ORR) Progressive Disease	31 Participants	8 Participants
Objective Response Rate (ORR) Not Evaluable	6 Participants	1 Participants

Adverse Events

Group 1 (CPI Naïve)

Serious events: 29 serious events

Other events: 61 other events

Deaths: 46 deaths

Group 2 (CPI Relapse)

Serious events: 10 serious events

Other events: 19 other events

Deaths: 12 deaths

Serious adverse events

Measure	Group 1 (CPI Naïve) n=61 participants at risk Group 1 participants had progressed on standard chemotherapy and were naïve to CPI therapy. Participants received bavituximab at 3 mg/kg on Days 1, 8, and 15 of a 3-week cycle through IV infusion. Participants received pembrolizumab at 200 mg on Day 1 of a 3-week cycle through IV infusion.	Group 2 (CPI Relapse) n=19 participants at risk Group 2 participants had achieved SD or better and then subsequently progressed following treatment with CPI either alone or in combination with chemotherapy. Participants received bavituximab at 3 mg/kg on Days 1, 8, and 15 of a 3-week cycle through IV infusion. Participants received pembrolizumab at 200 mg on Day 1 of a 3-week cycle through IV infusion.
Blood and lymphatic system disorders Anaemia	1.6% 1/61 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.	0.00% 0/19 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.
Cardiac disorders Acute myocardial infarction	1.6% 1/61 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.	0.00% 0/19 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.
Cardiac disorders Atrioventricular block	1.6% 1/61 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.	0.00% 0/19 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.
Cardiac disorders Cardiac arrest	1.6% 1/61 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.	0.00% 0/19 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.
Gastrointestinal disorders Ascites	3.3% 2/61 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.	0.00% 0/19 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.
Gastrointestinal disorders Dysphagia	1.6% 1/61 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.	5.3% 1/19 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.
Gastrointestinal disorders Upper gastrointestinal haemorrhage	3.3% 2/61 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.	0.00% 0/19 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.
Gastrointestinal disorders Diarrhoea	1.6% 1/61 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.	0.00% 0/19 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.
Gastrointestinal disorders Large intestinal obstruction	1.6% 1/61 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.	0.00% 0/19 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.
Gastrointestinal disorders Nausea	1.6% 1/61 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.	0.00% 0/19 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.
Gastrointestinal disorders Obstruction gastric	1.6% 1/61 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.	0.00% 0/19 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.
Gastrointestinal disorders Vomiting	1.6% 1/61 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.	0.00% 0/19 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.
General disorders Death	3.3% 2/61 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.	0.00% 0/19 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.
General disorders Pyrexia	1.6% 1/61 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.	5.3% 1/19 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.
General disorders Disease progression	1.6% 1/61 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.	0.00% 0/19 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.
General disorders Multiple organ dysfunction syndrome	1.6% 1/61 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.	0.00% 0/19 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.
Infections and infestations Sepsis	0.00% 0/61 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.	10.5% 2/19 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.
Infections and infestations Biliary tract infection	1.6% 1/61 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.	0.00% 0/19 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.
Infections and infestations Corona virus infection	1.6% 1/61 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.	0.00% 0/19 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.
Infections and infestations Upper respiratory tract infection	0.00% 0/61 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.	5.3% 1/19 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.
Infections and infestations Urinary tract infection	1.6% 1/61 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.	0.00% 0/19 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.
Injury, poisoning and procedural complications Infusion related reaction	0.00% 0/61 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.	5.3% 1/19 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.
Injury, poisoning and procedural complications Injury	0.00% 0/61 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.	5.3% 1/19 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.
Metabolism and nutrition disorders Dehydration	3.3% 2/61 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.	0.00% 0/19 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.
Metabolism and nutrition disorders Hypoalbuminaemia	1.6% 1/61 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.	0.00% 0/19 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastric cancer	11.5% 7/61 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.	15.8% 3/19 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer pain	1.6% 1/61 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.	0.00% 0/19 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant ascites	1.6% 1/61 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.	0.00% 0/19 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic gastric cancer	1.6% 1/61 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.	0.00% 0/19 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oesophageal cancer metastatic	1.6% 1/61 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.	0.00% 0/19 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.
Nervous system disorders Encephalopathy	1.6% 1/61 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.	0.00% 0/19 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.
Nervous system disorders Facial paralysis	1.6% 1/61 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.	0.00% 0/19 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.
Nervous system disorders Loss of consciousness	1.6% 1/61 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.	0.00% 0/19 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.
Nervous system disorders Transient ischaemic attack	1.6% 1/61 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.	0.00% 0/19 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.
Renal and urinary disorders Acute kidney injury	1.6% 1/61 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.	0.00% 0/19 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.
Renal and urinary disorders Malignant urinary tract obstruction	1.6% 1/61 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.	0.00% 0/19 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.
Renal and urinary disorders Urinary tract obstruction	1.6% 1/61 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.	0.00% 0/19 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.
Reproductive system and breast disorders Benign prostatic hyperplasia	1.6% 1/61 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.	0.00% 0/19 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.
Respiratory, thoracic and mediastinal disorders Pleural effusion	4.9% 3/61 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.	0.00% 0/19 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	1.6% 1/61 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.	0.00% 0/19 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.
Respiratory, thoracic and mediastinal disorders Dyspnoea	1.6% 1/61 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.	0.00% 0/19 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.
Respiratory, thoracic and mediastinal disorders Hypoxia	1.6% 1/61 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.	0.00% 0/19 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	1.6% 1/61 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.	0.00% 0/19 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.
Respiratory, thoracic and mediastinal disorders Pneumonitis	1.6% 1/61 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.	0.00% 0/19 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/61 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.	5.3% 1/19 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.
Respiratory, thoracic and mediastinal disorders Respiratory failure	1.6% 1/61 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.	0.00% 0/19 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.
Gastrointestinal disorders Abdominal pain	0.00% 0/61 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.	5.3% 1/19 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.
Gastrointestinal disorders Gastrointestinal haemorrhage	1.6% 1/61 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.	0.00% 0/19 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.
General disorders Asthenia	1.6% 1/61 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.	0.00% 0/19 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.

Other adverse events

Measure	Group 1 (CPI Naïve) n=61 participants at risk Group 1 participants had progressed on standard chemotherapy and were naïve to CPI therapy. Participants received bavituximab at 3 mg/kg on Days 1, 8, and 15 of a 3-week cycle through IV infusion. Participants received pembrolizumab at 200 mg on Day 1 of a 3-week cycle through IV infusion.	Group 2 (CPI Relapse) n=19 participants at risk Group 2 participants had achieved SD or better and then subsequently progressed following treatment with CPI either alone or in combination with chemotherapy. Participants received bavituximab at 3 mg/kg on Days 1, 8, and 15 of a 3-week cycle through IV infusion. Participants received pembrolizumab at 200 mg on Day 1 of a 3-week cycle through IV infusion.
Blood and lymphatic system disorders Anaemia	23.0% 14/61 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.	15.8% 3/19 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.
Blood and lymphatic system disorders Coagulopathy	0.00% 0/61 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.	5.3% 1/19 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.
Endocrine disorders Hypothyroidism	11.5% 7/61 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.	0.00% 0/19 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.
Gastrointestinal disorders Constipation	26.2% 16/61 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.	47.4% 9/19 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.
Gastrointestinal disorders Nausea	29.5% 18/61 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.	26.3% 5/19 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.
Gastrointestinal disorders Diarrhoea	26.2% 16/61 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.	26.3% 5/19 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.
Gastrointestinal disorders Vomiting	24.6% 15/61 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.	15.8% 3/19 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.
Gastrointestinal disorders Abdominal pain	21.3% 13/61 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.	21.1% 4/19 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.
Gastrointestinal disorders Abdominal pain upper	13.1% 8/61 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.	10.5% 2/19 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.
Gastrointestinal disorders Abdominal distention	9.8% 6/61 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.	10.5% 2/19 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.
Gastrointestinal disorders Ascites	8.2% 5/61 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.	15.8% 3/19 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.
Gastrointestinal disorders Dysphagia	8.2% 5/61 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.	15.8% 3/19 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.
Gastrointestinal disorders Dyspepsia	6.6% 4/61 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.	10.5% 2/19 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.
Gastrointestinal disorders Gastrointestinal pain	0.00% 0/61 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.	5.3% 1/19 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.
General disorders Fatigue	32.8% 20/61 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.	31.6% 6/19 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.
General disorders Oedema peripheral	16.4% 10/61 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.	15.8% 3/19 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.
General disorders Pyrexia	14.8% 9/61 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.	10.5% 2/19 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.
General disorders Asthenia	9.8% 6/61 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.	5.3% 1/19 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.
General disorders Generalized oedema	3.3% 2/61 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.	5.3% 1/19 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.
General disorders Non-cardiac chest pain	0.00% 0/61 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.	5.3% 1/19 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.
General disorders Swelling	0.00% 0/61 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.	5.3% 1/19 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.
Hepatobiliary disorders Cholangitis	0.00% 0/61 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.	5.3% 1/19 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.
Hepatobiliary disorders Dilatation intrahepatic duct acquired	0.00% 0/61 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.	5.3% 1/19 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.
Infections and infestations Urinary tract infection	8.2% 5/61 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.	5.3% 1/19 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.
Infections and infestations Sepsis	0.00% 0/61 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.	10.5% 2/19 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.
Infections and infestations Upper respiratory tract infection	1.6% 1/61 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.	5.3% 1/19 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.
Infections and infestations Cystitis	0.00% 0/61 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.	5.3% 1/19 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.
Infections and infestations Emphysematous cholecystitis	0.00% 0/61 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.	5.3% 1/19 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.
Injury, poisoning and procedural complications Fall	6.6% 4/61 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.	0.00% 0/19 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.
Injury, poisoning and procedural complications Infusion related reaction	4.9% 3/61 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.	5.3% 1/19 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.
Injury, poisoning and procedural complications Injury	0.00% 0/61 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.	5.3% 1/19 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.
Investigations Weight decreased	16.4% 10/61 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.	15.8% 3/19 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.
Investigations Aspartate aminotransferase increased	13.1% 8/61 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.	10.5% 2/19 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.
Investigations Alanine aminotransferase increased	13.1% 8/61 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.	5.3% 1/19 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.
Investigations Blood alkaline phosphatase increased	6.6% 4/61 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.	10.5% 2/19 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.
Investigations Blood bilirubin increased	3.3% 2/61 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.	10.5% 2/19 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.
Investigations Blood creatinine increased	6.6% 4/61 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.	0.00% 0/19 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.
Investigations Blood cholesterol increased	1.6% 1/61 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.	5.3% 1/19 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.
Investigations Neutrophil count decreased	1.6% 1/61 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.	5.3% 1/19 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.
Investigations Liver function test increased	0.00% 0/61 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.	5.3% 1/19 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.
Investigations Weight increased	0.00% 0/61 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.	5.3% 1/19 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.
Metabolism and nutrition disorders Decreased appetite	34.4% 21/61 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.	21.1% 4/19 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.
Metabolism and nutrition disorders Hypoalbuminaemia	9.8% 6/61 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.	0.00% 0/19 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.
Metabolism and nutrition disorders Hyponatraemia	6.6% 4/61 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.	5.3% 1/19 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.
Metabolism and nutrition disorders Hyperkalaemia	4.9% 3/61 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.	5.3% 1/19 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.
Metabolism and nutrition disorders Hypokalaemia	3.3% 2/61 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.	5.3% 1/19 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.
Metabolism and nutrition disorders Hypophosphataemia	3.3% 2/61 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.	5.3% 1/19 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.
Musculoskeletal and connective tissue disorders Myalgia	11.5% 7/61 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.	26.3% 5/19 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.
Musculoskeletal and connective tissue disorders Arthralgia	11.5% 7/61 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.	10.5% 2/19 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.
Musculoskeletal and connective tissue disorders Back pain	9.8% 6/61 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.	0.00% 0/19 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.
Musculoskeletal and connective tissue disorders Muscular weakness	8.2% 5/61 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.	5.3% 1/19 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.
Musculoskeletal and connective tissue disorders Arthritis	0.00% 0/61 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.	5.3% 1/19 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/61 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.	5.3% 1/19 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.
Musculoskeletal and connective tissue disorders Myositis	0.00% 0/61 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.	5.3% 1/19 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastric cancer	11.5% 7/61 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.	15.8% 3/19 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour haemorrhage	0.00% 0/61 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.	5.3% 1/19 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.
Nervous system disorders Headache	11.5% 7/61 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.	21.1% 4/19 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.
Nervous system disorders Dizziness	14.8% 9/61 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.	0.00% 0/19 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.
Nervous system disorders Peripheral sensory neuropathy	3.3% 2/61 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.	5.3% 1/19 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.
Nervous system disorders Dysgeusia	0.00% 0/61 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.	5.3% 1/19 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.
Nervous system disorders Tremor	0.00% 0/61 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.	5.3% 1/19 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.
Psychiatric disorders Insomnia	8.2% 5/61 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.	10.5% 2/19 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.
Psychiatric disorders Depression	8.2% 5/61 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.	0.00% 0/19 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.
Renal and urinary disorders Dysuria	4.9% 3/61 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.	10.5% 2/19 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.
Renal and urinary disorders Obstructive nephropathy	0.00% 0/61 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.	5.3% 1/19 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.
Renal and urinary disorders Pollakiuria	0.00% 0/61 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.	5.3% 1/19 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.
Reproductive system and breast disorders Pelvic pain	1.6% 1/61 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.	5.3% 1/19 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.
Respiratory, thoracic and mediastinal disorders Dyspnoea	18.0% 11/61 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.	26.3% 5/19 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.
Respiratory, thoracic and mediastinal disorders Pleural effusion	6.6% 4/61 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.	10.5% 2/19 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.
Respiratory, thoracic and mediastinal disorders Cough	3.3% 2/61 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.	15.8% 3/19 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/61 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.	10.5% 2/19 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/61 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.	5.3% 1/19 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/61 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.	5.3% 1/19 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.
Skin and subcutaneous tissue disorders Dry skin	4.9% 3/61 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.	10.5% 2/19 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.
Vascular disorders Hypertension	11.5% 7/61 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.	5.3% 1/19 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.
Vascular disorders Hypotension	4.9% 3/61 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.	5.3% 1/19 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.
Eye disorders Vision blurred	3.3% 2/61 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.	5.3% 1/19 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.
Gastrointestinal disorders Oesophageal haemorrhage	0.00% 0/61 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.	5.3% 1/19 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.
Gastrointestinal disorders Pancreatitis	0.00% 0/61 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.	5.3% 1/19 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.
Gastrointestinal disorders Toothache	0.00% 0/61 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.	5.3% 1/19 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.
Gastrointestinal disorders Abdominal discomfort	4.9% 3/61 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.	5.3% 1/19 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.
General disorders Chills	13.1% 8/61 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.	0.00% 0/19 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.
Skin and subcutaneous tissue disorders Rash	8.2% 5/61 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.	0.00% 0/19 • From first dose through 30 days after last dose of study drug. Maximum exposure: 567 days. Safety population included all enrolled participants who received at least 1 dose of study drug, regardless of their eligibility for the study.

Additional Information

CDO, OncXerna Therapeutics, Inc.

OncXerna Therapeutics, Inc.

Phone: (781) 907-7810

Email: medical@oncxerna.com

Results disclosure agreements

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