Trial Outcomes & Findings for A Phase 2 Study of Cediranib in Combination With Olaparib in Advanced Solid Tumors (NCT NCT02498613)

Last Updated: 2025-09-25

Results Overview

Measured by Response Evaluation Criteria in Solid Tumors version 1.1. The exact two-sided 95% confidence interval for the objective response rate will be reported.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE2

Target enrollment

122 participants

Primary outcome timeframe

Up to 4 weeks after completion of study treatment (Up to 43 months)

Results posted on

2025-09-25

Participant Flow

Participant milestones

Participant milestones
Measure	NSCLC Cohort Non-Small Cell Lung Cancer (NSCLC) participant cohort.	TNBC Cohort Triple-Negative Breast Cancer (TNBC) participant cohort.	PDAC Cohort Pancreatic Ductal Adenocarcinoma (PDAC) participant cohort.	SCLC Cohort Small Cell Lung Cancer (SCLC) participant cohort.
Overall Study STARTED	31	39	24	28
Overall Study Began Treatment	29	38	19	27
Overall Study COMPLETED	26	37	19	27
Overall Study NOT COMPLETED	5	2	5	1

Reasons for withdrawal

Reasons for withdrawal
Measure	NSCLC Cohort Non-Small Cell Lung Cancer (NSCLC) participant cohort.	TNBC Cohort Triple-Negative Breast Cancer (TNBC) participant cohort.	PDAC Cohort Pancreatic Ductal Adenocarcinoma (PDAC) participant cohort.	SCLC Cohort Small Cell Lung Cancer (SCLC) participant cohort.
Overall Study Tx Initiation Criteria Not Met	2	1	5	1
Overall Study Withdrawal by Subject	3	1	0	0

Baseline Characteristics

A Phase 2 Study of Cediranib in Combination With Olaparib in Advanced Solid Tumors

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	NSCLC Cohort n=31 Participants Non-Small Cell Lung Cancer (NSCLC) participant cohort.	TNBC Cohort n=39 Participants Triple-Negative Breast Cancer (TNBC) participant cohort.	PDAC Cohort n=24 Participants Pancreatic Ductal Adenocarcinoma (PDAC) participant cohort.	SCLC Cohort n=28 Participants Small Cell Lung Cancer (SCLC) participant cohort.	Total n=122 Participants Total of all reporting groups
Age, Continuous	64.6 years STANDARD_DEVIATION 7.8 • n=5 Participants	50.1 years STANDARD_DEVIATION 8.2 • n=7 Participants	64.2 years STANDARD_DEVIATION 10.9 • n=5 Participants	63.2 years STANDARD_DEVIATION 9.0 • n=4 Participants	59.6 years STANDARD_DEVIATION 10.9 • n=21 Participants
Sex: Female, Male Female	14 Participants n=5 Participants	39 Participants n=7 Participants	10 Participants n=5 Participants	14 Participants n=4 Participants	77 Participants n=21 Participants
Sex: Female, Male Male	17 Participants n=5 Participants	0 Participants n=7 Participants	14 Participants n=5 Participants	14 Participants n=4 Participants	45 Participants n=21 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	3 Participants n=21 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	31 Participants n=5 Participants	35 Participants n=7 Participants	23 Participants n=5 Participants	26 Participants n=4 Participants	115 Participants n=21 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	3 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	4 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) White	24 Participants n=5 Participants	23 Participants n=7 Participants	19 Participants n=5 Participants	24 Participants n=4 Participants	90 Participants n=21 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	7 Participants n=5 Participants	16 Participants n=7 Participants	5 Participants n=5 Participants	4 Participants n=4 Participants	32 Participants n=21 Participants
Region of Enrollment Canada	1 participants n=5 Participants	10 participants n=7 Participants	0 participants n=5 Participants	1 participants n=4 Participants	12 participants n=21 Participants
Region of Enrollment United States	30 participants n=5 Participants	29 participants n=7 Participants	24 participants n=5 Participants	27 participants n=4 Participants	110 participants n=21 Participants
Eastern Cooperative Oncology Group (ECOG) 0	7 Participants n=5 Participants	9 Participants n=7 Participants	7 Participants n=5 Participants	5 Participants n=4 Participants	28 Participants n=21 Participants
Eastern Cooperative Oncology Group (ECOG) 1	20 Participants n=5 Participants	29 Participants n=7 Participants	15 Participants n=5 Participants	23 Participants n=4 Participants	87 Participants n=21 Participants
Eastern Cooperative Oncology Group (ECOG) 2	4 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	0 Participants n=4 Participants	7 Participants n=21 Participants
Eastern Cooperative Oncology Group (ECOG) 3	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Eastern Cooperative Oncology Group (ECOG) 4	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Eastern Cooperative Oncology Group (ECOG) 5	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants

PRIMARY outcome

Timeframe: Up to 4 weeks after completion of study treatment (Up to 43 months)

Population: Those analyzed for clinical activity.

Measured by Response Evaluation Criteria in Solid Tumors version 1.1. The exact two-sided 95% confidence interval for the objective response rate will be reported.

Outcome measures

Outcome measures
Measure	NSCLC Cohort n=26 Participants Non-Small Cell Lung Cancer (NSCLC) participant cohort.	TNBC Cohort n=37 Participants Triple-Negative Breast Cancer (TNBC) participant cohort.	SCLC Cohort n=27 Participants Small Cell Lung Cancer (SCLC) participant cohort.	PDAC Cohort n=19 Participants Pancreatic Ductal Adenocarcinoma (PDAC) participant cohort.
Objective Response Rate	0.08 proportion of participants Interval 0.01 to 0.15	0.16 proportion of participants Interval 0.09 to 0.24	0.26 proportion of participants Interval 0.16 to 0.36	0 proportion of participants There were no responders in this cohort.

SECONDARY outcome

Timeframe: Up to 4 weeks after completion of study treatment (Up to 44 months)

Population: All graded adverse events (serious and non serious).

Graded according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. The outcome was updated upon results entry to reflect the number of graded adverse events per cohort separated by Grade 3 and Grade 4.

Outcome measures

Outcome measures
Measure	NSCLC Cohort n=787 Adverse Events Non-Small Cell Lung Cancer (NSCLC) participant cohort.	TNBC Cohort n=830 Adverse Events Triple-Negative Breast Cancer (TNBC) participant cohort.	SCLC Cohort n=392 Adverse Events Small Cell Lung Cancer (SCLC) participant cohort.	PDAC Cohort n=624 Adverse Events Pancreatic Ductal Adenocarcinoma (PDAC) participant cohort.
Incidence of Adverse Events Grade 3	60 Adverse Events	71 Adverse Events	37 Adverse Events	61 Adverse Events
Incidence of Adverse Events Grade 4	2 Adverse Events	1 Adverse Events	2 Adverse Events	7 Adverse Events

SECONDARY outcome

Timeframe: Up to 4 weeks after completion of study treatment (Up to 44 months)

Population: Those with evaluable responses.

This outcome was updated at the time of results entry to include the median PFS and the full range of survival time in months for each cohort. The time frame was updated as well. PFS was calculated as the duration of time from start of treatment to time of progression or death, whichever occurs first, assessed up to 4 weeks after completion of study treatment.

Outcome measures

Outcome measures
Measure	NSCLC Cohort n=26 Participants Non-Small Cell Lung Cancer (NSCLC) participant cohort.	TNBC Cohort n=37 Participants Triple-Negative Breast Cancer (TNBC) participant cohort.	SCLC Cohort n=19 Participants Small Cell Lung Cancer (SCLC) participant cohort.	PDAC Cohort n=27 Participants Pancreatic Ductal Adenocarcinoma (PDAC) participant cohort.
Progression-free Survival	3.8 months Interval 0.1 to 13.3	3.4 months Interval 1.4 to 42.7	1.8 months Interval 1.8 to 7.5	4.0 months Interval 0.8 to 14.5

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 2 years

Other events: 38 other events

Deaths: 1 deaths

PDAC Cohort

Serious events: 12 serious events

Other events: 19 other events

Deaths: 7 deaths

SCLC Cohort

Serious events: 10 serious events

Other events: 27 other events

Deaths: 1 deaths

Serious adverse events

Other adverse events

Additional Information

Joseph Kim, MD

Yale School of Medicine

Phone: (203) 200-4822

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60

Serious adverse events
Measure	NSCLC Cohort n=29 participants at risk Non-Small Cell Lung Cancer (NSCLC) participant cohort.	TNBC Cohort n=38 participants at risk Triple-Negative Breast Cancer (TNBC) participant cohort.	PDAC Cohort n=19 participants at risk Pancreatic Ductal Adenocarcinoma (PDAC) participant cohort.	SCLC Cohort n=27 participants at risk Small Cell Lung Cancer (SCLC) participant cohort.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) TUMOR PAIN	0.00% 0/29 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	7.9% 3/38 • Number of events 4 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	0.00% 0/19 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	0.00% 0/27 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.
Infections and infestations URINARY TRACT INFECTION	0.00% 0/29 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	0.00% 0/38 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	10.5% 2/19 • Number of events 2 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	3.7% 1/27 • Number of events 1 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.
Gastrointestinal disorders VOMITING	3.4% 1/29 • Number of events 1 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	2.6% 1/38 • Number of events 1 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	0.00% 0/19 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	7.4% 2/27 • Number of events 4 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.
Infections and infestations ABDOMINAL INFECTION	0.00% 0/29 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	0.00% 0/38 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	5.3% 1/19 • Number of events 1 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	0.00% 0/27 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.
Gastrointestinal disorders ABDOMINAL PAIN	0.00% 0/29 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	2.6% 1/38 • Number of events 1 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	15.8% 3/19 • Number of events 5 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	0.00% 0/27 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.
Renal and urinary disorders ACUTE KIDNEY INJURY	3.4% 1/29 • Number of events 1 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	0.00% 0/38 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	0.00% 0/19 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	3.7% 1/27 • Number of events 1 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.
Respiratory, thoracic and mediastinal disorders ADULT RESPIRATORY DISTRESS SYNDROME	3.4% 1/29 • Number of events 1 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	0.00% 0/38 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	0.00% 0/19 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	0.00% 0/27 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.
Investigations ALANINE AMINOTRANSFERASE INCREASED	0.00% 0/29 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	0.00% 0/38 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	0.00% 0/19 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	3.7% 1/27 • Number of events 1 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.
Investigations ALKALINE PHOSPHATASE INCREASED	0.00% 0/29 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	2.6% 1/38 • Number of events 1 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	0.00% 0/19 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	0.00% 0/27 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.
Nervous system disorders ALTERED MENTAL STATUS	0.00% 0/29 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	0.00% 0/38 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	5.3% 1/19 • Number of events 1 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	0.00% 0/27 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.
Blood and lymphatic system disorders ANEMIA	3.4% 1/29 • Number of events 1 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	0.00% 0/38 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	0.00% 0/19 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	0.00% 0/27 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.
Investigations ASPARTATE AMINOTRANSFERASE INCREASED	0.00% 0/29 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	0.00% 0/38 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	0.00% 0/19 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	3.7% 1/27 • Number of events 1 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.
Musculoskeletal and connective tissue disorders BACK PAIN	3.4% 1/29 • Number of events 1 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	0.00% 0/38 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	0.00% 0/19 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	0.00% 0/27 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.
Hepatobiliary disorders BILIARY OBSTRUCTION	0.00% 0/29 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	0.00% 0/38 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	5.3% 1/19 • Number of events 2 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	0.00% 0/27 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.
Infections and infestations BILIARY TRACT INFECTION	0.00% 0/29 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	0.00% 0/38 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	5.3% 1/19 • Number of events 1 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	0.00% 0/27 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.
Investigations BLOOD BILIRUBIN INCREASED	0.00% 0/29 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	0.00% 0/38 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	5.3% 1/19 • Number of events 1 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	0.00% 0/27 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.
Eye disorders BLURRED VISION	0.00% 0/29 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	2.6% 1/38 • Number of events 1 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	0.00% 0/19 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	0.00% 0/27 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.
Musculoskeletal and connective tissue disorders CHEST WALL PAIN	3.4% 1/29 • Number of events 1 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	0.00% 0/38 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	0.00% 0/19 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	0.00% 0/27 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.
Psychiatric disorders CONFUSION	3.4% 1/29 • Number of events 1 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	0.00% 0/38 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	0.00% 0/19 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	3.7% 1/27 • Number of events 1 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.
General disorders DEATH NOS	0.00% 0/29 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	0.00% 0/38 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	10.5% 2/19 • Number of events 2 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	0.00% 0/27 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.
Metabolism and nutrition disorders DEHYDRATION	6.9% 2/29 • Number of events 2 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	2.6% 1/38 • Number of events 1 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	0.00% 0/19 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	0.00% 0/27 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.
Gastrointestinal disorders DIARRHEA	3.4% 1/29 • Number of events 1 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	5.3% 2/38 • Number of events 2 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	0.00% 0/19 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	0.00% 0/27 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) DISEASE PROGRESSION	0.00% 0/29 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	0.00% 0/38 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	10.5% 2/19 • Number of events 2 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	0.00% 0/27 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.
Nervous system disorders DIZZINESS	0.00% 0/29 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	2.6% 1/38 • Number of events 1 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	0.00% 0/19 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	0.00% 0/27 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.
General disorders DRY MUCOUS MEMORIES	3.4% 1/29 • Number of events 1 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	0.00% 0/38 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	0.00% 0/19 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	0.00% 0/27 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.
Gastrointestinal disorders DYSPEPSIA	3.4% 1/29 • Number of events 1 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	0.00% 0/38 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	0.00% 0/19 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	0.00% 0/27 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.
Gastrointestinal disorders DYSPHAGIA	0.00% 0/29 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	0.00% 0/38 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	0.00% 0/19 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	3.7% 1/27 • Number of events 1 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.
Respiratory, thoracic and mediastinal disorders DYSPNEA	6.9% 2/29 • Number of events 2 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	5.3% 2/38 • Number of events 2 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	10.5% 2/19 • Number of events 2 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	3.7% 1/27 • Number of events 3 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.
General disorders EDEMA FACE	3.4% 1/29 • Number of events 1 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	0.00% 0/38 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	0.00% 0/19 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	0.00% 0/27 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.
General disorders EDEMA LIMBS	3.4% 1/29 • Number of events 1 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	0.00% 0/38 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	0.00% 0/19 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	0.00% 0/27 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.
Nervous system disorders ENCEPHALOPATHY	3.4% 1/29 • Number of events 1 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	0.00% 0/38 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	0.00% 0/19 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	0.00% 0/27 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.
General disorders FEVER	0.00% 0/29 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	2.6% 1/38 • Number of events 1 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	0.00% 0/19 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	0.00% 0/27 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.
Musculoskeletal and connective tissue disorders FLANK PAIN	3.4% 1/29 • Number of events 2 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	0.00% 0/38 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	0.00% 0/19 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	0.00% 0/27 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.
Injury, poisoning and procedural complications FRACTURE	0.00% 0/29 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	0.00% 0/38 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	0.00% 0/19 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	3.7% 1/27 • Number of events 1 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.
Vascular disorders HYPERTENSION	6.9% 2/29 • Number of events 2 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	0.00% 0/38 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	0.00% 0/19 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	3.7% 1/27 • Number of events 1 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.
Vascular disorders HYPOTENSION	6.9% 2/29 • Number of events 2 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	0.00% 0/38 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	0.00% 0/19 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	0.00% 0/27 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.
Respiratory, thoracic and mediastinal disorders HYPOXIA	3.4% 1/29 • Number of events 1 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	0.00% 0/38 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	0.00% 0/19 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	0.00% 0/27 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.
Infections and infestations LUNG INFECTION	0.00% 0/29 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	5.3% 2/38 • Number of events 2 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	0.00% 0/19 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	3.7% 1/27 • Number of events 1 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) MALIGNANT DISEASE	0.00% 0/29 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	0.00% 0/38 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	5.3% 1/19 • Number of events 1 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	0.00% 0/27 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.
Nervous system disorders MEMORY IMPAIRMENT	3.4% 1/29 • Number of events 1 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	0.00% 0/38 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	0.00% 0/19 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	0.00% 0/27 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.

Other adverse events
Measure	NSCLC Cohort n=29 participants at risk Non-Small Cell Lung Cancer (NSCLC) participant cohort.	TNBC Cohort n=38 participants at risk Triple-Negative Breast Cancer (TNBC) participant cohort.	PDAC Cohort n=19 participants at risk Pancreatic Ductal Adenocarcinoma (PDAC) participant cohort.	SCLC Cohort n=27 participants at risk Small Cell Lung Cancer (SCLC) participant cohort.
Skin and subcutaneous tissue disorders CLUBBING OF FINGERNAILS	3.4% 1/29 • Number of events 1 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	0.00% 0/38 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	0.00% 0/19 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	0.00% 0/27 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.
Nervous system disorders COGNITIVE DISTURBANCE	0.00% 0/29 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	2.6% 1/38 • Number of events 1 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	0.00% 0/19 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	0.00% 0/27 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.
Gastrointestinal disorders COLITIS	3.4% 1/29 • Number of events 1 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	2.6% 1/38 • Number of events 4 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	0.00% 0/19 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	3.7% 1/27 • Number of events 1 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.
Psychiatric disorders CONFUSION	13.8% 4/29 • Number of events 4 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	5.3% 2/38 • Number of events 2 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	10.5% 2/19 • Number of events 2 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	0.00% 0/27 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.
Gastrointestinal disorders CONSTIPATION	13.8% 4/29 • Number of events 4 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	28.9% 11/38 • Number of events 12 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	26.3% 5/19 • Number of events 5 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	33.3% 9/27 • Number of events 11 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.
Respiratory, thoracic and mediastinal disorders COPD	0.00% 0/29 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	0.00% 0/38 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	5.3% 1/19 • Number of events 1 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	0.00% 0/27 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.
Respiratory, thoracic and mediastinal disorders COPD EXACERBATION	0.00% 0/29 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	0.00% 0/38 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	5.3% 1/19 • Number of events 1 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	0.00% 0/27 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.
Respiratory, thoracic and mediastinal disorders COUGH	24.1% 7/29 • Number of events 10 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	13.2% 5/38 • Number of events 7 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	10.5% 2/19 • Number of events 2 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	25.9% 7/27 • Number of events 8 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.
Musculoskeletal and connective tissue disorders CRAMPS	0.00% 0/29 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	0.00% 0/38 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	5.3% 1/19 • Number of events 1 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	0.00% 0/27 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.
Investigations CREATININE INCREASED	27.6% 8/29 • Number of events 17 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	18.4% 7/38 • Number of events 19 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	5.3% 1/19 • Number of events 1 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	29.6% 8/27 • Number of events 18 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.
Vascular disorders CYANOSIS	0.00% 0/29 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	0.00% 0/38 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	0.00% 0/19 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	3.7% 1/27 • Number of events 1 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.
Respiratory, thoracic and mediastinal disorders DECREASED AIR ENTRY RIGHT SIDE	0.00% 0/29 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	0.00% 0/38 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	5.3% 1/19 • Number of events 1 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	0.00% 0/27 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.
Investigations DECREASED ALK PHOS	3.4% 1/29 • Number of events 1 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	0.00% 0/38 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	0.00% 0/19 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	0.00% 0/27 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.
General disorders DECREASED APPETITE	3.4% 1/29 • Number of events 1 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	0.00% 0/38 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	0.00% 0/19 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	0.00% 0/27 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.
Investigations DECREASED AST	3.4% 1/29 • Number of events 2 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	0.00% 0/38 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	0.00% 0/19 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	0.00% 0/27 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.
Respiratory, thoracic and mediastinal disorders DECREASED BREATH SOUNDS	3.4% 1/29 • Number of events 1 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	0.00% 0/38 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	0.00% 0/19 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	3.7% 1/27 • Number of events 1 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.
Investigations DECREASED BUN (BLOOD UREA NITR	0.00% 0/29 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	2.6% 1/38 • Number of events 1 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	0.00% 0/19 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	0.00% 0/27 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.
Investigations DECREASED CHLORIDE	3.4% 1/29 • Number of events 1 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	0.00% 0/38 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	0.00% 0/19 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	0.00% 0/27 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.
Investigations DECREASED CREATININE	0.00% 0/29 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	2.6% 1/38 • Number of events 1 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	0.00% 0/19 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	0.00% 0/27 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.
Renal and urinary disorders DECREASED GFR	3.4% 1/29 • Number of events 1 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	0.00% 0/38 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	0.00% 0/19 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	0.00% 0/27 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.
Blood and lymphatic system disorders DECREASED HEMATOCRIT	3.4% 1/29 • Number of events 1 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	2.6% 1/38 • Number of events 1 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	0.00% 0/19 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	0.00% 0/27 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.
Blood and lymphatic system disorders DECREASED INR	3.4% 1/29 • Number of events 1 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	0.00% 0/38 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	0.00% 0/19 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	0.00% 0/27 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.
Investigations DECREASED TOTAL PROTEIN	0.00% 0/29 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	2.6% 1/38 • Number of events 1 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	0.00% 0/19 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	0.00% 0/27 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.
Investigations DECREASED URINE CREATINIE	0.00% 0/29 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	2.6% 1/38 • Number of events 1 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	0.00% 0/19 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	0.00% 0/27 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.
Metabolism and nutrition disorders DEHYDRATION	31.0% 9/29 • Number of events 16 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	18.4% 7/38 • Number of events 7 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	26.3% 5/19 • Number of events 5 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	37.0% 10/27 • Number of events 19 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.
Psychiatric disorders DELIRIUM	3.4% 1/29 • Number of events 1 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	2.6% 1/38 • Number of events 1 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	0.00% 0/19 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	0.00% 0/27 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.
Infections and infestations DENTAL	0.00% 0/29 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	0.00% 0/38 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	0.00% 0/19 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	3.7% 1/27 • Number of events 1 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.
Gastrointestinal disorders DENTAL CARIES	0.00% 0/29 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	0.00% 0/38 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	0.00% 0/19 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	3.7% 1/27 • Number of events 1 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.
Blood and lymphatic system disorders DECREASED ANION GAP	0.00% 0/29 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	2.6% 1/38 • Number of events 1 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	0.00% 0/19 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	0.00% 0/27 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.
Gastrointestinal disorders DIARRHEA	58.6% 17/29 • Number of events 38 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	71.1% 27/38 • Number of events 42 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	47.4% 9/19 • Number of events 13 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	70.4% 19/27 • Number of events 31 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.
Gastrointestinal disorders DIVERTICULOSIS COLI	0.00% 0/29 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	0.00% 0/38 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	5.3% 1/19 • Number of events 1 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	0.00% 0/27 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.
Nervous system disorders DEPRESSED LEVEL OF CONSCIOUSNE	0.00% 0/29 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	2.6% 1/38 • Number of events 1 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	0.00% 0/19 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	0.00% 0/27 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.
Psychiatric disorders DEPRESSION	3.4% 1/29 • Number of events 1 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	7.9% 3/38 • Number of events 3 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	5.3% 1/19 • Number of events 1 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	11.1% 3/27 • Number of events 4 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.
Gastrointestinal disorders DRY MOUTH	13.8% 4/29 • Number of events 4 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	10.5% 4/38 • Number of events 4 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	15.8% 3/19 • Number of events 3 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	14.8% 4/27 • Number of events 4 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.
General disorders DRY MUCOUS MEMBRANES	3.4% 1/29 • Number of events 1 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	0.00% 0/38 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	0.00% 0/19 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	0.00% 0/27 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.
Skin and subcutaneous tissue disorders DRY SKIN	6.9% 2/29 • Number of events 4 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	0.00% 0/38 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	5.3% 1/19 • Number of events 1 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	14.8% 4/27 • Number of events 4 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.
Nervous system disorders DIZZINESS	3.4% 1/29 • Number of events 2 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	0.00% 0/38 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	0.00% 0/19 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	0.00% 0/27 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.
Endocrine disorders DM TYPE II	0.00% 0/29 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	0.00% 0/38 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	5.3% 1/19 • Number of events 1 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	0.00% 0/27 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.
Eye disorders DOUBLE VISION	0.00% 0/29 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	0.00% 0/38 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	0.00% 0/19 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	3.7% 1/27 • Number of events 1 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.
Eye disorders DRY EYE	3.4% 1/29 • Number of events 1 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	2.6% 1/38 • Number of events 1 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	5.3% 1/19 • Number of events 1 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.	0.00% 0/27 • Up to 44 months Data are presented for the safety population- those that received at least 1 dose.