Trial Outcomes & Findings for MGD007 Combined With MGA012 in Relapsed/Refractory Metastatic Colorectal Cancer (NCT NCT03531632)

NCT ID: NCT03531632

Last Updated: 2022-02-08

Results Overview

Adverse Events, Serious Adverse Events

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

38 participants

Primary outcome timeframe

Up to approximately 12 weeks

Results posted on

2022-02-08

Participant Flow

Patients were recruited at 6 academic/oncology centers experienced in the conduct of clinical trials.

Participant milestones

Participant milestones
Measure	Dose Level 1 0.4 mcg/kg MGD007 administered by intravenous (IV) infusion once per week in 8-week cycles, plus 3 mg/kg MGA012 administered by IV infusion once every 2 weeks.	Dose Level 2 0.6 mcg/kg MGD007 administered by intravenous (IV) infusion once per week in 8-week cycles, plus 3 mg/kg MGA012 administered by IV infusion once every 2 weeks.	Dose Level 3 0.8 mcg/kg MGD007 administered by intravenous (IV) infusion once per week in 8-week cycles, plus 3 mg/kg MGA012 administered by IV infusion once every 2 weeks.
Overall Study STARTED	5	3	28
Overall Study Safety Population	5	3	28
Overall Study Response Evaluable Population	5	3	24
Overall Study COMPLETED	0	0	2
Overall Study NOT COMPLETED	5	3	26

Reasons for withdrawal

Reasons for withdrawal
Measure	Dose Level 1 0.4 mcg/kg MGD007 administered by intravenous (IV) infusion once per week in 8-week cycles, plus 3 mg/kg MGA012 administered by IV infusion once every 2 weeks.	Dose Level 2 0.6 mcg/kg MGD007 administered by intravenous (IV) infusion once per week in 8-week cycles, plus 3 mg/kg MGA012 administered by IV infusion once every 2 weeks.	Dose Level 3 0.8 mcg/kg MGD007 administered by intravenous (IV) infusion once per week in 8-week cycles, plus 3 mg/kg MGA012 administered by IV infusion once every 2 weeks.
Overall Study Adverse Event	0	0	1
Overall Study Death	4	0	14
Overall Study Study Terminated	1	3	11

Baseline Characteristics

MGD007 Combined With MGA012 in Relapsed/Refractory Metastatic Colorectal Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Dose Level 1 n=5 Participants 0.4 mcg/kg MGD007 administered by intravenous (IV) infusion once per week in 8-week cycles, plus 3 mg/kg MGA012 administered by IV infusion once every 2 weeks.	Dose Level 2 n=3 Participants 0.6 mcg/kg MGD007 administered by intravenous (IV) infusion once per week in 8-week cycles, plus 3 mg/kg MGA012 administered by IV infusion once every 2 weeks.	Dose Level 3 n=28 Participants 0.8 mcg/kg MGD007 administered by intravenous (IV) infusion once per week in 8-week cycles, plus 3 mg/kg MGA012 administered by IV infusion once every 2 weeks.	Total n=36 Participants Total of all reporting groups
Age, Continuous	53.4 Years STANDARD_DEVIATION 5.13 • n=5 Participants	46.3 Years STANDARD_DEVIATION 2.89 • n=7 Participants	55.5 Years STANDARD_DEVIATION 7.54 • n=5 Participants	54.5 Years STANDARD_DEVIATION 7.36 • n=4 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	0 Participants n=7 Participants	13 Participants n=5 Participants	16 Participants n=4 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	3 Participants n=7 Participants	15 Participants n=5 Participants	20 Participants n=4 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
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 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
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	3 Participants n=4 Participants
Race (NIH/OMB) White	5 Participants n=5 Participants	2 Participants n=7 Participants	25 Participants n=5 Participants	32 Participants n=4 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
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Region of Enrollment United States	5 participants n=5 Participants	3 participants n=7 Participants	28 participants n=5 Participants	36 participants n=4 Participants
ECOG Performance Status ECOG Performance Status 0 (Fully active without restriction)	2 Participants n=5 Participants	1 Participants n=7 Participants	15 Participants n=5 Participants	18 Participants n=4 Participants
ECOG Performance Status ECOG Performance Status 1 (restricted in physically strenuous activity, but ambulatory)	3 Participants n=5 Participants	2 Participants n=7 Participants	13 Participants n=5 Participants	18 Participants n=4 Participants

PRIMARY outcome

Timeframe: Up to approximately 12 weeks

Population: All patients who received at least one dose of study drug and reporting at least one adverse event

Adverse Events, Serious Adverse Events

Outcome measures

Outcome measures
Measure	Dose Level 1 n=5 Participants 0.4 mcg/kg MGD007 administered by intravenous (IV) infusion once per week in 8-week cycles, plus 3 mg/kg MGA012 administered by IV infusion once every 2 weeks.	Dose Level 2 n=3 Participants 0.6 mcg/kg MGD007 administered by intravenous (IV) infusion once per week in 8-week cycles, plus 3 mg/kg MGA012 administered by IV infusion once every 2 weeks.	Dose Level 3 n=28 Participants 0.8 mcg/kg MGD007 administered by intravenous (IV) infusion once per week in 8-week cycles, plus 3 mg/kg MGA012 administered by IV infusion once every 2 weeks.
Number of Participants With Adverse Events	5 Participants	3 Participants	28 Participants

SECONDARY outcome

Timeframe: 7 weeks

Population: PK assays were not performed since the Sponsor has decided not to continue clinical development of MGD007.

PK of MGD007 and MGA012 in combination

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1 year

Population: ADA assays were not performed since the Sponsor has decided not to continue clinical development of MGD007.

Proportion of patients who develop anti-MGD007/MGA012 antibodies, immunogenicity

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Every 8 weeks

Population: Response evaluable population

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) and immune related RECIST criteria: number of patients with either complete response (CR) or partial response (PR) will determine the Overall Response Rate (ORR)

Outcome measures

Outcome measures
Measure	Dose Level 1 n=5 Participants 0.4 mcg/kg MGD007 administered by intravenous (IV) infusion once per week in 8-week cycles, plus 3 mg/kg MGA012 administered by IV infusion once every 2 weeks.	Dose Level 2 n=3 Participants 0.6 mcg/kg MGD007 administered by intravenous (IV) infusion once per week in 8-week cycles, plus 3 mg/kg MGA012 administered by IV infusion once every 2 weeks.	Dose Level 3 n=24 Participants 0.8 mcg/kg MGD007 administered by intravenous (IV) infusion once per week in 8-week cycles, plus 3 mg/kg MGA012 administered by IV infusion once every 2 weeks.
The Number of Participants With Response Based on the Change in Tumor Volume Stable Disease	0 Participants	1 Participants	10 Participants
The Number of Participants With Response Based on the Change in Tumor Volume Progressive Disease	5 Participants	2 Participants	14 Participants

Adverse Events

Dose Level 1

Serious events: 1 serious events

Other events: 5 other events

Deaths: 4 deaths

Dose Level 2

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

Dose Level 3

Serious events: 14 serious events

Other events: 28 other events

Deaths: 14 deaths

Serious adverse events

Other adverse events

Additional Information

Stephen Eck, M.D., Chief Medical Officer

MacroGenics, Inc.

Phone: 301 251-5172

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Institution shall allow SPONSOR at least 45 days to review manuscript and at least 21 days to review poster, abstract or other material. SPONSOR can review publications solely for identifying Proprietary Information, which shall be removed upon SPONSOR's request to the extent deletion does not preclude complete/accurate presentation and interpretation of Study results; to identify patentable Inventions, and provide other comments, provided that Investigator isn't obligated to address comments.
Publication restrictions are in place

Restriction type: OTHER

Serious adverse events
Measure	Dose Level 1 n=5 participants at risk 0.4 mcg/kg MGD007 administered by intravenous (IV) infusion once per week in 8-week cycles, plus 3 mg/kg MGA012 administered by IV infusion once every 2 weeks.	Dose Level 2 n=3 participants at risk 0.6 mcg/kg MGD007 administered by intravenous (IV) infusion once per week in 8-week cycles, plus 3 mg/kg MGA012 administered by IV infusion once every 2 weeks.	Dose Level 3 n=28 participants at risk 0.8 mcg/kg MGD007 administered by intravenous (IV) infusion once per week in 8-week cycles, plus 3 mg/kg MGA012 administered by IV infusion once every 2 weeks.
Gastrointestinal disorders Diarrhea	0.00% 0/5 • Study Day 1 through study completion, average 36 days. Treatment-emergent AEs were summarized by system organ class (SOC) and preferred term (PT), by relationship to study drugs, and by highest severity. For laboratory tests, number and percent of patients shifted from baseline to post-baseline maximum severity in CTCAE grade were summarized.	0.00% 0/3 • Study Day 1 through study completion, average 36 days. Treatment-emergent AEs were summarized by system organ class (SOC) and preferred term (PT), by relationship to study drugs, and by highest severity. For laboratory tests, number and percent of patients shifted from baseline to post-baseline maximum severity in CTCAE grade were summarized.	28.6% 8/28 • Number of events 8 • Study Day 1 through study completion, average 36 days. Treatment-emergent AEs were summarized by system organ class (SOC) and preferred term (PT), by relationship to study drugs, and by highest severity. For laboratory tests, number and percent of patients shifted from baseline to post-baseline maximum severity in CTCAE grade were summarized.
Gastrointestinal disorders Vomiting	0.00% 0/5 • Study Day 1 through study completion, average 36 days. Treatment-emergent AEs were summarized by system organ class (SOC) and preferred term (PT), by relationship to study drugs, and by highest severity. For laboratory tests, number and percent of patients shifted from baseline to post-baseline maximum severity in CTCAE grade were summarized.	0.00% 0/3 • Study Day 1 through study completion, average 36 days. Treatment-emergent AEs were summarized by system organ class (SOC) and preferred term (PT), by relationship to study drugs, and by highest severity. For laboratory tests, number and percent of patients shifted from baseline to post-baseline maximum severity in CTCAE grade were summarized.	28.6% 8/28 • Number of events 8 • Study Day 1 through study completion, average 36 days. Treatment-emergent AEs were summarized by system organ class (SOC) and preferred term (PT), by relationship to study drugs, and by highest severity. For laboratory tests, number and percent of patients shifted from baseline to post-baseline maximum severity in CTCAE grade were summarized.
Gastrointestinal disorders Nausea	0.00% 0/5 • Study Day 1 through study completion, average 36 days. Treatment-emergent AEs were summarized by system organ class (SOC) and preferred term (PT), by relationship to study drugs, and by highest severity. For laboratory tests, number and percent of patients shifted from baseline to post-baseline maximum severity in CTCAE grade were summarized.	0.00% 0/3 • Study Day 1 through study completion, average 36 days. Treatment-emergent AEs were summarized by system organ class (SOC) and preferred term (PT), by relationship to study drugs, and by highest severity. For laboratory tests, number and percent of patients shifted from baseline to post-baseline maximum severity in CTCAE grade were summarized.	14.3% 4/28 • Number of events 4 • Study Day 1 through study completion, average 36 days. Treatment-emergent AEs were summarized by system organ class (SOC) and preferred term (PT), by relationship to study drugs, and by highest severity. For laboratory tests, number and percent of patients shifted from baseline to post-baseline maximum severity in CTCAE grade were summarized.
General disorders Oedema peripheral	0.00% 0/5 • Study Day 1 through study completion, average 36 days. Treatment-emergent AEs were summarized by system organ class (SOC) and preferred term (PT), by relationship to study drugs, and by highest severity. For laboratory tests, number and percent of patients shifted from baseline to post-baseline maximum severity in CTCAE grade were summarized.	0.00% 0/3 • Study Day 1 through study completion, average 36 days. Treatment-emergent AEs were summarized by system organ class (SOC) and preferred term (PT), by relationship to study drugs, and by highest severity. For laboratory tests, number and percent of patients shifted from baseline to post-baseline maximum severity in CTCAE grade were summarized.	7.1% 2/28 • Number of events 2 • Study Day 1 through study completion, average 36 days. Treatment-emergent AEs were summarized by system organ class (SOC) and preferred term (PT), by relationship to study drugs, and by highest severity. For laboratory tests, number and percent of patients shifted from baseline to post-baseline maximum severity in CTCAE grade were summarized.
General disorders Pyrexia	0.00% 0/5 • Study Day 1 through study completion, average 36 days. Treatment-emergent AEs were summarized by system organ class (SOC) and preferred term (PT), by relationship to study drugs, and by highest severity. For laboratory tests, number and percent of patients shifted from baseline to post-baseline maximum severity in CTCAE grade were summarized.	0.00% 0/3 • Study Day 1 through study completion, average 36 days. Treatment-emergent AEs were summarized by system organ class (SOC) and preferred term (PT), by relationship to study drugs, and by highest severity. For laboratory tests, number and percent of patients shifted from baseline to post-baseline maximum severity in CTCAE grade were summarized.	7.1% 2/28 • Number of events 2 • Study Day 1 through study completion, average 36 days. Treatment-emergent AEs were summarized by system organ class (SOC) and preferred term (PT), by relationship to study drugs, and by highest severity. For laboratory tests, number and percent of patients shifted from baseline to post-baseline maximum severity in CTCAE grade were summarized.
Vascular disorders Hypotension	0.00% 0/5 • Study Day 1 through study completion, average 36 days. Treatment-emergent AEs were summarized by system organ class (SOC) and preferred term (PT), by relationship to study drugs, and by highest severity. For laboratory tests, number and percent of patients shifted from baseline to post-baseline maximum severity in CTCAE grade were summarized.	0.00% 0/3 • Study Day 1 through study completion, average 36 days. Treatment-emergent AEs were summarized by system organ class (SOC) and preferred term (PT), by relationship to study drugs, and by highest severity. For laboratory tests, number and percent of patients shifted from baseline to post-baseline maximum severity in CTCAE grade were summarized.	7.1% 2/28 • Number of events 2 • Study Day 1 through study completion, average 36 days. Treatment-emergent AEs were summarized by system organ class (SOC) and preferred term (PT), by relationship to study drugs, and by highest severity. For laboratory tests, number and percent of patients shifted from baseline to post-baseline maximum severity in CTCAE grade were summarized.
Injury, poisoning and procedural complications Infusion related reaction	20.0% 1/5 • Number of events 1 • Study Day 1 through study completion, average 36 days. Treatment-emergent AEs were summarized by system organ class (SOC) and preferred term (PT), by relationship to study drugs, and by highest severity. For laboratory tests, number and percent of patients shifted from baseline to post-baseline maximum severity in CTCAE grade were summarized.	0.00% 0/3 • Study Day 1 through study completion, average 36 days. Treatment-emergent AEs were summarized by system organ class (SOC) and preferred term (PT), by relationship to study drugs, and by highest severity. For laboratory tests, number and percent of patients shifted from baseline to post-baseline maximum severity in CTCAE grade were summarized.	0.00% 0/28 • Study Day 1 through study completion, average 36 days. Treatment-emergent AEs were summarized by system organ class (SOC) and preferred term (PT), by relationship to study drugs, and by highest severity. For laboratory tests, number and percent of patients shifted from baseline to post-baseline maximum severity in CTCAE grade were summarized.
Gastrointestinal disorders Intussusception	0.00% 0/5 • Study Day 1 through study completion, average 36 days. Treatment-emergent AEs were summarized by system organ class (SOC) and preferred term (PT), by relationship to study drugs, and by highest severity. For laboratory tests, number and percent of patients shifted from baseline to post-baseline maximum severity in CTCAE grade were summarized.	33.3% 1/3 • Number of events 1 • Study Day 1 through study completion, average 36 days. Treatment-emergent AEs were summarized by system organ class (SOC) and preferred term (PT), by relationship to study drugs, and by highest severity. For laboratory tests, number and percent of patients shifted from baseline to post-baseline maximum severity in CTCAE grade were summarized.	0.00% 0/28 • Study Day 1 through study completion, average 36 days. Treatment-emergent AEs were summarized by system organ class (SOC) and preferred term (PT), by relationship to study drugs, and by highest severity. For laboratory tests, number and percent of patients shifted from baseline to post-baseline maximum severity in CTCAE grade were summarized.
Gastrointestinal disorders Abdominal pain	0.00% 0/5 • Study Day 1 through study completion, average 36 days. Treatment-emergent AEs were summarized by system organ class (SOC) and preferred term (PT), by relationship to study drugs, and by highest severity. For laboratory tests, number and percent of patients shifted from baseline to post-baseline maximum severity in CTCAE grade were summarized.	0.00% 0/3 • Study Day 1 through study completion, average 36 days. Treatment-emergent AEs were summarized by system organ class (SOC) and preferred term (PT), by relationship to study drugs, and by highest severity. For laboratory tests, number and percent of patients shifted from baseline to post-baseline maximum severity in CTCAE grade were summarized.	3.6% 1/28 • Number of events 1 • Study Day 1 through study completion, average 36 days. Treatment-emergent AEs were summarized by system organ class (SOC) and preferred term (PT), by relationship to study drugs, and by highest severity. For laboratory tests, number and percent of patients shifted from baseline to post-baseline maximum severity in CTCAE grade were summarized.
Gastrointestinal disorders Pancreatitis	0.00% 0/5 • Study Day 1 through study completion, average 36 days. Treatment-emergent AEs were summarized by system organ class (SOC) and preferred term (PT), by relationship to study drugs, and by highest severity. For laboratory tests, number and percent of patients shifted from baseline to post-baseline maximum severity in CTCAE grade were summarized.	0.00% 0/3 • Study Day 1 through study completion, average 36 days. Treatment-emergent AEs were summarized by system organ class (SOC) and preferred term (PT), by relationship to study drugs, and by highest severity. For laboratory tests, number and percent of patients shifted from baseline to post-baseline maximum severity in CTCAE grade were summarized.	3.6% 1/28 • Number of events 1 • Study Day 1 through study completion, average 36 days. Treatment-emergent AEs were summarized by system organ class (SOC) and preferred term (PT), by relationship to study drugs, and by highest severity. For laboratory tests, number and percent of patients shifted from baseline to post-baseline maximum severity in CTCAE grade were summarized.
Cardiac disorders Acute coronary syndrome	0.00% 0/5 • Study Day 1 through study completion, average 36 days. Treatment-emergent AEs were summarized by system organ class (SOC) and preferred term (PT), by relationship to study drugs, and by highest severity. For laboratory tests, number and percent of patients shifted from baseline to post-baseline maximum severity in CTCAE grade were summarized.	0.00% 0/3 • Study Day 1 through study completion, average 36 days. Treatment-emergent AEs were summarized by system organ class (SOC) and preferred term (PT), by relationship to study drugs, and by highest severity. For laboratory tests, number and percent of patients shifted from baseline to post-baseline maximum severity in CTCAE grade were summarized.	3.6% 1/28 • Number of events 1 • Study Day 1 through study completion, average 36 days. Treatment-emergent AEs were summarized by system organ class (SOC) and preferred term (PT), by relationship to study drugs, and by highest severity. For laboratory tests, number and percent of patients shifted from baseline to post-baseline maximum severity in CTCAE grade were summarized.
Cardiac disorders Acute myocardial infarction	0.00% 0/5 • Study Day 1 through study completion, average 36 days. Treatment-emergent AEs were summarized by system organ class (SOC) and preferred term (PT), by relationship to study drugs, and by highest severity. For laboratory tests, number and percent of patients shifted from baseline to post-baseline maximum severity in CTCAE grade were summarized.	0.00% 0/3 • Study Day 1 through study completion, average 36 days. Treatment-emergent AEs were summarized by system organ class (SOC) and preferred term (PT), by relationship to study drugs, and by highest severity. For laboratory tests, number and percent of patients shifted from baseline to post-baseline maximum severity in CTCAE grade were summarized.	3.6% 1/28 • Number of events 1 • Study Day 1 through study completion, average 36 days. Treatment-emergent AEs were summarized by system organ class (SOC) and preferred term (PT), by relationship to study drugs, and by highest severity. For laboratory tests, number and percent of patients shifted from baseline to post-baseline maximum severity in CTCAE grade were summarized.
Cardiac disorders Sinus tachycardia	0.00% 0/5 • Study Day 1 through study completion, average 36 days. Treatment-emergent AEs were summarized by system organ class (SOC) and preferred term (PT), by relationship to study drugs, and by highest severity. For laboratory tests, number and percent of patients shifted from baseline to post-baseline maximum severity in CTCAE grade were summarized.	0.00% 0/3 • Study Day 1 through study completion, average 36 days. Treatment-emergent AEs were summarized by system organ class (SOC) and preferred term (PT), by relationship to study drugs, and by highest severity. For laboratory tests, number and percent of patients shifted from baseline to post-baseline maximum severity in CTCAE grade were summarized.	3.6% 1/28 • Number of events 1 • Study Day 1 through study completion, average 36 days. Treatment-emergent AEs were summarized by system organ class (SOC) and preferred term (PT), by relationship to study drugs, and by highest severity. For laboratory tests, number and percent of patients shifted from baseline to post-baseline maximum severity in CTCAE grade were summarized.
Immune system disorders Cytokine release syndrome	0.00% 0/5 • Study Day 1 through study completion, average 36 days. Treatment-emergent AEs were summarized by system organ class (SOC) and preferred term (PT), by relationship to study drugs, and by highest severity. For laboratory tests, number and percent of patients shifted from baseline to post-baseline maximum severity in CTCAE grade were summarized.	0.00% 0/3 • Study Day 1 through study completion, average 36 days. Treatment-emergent AEs were summarized by system organ class (SOC) and preferred term (PT), by relationship to study drugs, and by highest severity. For laboratory tests, number and percent of patients shifted from baseline to post-baseline maximum severity in CTCAE grade were summarized.	3.6% 1/28 • Number of events 1 • Study Day 1 through study completion, average 36 days. Treatment-emergent AEs were summarized by system organ class (SOC) and preferred term (PT), by relationship to study drugs, and by highest severity. For laboratory tests, number and percent of patients shifted from baseline to post-baseline maximum severity in CTCAE grade were summarized.
Infections and infestations Biliary tract infection	0.00% 0/5 • Study Day 1 through study completion, average 36 days. Treatment-emergent AEs were summarized by system organ class (SOC) and preferred term (PT), by relationship to study drugs, and by highest severity. For laboratory tests, number and percent of patients shifted from baseline to post-baseline maximum severity in CTCAE grade were summarized.	0.00% 0/3 • Study Day 1 through study completion, average 36 days. Treatment-emergent AEs were summarized by system organ class (SOC) and preferred term (PT), by relationship to study drugs, and by highest severity. For laboratory tests, number and percent of patients shifted from baseline to post-baseline maximum severity in CTCAE grade were summarized.	3.6% 1/28 • Number of events 1 • Study Day 1 through study completion, average 36 days. Treatment-emergent AEs were summarized by system organ class (SOC) and preferred term (PT), by relationship to study drugs, and by highest severity. For laboratory tests, number and percent of patients shifted from baseline to post-baseline maximum severity in CTCAE grade were summarized.
Infections and infestations Klebsiella sepsis	0.00% 0/5 • Study Day 1 through study completion, average 36 days. Treatment-emergent AEs were summarized by system organ class (SOC) and preferred term (PT), by relationship to study drugs, and by highest severity. For laboratory tests, number and percent of patients shifted from baseline to post-baseline maximum severity in CTCAE grade were summarized.	0.00% 0/3 • Study Day 1 through study completion, average 36 days. Treatment-emergent AEs were summarized by system organ class (SOC) and preferred term (PT), by relationship to study drugs, and by highest severity. For laboratory tests, number and percent of patients shifted from baseline to post-baseline maximum severity in CTCAE grade were summarized.	3.6% 1/28 • Number of events 1 • Study Day 1 through study completion, average 36 days. Treatment-emergent AEs were summarized by system organ class (SOC) and preferred term (PT), by relationship to study drugs, and by highest severity. For laboratory tests, number and percent of patients shifted from baseline to post-baseline maximum severity in CTCAE grade were summarized.
Infections and infestations Liver abscess	0.00% 0/5 • Study Day 1 through study completion, average 36 days. Treatment-emergent AEs were summarized by system organ class (SOC) and preferred term (PT), by relationship to study drugs, and by highest severity. For laboratory tests, number and percent of patients shifted from baseline to post-baseline maximum severity in CTCAE grade were summarized.	0.00% 0/3 • Study Day 1 through study completion, average 36 days. Treatment-emergent AEs were summarized by system organ class (SOC) and preferred term (PT), by relationship to study drugs, and by highest severity. For laboratory tests, number and percent of patients shifted from baseline to post-baseline maximum severity in CTCAE grade were summarized.	3.6% 1/28 • Number of events 1 • Study Day 1 through study completion, average 36 days. Treatment-emergent AEs were summarized by system organ class (SOC) and preferred term (PT), by relationship to study drugs, and by highest severity. For laboratory tests, number and percent of patients shifted from baseline to post-baseline maximum severity in CTCAE grade were summarized.
Renal and urinary disorders Renal colic	0.00% 0/5 • Study Day 1 through study completion, average 36 days. Treatment-emergent AEs were summarized by system organ class (SOC) and preferred term (PT), by relationship to study drugs, and by highest severity. For laboratory tests, number and percent of patients shifted from baseline to post-baseline maximum severity in CTCAE grade were summarized.	0.00% 0/3 • Study Day 1 through study completion, average 36 days. Treatment-emergent AEs were summarized by system organ class (SOC) and preferred term (PT), by relationship to study drugs, and by highest severity. For laboratory tests, number and percent of patients shifted from baseline to post-baseline maximum severity in CTCAE grade were summarized.	3.6% 1/28 • Number of events 1 • Study Day 1 through study completion, average 36 days. Treatment-emergent AEs were summarized by system organ class (SOC) and preferred term (PT), by relationship to study drugs, and by highest severity. For laboratory tests, number and percent of patients shifted from baseline to post-baseline maximum severity in CTCAE grade were summarized.
Respiratory, thoracic and mediastinal disorders Dyspnea	0.00% 0/5 • Study Day 1 through study completion, average 36 days. Treatment-emergent AEs were summarized by system organ class (SOC) and preferred term (PT), by relationship to study drugs, and by highest severity. For laboratory tests, number and percent of patients shifted from baseline to post-baseline maximum severity in CTCAE grade were summarized.	0.00% 0/3 • Study Day 1 through study completion, average 36 days. Treatment-emergent AEs were summarized by system organ class (SOC) and preferred term (PT), by relationship to study drugs, and by highest severity. For laboratory tests, number and percent of patients shifted from baseline to post-baseline maximum severity in CTCAE grade were summarized.	3.6% 1/28 • Number of events 1 • Study Day 1 through study completion, average 36 days. Treatment-emergent AEs were summarized by system organ class (SOC) and preferred term (PT), by relationship to study drugs, and by highest severity. For laboratory tests, number and percent of patients shifted from baseline to post-baseline maximum severity in CTCAE grade were summarized.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/5 • Study Day 1 through study completion, average 36 days. Treatment-emergent AEs were summarized by system organ class (SOC) and preferred term (PT), by relationship to study drugs, and by highest severity. For laboratory tests, number and percent of patients shifted from baseline to post-baseline maximum severity in CTCAE grade were summarized.	0.00% 0/3 • Study Day 1 through study completion, average 36 days. Treatment-emergent AEs were summarized by system organ class (SOC) and preferred term (PT), by relationship to study drugs, and by highest severity. For laboratory tests, number and percent of patients shifted from baseline to post-baseline maximum severity in CTCAE grade were summarized.	3.6% 1/28 • Number of events 1 • Study Day 1 through study completion, average 36 days. Treatment-emergent AEs were summarized by system organ class (SOC) and preferred term (PT), by relationship to study drugs, and by highest severity. For laboratory tests, number and percent of patients shifted from baseline to post-baseline maximum severity in CTCAE grade were summarized.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/5 • Study Day 1 through study completion, average 36 days. Treatment-emergent AEs were summarized by system organ class (SOC) and preferred term (PT), by relationship to study drugs, and by highest severity. For laboratory tests, number and percent of patients shifted from baseline to post-baseline maximum severity in CTCAE grade were summarized.	0.00% 0/3 • Study Day 1 through study completion, average 36 days. Treatment-emergent AEs were summarized by system organ class (SOC) and preferred term (PT), by relationship to study drugs, and by highest severity. For laboratory tests, number and percent of patients shifted from baseline to post-baseline maximum severity in CTCAE grade were summarized.	3.6% 1/28 • Number of events 1 • Study Day 1 through study completion, average 36 days. Treatment-emergent AEs were summarized by system organ class (SOC) and preferred term (PT), by relationship to study drugs, and by highest severity. For laboratory tests, number and percent of patients shifted from baseline to post-baseline maximum severity in CTCAE grade were summarized.
Vascular disorders Embolism	0.00% 0/5 • Study Day 1 through study completion, average 36 days. Treatment-emergent AEs were summarized by system organ class (SOC) and preferred term (PT), by relationship to study drugs, and by highest severity. For laboratory tests, number and percent of patients shifted from baseline to post-baseline maximum severity in CTCAE grade were summarized.	0.00% 0/3 • Study Day 1 through study completion, average 36 days. Treatment-emergent AEs were summarized by system organ class (SOC) and preferred term (PT), by relationship to study drugs, and by highest severity. For laboratory tests, number and percent of patients shifted from baseline to post-baseline maximum severity in CTCAE grade were summarized.	3.6% 1/28 • Number of events 1 • Study Day 1 through study completion, average 36 days. Treatment-emergent AEs were summarized by system organ class (SOC) and preferred term (PT), by relationship to study drugs, and by highest severity. For laboratory tests, number and percent of patients shifted from baseline to post-baseline maximum severity in CTCAE grade were summarized.

Other adverse events
Measure	Dose Level 1 n=5 participants at risk 0.4 mcg/kg MGD007 administered by intravenous (IV) infusion once per week in 8-week cycles, plus 3 mg/kg MGA012 administered by IV infusion once every 2 weeks.	Dose Level 2 n=3 participants at risk 0.6 mcg/kg MGD007 administered by intravenous (IV) infusion once per week in 8-week cycles, plus 3 mg/kg MGA012 administered by IV infusion once every 2 weeks.	Dose Level 3 n=28 participants at risk 0.8 mcg/kg MGD007 administered by intravenous (IV) infusion once per week in 8-week cycles, plus 3 mg/kg MGA012 administered by IV infusion once every 2 weeks.
Blood and lymphatic system disorders Anaemia	0.00% 0/5 • Study Day 1 through study completion, average 36 days. Treatment-emergent AEs were summarized by system organ class (SOC) and preferred term (PT), by relationship to study drugs, and by highest severity. For laboratory tests, number and percent of patients shifted from baseline to post-baseline maximum severity in CTCAE grade were summarized.	33.3% 1/3 • Number of events 1 • Study Day 1 through study completion, average 36 days. Treatment-emergent AEs were summarized by system organ class (SOC) and preferred term (PT), by relationship to study drugs, and by highest severity. For laboratory tests, number and percent of patients shifted from baseline to post-baseline maximum severity in CTCAE grade were summarized.	25.0% 7/28 • Number of events 7 • Study Day 1 through study completion, average 36 days. Treatment-emergent AEs were summarized by system organ class (SOC) and preferred term (PT), by relationship to study drugs, and by highest severity. For laboratory tests, number and percent of patients shifted from baseline to post-baseline maximum severity in CTCAE grade were summarized.
Blood and lymphatic system disorders Lymphopenia	60.0% 3/5 • Number of events 3 • Study Day 1 through study completion, average 36 days. Treatment-emergent AEs were summarized by system organ class (SOC) and preferred term (PT), by relationship to study drugs, and by highest severity. For laboratory tests, number and percent of patients shifted from baseline to post-baseline maximum severity in CTCAE grade were summarized.	33.3% 1/3 • Number of events 1 • Study Day 1 through study completion, average 36 days. Treatment-emergent AEs were summarized by system organ class (SOC) and preferred term (PT), by relationship to study drugs, and by highest severity. For laboratory tests, number and percent of patients shifted from baseline to post-baseline maximum severity in CTCAE grade were summarized.	3.6% 1/28 • Number of events 1 • Study Day 1 through study completion, average 36 days. Treatment-emergent AEs were summarized by system organ class (SOC) and preferred term (PT), by relationship to study drugs, and by highest severity. For laboratory tests, number and percent of patients shifted from baseline to post-baseline maximum severity in CTCAE grade were summarized.
Cardiac disorders Tachycardia	0.00% 0/5 • Study Day 1 through study completion, average 36 days. Treatment-emergent AEs were summarized by system organ class (SOC) and preferred term (PT), by relationship to study drugs, and by highest severity. For laboratory tests, number and percent of patients shifted from baseline to post-baseline maximum severity in CTCAE grade were summarized.	33.3% 1/3 • Number of events 1 • Study Day 1 through study completion, average 36 days. Treatment-emergent AEs were summarized by system organ class (SOC) and preferred term (PT), by relationship to study drugs, and by highest severity. For laboratory tests, number and percent of patients shifted from baseline to post-baseline maximum severity in CTCAE grade were summarized.	7.1% 2/28 • Number of events 2 • Study Day 1 through study completion, average 36 days. Treatment-emergent AEs were summarized by system organ class (SOC) and preferred term (PT), by relationship to study drugs, and by highest severity. For laboratory tests, number and percent of patients shifted from baseline to post-baseline maximum severity in CTCAE grade were summarized.
Cardiac disorders Sinus tachycardia	0.00% 0/5 • Study Day 1 through study completion, average 36 days. Treatment-emergent AEs were summarized by system organ class (SOC) and preferred term (PT), by relationship to study drugs, and by highest severity. For laboratory tests, number and percent of patients shifted from baseline to post-baseline maximum severity in CTCAE grade were summarized.	0.00% 0/3 • Study Day 1 through study completion, average 36 days. Treatment-emergent AEs were summarized by system organ class (SOC) and preferred term (PT), by relationship to study drugs, and by highest severity. For laboratory tests, number and percent of patients shifted from baseline to post-baseline maximum severity in CTCAE grade were summarized.	7.1% 2/28 • Number of events 2 • Study Day 1 through study completion, average 36 days. Treatment-emergent AEs were summarized by system organ class (SOC) and preferred term (PT), by relationship to study drugs, and by highest severity. For laboratory tests, number and percent of patients shifted from baseline to post-baseline maximum severity in CTCAE grade were summarized.
Cardiac disorders Sinus bradycardia	20.0% 1/5 • Number of events 1 • Study Day 1 through study completion, average 36 days. Treatment-emergent AEs were summarized by system organ class (SOC) and preferred term (PT), by relationship to study drugs, and by highest severity. For laboratory tests, number and percent of patients shifted from baseline to post-baseline maximum severity in CTCAE grade were summarized.	0.00% 0/3 • Study Day 1 through study completion, average 36 days. Treatment-emergent AEs were summarized by system organ class (SOC) and preferred term (PT), by relationship to study drugs, and by highest severity. For laboratory tests, number and percent of patients shifted from baseline to post-baseline maximum severity in CTCAE grade were summarized.	0.00% 0/28 • Study Day 1 through study completion, average 36 days. Treatment-emergent AEs were summarized by system organ class (SOC) and preferred term (PT), by relationship to study drugs, and by highest severity. For laboratory tests, number and percent of patients shifted from baseline to post-baseline maximum severity in CTCAE grade were summarized.
Endocrine disorders Hypothyroidism	0.00% 0/5 • Study Day 1 through study completion, average 36 days. Treatment-emergent AEs were summarized by system organ class (SOC) and preferred term (PT), by relationship to study drugs, and by highest severity. For laboratory tests, number and percent of patients shifted from baseline to post-baseline maximum severity in CTCAE grade were summarized.	33.3% 1/3 • Number of events 1 • Study Day 1 through study completion, average 36 days. Treatment-emergent AEs were summarized by system organ class (SOC) and preferred term (PT), by relationship to study drugs, and by highest severity. For laboratory tests, number and percent of patients shifted from baseline to post-baseline maximum severity in CTCAE grade were summarized.	0.00% 0/28 • Study Day 1 through study completion, average 36 days. Treatment-emergent AEs were summarized by system organ class (SOC) and preferred term (PT), by relationship to study drugs, and by highest severity. For laboratory tests, number and percent of patients shifted from baseline to post-baseline maximum severity in CTCAE grade were summarized.
Gastrointestinal disorders Diarrhoea	20.0% 1/5 • Number of events 1 • Study Day 1 through study completion, average 36 days. Treatment-emergent AEs were summarized by system organ class (SOC) and preferred term (PT), by relationship to study drugs, and by highest severity. For laboratory tests, number and percent of patients shifted from baseline to post-baseline maximum severity in CTCAE grade were summarized.	0.00% 0/3 • Study Day 1 through study completion, average 36 days. Treatment-emergent AEs were summarized by system organ class (SOC) and preferred term (PT), by relationship to study drugs, and by highest severity. For laboratory tests, number and percent of patients shifted from baseline to post-baseline maximum severity in CTCAE grade were summarized.	85.7% 24/28 • Number of events 24 • Study Day 1 through study completion, average 36 days. Treatment-emergent AEs were summarized by system organ class (SOC) and preferred term (PT), by relationship to study drugs, and by highest severity. For laboratory tests, number and percent of patients shifted from baseline to post-baseline maximum severity in CTCAE grade were summarized.
Gastrointestinal disorders Vomiting	0.00% 0/5 • Study Day 1 through study completion, average 36 days. Treatment-emergent AEs were summarized by system organ class (SOC) and preferred term (PT), by relationship to study drugs, and by highest severity. For laboratory tests, number and percent of patients shifted from baseline to post-baseline maximum severity in CTCAE grade were summarized.	66.7% 2/3 • Number of events 2 • Study Day 1 through study completion, average 36 days. Treatment-emergent AEs were summarized by system organ class (SOC) and preferred term (PT), by relationship to study drugs, and by highest severity. For laboratory tests, number and percent of patients shifted from baseline to post-baseline maximum severity in CTCAE grade were summarized.	82.1% 23/28 • Number of events 23 • Study Day 1 through study completion, average 36 days. Treatment-emergent AEs were summarized by system organ class (SOC) and preferred term (PT), by relationship to study drugs, and by highest severity. For laboratory tests, number and percent of patients shifted from baseline to post-baseline maximum severity in CTCAE grade were summarized.
Gastrointestinal disorders Abdominal pain	100.0% 5/5 • Number of events 5 • Study Day 1 through study completion, average 36 days. Treatment-emergent AEs were summarized by system organ class (SOC) and preferred term (PT), by relationship to study drugs, and by highest severity. For laboratory tests, number and percent of patients shifted from baseline to post-baseline maximum severity in CTCAE grade were summarized.	66.7% 2/3 • Number of events 2 • Study Day 1 through study completion, average 36 days. Treatment-emergent AEs were summarized by system organ class (SOC) and preferred term (PT), by relationship to study drugs, and by highest severity. For laboratory tests, number and percent of patients shifted from baseline to post-baseline maximum severity in CTCAE grade were summarized.	57.1% 16/28 • Number of events 16 • Study Day 1 through study completion, average 36 days. Treatment-emergent AEs were summarized by system organ class (SOC) and preferred term (PT), by relationship to study drugs, and by highest severity. For laboratory tests, number and percent of patients shifted from baseline to post-baseline maximum severity in CTCAE grade were summarized.
Gastrointestinal disorders Nausea	40.0% 2/5 • Number of events 2 • Study Day 1 through study completion, average 36 days. Treatment-emergent AEs were summarized by system organ class (SOC) and preferred term (PT), by relationship to study drugs, and by highest severity. For laboratory tests, number and percent of patients shifted from baseline to post-baseline maximum severity in CTCAE grade were summarized.	33.3% 1/3 • Number of events 1 • Study Day 1 through study completion, average 36 days. Treatment-emergent AEs were summarized by system organ class (SOC) and preferred term (PT), by relationship to study drugs, and by highest severity. For laboratory tests, number and percent of patients shifted from baseline to post-baseline maximum severity in CTCAE grade were summarized.	71.4% 20/28 • Number of events 20 • Study Day 1 through study completion, average 36 days. Treatment-emergent AEs were summarized by system organ class (SOC) and preferred term (PT), by relationship to study drugs, and by highest severity. For laboratory tests, number and percent of patients shifted from baseline to post-baseline maximum severity in CTCAE grade were summarized.
Gastrointestinal disorders Abdominal distension	40.0% 2/5 • Number of events 2 • Study Day 1 through study completion, average 36 days. Treatment-emergent AEs were summarized by system organ class (SOC) and preferred term (PT), by relationship to study drugs, and by highest severity. For laboratory tests, number and percent of patients shifted from baseline to post-baseline maximum severity in CTCAE grade were summarized.	33.3% 1/3 • Number of events 1 • Study Day 1 through study completion, average 36 days. Treatment-emergent AEs were summarized by system organ class (SOC) and preferred term (PT), by relationship to study drugs, and by highest severity. For laboratory tests, number and percent of patients shifted from baseline to post-baseline maximum severity in CTCAE grade were summarized.	21.4% 6/28 • Number of events 6 • Study Day 1 through study completion, average 36 days. Treatment-emergent AEs were summarized by system organ class (SOC) and preferred term (PT), by relationship to study drugs, and by highest severity. For laboratory tests, number and percent of patients shifted from baseline to post-baseline maximum severity in CTCAE grade were summarized.
Gastrointestinal disorders Constipation	20.0% 1/5 • Number of events 1 • Study Day 1 through study completion, average 36 days. Treatment-emergent AEs were summarized by system organ class (SOC) and preferred term (PT), by relationship to study drugs, and by highest severity. For laboratory tests, number and percent of patients shifted from baseline to post-baseline maximum severity in CTCAE grade were summarized.	66.7% 2/3 • Number of events 2 • Study Day 1 through study completion, average 36 days. Treatment-emergent AEs were summarized by system organ class (SOC) and preferred term (PT), by relationship to study drugs, and by highest severity. For laboratory tests, number and percent of patients shifted from baseline to post-baseline maximum severity in CTCAE grade were summarized.	17.9% 5/28 • Number of events 5 • Study Day 1 through study completion, average 36 days. Treatment-emergent AEs were summarized by system organ class (SOC) and preferred term (PT), by relationship to study drugs, and by highest severity. For laboratory tests, number and percent of patients shifted from baseline to post-baseline maximum severity in CTCAE grade were summarized.
Gastrointestinal disorders Ascites	20.0% 1/5 • Number of events 1 • Study Day 1 through study completion, average 36 days. Treatment-emergent AEs were summarized by system organ class (SOC) and preferred term (PT), by relationship to study drugs, and by highest severity. For laboratory tests, number and percent of patients shifted from baseline to post-baseline maximum severity in CTCAE grade were summarized.	0.00% 0/3 • Study Day 1 through study completion, average 36 days. Treatment-emergent AEs were summarized by system organ class (SOC) and preferred term (PT), by relationship to study drugs, and by highest severity. For laboratory tests, number and percent of patients shifted from baseline to post-baseline maximum severity in CTCAE grade were summarized.	10.7% 3/28 • Number of events 3 • Study Day 1 through study completion, average 36 days. Treatment-emergent AEs were summarized by system organ class (SOC) and preferred term (PT), by relationship to study drugs, and by highest severity. For laboratory tests, number and percent of patients shifted from baseline to post-baseline maximum severity in CTCAE grade were summarized.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/5 • Study Day 1 through study completion, average 36 days. Treatment-emergent AEs were summarized by system organ class (SOC) and preferred term (PT), by relationship to study drugs, and by highest severity. For laboratory tests, number and percent of patients shifted from baseline to post-baseline maximum severity in CTCAE grade were summarized.	0.00% 0/3 • Study Day 1 through study completion, average 36 days. Treatment-emergent AEs were summarized by system organ class (SOC) and preferred term (PT), by relationship to study drugs, and by highest severity. For laboratory tests, number and percent of patients shifted from baseline to post-baseline maximum severity in CTCAE grade were summarized.	10.7% 3/28 • Number of events 3 • Study Day 1 through study completion, average 36 days. Treatment-emergent AEs were summarized by system organ class (SOC) and preferred term (PT), by relationship to study drugs, and by highest severity. For laboratory tests, number and percent of patients shifted from baseline to post-baseline maximum severity in CTCAE grade were summarized.
Gastrointestinal disorders Flatulence	0.00% 0/5 • Study Day 1 through study completion, average 36 days. Treatment-emergent AEs were summarized by system organ class (SOC) and preferred term (PT), by relationship to study drugs, and by highest severity. For laboratory tests, number and percent of patients shifted from baseline to post-baseline maximum severity in CTCAE grade were summarized.	0.00% 0/3 • Study Day 1 through study completion, average 36 days. Treatment-emergent AEs were summarized by system organ class (SOC) and preferred term (PT), by relationship to study drugs, and by highest severity. For laboratory tests, number and percent of patients shifted from baseline to post-baseline maximum severity in CTCAE grade were summarized.	10.7% 3/28 • Number of events 3 • Study Day 1 through study completion, average 36 days. Treatment-emergent AEs were summarized by system organ class (SOC) and preferred term (PT), by relationship to study drugs, and by highest severity. For laboratory tests, number and percent of patients shifted from baseline to post-baseline maximum severity in CTCAE grade were summarized.
Gastrointestinal disorders Gastritis	0.00% 0/5 • Study Day 1 through study completion, average 36 days. Treatment-emergent AEs were summarized by system organ class (SOC) and preferred term (PT), by relationship to study drugs, and by highest severity. For laboratory tests, number and percent of patients shifted from baseline to post-baseline maximum severity in CTCAE grade were summarized.	33.3% 1/3 • Number of events 1 • Study Day 1 through study completion, average 36 days. Treatment-emergent AEs were summarized by system organ class (SOC) and preferred term (PT), by relationship to study drugs, and by highest severity. For laboratory tests, number and percent of patients shifted from baseline to post-baseline maximum severity in CTCAE grade were summarized.	3.6% 1/28 • Number of events 1 • Study Day 1 through study completion, average 36 days. Treatment-emergent AEs were summarized by system organ class (SOC) and preferred term (PT), by relationship to study drugs, and by highest severity. For laboratory tests, number and percent of patients shifted from baseline to post-baseline maximum severity in CTCAE grade were summarized.
Gastrointestinal disorders Haematochezia	0.00% 0/5 • Study Day 1 through study completion, average 36 days. Treatment-emergent AEs were summarized by system organ class (SOC) and preferred term (PT), by relationship to study drugs, and by highest severity. For laboratory tests, number and percent of patients shifted from baseline to post-baseline maximum severity in CTCAE grade were summarized.	0.00% 0/3 • Study Day 1 through study completion, average 36 days. Treatment-emergent AEs were summarized by system organ class (SOC) and preferred term (PT), by relationship to study drugs, and by highest severity. For laboratory tests, number and percent of patients shifted from baseline to post-baseline maximum severity in CTCAE grade were summarized.	7.1% 2/28 • Number of events 2 • Study Day 1 through study completion, average 36 days. Treatment-emergent AEs were summarized by system organ class (SOC) and preferred term (PT), by relationship to study drugs, and by highest severity. For laboratory tests, number and percent of patients shifted from baseline to post-baseline maximum severity in CTCAE grade were summarized.
Gastrointestinal disorders Proctitis	0.00% 0/5 • Study Day 1 through study completion, average 36 days. Treatment-emergent AEs were summarized by system organ class (SOC) and preferred term (PT), by relationship to study drugs, and by highest severity. For laboratory tests, number and percent of patients shifted from baseline to post-baseline maximum severity in CTCAE grade were summarized.	33.3% 1/3 • Number of events 1 • Study Day 1 through study completion, average 36 days. Treatment-emergent AEs were summarized by system organ class (SOC) and preferred term (PT), by relationship to study drugs, and by highest severity. For laboratory tests, number and percent of patients shifted from baseline to post-baseline maximum severity in CTCAE grade were summarized.	3.6% 1/28 • Number of events 1 • Study Day 1 through study completion, average 36 days. Treatment-emergent AEs were summarized by system organ class (SOC) and preferred term (PT), by relationship to study drugs, and by highest severity. For laboratory tests, number and percent of patients shifted from baseline to post-baseline maximum severity in CTCAE grade were summarized.
Gastrointestinal disorders Intussusception	0.00% 0/5 • Study Day 1 through study completion, average 36 days. Treatment-emergent AEs were summarized by system organ class (SOC) and preferred term (PT), by relationship to study drugs, and by highest severity. For laboratory tests, number and percent of patients shifted from baseline to post-baseline maximum severity in CTCAE grade were summarized.	33.3% 1/3 • Number of events 1 • Study Day 1 through study completion, average 36 days. Treatment-emergent AEs were summarized by system organ class (SOC) and preferred term (PT), by relationship to study drugs, and by highest severity. For laboratory tests, number and percent of patients shifted from baseline to post-baseline maximum severity in CTCAE grade were summarized.	0.00% 0/28 • Study Day 1 through study completion, average 36 days. Treatment-emergent AEs were summarized by system organ class (SOC) and preferred term (PT), by relationship to study drugs, and by highest severity. For laboratory tests, number and percent of patients shifted from baseline to post-baseline maximum severity in CTCAE grade were summarized.
Gastrointestinal disorders Proctalgia	0.00% 0/5 • Study Day 1 through study completion, average 36 days. Treatment-emergent AEs were summarized by system organ class (SOC) and preferred term (PT), by relationship to study drugs, and by highest severity. For laboratory tests, number and percent of patients shifted from baseline to post-baseline maximum severity in CTCAE grade were summarized.	33.3% 1/3 • Number of events 1 • Study Day 1 through study completion, average 36 days. Treatment-emergent AEs were summarized by system organ class (SOC) and preferred term (PT), by relationship to study drugs, and by highest severity. For laboratory tests, number and percent of patients shifted from baseline to post-baseline maximum severity in CTCAE grade were summarized.	0.00% 0/28 • Study Day 1 through study completion, average 36 days. Treatment-emergent AEs were summarized by system organ class (SOC) and preferred term (PT), by relationship to study drugs, and by highest severity. For laboratory tests, number and percent of patients shifted from baseline to post-baseline maximum severity in CTCAE grade were summarized.
General disorders Fatigue	20.0% 1/5 • Number of events 1 • Study Day 1 through study completion, average 36 days. Treatment-emergent AEs were summarized by system organ class (SOC) and preferred term (PT), by relationship to study drugs, and by highest severity. For laboratory tests, number and percent of patients shifted from baseline to post-baseline maximum severity in CTCAE grade were summarized.	33.3% 1/3 • Number of events 1 • Study Day 1 through study completion, average 36 days. Treatment-emergent AEs were summarized by system organ class (SOC) and preferred term (PT), by relationship to study drugs, and by highest severity. For laboratory tests, number and percent of patients shifted from baseline to post-baseline maximum severity in CTCAE grade were summarized.	57.1% 16/28 • Number of events 16 • Study Day 1 through study completion, average 36 days. Treatment-emergent AEs were summarized by system organ class (SOC) and preferred term (PT), by relationship to study drugs, and by highest severity. For laboratory tests, number and percent of patients shifted from baseline to post-baseline maximum severity in CTCAE grade were summarized.
General disorders Pyrexia	20.0% 1/5 • Number of events 1 • Study Day 1 through study completion, average 36 days. Treatment-emergent AEs were summarized by system organ class (SOC) and preferred term (PT), by relationship to study drugs, and by highest severity. For laboratory tests, number and percent of patients shifted from baseline to post-baseline maximum severity in CTCAE grade were summarized.	33.3% 1/3 • Number of events 1 • Study Day 1 through study completion, average 36 days. Treatment-emergent AEs were summarized by system organ class (SOC) and preferred term (PT), by relationship to study drugs, and by highest severity. For laboratory tests, number and percent of patients shifted from baseline to post-baseline maximum severity in CTCAE grade were summarized.	35.7% 10/28 • Number of events 10 • Study Day 1 through study completion, average 36 days. Treatment-emergent AEs were summarized by system organ class (SOC) and preferred term (PT), by relationship to study drugs, and by highest severity. For laboratory tests, number and percent of patients shifted from baseline to post-baseline maximum severity in CTCAE grade were summarized.
General disorders Oedema peripheral	40.0% 2/5 • Number of events 2 • Study Day 1 through study completion, average 36 days. Treatment-emergent AEs were summarized by system organ class (SOC) and preferred term (PT), by relationship to study drugs, and by highest severity. For laboratory tests, number and percent of patients shifted from baseline to post-baseline maximum severity in CTCAE grade were summarized.	0.00% 0/3 • Study Day 1 through study completion, average 36 days. Treatment-emergent AEs were summarized by system organ class (SOC) and preferred term (PT), by relationship to study drugs, and by highest severity. For laboratory tests, number and percent of patients shifted from baseline to post-baseline maximum severity in CTCAE grade were summarized.	25.0% 7/28 • Number of events 7 • Study Day 1 through study completion, average 36 days. Treatment-emergent AEs were summarized by system organ class (SOC) and preferred term (PT), by relationship to study drugs, and by highest severity. For laboratory tests, number and percent of patients shifted from baseline to post-baseline maximum severity in CTCAE grade were summarized.
General disorders Chills	0.00% 0/5 • Study Day 1 through study completion, average 36 days. Treatment-emergent AEs were summarized by system organ class (SOC) and preferred term (PT), by relationship to study drugs, and by highest severity. For laboratory tests, number and percent of patients shifted from baseline to post-baseline maximum severity in CTCAE grade were summarized.	0.00% 0/3 • Study Day 1 through study completion, average 36 days. Treatment-emergent AEs were summarized by system organ class (SOC) and preferred term (PT), by relationship to study drugs, and by highest severity. For laboratory tests, number and percent of patients shifted from baseline to post-baseline maximum severity in CTCAE grade were summarized.	21.4% 6/28 • Number of events 6 • Study Day 1 through study completion, average 36 days. Treatment-emergent AEs were summarized by system organ class (SOC) and preferred term (PT), by relationship to study drugs, and by highest severity. For laboratory tests, number and percent of patients shifted from baseline to post-baseline maximum severity in CTCAE grade were summarized.
General disorders Non-cardiac chest pain	0.00% 0/5 • Study Day 1 through study completion, average 36 days. Treatment-emergent AEs were summarized by system organ class (SOC) and preferred term (PT), by relationship to study drugs, and by highest severity. For laboratory tests, number and percent of patients shifted from baseline to post-baseline maximum severity in CTCAE grade were summarized.	0.00% 0/3 • Study Day 1 through study completion, average 36 days. Treatment-emergent AEs were summarized by system organ class (SOC) and preferred term (PT), by relationship to study drugs, and by highest severity. For laboratory tests, number and percent of patients shifted from baseline to post-baseline maximum severity in CTCAE grade were summarized.	10.7% 3/28 • Number of events 3 • Study Day 1 through study completion, average 36 days. Treatment-emergent AEs were summarized by system organ class (SOC) and preferred term (PT), by relationship to study drugs, and by highest severity. For laboratory tests, number and percent of patients shifted from baseline to post-baseline maximum severity in CTCAE grade were summarized.
General disorders Influenza like illness	0.00% 0/5 • Study Day 1 through study completion, average 36 days. Treatment-emergent AEs were summarized by system organ class (SOC) and preferred term (PT), by relationship to study drugs, and by highest severity. For laboratory tests, number and percent of patients shifted from baseline to post-baseline maximum severity in CTCAE grade were summarized.	0.00% 0/3 • Study Day 1 through study completion, average 36 days. Treatment-emergent AEs were summarized by system organ class (SOC) and preferred term (PT), by relationship to study drugs, and by highest severity. For laboratory tests, number and percent of patients shifted from baseline to post-baseline maximum severity in CTCAE grade were summarized.	7.1% 2/28 • Number of events 2 • Study Day 1 through study completion, average 36 days. Treatment-emergent AEs were summarized by system organ class (SOC) and preferred term (PT), by relationship to study drugs, and by highest severity. For laboratory tests, number and percent of patients shifted from baseline to post-baseline maximum severity in CTCAE grade were summarized.
General disorders Injection site reaction	0.00% 0/5 • Study Day 1 through study completion, average 36 days. Treatment-emergent AEs were summarized by system organ class (SOC) and preferred term (PT), by relationship to study drugs, and by highest severity. For laboratory tests, number and percent of patients shifted from baseline to post-baseline maximum severity in CTCAE grade were summarized.	33.3% 1/3 • Number of events 1 • Study Day 1 through study completion, average 36 days. Treatment-emergent AEs were summarized by system organ class (SOC) and preferred term (PT), by relationship to study drugs, and by highest severity. For laboratory tests, number and percent of patients shifted from baseline to post-baseline maximum severity in CTCAE grade were summarized.	0.00% 0/28 • Study Day 1 through study completion, average 36 days. Treatment-emergent AEs were summarized by system organ class (SOC) and preferred term (PT), by relationship to study drugs, and by highest severity. For laboratory tests, number and percent of patients shifted from baseline to post-baseline maximum severity in CTCAE grade were summarized.
General disorders Cytokine release syndrome	0.00% 0/5 • Study Day 1 through study completion, average 36 days. Treatment-emergent AEs were summarized by system organ class (SOC) and preferred term (PT), by relationship to study drugs, and by highest severity. For laboratory tests, number and percent of patients shifted from baseline to post-baseline maximum severity in CTCAE grade were summarized.	0.00% 0/3 • Study Day 1 through study completion, average 36 days. Treatment-emergent AEs were summarized by system organ class (SOC) and preferred term (PT), by relationship to study drugs, and by highest severity. For laboratory tests, number and percent of patients shifted from baseline to post-baseline maximum severity in CTCAE grade were summarized.	7.1% 2/28 • Number of events 2 • Study Day 1 through study completion, average 36 days. Treatment-emergent AEs were summarized by system organ class (SOC) and preferred term (PT), by relationship to study drugs, and by highest severity. For laboratory tests, number and percent of patients shifted from baseline to post-baseline maximum severity in CTCAE grade were summarized.
Infections and infestations Upper respiratory tract infection	0.00% 0/5 • Study Day 1 through study completion, average 36 days. Treatment-emergent AEs were summarized by system organ class (SOC) and preferred term (PT), by relationship to study drugs, and by highest severity. For laboratory tests, number and percent of patients shifted from baseline to post-baseline maximum severity in CTCAE grade were summarized.	0.00% 0/3 • Study Day 1 through study completion, average 36 days. Treatment-emergent AEs were summarized by system organ class (SOC) and preferred term (PT), by relationship to study drugs, and by highest severity. For laboratory tests, number and percent of patients shifted from baseline to post-baseline maximum severity in CTCAE grade were summarized.	7.1% 2/28 • Number of events 2 • Study Day 1 through study completion, average 36 days. Treatment-emergent AEs were summarized by system organ class (SOC) and preferred term (PT), by relationship to study drugs, and by highest severity. For laboratory tests, number and percent of patients shifted from baseline to post-baseline maximum severity in CTCAE grade were summarized.
Infections and infestations Urinary tract infection	0.00% 0/5 • Study Day 1 through study completion, average 36 days. Treatment-emergent AEs were summarized by system organ class (SOC) and preferred term (PT), by relationship to study drugs, and by highest severity. For laboratory tests, number and percent of patients shifted from baseline to post-baseline maximum severity in CTCAE grade were summarized.	0.00% 0/3 • Study Day 1 through study completion, average 36 days. Treatment-emergent AEs were summarized by system organ class (SOC) and preferred term (PT), by relationship to study drugs, and by highest severity. For laboratory tests, number and percent of patients shifted from baseline to post-baseline maximum severity in CTCAE grade were summarized.	7.1% 2/28 • Number of events 2 • Study Day 1 through study completion, average 36 days. Treatment-emergent AEs were summarized by system organ class (SOC) and preferred term (PT), by relationship to study drugs, and by highest severity. For laboratory tests, number and percent of patients shifted from baseline to post-baseline maximum severity in CTCAE grade were summarized.
Injury, poisoning and procedural complications Infusion related reaction	40.0% 2/5 • Number of events 2 • Study Day 1 through study completion, average 36 days. Treatment-emergent AEs were summarized by system organ class (SOC) and preferred term (PT), by relationship to study drugs, and by highest severity. For laboratory tests, number and percent of patients shifted from baseline to post-baseline maximum severity in CTCAE grade were summarized.	0.00% 0/3 • Study Day 1 through study completion, average 36 days. Treatment-emergent AEs were summarized by system organ class (SOC) and preferred term (PT), by relationship to study drugs, and by highest severity. For laboratory tests, number and percent of patients shifted from baseline to post-baseline maximum severity in CTCAE grade were summarized.	0.00% 0/28 • Study Day 1 through study completion, average 36 days. Treatment-emergent AEs were summarized by system organ class (SOC) and preferred term (PT), by relationship to study drugs, and by highest severity. For laboratory tests, number and percent of patients shifted from baseline to post-baseline maximum severity in CTCAE grade were summarized.
Injury, poisoning and procedural complications Spinal compression fracture	20.0% 1/5 • Number of events 1 • Study Day 1 through study completion, average 36 days. Treatment-emergent AEs were summarized by system organ class (SOC) and preferred term (PT), by relationship to study drugs, and by highest severity. For laboratory tests, number and percent of patients shifted from baseline to post-baseline maximum severity in CTCAE grade were summarized.	0.00% 0/3 • Study Day 1 through study completion, average 36 days. Treatment-emergent AEs were summarized by system organ class (SOC) and preferred term (PT), by relationship to study drugs, and by highest severity. For laboratory tests, number and percent of patients shifted from baseline to post-baseline maximum severity in CTCAE grade were summarized.	0.00% 0/28 • Study Day 1 through study completion, average 36 days. Treatment-emergent AEs were summarized by system organ class (SOC) and preferred term (PT), by relationship to study drugs, and by highest severity. For laboratory tests, number and percent of patients shifted from baseline to post-baseline maximum severity in CTCAE grade were summarized.
Injury, poisoning and procedural complications Stoma site inflammation	20.0% 1/5 • Number of events 1 • Study Day 1 through study completion, average 36 days. Treatment-emergent AEs were summarized by system organ class (SOC) and preferred term (PT), by relationship to study drugs, and by highest severity. For laboratory tests, number and percent of patients shifted from baseline to post-baseline maximum severity in CTCAE grade were summarized.	0.00% 0/3 • Study Day 1 through study completion, average 36 days. Treatment-emergent AEs were summarized by system organ class (SOC) and preferred term (PT), by relationship to study drugs, and by highest severity. For laboratory tests, number and percent of patients shifted from baseline to post-baseline maximum severity in CTCAE grade were summarized.	0.00% 0/28 • Study Day 1 through study completion, average 36 days. Treatment-emergent AEs were summarized by system organ class (SOC) and preferred term (PT), by relationship to study drugs, and by highest severity. For laboratory tests, number and percent of patients shifted from baseline to post-baseline maximum severity in CTCAE grade were summarized.
Investigations Lymphocyte count decreased	20.0% 1/5 • Number of events 1 • Study Day 1 through study completion, average 36 days. Treatment-emergent AEs were summarized by system organ class (SOC) and preferred term (PT), by relationship to study drugs, and by highest severity. For laboratory tests, number and percent of patients shifted from baseline to post-baseline maximum severity in CTCAE grade were summarized.	0.00% 0/3 • Study Day 1 through study completion, average 36 days. Treatment-emergent AEs were summarized by system organ class (SOC) and preferred term (PT), by relationship to study drugs, and by highest severity. For laboratory tests, number and percent of patients shifted from baseline to post-baseline maximum severity in CTCAE grade were summarized.	25.0% 7/28 • Number of events 7 • Study Day 1 through study completion, average 36 days. Treatment-emergent AEs were summarized by system organ class (SOC) and preferred term (PT), by relationship to study drugs, and by highest severity. For laboratory tests, number and percent of patients shifted from baseline to post-baseline maximum severity in CTCAE grade were summarized.
Investigations Alanine aminotransferase increased	60.0% 3/5 • Number of events 3 • Study Day 1 through study completion, average 36 days. Treatment-emergent AEs were summarized by system organ class (SOC) and preferred term (PT), by relationship to study drugs, and by highest severity. For laboratory tests, number and percent of patients shifted from baseline to post-baseline maximum severity in CTCAE grade were summarized.	0.00% 0/3 • Study Day 1 through study completion, average 36 days. Treatment-emergent AEs were summarized by system organ class (SOC) and preferred term (PT), by relationship to study drugs, and by highest severity. For laboratory tests, number and percent of patients shifted from baseline to post-baseline maximum severity in CTCAE grade were summarized.	14.3% 4/28 • Number of events 4 • Study Day 1 through study completion, average 36 days. Treatment-emergent AEs were summarized by system organ class (SOC) and preferred term (PT), by relationship to study drugs, and by highest severity. For laboratory tests, number and percent of patients shifted from baseline to post-baseline maximum severity in CTCAE grade were summarized.
Investigations Aspartate aminotransferase increased	40.0% 2/5 • Number of events 2 • Study Day 1 through study completion, average 36 days. Treatment-emergent AEs were summarized by system organ class (SOC) and preferred term (PT), by relationship to study drugs, and by highest severity. For laboratory tests, number and percent of patients shifted from baseline to post-baseline maximum severity in CTCAE grade were summarized.	0.00% 0/3 • Study Day 1 through study completion, average 36 days. Treatment-emergent AEs were summarized by system organ class (SOC) and preferred term (PT), by relationship to study drugs, and by highest severity. For laboratory tests, number and percent of patients shifted from baseline to post-baseline maximum severity in CTCAE grade were summarized.	17.9% 5/28 • Number of events 5 • Study Day 1 through study completion, average 36 days. Treatment-emergent AEs were summarized by system organ class (SOC) and preferred term (PT), by relationship to study drugs, and by highest severity. For laboratory tests, number and percent of patients shifted from baseline to post-baseline maximum severity in CTCAE grade were summarized.
Investigations Blood bilirubin increased	40.0% 2/5 • Number of events 2 • Study Day 1 through study completion, average 36 days. Treatment-emergent AEs were summarized by system organ class (SOC) and preferred term (PT), by relationship to study drugs, and by highest severity. For laboratory tests, number and percent of patients shifted from baseline to post-baseline maximum severity in CTCAE grade were summarized.	0.00% 0/3 • Study Day 1 through study completion, average 36 days. Treatment-emergent AEs were summarized by system organ class (SOC) and preferred term (PT), by relationship to study drugs, and by highest severity. For laboratory tests, number and percent of patients shifted from baseline to post-baseline maximum severity in CTCAE grade were summarized.	7.1% 2/28 • Number of events 2 • Study Day 1 through study completion, average 36 days. Treatment-emergent AEs were summarized by system organ class (SOC) and preferred term (PT), by relationship to study drugs, and by highest severity. For laboratory tests, number and percent of patients shifted from baseline to post-baseline maximum severity in CTCAE grade were summarized.
Investigations Lipase increased	0.00% 0/5 • Study Day 1 through study completion, average 36 days. Treatment-emergent AEs were summarized by system organ class (SOC) and preferred term (PT), by relationship to study drugs, and by highest severity. For laboratory tests, number and percent of patients shifted from baseline to post-baseline maximum severity in CTCAE grade were summarized.	0.00% 0/3 • Study Day 1 through study completion, average 36 days. Treatment-emergent AEs were summarized by system organ class (SOC) and preferred term (PT), by relationship to study drugs, and by highest severity. For laboratory tests, number and percent of patients shifted from baseline to post-baseline maximum severity in CTCAE grade were summarized.	14.3% 4/28 • Number of events 4 • Study Day 1 through study completion, average 36 days. Treatment-emergent AEs were summarized by system organ class (SOC) and preferred term (PT), by relationship to study drugs, and by highest severity. For laboratory tests, number and percent of patients shifted from baseline to post-baseline maximum severity in CTCAE grade were summarized.
Investigations Activated partial thromboplastin time prolonged	0.00% 0/5 • Study Day 1 through study completion, average 36 days. Treatment-emergent AEs were summarized by system organ class (SOC) and preferred term (PT), by relationship to study drugs, and by highest severity. For laboratory tests, number and percent of patients shifted from baseline to post-baseline maximum severity in CTCAE grade were summarized.	0.00% 0/3 • Study Day 1 through study completion, average 36 days. Treatment-emergent AEs were summarized by system organ class (SOC) and preferred term (PT), by relationship to study drugs, and by highest severity. For laboratory tests, number and percent of patients shifted from baseline to post-baseline maximum severity in CTCAE grade were summarized.	10.7% 3/28 • Number of events 3 • Study Day 1 through study completion, average 36 days. Treatment-emergent AEs were summarized by system organ class (SOC) and preferred term (PT), by relationship to study drugs, and by highest severity. For laboratory tests, number and percent of patients shifted from baseline to post-baseline maximum severity in CTCAE grade were summarized.
Investigations Blood alkaline phophatase increased	20.0% 1/5 • Number of events 1 • Study Day 1 through study completion, average 36 days. Treatment-emergent AEs were summarized by system organ class (SOC) and preferred term (PT), by relationship to study drugs, and by highest severity. For laboratory tests, number and percent of patients shifted from baseline to post-baseline maximum severity in CTCAE grade were summarized.	0.00% 0/3 • Study Day 1 through study completion, average 36 days. Treatment-emergent AEs were summarized by system organ class (SOC) and preferred term (PT), by relationship to study drugs, and by highest severity. For laboratory tests, number and percent of patients shifted from baseline to post-baseline maximum severity in CTCAE grade were summarized.	7.1% 2/28 • Number of events 2 • Study Day 1 through study completion, average 36 days. Treatment-emergent AEs were summarized by system organ class (SOC) and preferred term (PT), by relationship to study drugs, and by highest severity. For laboratory tests, number and percent of patients shifted from baseline to post-baseline maximum severity in CTCAE grade were summarized.