Trial Outcomes & Findings for Study of Evorpacept (ALX148) With Cetuximab and Pembrolizumab for Refractory Microsatellite Stable Metastatic Colorectal Cancer (NCT NCT05167409)

Last Updated: 2026-07-22

Results Overview

A patient is considered to be an objective responder if their best overall response (BOR) of their follow-up tumor assessments was assessed to be complete response (CR) or partial response (PR) per RECIST v1.1. ORR is defined as the proportion of patients who were classified as objective responders.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

19 participants

Primary outcome timeframe

The duration of time during which tumor assessments were performed for each individual patient. Per protocol, assessments will continue until disease progression. The latest assessment was performed at Cycle 21, Day 15 (14.5 mo after informed consent)

Results posted on

2026-07-22

Participant Flow

Pts with refractory MSS CRC were treated with triple therapy in a safety run-in (Stage 1) followed by expansion (Stage 2). Primary objectives were to determine recommended dose of evorpacept and objective response rate (vs historical control). Trial enrollment was terminated early due to safety concerns.

Patients were eligible for this study if they were 18 years of age or older, had an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1, and had pMMR/MSS mCRC which had progressed on at least two prior lines of therapy in the metastatic setting (a prior single line of therapy for metastatic disease including a fluoropyrimidine, oxaliplatin, and irinotecan was allowed. Three (3) enrolled subjects did not start treatment, 2 due to the trial being halted, and 1 withdrew consent.

Participant milestones

Participant milestones
Measure	Experimental : Stage 1: Safety run-in Evaluating Evorpacept at 15 mg/kg Weekly In Stage 1: Safety run-in evaluating evorpacept at 15 mg/kg weekly, 6 patients were enrolled and treated with evorpacept at dose level 1 (15 mg/kg weekly), cetuximab (400 mg/m2 then 250 mg/m2 weekly), and pembrolizumab (200 mg every 3 weeks). One (1) patient experienced a grade 5 DLT (hemophagocytic lymphohistiocytosis, HLH). The protocol was amended to allow additional evaluation in Stage 1, at evorpacept dose levels -1 and 1. After 3 patients were treated and tolerated at evorpacept DL -1 (i.e. in Arm 2), an additional 3 patients were enrolled and treated at evorpacept DL 1 (Arm 1--this arm), resulting in a total of 9 patients treated at DL 1 during Stage 1 (the safety run-in).	Experimental : Stage 1: Safety run-in Evaluating Evorpacept at 10 mg/kg Weekly In Stage 1: Safety run-in evaluating evorpacept at 10 mg/kg weekly, 3 patients were enrolled and treated with evorpacept at dose level -1 (10 mg/kg weekly), cetuximab (400 mg/m2 then 250 mg/m2 weekly), and pembrolizumab (200 mg every 3 weeks).	Experimental: Stage 2: Expansion Cohort Using Recommended Dose (RD) of Evorpacept In Stage 2: Expansion cohort using recommended dose (RD) of evorpacept, 7 patients were enrolled. 3 patients never started treatment (2 because the trial was halted, and 1 patient withdrew consent). 4 patients were treated with evorpacept at dose level 1 (15 mg/kg weekly), cetuximab (400 mg/m2 then 250 mg/m2 weekly), and pembrolizumab (200 mg every 3 weeks). One (1) patient experienced a grade 5 DLT (hemophagocytic lymphohistiocytosis, HLH).
Overall Study STARTED	9	3	4
Overall Study COMPLETED	9	3	4
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

This report summarizes the analysis population, comprised of all subjects who received any study drug.

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: The duration of time during which tumor assessments were performed for each individual patient. Per protocol, assessments will continue until disease progression. The latest assessment was performed at Cycle 21, Day 15 (14.5 mo after informed consent)

Population: Per the protocol, all analyses were to be conducted using the safety-evaluable population, consisting of all patients who received any amount of study drug.

Outcome measures

Outcome measures
Measure	Experimental: Stage 1: Safety run-in Evaluating Evorpacept at 10 mg/kg Weekly n=3 Participants Subjects in Stage 1 (Safety run-in), Receiving evorpacept at 10 mg/kg weekly, cetuximab at 400 mg/m2, then 250 mg/m2 weekly, and pembrolizumab at 200 mg q 3 wks	Experimental: Stage 1: Safety run-in Evaluating Evorpacept at 15 mg/kg Weekly n=9 Participants Subjects in Stage 1 (Safety run-in), Receiving evorpacept at 15 mg/kg weekly, cetuximab at 400 mg/m2, then 250 mg/m2 weekly, and pembrolizumab at 200 mg q 3 wks	Experimental: Stage 2: Expansion Cohort Using Recommended Dose (RD) of Evorpacept n=4 Participants Subjects in Stage 2 (Expansion cohort), Receiving evorpacept at 15 mg/kg weekly, cetuximab at 400 mg/m2, then 250 mg/m2 weekly, and pembrolizumab at 200 mg q 3 wks
Objective Response Rate (ORR)	0 Participants Interval 0.002 to 0.302	0 Participants	1 Participants

PRIMARY outcome

Timeframe: During the safety run-in, each patient must have completed at least the 1st cycle (3 weeks) of treatment.

Population: All patients who receive any amount of study drug.

The recommended dose (RD) of evorpacept was determined by evaluating the totality of the first-cycle clinical data. Rules to determine the RD based on the number of patients experiencing a dose-limiting toxicity (DLT) were defined in the protocol.

Outcome measures

Outcome measures
Measure	Experimental: Stage 1: Safety run-in Evaluating Evorpacept at 10 mg/kg Weekly n=3 Participants Subjects in Stage 1 (Safety run-in), Receiving evorpacept at 10 mg/kg weekly, cetuximab at 400 mg/m2, then 250 mg/m2 weekly, and pembrolizumab at 200 mg q 3 wks	Experimental: Stage 1: Safety run-in Evaluating Evorpacept at 15 mg/kg Weekly n=9 Participants Subjects in Stage 1 (Safety run-in), Receiving evorpacept at 15 mg/kg weekly, cetuximab at 400 mg/m2, then 250 mg/m2 weekly, and pembrolizumab at 200 mg q 3 wks	Experimental: Stage 2: Expansion Cohort Using Recommended Dose (RD) of Evorpacept n=4 Participants Subjects in Stage 2 (Expansion cohort), Receiving evorpacept at 15 mg/kg weekly, cetuximab at 400 mg/m2, then 250 mg/m2 weekly, and pembrolizumab at 200 mg q 3 wks
Determine the Recommended Dose (RD) of Evorpacept (ALX148) in Combination With Cetuximab and Pembrolizumab	0 Participants	1 Participants	0 Participants

SECONDARY outcome

A patient is classified as 'Disease Controlled' if their best overall response (BOR) of their follow-up tumor assessments was assessed to be complete response (CR), partial response (PR), or stable disease (SD) per RECIST v1.1. DCR is defined as the proportion of patients who were classified as 'Disease Controlled'.

Outcome measures

Outcome measures
Measure	Experimental: Stage 1: Safety run-in Evaluating Evorpacept at 10 mg/kg Weekly n=3 Participants Subjects in Stage 1 (Safety run-in), Receiving evorpacept at 10 mg/kg weekly, cetuximab at 400 mg/m2, then 250 mg/m2 weekly, and pembrolizumab at 200 mg q 3 wks	Experimental: Stage 1: Safety run-in Evaluating Evorpacept at 15 mg/kg Weekly n=9 Participants Subjects in Stage 1 (Safety run-in), Receiving evorpacept at 15 mg/kg weekly, cetuximab at 400 mg/m2, then 250 mg/m2 weekly, and pembrolizumab at 200 mg q 3 wks	Experimental: Stage 2: Expansion Cohort Using Recommended Dose (RD) of Evorpacept n=4 Participants Subjects in Stage 2 (Expansion cohort), Receiving evorpacept at 15 mg/kg weekly, cetuximab at 400 mg/m2, then 250 mg/m2 weekly, and pembrolizumab at 200 mg q 3 wks
Disease Control Rate (DCR)	0 Participants Interval 0.016 to 0.383	1 Participants	1 Participants

SECONDARY outcome

Timeframe: From date of 1st response (CR or PR) until either progression (PD or death) or censoring date

Population: Only 1 patient experienced response. Therefore there is only a point estimate, but no measures of dispersion

DOR is defined as the length of time (months) from the 1st response (CR or PR per RECIST v1.1) until either the first observation of progressive disease (PD) or death from any cause. Patients who did not experience PD or die are considered to be censored at the latest date they are confirmed to be alive, which is the most recent of their discontinuation date or latest follow-up date. This is a subgroup analysis, consisting of all patients who experienced response (CR or PR per RECIST v1.1)

Outcome measures

Outcome measures
Measure	Experimental: Stage 1: Safety run-in Evaluating Evorpacept at 10 mg/kg Weekly Subjects in Stage 1 (Safety run-in), Receiving evorpacept at 10 mg/kg weekly, cetuximab at 400 mg/m2, then 250 mg/m2 weekly, and pembrolizumab at 200 mg q 3 wks	Experimental: Stage 1: Safety run-in Evaluating Evorpacept at 15 mg/kg Weekly Subjects in Stage 1 (Safety run-in), Receiving evorpacept at 15 mg/kg weekly, cetuximab at 400 mg/m2, then 250 mg/m2 weekly, and pembrolizumab at 200 mg q 3 wks	Experimental: Stage 2: Expansion Cohort Using Recommended Dose (RD) of Evorpacept n=1 Participants Subjects in Stage 2 (Expansion cohort), Receiving evorpacept at 15 mg/kg weekly, cetuximab at 400 mg/m2, then 250 mg/m2 weekly, and pembrolizumab at 200 mg q 3 wks
Duration Of Response (DOR)	—	—	13.2 Months

SECONDARY outcome

Timeframe: For each subject, from enrollment until the end of their months-to-progression (as defined above)

Months-to-Progression is defined as the length of time (in months) from enrollment until either the first observation of progressive disease (PD) using RECIST v1.1 or death from any cause. Patients who did not have PD or die will be considered to be censored at the latest date they are confirmed to be alive, which is the most recent of their discontinuation date or latest follow-up date. PFS is a survival analysis involving both the binary endpoint of whether or not each patient progressed or not (i.e. were censored), and the months-to-progression times for each patient.

Outcome measures

Outcome measures
Measure	Experimental: Stage 1: Safety run-in Evaluating Evorpacept at 10 mg/kg Weekly n=3 Participants Subjects in Stage 1 (Safety run-in), Receiving evorpacept at 10 mg/kg weekly, cetuximab at 400 mg/m2, then 250 mg/m2 weekly, and pembrolizumab at 200 mg q 3 wks	Experimental: Stage 1: Safety run-in Evaluating Evorpacept at 15 mg/kg Weekly n=9 Participants Subjects in Stage 1 (Safety run-in), Receiving evorpacept at 15 mg/kg weekly, cetuximab at 400 mg/m2, then 250 mg/m2 weekly, and pembrolizumab at 200 mg q 3 wks	Experimental: Stage 2: Expansion Cohort Using Recommended Dose (RD) of Evorpacept n=4 Participants Subjects in Stage 2 (Expansion cohort), Receiving evorpacept at 15 mg/kg weekly, cetuximab at 400 mg/m2, then 250 mg/m2 weekly, and pembrolizumab at 200 mg q 3 wks
Progression-Free Survival (PFS)	2.3 months Interval 2.2 to The 95% CI upper bound is infinity.	2.2 months Interval 1.2 to 2.6	2.8 months Interval 0.7 to The 95% CI upper bound is infinity.

SECONDARY outcome

Timeframe: For each subject, from enrollment until the end of their months-to-death time (as defined above)

Months-to-death is defined as the number of months from enrollment until death from any cause. Subjects who did not die will be considered to be censored at the latest date they are confirmed to be alive, which is the most recent of their discontinuation date or latest follow-up date. OS is a survival analysis involving both the binary endpoint of whether or not each patient died or not, and the months-to-death times for each patient.

Outcome measures

Outcome measures
Measure	Experimental: Stage 1: Safety run-in Evaluating Evorpacept at 10 mg/kg Weekly n=3 Participants Subjects in Stage 1 (Safety run-in), Receiving evorpacept at 10 mg/kg weekly, cetuximab at 400 mg/m2, then 250 mg/m2 weekly, and pembrolizumab at 200 mg q 3 wks	Experimental: Stage 1: Safety run-in Evaluating Evorpacept at 15 mg/kg Weekly n=9 Participants Subjects in Stage 1 (Safety run-in), Receiving evorpacept at 15 mg/kg weekly, cetuximab at 400 mg/m2, then 250 mg/m2 weekly, and pembrolizumab at 200 mg q 3 wks	Experimental: Stage 2: Expansion Cohort Using Recommended Dose (RD) of Evorpacept n=4 Participants Subjects in Stage 2 (Expansion cohort), Receiving evorpacept at 15 mg/kg weekly, cetuximab at 400 mg/m2, then 250 mg/m2 weekly, and pembrolizumab at 200 mg q 3 wks
Overall Survival (OS)	NA months Interval 4.7 to The median OS is infinity. The 95% CI upper bound is infinity.	7.2 months Interval 1.2 to The 95% CI upper bound is infinity.	NA months Interval 0.7 to The median OS is infinity. The 95% CI upper bound is infinity.

OTHER_PRE_SPECIFIED outcome

Timeframe: The duration of time during which tumor assessments were performed for each patient, until they experience disease progression. The latest timepoint an assessment was performed was at Cycle 21 Day 15.

Population: The response-evaluable population consisted of all patients who had a follow-up tumor assessment.

Outcome measures

Outcome measures
Measure	Experimental: Stage 1: Safety run-in Evaluating Evorpacept at 10 mg/kg Weekly n=3 Participants Subjects in Stage 1 (Safety run-in), Receiving evorpacept at 10 mg/kg weekly, cetuximab at 400 mg/m2, then 250 mg/m2 weekly, and pembrolizumab at 200 mg q 3 wks	Experimental: Stage 1: Safety run-in Evaluating Evorpacept at 15 mg/kg Weekly n=6 Participants Subjects in Stage 1 (Safety run-in), Receiving evorpacept at 15 mg/kg weekly, cetuximab at 400 mg/m2, then 250 mg/m2 weekly, and pembrolizumab at 200 mg q 3 wks	Experimental: Stage 2: Expansion Cohort Using Recommended Dose (RD) of Evorpacept n=3 Participants Subjects in Stage 2 (Expansion cohort), Receiving evorpacept at 15 mg/kg weekly, cetuximab at 400 mg/m2, then 250 mg/m2 weekly, and pembrolizumab at 200 mg q 3 wks
ORR - Response-Evaluable Population	0 Participants	0 Participants	1 Participants

OTHER_PRE_SPECIFIED outcome

Population: The response-evaluable population consisted of all patients who had a follow-up tumor assessment.

Outcome measures

Outcome measures
Measure	Experimental: Stage 1: Safety run-in Evaluating Evorpacept at 10 mg/kg Weekly n=3 Participants Subjects in Stage 1 (Safety run-in), Receiving evorpacept at 10 mg/kg weekly, cetuximab at 400 mg/m2, then 250 mg/m2 weekly, and pembrolizumab at 200 mg q 3 wks	Experimental: Stage 1: Safety run-in Evaluating Evorpacept at 15 mg/kg Weekly n=6 Participants Subjects in Stage 1 (Safety run-in), Receiving evorpacept at 15 mg/kg weekly, cetuximab at 400 mg/m2, then 250 mg/m2 weekly, and pembrolizumab at 200 mg q 3 wks	Experimental: Stage 2: Expansion Cohort Using Recommended Dose (RD) of Evorpacept n=3 Participants Subjects in Stage 2 (Expansion cohort), Receiving evorpacept at 15 mg/kg weekly, cetuximab at 400 mg/m2, then 250 mg/m2 weekly, and pembrolizumab at 200 mg q 3 wks
DCR - Response-Evaluable Population	0 Participants	1 Participants	1 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: For each subject, from enrollment until the end of their months-to-progression (as defined above)

Population: The response-evaluable population consisted of all patients who had a follow-up tumor assessment.

Outcome measures

Outcome measures
Measure	Experimental: Stage 1: Safety run-in Evaluating Evorpacept at 10 mg/kg Weekly n=3 Participants Subjects in Stage 1 (Safety run-in), Receiving evorpacept at 10 mg/kg weekly, cetuximab at 400 mg/m2, then 250 mg/m2 weekly, and pembrolizumab at 200 mg q 3 wks	Experimental: Stage 1: Safety run-in Evaluating Evorpacept at 15 mg/kg Weekly n=6 Participants Subjects in Stage 1 (Safety run-in), Receiving evorpacept at 15 mg/kg weekly, cetuximab at 400 mg/m2, then 250 mg/m2 weekly, and pembrolizumab at 200 mg q 3 wks	Experimental: Stage 2: Expansion Cohort Using Recommended Dose (RD) of Evorpacept n=3 Participants Subjects in Stage 2 (Expansion cohort), Receiving evorpacept at 15 mg/kg weekly, cetuximab at 400 mg/m2, then 250 mg/m2 weekly, and pembrolizumab at 200 mg q 3 wks
PFS - Response-Evaluable Population	2.3 months Interval 2.2 to The 95% CI upper bound is infinity.	2.4 months Interval 1.4 to The 95% CI upper bound is infinity.	2.9 months Interval 2.7 to The 95% CI upper bound is infinity.

OTHER_PRE_SPECIFIED outcome

Timeframe: For each subject, from enrollment until the end of their months-to-death time (as defined above)

Population: The response-evaluable population consisted of all patients who had a follow-up tumor assessment.

Outcome measures

Outcome measures
Measure	Experimental: Stage 1: Safety run-in Evaluating Evorpacept at 10 mg/kg Weekly n=3 Participants Subjects in Stage 1 (Safety run-in), Receiving evorpacept at 10 mg/kg weekly, cetuximab at 400 mg/m2, then 250 mg/m2 weekly, and pembrolizumab at 200 mg q 3 wks	Experimental: Stage 1: Safety run-in Evaluating Evorpacept at 15 mg/kg Weekly n=6 Participants Subjects in Stage 1 (Safety run-in), Receiving evorpacept at 15 mg/kg weekly, cetuximab at 400 mg/m2, then 250 mg/m2 weekly, and pembrolizumab at 200 mg q 3 wks	Experimental: Stage 2: Expansion Cohort Using Recommended Dose (RD) of Evorpacept n=3 Participants Subjects in Stage 2 (Expansion cohort), Receiving evorpacept at 15 mg/kg weekly, cetuximab at 400 mg/m2, then 250 mg/m2 weekly, and pembrolizumab at 200 mg q 3 wks
OS - Response-Evaluable Population	NA months Interval 4.7 to The median OS is infinity. The 95% CI upper bound is infinity.	16.9 months Interval 3.3 to The 95% CI upper bound is infinity.	NA months The median OS is infinity. The 95% CI lower bound \& upper bound are both infinity.

Adverse Events

Experimental: Stage 1: Safety run-in Evaluating Evorpacept at 10 mg/kg Weekly

Serious events: 2 serious events

Other events: 3 other events

Deaths: 1 deaths

Experimental: Stage 1: Safety run-in Evaluating Evorpacept at 15 mg/kg Weekly

Serious events: 5 serious events

Other events: 9 other events

Deaths: 6 deaths

Experimental: Stage 2: Expansion Cohort Using Recommended Dose (RD) of Evorpacept

Serious events: 4 serious events

Other events: 4 other events

Deaths: 1 deaths

Serious adverse events

Other adverse events

Additional Information

Wells Messersmith, MD

University of Colorado

Phone: 303-724-0747

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Experimental: Stage 1: Safety run-in Evaluating Evorpacept at 10 mg/kg Weekly n=3 Participants Subjects in Stage 1 (Safety run-in), Receiving evorpacept at 10 mg/kg weekly, cetuximab at 400 mg/m2, then 250 mg/m2 weekly, and pembrolizumab at 200 mg q 3 wks	Experimental: Stage 1: Safety run-in Evaluating Evorpacept at 15 mg/kg Weekly n=9 Participants Subjects in Stage 1 (Safety run-in), Receiving evorpacept at 15 mg/kg weekly, cetuximab at 400 mg/m2, then 250 mg/m2 weekly, and pembrolizumab at 200 mg q 3 wks	Experimental: Stage 2: Expansion Cohort Using Recommended Dose (RD) of Evorpacept n=4 Participants Subjects in Stage 2 (Expansion cohort), Receiving evorpacept at 15 mg/kg weekly, cetuximab at 400 mg/m2, then 250 mg/m2 weekly, and pembrolizumab at 200 mg q 3 wks	Total n=16 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=9 Participants • This report summarizes the analysis population, comprised of all subjects who received any study drug.	0 Participants n=27 Participants • This report summarizes the analysis population, comprised of all subjects who received any study drug.	0 Participants n=267 Participants • This report summarizes the analysis population, comprised of all subjects who received any study drug.	0 Participants n=265 Participants • This report summarizes the analysis population, comprised of all subjects who received any study drug.
Age, Categorical Between 18 and 65 years	3 Participants n=9 Participants • This report summarizes the analysis population, comprised of all subjects who received any study drug.	7 Participants n=27 Participants • This report summarizes the analysis population, comprised of all subjects who received any study drug.	2 Participants n=267 Participants • This report summarizes the analysis population, comprised of all subjects who received any study drug.	12 Participants n=265 Participants • This report summarizes the analysis population, comprised of all subjects who received any study drug.
Age, Categorical >=65 years	0 Participants n=9 Participants • This report summarizes the analysis population, comprised of all subjects who received any study drug.	2 Participants n=27 Participants • This report summarizes the analysis population, comprised of all subjects who received any study drug.	2 Participants n=267 Participants • This report summarizes the analysis population, comprised of all subjects who received any study drug.	4 Participants n=265 Participants • This report summarizes the analysis population, comprised of all subjects who received any study drug.
Sex: Female, Male Female	0 Participants n=9 Participants • This report summarizes the analysis population, comprised of all subjects who received any study drug.	3 Participants n=27 Participants • This report summarizes the analysis population, comprised of all subjects who received any study drug.	2 Participants n=267 Participants • This report summarizes the analysis population, comprised of all subjects who received any study drug.	5 Participants n=265 Participants • This report summarizes the analysis population, comprised of all subjects who received any study drug.
Sex: Female, Male Male	3 Participants n=9 Participants • This report summarizes the analysis population, comprised of all subjects who received any study drug.	6 Participants n=27 Participants • This report summarizes the analysis population, comprised of all subjects who received any study drug.	2 Participants n=267 Participants • This report summarizes the analysis population, comprised of all subjects who received any study drug.	11 Participants n=265 Participants • This report summarizes the analysis population, comprised of all subjects who received any study drug.
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=9 Participants • This report summarizes the analysis population, comprised of all subjects who received any study drug.	0 Participants n=27 Participants • This report summarizes the analysis population, comprised of all subjects who received any study drug.	0 Participants n=267 Participants • This report summarizes the analysis population, comprised of all subjects who received any study drug.	0 Participants n=265 Participants • This report summarizes the analysis population, comprised of all subjects who received any study drug.
Race (NIH/OMB) Asian	0 Participants n=9 Participants • This report summarizes the analysis population, comprised of all subjects who received any study drug.	0 Participants n=27 Participants • This report summarizes the analysis population, comprised of all subjects who received any study drug.	1 Participants n=267 Participants • This report summarizes the analysis population, comprised of all subjects who received any study drug.	1 Participants n=265 Participants • This report summarizes the analysis population, comprised of all subjects who received any study drug.
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=9 Participants • This report summarizes the analysis population, comprised of all subjects who received any study drug.	0 Participants n=27 Participants • This report summarizes the analysis population, comprised of all subjects who received any study drug.	0 Participants n=267 Participants • This report summarizes the analysis population, comprised of all subjects who received any study drug.	0 Participants n=265 Participants • This report summarizes the analysis population, comprised of all subjects who received any study drug.
Race (NIH/OMB) Black or African American	0 Participants n=9 Participants • This report summarizes the analysis population, comprised of all subjects who received any study drug.	0 Participants n=27 Participants • This report summarizes the analysis population, comprised of all subjects who received any study drug.	1 Participants n=267 Participants • This report summarizes the analysis population, comprised of all subjects who received any study drug.	1 Participants n=265 Participants • This report summarizes the analysis population, comprised of all subjects who received any study drug.
Race (NIH/OMB) White	3 Participants n=9 Participants • This report summarizes the analysis population, comprised of all subjects who received any study drug.	8 Participants n=27 Participants • This report summarizes the analysis population, comprised of all subjects who received any study drug.	2 Participants n=267 Participants • This report summarizes the analysis population, comprised of all subjects who received any study drug.	13 Participants n=265 Participants • This report summarizes the analysis population, comprised of all subjects who received any study drug.
Race (NIH/OMB) More than one race	0 Participants n=9 Participants • This report summarizes the analysis population, comprised of all subjects who received any study drug.	1 Participants n=27 Participants • This report summarizes the analysis population, comprised of all subjects who received any study drug.	0 Participants n=267 Participants • This report summarizes the analysis population, comprised of all subjects who received any study drug.	1 Participants n=265 Participants • This report summarizes the analysis population, comprised of all subjects who received any study drug.
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=9 Participants • This report summarizes the analysis population, comprised of all subjects who received any study drug.	0 Participants n=27 Participants • This report summarizes the analysis population, comprised of all subjects who received any study drug.	0 Participants n=267 Participants • This report summarizes the analysis population, comprised of all subjects who received any study drug.	0 Participants n=265 Participants • This report summarizes the analysis population, comprised of all subjects who received any study drug.
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=9 Participants • This report summarizes the analysis population, comprised of all subjects who received any study drug.	0 Participants n=27 Participants • This report summarizes the analysis population, comprised of all subjects who received any study drug.	0 Participants n=267 Participants • This report summarizes the analysis population, comprised of all subjects who received any study drug.	1 Participants n=265 Participants • This report summarizes the analysis population, comprised of all subjects who received any study drug.
Ethnicity (NIH/OMB) Not Hispanic or Latino	2 Participants n=9 Participants • This report summarizes the analysis population, comprised of all subjects who received any study drug.	9 Participants n=27 Participants • This report summarizes the analysis population, comprised of all subjects who received any study drug.	4 Participants n=267 Participants • This report summarizes the analysis population, comprised of all subjects who received any study drug.	15 Participants n=265 Participants • This report summarizes the analysis population, comprised of all subjects who received any study drug.
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=9 Participants • This report summarizes the analysis population, comprised of all subjects who received any study drug.	0 Participants n=27 Participants • This report summarizes the analysis population, comprised of all subjects who received any study drug.	0 Participants n=267 Participants • This report summarizes the analysis population, comprised of all subjects who received any study drug.	0 Participants n=265 Participants • This report summarizes the analysis population, comprised of all subjects who received any study drug.

Measure	Experimental: Stage 1: Safety run-in Evaluating Evorpacept at 10 mg/kg Weekly n=3 participants at risk Subjects in Stage 1 (Safety run-in), Receiving evorpacept at 10 mg/kg weekly, cetuximab at 400 mg/m2, then 250 mg/m2 weekly, and pembrolizumab at 200 mg q 3 wks	Experimental: Stage 1: Safety run-in Evaluating Evorpacept at 15 mg/kg Weekly n=9 participants at risk Subjects in Stage 1 (Safety run-in), Receiving evorpacept at 15 mg/kg weekly, cetuximab at 400 mg/m2, then 250 mg/m2 weekly, and pembrolizumab at 200 mg q 3 wks	Experimental: Stage 2: Expansion Cohort Using Recommended Dose (RD) of Evorpacept n=4 participants at risk Subjects in Stage 2 (Expansion cohort), Receiving evorpacept at 15 mg/kg weekly, cetuximab at 400 mg/m2, then 250 mg/m2 weekly, and pembrolizumab at 200 mg q 3 wks
Gastrointestinal disorders Abdominal Pain	0.00% 0/3 • Study patients were assessed for the occurrence of adverse events (AEs) from the time they enrolled onto the trial until the most recent of their study discontinuation date or follow-up date, up to 24 months. The mean follow-up time was 10.3 months. Adverse Events collected per CTCAE v5.0	11.1% 1/9 • Number of events 1 • Study patients were assessed for the occurrence of adverse events (AEs) from the time they enrolled onto the trial until the most recent of their study discontinuation date or follow-up date, up to 24 months. The mean follow-up time was 10.3 months. Adverse Events collected per CTCAE v5.0	0.00% 0/4 • Study patients were assessed for the occurrence of adverse events (AEs) from the time they enrolled onto the trial until the most recent of their study discontinuation date or follow-up date, up to 24 months. The mean follow-up time was 10.3 months. Adverse Events collected per CTCAE v5.0
Respiratory, thoracic and mediastinal disorders pneumonitis	0.00% 0/3 • Study patients were assessed for the occurrence of adverse events (AEs) from the time they enrolled onto the trial until the most recent of their study discontinuation date or follow-up date, up to 24 months. The mean follow-up time was 10.3 months. Adverse Events collected per CTCAE v5.0	11.1% 1/9 • Number of events 1 • Study patients were assessed for the occurrence of adverse events (AEs) from the time they enrolled onto the trial until the most recent of their study discontinuation date or follow-up date, up to 24 months. The mean follow-up time was 10.3 months. Adverse Events collected per CTCAE v5.0	0.00% 0/4 • Study patients were assessed for the occurrence of adverse events (AEs) from the time they enrolled onto the trial until the most recent of their study discontinuation date or follow-up date, up to 24 months. The mean follow-up time was 10.3 months. Adverse Events collected per CTCAE v5.0
Respiratory, thoracic and mediastinal disorders pneumonia	0.00% 0/3 • Study patients were assessed for the occurrence of adverse events (AEs) from the time they enrolled onto the trial until the most recent of their study discontinuation date or follow-up date, up to 24 months. The mean follow-up time was 10.3 months. Adverse Events collected per CTCAE v5.0	11.1% 1/9 • Number of events 1 • Study patients were assessed for the occurrence of adverse events (AEs) from the time they enrolled onto the trial until the most recent of their study discontinuation date or follow-up date, up to 24 months. The mean follow-up time was 10.3 months. Adverse Events collected per CTCAE v5.0	0.00% 0/4 • Study patients were assessed for the occurrence of adverse events (AEs) from the time they enrolled onto the trial until the most recent of their study discontinuation date or follow-up date, up to 24 months. The mean follow-up time was 10.3 months. Adverse Events collected per CTCAE v5.0
Respiratory, thoracic and mediastinal disorders hypoxia	0.00% 0/3 • Study patients were assessed for the occurrence of adverse events (AEs) from the time they enrolled onto the trial until the most recent of their study discontinuation date or follow-up date, up to 24 months. The mean follow-up time was 10.3 months. Adverse Events collected per CTCAE v5.0	11.1% 1/9 • Number of events 1 • Study patients were assessed for the occurrence of adverse events (AEs) from the time they enrolled onto the trial until the most recent of their study discontinuation date or follow-up date, up to 24 months. The mean follow-up time was 10.3 months. Adverse Events collected per CTCAE v5.0	0.00% 0/4 • Study patients were assessed for the occurrence of adverse events (AEs) from the time they enrolled onto the trial until the most recent of their study discontinuation date or follow-up date, up to 24 months. The mean follow-up time was 10.3 months. Adverse Events collected per CTCAE v5.0
Blood and lymphatic system disorders Anemia	0.00% 0/3 • Study patients were assessed for the occurrence of adverse events (AEs) from the time they enrolled onto the trial until the most recent of their study discontinuation date or follow-up date, up to 24 months. The mean follow-up time was 10.3 months. Adverse Events collected per CTCAE v5.0	11.1% 1/9 • Number of events 1 • Study patients were assessed for the occurrence of adverse events (AEs) from the time they enrolled onto the trial until the most recent of their study discontinuation date or follow-up date, up to 24 months. The mean follow-up time was 10.3 months. Adverse Events collected per CTCAE v5.0	0.00% 0/4 • Study patients were assessed for the occurrence of adverse events (AEs) from the time they enrolled onto the trial until the most recent of their study discontinuation date or follow-up date, up to 24 months. The mean follow-up time was 10.3 months. Adverse Events collected per CTCAE v5.0
Hepatobiliary disorders Hepatic Failure	0.00% 0/3 • Study patients were assessed for the occurrence of adverse events (AEs) from the time they enrolled onto the trial until the most recent of their study discontinuation date or follow-up date, up to 24 months. The mean follow-up time was 10.3 months. Adverse Events collected per CTCAE v5.0	11.1% 1/9 • Number of events 1 • Study patients were assessed for the occurrence of adverse events (AEs) from the time they enrolled onto the trial until the most recent of their study discontinuation date or follow-up date, up to 24 months. The mean follow-up time was 10.3 months. Adverse Events collected per CTCAE v5.0	0.00% 0/4 • Study patients were assessed for the occurrence of adverse events (AEs) from the time they enrolled onto the trial until the most recent of their study discontinuation date or follow-up date, up to 24 months. The mean follow-up time was 10.3 months. Adverse Events collected per CTCAE v5.0
Immune system disorders hemophagocytic lymphohistiocytosis	0.00% 0/3 • Study patients were assessed for the occurrence of adverse events (AEs) from the time they enrolled onto the trial until the most recent of their study discontinuation date or follow-up date, up to 24 months. The mean follow-up time was 10.3 months. Adverse Events collected per CTCAE v5.0	11.1% 1/9 • Number of events 1 • Study patients were assessed for the occurrence of adverse events (AEs) from the time they enrolled onto the trial until the most recent of their study discontinuation date or follow-up date, up to 24 months. The mean follow-up time was 10.3 months. Adverse Events collected per CTCAE v5.0	0.00% 0/4 • Study patients were assessed for the occurrence of adverse events (AEs) from the time they enrolled onto the trial until the most recent of their study discontinuation date or follow-up date, up to 24 months. The mean follow-up time was 10.3 months. Adverse Events collected per CTCAE v5.0
Renal and urinary disorders Urinary Tract Infection	33.3% 1/3 • Number of events 1 • Study patients were assessed for the occurrence of adverse events (AEs) from the time they enrolled onto the trial until the most recent of their study discontinuation date or follow-up date, up to 24 months. The mean follow-up time was 10.3 months. Adverse Events collected per CTCAE v5.0	0.00% 0/9 • Study patients were assessed for the occurrence of adverse events (AEs) from the time they enrolled onto the trial until the most recent of their study discontinuation date or follow-up date, up to 24 months. The mean follow-up time was 10.3 months. Adverse Events collected per CTCAE v5.0	0.00% 0/4 • Study patients were assessed for the occurrence of adverse events (AEs) from the time they enrolled onto the trial until the most recent of their study discontinuation date or follow-up date, up to 24 months. The mean follow-up time was 10.3 months. Adverse Events collected per CTCAE v5.0
Nervous system disorders Headache	33.3% 1/3 • Number of events 1 • Study patients were assessed for the occurrence of adverse events (AEs) from the time they enrolled onto the trial until the most recent of their study discontinuation date or follow-up date, up to 24 months. The mean follow-up time was 10.3 months. Adverse Events collected per CTCAE v5.0	0.00% 0/9 • Study patients were assessed for the occurrence of adverse events (AEs) from the time they enrolled onto the trial until the most recent of their study discontinuation date or follow-up date, up to 24 months. The mean follow-up time was 10.3 months. Adverse Events collected per CTCAE v5.0	0.00% 0/4 • Study patients were assessed for the occurrence of adverse events (AEs) from the time they enrolled onto the trial until the most recent of their study discontinuation date or follow-up date, up to 24 months. The mean follow-up time was 10.3 months. Adverse Events collected per CTCAE v5.0
Hepatobiliary disorders Hepatobiliary Disorder (choledocholithiasis)	0.00% 0/3 • Study patients were assessed for the occurrence of adverse events (AEs) from the time they enrolled onto the trial until the most recent of their study discontinuation date or follow-up date, up to 24 months. The mean follow-up time was 10.3 months. Adverse Events collected per CTCAE v5.0	0.00% 0/9 • Study patients were assessed for the occurrence of adverse events (AEs) from the time they enrolled onto the trial until the most recent of their study discontinuation date or follow-up date, up to 24 months. The mean follow-up time was 10.3 months. Adverse Events collected per CTCAE v5.0	25.0% 1/4 • Number of events 1 • Study patients were assessed for the occurrence of adverse events (AEs) from the time they enrolled onto the trial until the most recent of their study discontinuation date or follow-up date, up to 24 months. The mean follow-up time was 10.3 months. Adverse Events collected per CTCAE v5.0
Respiratory, thoracic and mediastinal disorders Atelectasis	0.00% 0/3 • Study patients were assessed for the occurrence of adverse events (AEs) from the time they enrolled onto the trial until the most recent of their study discontinuation date or follow-up date, up to 24 months. The mean follow-up time was 10.3 months. Adverse Events collected per CTCAE v5.0	11.1% 1/9 • Number of events 1 • Study patients were assessed for the occurrence of adverse events (AEs) from the time they enrolled onto the trial until the most recent of their study discontinuation date or follow-up date, up to 24 months. The mean follow-up time was 10.3 months. Adverse Events collected per CTCAE v5.0	0.00% 0/4 • Study patients were assessed for the occurrence of adverse events (AEs) from the time they enrolled onto the trial until the most recent of their study discontinuation date or follow-up date, up to 24 months. The mean follow-up time was 10.3 months. Adverse Events collected per CTCAE v5.0
Respiratory, thoracic and mediastinal disorders Dyspnea	0.00% 0/3 • Study patients were assessed for the occurrence of adverse events (AEs) from the time they enrolled onto the trial until the most recent of their study discontinuation date or follow-up date, up to 24 months. The mean follow-up time was 10.3 months. Adverse Events collected per CTCAE v5.0	22.2% 2/9 • Number of events 3 • Study patients were assessed for the occurrence of adverse events (AEs) from the time they enrolled onto the trial until the most recent of their study discontinuation date or follow-up date, up to 24 months. The mean follow-up time was 10.3 months. Adverse Events collected per CTCAE v5.0	0.00% 0/4 • Study patients were assessed for the occurrence of adverse events (AEs) from the time they enrolled onto the trial until the most recent of their study discontinuation date or follow-up date, up to 24 months. The mean follow-up time was 10.3 months. Adverse Events collected per CTCAE v5.0
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/3 • Study patients were assessed for the occurrence of adverse events (AEs) from the time they enrolled onto the trial until the most recent of their study discontinuation date or follow-up date, up to 24 months. The mean follow-up time was 10.3 months. Adverse Events collected per CTCAE v5.0	11.1% 1/9 • Number of events 1 • Study patients were assessed for the occurrence of adverse events (AEs) from the time they enrolled onto the trial until the most recent of their study discontinuation date or follow-up date, up to 24 months. The mean follow-up time was 10.3 months. Adverse Events collected per CTCAE v5.0	0.00% 0/4 • Study patients were assessed for the occurrence of adverse events (AEs) from the time they enrolled onto the trial until the most recent of their study discontinuation date or follow-up date, up to 24 months. The mean follow-up time was 10.3 months. Adverse Events collected per CTCAE v5.0
Cardiac disorders Stroke	0.00% 0/3 • Study patients were assessed for the occurrence of adverse events (AEs) from the time they enrolled onto the trial until the most recent of their study discontinuation date or follow-up date, up to 24 months. The mean follow-up time was 10.3 months. Adverse Events collected per CTCAE v5.0	11.1% 1/9 • Number of events 1 • Study patients were assessed for the occurrence of adverse events (AEs) from the time they enrolled onto the trial until the most recent of their study discontinuation date or follow-up date, up to 24 months. The mean follow-up time was 10.3 months. Adverse Events collected per CTCAE v5.0	0.00% 0/4 • Study patients were assessed for the occurrence of adverse events (AEs) from the time they enrolled onto the trial until the most recent of their study discontinuation date or follow-up date, up to 24 months. The mean follow-up time was 10.3 months. Adverse Events collected per CTCAE v5.0
Gastrointestinal disorders Mucositis Oral	0.00% 0/3 • Study patients were assessed for the occurrence of adverse events (AEs) from the time they enrolled onto the trial until the most recent of their study discontinuation date or follow-up date, up to 24 months. The mean follow-up time was 10.3 months. Adverse Events collected per CTCAE v5.0	0.00% 0/9 • Study patients were assessed for the occurrence of adverse events (AEs) from the time they enrolled onto the trial until the most recent of their study discontinuation date or follow-up date, up to 24 months. The mean follow-up time was 10.3 months. Adverse Events collected per CTCAE v5.0	25.0% 1/4 • Number of events 1 • Study patients were assessed for the occurrence of adverse events (AEs) from the time they enrolled onto the trial until the most recent of their study discontinuation date or follow-up date, up to 24 months. The mean follow-up time was 10.3 months. Adverse Events collected per CTCAE v5.0
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate Cancer	0.00% 0/3 • Study patients were assessed for the occurrence of adverse events (AEs) from the time they enrolled onto the trial until the most recent of their study discontinuation date or follow-up date, up to 24 months. The mean follow-up time was 10.3 months. Adverse Events collected per CTCAE v5.0	0.00% 0/9 • Study patients were assessed for the occurrence of adverse events (AEs) from the time they enrolled onto the trial until the most recent of their study discontinuation date or follow-up date, up to 24 months. The mean follow-up time was 10.3 months. Adverse Events collected per CTCAE v5.0	25.0% 1/4 • Number of events 1 • Study patients were assessed for the occurrence of adverse events (AEs) from the time they enrolled onto the trial until the most recent of their study discontinuation date or follow-up date, up to 24 months. The mean follow-up time was 10.3 months. Adverse Events collected per CTCAE v5.0
Vascular disorders Thromboembolic event	0.00% 0/3 • Study patients were assessed for the occurrence of adverse events (AEs) from the time they enrolled onto the trial until the most recent of their study discontinuation date or follow-up date, up to 24 months. The mean follow-up time was 10.3 months. Adverse Events collected per CTCAE v5.0	11.1% 1/9 • Number of events 1 • Study patients were assessed for the occurrence of adverse events (AEs) from the time they enrolled onto the trial until the most recent of their study discontinuation date or follow-up date, up to 24 months. The mean follow-up time was 10.3 months. Adverse Events collected per CTCAE v5.0	0.00% 0/4 • Study patients were assessed for the occurrence of adverse events (AEs) from the time they enrolled onto the trial until the most recent of their study discontinuation date or follow-up date, up to 24 months. The mean follow-up time was 10.3 months. Adverse Events collected per CTCAE v5.0
Immune system disorders Cytokine Release Syndrome	0.00% 0/3 • Study patients were assessed for the occurrence of adverse events (AEs) from the time they enrolled onto the trial until the most recent of their study discontinuation date or follow-up date, up to 24 months. The mean follow-up time was 10.3 months. Adverse Events collected per CTCAE v5.0	0.00% 0/9 • Study patients were assessed for the occurrence of adverse events (AEs) from the time they enrolled onto the trial until the most recent of their study discontinuation date or follow-up date, up to 24 months. The mean follow-up time was 10.3 months. Adverse Events collected per CTCAE v5.0	25.0% 1/4 • Number of events 1 • Study patients were assessed for the occurrence of adverse events (AEs) from the time they enrolled onto the trial until the most recent of their study discontinuation date or follow-up date, up to 24 months. The mean follow-up time was 10.3 months. Adverse Events collected per CTCAE v5.0
Renal and urinary disorders Creatinine Increased	33.3% 1/3 • Number of events 1 • Study patients were assessed for the occurrence of adverse events (AEs) from the time they enrolled onto the trial until the most recent of their study discontinuation date or follow-up date, up to 24 months. The mean follow-up time was 10.3 months. Adverse Events collected per CTCAE v5.0	0.00% 0/9 • Study patients were assessed for the occurrence of adverse events (AEs) from the time they enrolled onto the trial until the most recent of their study discontinuation date or follow-up date, up to 24 months. The mean follow-up time was 10.3 months. Adverse Events collected per CTCAE v5.0	0.00% 0/4 • Study patients were assessed for the occurrence of adverse events (AEs) from the time they enrolled onto the trial until the most recent of their study discontinuation date or follow-up date, up to 24 months. The mean follow-up time was 10.3 months. Adverse Events collected per CTCAE v5.0