BENITIONSClinical Trial Intelligence

Study of Evorpacept (ALX148) With Cetuximab and Pembrolizumab for Refractory Microsatellite Stable Metastatic Colorectal Cancer

Phase 2 Terminated NCT05167409

ConditionMicrosatellite Stable Metastatic Colorectal Cancer
PhasePhase 2
SponsorUniversity of Colorado, Denver
StatusTerminated
Enrollment19 participants
InterventionsEvorpacept (ALX148), Cetuximab, Pembrolizumab
Start dateJul 28, 2022
Completion dateOct 30, 2024
Results postedJul 22, 2026

Summary

This Phase 2 clinical study will evaluate evorpacept (ALX148) in combination with cetuximab and pembrolizumab for refractory microsatellite stable metastatic colorectal cancer

Objective Response Rate (ORR)

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) · Participants

Experimental: Stage 1: Safety run-in Evaluating Evorpacept at 10 mg/kg Weekly0 Participants
Experimental: Stage 1: Safety run-in Evaluating Evorpacept at 15 mg/kg Weekly0 Participants
Experimental: Stage 2: Expansion Cohort Using Recommended Dose (RD) of Evorpacept1 Participants

Determine the Recommended Dose (RD) of Evorpacept (ALX148) in Combination With Cetuximab and Pembrolizumab

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

Experimental: Stage 1: Safety run-in Evaluating Evorpacept at 10 mg/kg Weekly0 Participants
Experimental: Stage 1: Safety run-in Evaluating Evorpacept at 15 mg/kg Weekly1 Participants
Experimental: Stage 2: Expansion Cohort Using Recommended Dose (RD) of Evorpacept0 Participants

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