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

Conditions

• Microsatellite Stable Metastatic Colorectal Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Evorpacept (ALX148) — DRUG
  IV QW
• Cetuximab — DRUG
  IV QW
• Pembrolizumab — DRUG
  IV Q3W

Study Details

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

Key Dates

First listed

Dec 22, 2021

Start date

Jul 28, 2022

Status verified

Jun 2026

Primary completion

Oct 30, 2024

Completion

Oct 30, 2024

Study Design

Enrollment

19 participants (actual)

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: Stage 1: Safety run-in evaluating evorpacept at 15 mg/kg weekly
  Doses: * Evorpacept (ALX148) dose level (DL) 1: 15 mg/kg weekly * Cetuximab: 400 mg/m2, then 250 mg/m2 weekly * Pembrolizumab: 200 mg every 3 weeks
• Experimental: Stage 1: Safety run-in evaluating evorpacept at 10 mg/kg weekly
  Doses: * Evorpacept (ALX148) dose level (DL) -1: 10 mg/kg weekly * Cetuximab: 400 mg/m2, then 250 mg/m2 weekly * Pembrolizumab: 200 mg every 3 weeks
• Experimental: Stage 2: Expansion cohort using recommended dose (RD) of evorpacept
  Doses: * Evorpacept (ALX148) dose level (DL) 1: 15 mg/kg weekly * Cetuximab: 400 mg/m2, then 250 mg/m2 weekly * Pembrolizumab: 200 mg every 3 weeks

Primary Outcome Measure

Objective Response Rate (ORR) [ Time Frame: 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) ]

Locations (4)

Related coverage on Hipa.ai

• Pembrolizumab Combo Trial for mCRC Terminated, Shows Limited Response
  Pembrolizumab · Jul 22, 2026 · ClinicalTrials.gov

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