This Phase 2 clinical study will evaluate evorpacept (ALX148) in combination with cetuximab and pembrolizumab for refractory microsatellite stable metastatic colorectal cancer
This is an open-label, multi-center, single-arm phase II clinical trial (with safety run-in) evaluating the combination of evorpacept (ALX148), cetuximab, and pembrolizumab in patients with metastatic microsatellite stable colorectal cancer who have progressed on at least 2 lines of systemic therapy. A subset of patients will undergo study-related biopsies. There will be a safety run-in stage followed by a dose expansion stage. Patients in both stages will continue to receive study therapy until disease progression according to RECIST v1.1.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
48
University of Arizona Cancer Center
Tucson, Arizona, United States
University of Colorado Cancer Center
Aurora, Colorado, United States
Rutgers Cancer insititute
New Brunswick, New Jersey, United States
Inova Schar Cancer Institute
Fairfax, Virginia, United States
Recommended dose (RD) of evorpacept (ALX148) in combination with cetuximab and pembrolizumab 1.(mg/kg)
To determine the recommended dose (RD) of evorpacept (ALX148) in combination with cetuximab and pembrolizumab
Time frame: 4 months
Objective response rate (ORR, per RECIST v1.1) (%)
To determine the objective response rate (ORR), defined as partial response or complete response, with evorpacept (ALX148), cetuximab, and pembrolizumab using RECIST v1.1 in patients with microsatellite stable (MSS) metastatic colorectal cancer (mCRC) who have progressed on at least two lines of standard therapy
Time frame: 6 months
Disease control rate per RECIST v1.1. (%)
To determine the disease-control rate (DCR), defined as stable disease, partial response, or complete response with evorpacept (ALX148), cetuximab, and pembrolizumab using RECIST v1.1
Time frame: 24 months
Duration of response per RECIST v1.1. (months)
To determine the duration of response (DOR) with evorpacept (ALX148), cetuximab, and pembrolizumab, defined as the time from response (partial or complete) to progression
Time frame: 24 months
Progression-free survival (PFS, per RECIST v1.1) (months)
To determine the progression-free survival (PFS) with evorpacept (ALX148), cetuximab, and pembrolizumab, defined as the time from enrollment to the first observation of progression using RECIST v1.1 or death from any cause
Time frame: 48 months
Overall survival (OS)
To determine the overall survival (OS) with evorpacept (ALX148), cetuximab, and pembrolizumab, defined as the time from enrollment to death from any cause
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Time frame: 48 months
First cycle dose-limiting toxicities in the safety run-in stage
To determine the first cycle dose-limiting toxicities (DLT) of evorpacept (ALX148), cetuximab, and pembrolizumab in stage 1
Time frame: 4 months
Safety and tolerability according to the NCI CTCAE v5.0
To evaluate the safety and tolerability of evorpacept (ALX148), cetuximab, and pembrolizumab, defined and graded according to the NCI CTCAE v5.0
Time frame: 48 months