A Study of ALX148 With Cetuximab and Pembrolizumab for Refractory Microsatellite Stable Metastatic Colorectal Cancer

Program Status

Active, not recruiting

Phase

Phase 2

Prior Immunotherapy Allowed

No

CRC-directed Trial

Yes

Drugs

ALX148, cetuximab, Evorpacept (ALX148), Pembrolizumab, Erbitux, Keytruda

Tags

MSS/ MMRp

Comments

ALX148 + cetuximab + pembrolizumab for MSS patients who have received at least 2 lines of systemic therapy.
ALX148 (evorpacept): anti CD47, immunotherapy
Cetuximab: EGFR inhibitor (Erbitux)
Pembrolizumab: anti-PD1 checkpoint inhibitor, immunotherapy (Keytruda)

Left-sided RAS/BRAF Wild must have received EGFR inhibitor (cetuximab or panitumumab).

No prior checkpoint inhibitor (immunotherapy) allowed

Helpful Links

Location Location Status
United States
University of Arizona Cancer Center
Tucson, Arizona 85724
Active, not recruiting
University of Colorado Cancer Center
Aurora, Colorado 80045
Active, not recruiting
Rutgers Cancer insititute
New Brunswick, New Jersey 08903
Active, not recruiting
Inova Schar Cancer Institute
Fairfax, Virginia 22031
Active, not recruiting

Inclusion Criteria

Inclusion Criteria:

To be eligible to participate in this study, an individual must meet all of the following criteria:

* Have a diagnosis of metastatic colorectal cancer previously treated with at least two lines of therapy for unresectable/metastatic disease
* Have microsatellite stable disease
* Adequate hematologic and end organ function

Exclusion Criteria

Exclusion Criteria:

An individual who meets any of the following criteria will be excluded from participation in this study:

* Patients with known MSI-high status or known mismatch repair deficiency (dMMR)
* Patients in whom both mismatch repair and microsatellite stability status are unknown
* History of severe allergic, anaphylactic, or other hypersensitivity reactions to any of the study medications or their classes
* Left-sided (at or distal to the splenic flexure) RAS/BRAF wild-type metastatic colorectal cancer who are EGFR inhibitor naïve.
* Prior therapy with an anti-PD-1, anti-PD-L1, anti PD L2, anti-CD47, or anti-SIRPα agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX 40, CD137)

NCT ID

NCT05167409

Date Trial Added

2021-12-22

Updated Date

2025-01-13