NCT06557278

Combined AlloStim+Anti-PD-L1 in 4L MSS Metastatic Colorectal Cancer

Phase II Open-Label Study to Assess the Safety and Efficacy of AlloStim® + Anti-PDL1 as Fourth Line Therapy in 4L MSS Metastatic Colorectal Cancer

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Mirror Biologics, Inc. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Experimental immunotherapy in chemotherapy-refractory and immunotherapy-refractory metastatic colorectal cancer patients that have progressed, or are intolerant to, Longsurf (TAS-102) +/- Avastin (bevacizumab) or Stivarga (regorafenib) or Fruzaqla (fruquintinib) combining experimental AlloStim with an anti-programmed death ligand 1 (PD-L1) checkpoint inhibitor drug.

Detailed description

The protocol provides fourth-line experimental treatment for subjects with microsatellite stable (MSS)/ proficient mismatch repair (pMMR) metastatic colorectal cancer. These patients do not respond to checkpoint inhibitors. This study will investigate whether AlloStim® administered weekly in two-21 day cycles with each cycle consisting of 3 weekly intradermal (ID) doses followed the last week with an intravenous (IV) dose (3 cycles =Days 0 through 49) can prime patients to become responsive to checkpoint inhibition immunotherapy. A restaging computed tomography (CT) scan is conducted on day 56 after the priming and will be compared to the baseline CT scan by Response Evaluation Criteria in Solid Tumors (RECIST 1.1). Scans at day 56 are expected to be read as radiological progression upon restaging after AlloStim® priming, possibly due to immunological swelling, known as "pseudoprogression", consistent with the presumed inflammatory mechanism of action of AlloStim®. This mechanism may convert "cold" tumors to "hot" tumors. The immune cell infiltrates of tumors after AlloStim® include T-helper cell type 1 (Th1) memory cells which produce interferon-gamma. Interferon-gamma is known to increase expression of anti-programmed death ligand 1 (PD-L1) checkpoint molecules in the tumor microenvironment. Higher PD-L1 expression may convert checkpoint inhibitor unresponsive tumors to become checkpoint inhibitor responsive. After two 21-day cycles of AlloStim® priming, a combination of AlloStim® IV boosters and anti-PD-L1 checkpoint therapy (with avelumab 800 mg q/2 weeks) is scheduled between days 63 to day 98, A restaging CT scan at day 112 is then compared to day 56 and baseline to determine if the tumor target lesions\' size has changed. An expansion phase providing another cycle of combined AlloStim® and avelumab is provided for stable patients from days 119-154. A final restaging CT scan is conducted on Day 168 for all subjects.

Conditions

• Metastatic Colorectal Cancer

Interventions

Type	Name	Description
BIOLOGICAL	AlloStim	experimental immunotherapy to prime for checkpoint inhibitor
DRUG	Bavencio	anti-PDL1 checkpoint inhibitor

Timeline

• Start date: 2026-11-01
• Primary completion: 2028-06-01
• Completion: 2028-11-01
• First posted: 2024-08-16
• Last updated: 2025-10-21

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study