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Status:

WITHDRAWN

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

Lead Sponsor:

Mirror Biologics, Inc.

Conditions:

Metastatic Colorectal Cancer

Eligibility:

All Genders

18-80 years

Phase:

PHASE2

Brief Summary

Experimental immunotherapy in chemotherapy-refractory and immunotherapy-refractory metastatic colorectal cancer patients that have progressed, or are intolerant to, Longsurf (TAS-102) +/- Avastin (bev...

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...

Eligibility Criteria

Inclusion

  • Adult male and female subjects aged 18-80 years at screening visit
  • Pathologically confirmed diagnosis of MSS/pMMR colorectal adenocarcinoma
  • Presenting with metastatic disease:
  • Primary tumor can be intact or previously resected
  • Previous treatment failure of at least two lines of active systemic chemotherapy:
  • Previous chemotherapy must have included a fluoropyrimidine, oxaliplatin (e.g. FOLFOX, CAPOX), and irinotecan-containing (e.g. FOLFIRI) regimens (single regimen of FOLFIRINOX satisfies)
  • Administered in adjuvant setting or for treatment of metastatic disease
  • If KRAS wild type, must have at least one prior anti-EGFR therapy if left sided primary tumor
  • Treatment failure or refusal/not qualified for at least one third-line treatment
  • TAS-102 +/- bevacizumab or regorafenib or fruquinib
  • Treatment failure can be due to disease progression or toxicity
  • Time from last treatment failure to Informed Consent must be no more than 30 days
  • ECOG performance score: 0-1
  • Adequate hematological function:
  • Absolute granulocyte count ≥ 1,200/mm3
  • Platelet count ≥ 100,000/mm3
  • Hemoglobin ≥ 9.0 g/dL (may be corrected by transfusion)
  • Adequate Organ Function:
  • Creatinine ≤ 1.5 mg/dL
  • Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • Alkaline phosphatase ≤ 2.5 times ULN \*
  • Aspartate aminotransferase (AST) or (SGOT) ≤ 2.5 times ULN \*
  • Alanine aminotransferase (ALT) or (SGPT) ≤ 2.5 times ULN\*
  • EKG without clinically relevant abnormalities
  • Female subjects: Not pregnant or lactating
  • Patients with childbearing potential must have a negative ß-HCG test and agree to use a highly effective contraceptive method during the course of the study
  • Study specific Informed Consent in the native language of the subject
  • ≤ 5 times ULN if liver involvement

Exclusion

  • High frequency microsatellite instability (MSI-H) or deficient mismatched repair dMMR
  • Bowel obstruction or high risk for obstruction if tumors become inflamed
  • Moderate or severe ascites requiring medical intervention
  • Clinical evidence of brain metastasis or leptomeningeal involvement
  • Widespread peritoneal carcinomatous (e.g. CT scan shows innumerable lesions visible and/or abnormal thickening of greater omentum) that increases risk of a major morbidity (e.g. bowel obstruction) in the opinion of the Investigator
  • COPD
  • Pulmonary lymphangitis or symptomatic pleural effusion (grade ≥ 2) that results in pulmonary dysfunction requiring active treatment; or, oxygen saturation \<92% on room air
  • Any of the following mood disorders: active major depressive episode, recent history of suicidal attempt or ideation
  • Prior allogeneic bone marrow/stem cell or solid organ transplant
  • Chronic use (\> 2 weeks) of greater than physiologic doses of a corticosteroid agent (dose equivalent to \> 5 mg/day of prednisone) planned or anticipated during the study before the end of the Safety Evaluation Period (28 days after the last dose of IP)
  • Topical corticosteroids are permitted
  • Prior diagnosis of an active autoimmune disease (e.g., rheumatoid arthritis, multiple sclerosis, autoimmune thyroid disease, uveitis)
  • Well controlled Type I diabetes allowed (HbA1c \< 8.5%)
  • Prior experimental immunotherapy
  • History of blood transfusion reactions
  • Progressive viral or bacterial infection
  • o All infections must be resolved and the subject must remain afebrile for seven days without antibiotics prior to being placed on study
  • Cardiac disease of symptomatic nature
  • History of HIV positivity or AIDS
  • History of severe hypersensitivity to monoclonal antibody drugs
  • Psychiatric or addictive disorders or other condition that, in the opinion of the Investigator, would preclude study participation.
  • Subjects that lack ability to provide consent for themselves
  • Any prior cancer diagnosis (other than cured basal cell carcinoma, head and neck carcinoma in-situ, superficial Ta, Tis, T1 bladder cancer, or papillary carcinoma of thyroid) or concurrent cancer histologically different than colorectal adenocarcinoma

Key Trial Info

Start Date :

November 1 2026

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

November 1 2028

Estimated Enrollment :

Patients enrolled

Trial Details

Trial ID

NCT06557278

Start Date

November 1 2026

End Date

November 1 2028

Last Update

October 21 2025

Active Locations (3)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 1 (3 locations)

1

Mt. Sinai Comprehensive Cancer Center

Miami Beach, Florida, United States, 33140

2

Hirschfield Oncology Center

Brooklyn, New York, United States, 11206

3

New York Cancer and Blood Specialists

Shirley, New York, United States, 11967