Status:
COMPLETED
Immunotherapy for Third Line Metastatic Colorectal Cancer
Lead Sponsor:
Mirror Biologics, Inc.
Conditions:
Metastatic Colorectal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This is a Phase IIB multi-site, open label study of a next generation immunotherapy for third-line MSI-S metastatic colorectal cancer using an "off-the-shelf", non-genetically manipulated living immun...
Detailed Description
This is a Phase IIB open label immunotherapy protocol called "StimVax". The protocol design is based upon information obtained from a previous Phase IIA dose level and dose frequency ranging study. Th...
Eligibility Criteria
Inclusion
- Adult males and female subjects aged 18-80 years at screening visit
- Pathologically confirmed diagnosis of colorectal adenocarcinoma
- Presenting with metastatic disease:
- Previous treatment failure of two previous lines of active systemic chemotherapy:
- Previous chemotherapy must have included an oxaliplatin-containing (e.g. FOLFOX) and an irinotecan-containing (e.g. FOLFIRI) regimen
- With or without bevacizumab
- Administered in adjuvant setting or for treatment of metastatic disease
- If KRAS wild type, must have at least one prior anti-EGFR therapy
- Treatment failure can be due to disease progression or toxicity
- Disease progression on second line therapy must be documented radiologically and must have occurred during or within 30 days following the last administration of treatment for metastatic disease
- ECOG performance score: 0-1
- Adequate hematological function:
- Absolute granulocyte count ≥ 1,200/mm3
- Platelet count ≥ 100,000/mm3
- PT/INR ≤ 1.5 or correctable to \<1.5 at time of interventional procedures
- Hemoglobin ≥ 9 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 \* \*or ≤5x ULN if liver involvement
- EKG without clinically relevant abnormalities
- Female subjects: Not pregnant or lactating
- Patients with child bearing potential must agree to use adequate contraception
- Study specific informed consent in the native language of the subject.
Exclusion
- high frequency microsatellite instability (MSI-H)
- Bowel obstruction or high risk for obstruction if tumors become inflamed
- Moderate or severe ascites requiring medical intervention
- Clinical evidence or radiological evidence of brain metastasis or leptomeningeal involvement
- Peritoneal carcinomatosis
- Symptomatic asthma or COPD
- Pulmonary lymphangitis or symptomatic pleural effusion (grade ≥ 2) that results in pulmonary dysfunction requiring active treatment; or, oxygen saturation \<92% on room air
- Bevacizumab (Avastin®) treatment within 6 weeks of baseline scheduled biopsy procedure
- Any of the following mood disorders: active major depressive episode, 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) within 30 days of the first day of study drug treatment
- 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
- Prior experimental therapy
- History of blood transfusion reactions
- Progressive viral or bacterial infection
- 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
- Concurrent medication known to interfere with platelet function or coagulation (e.g., aspirin, ibuprofen, clopidogrel, or warfarin) unless such medications can be discontinued for an appropriate time period based on the drug half-life and known activity (e.g., aspirin for 7 days) prior to biopsy procedures
- 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.
Key Trial Info
Start Date :
July 12 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2025
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT04444622
Start Date
July 12 2021
End Date
March 31 2025
Last Update
October 20 2025
Active Locations (4)
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1
Mt. Sinai Comprehensive Cancer Center
Miami Beach, Florida, United States, 33140
2
Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
3
Summit Health
Florham Park, New Jersey, United States, 07932
4
Hirschfield Oncology Center
The Bronx, New York, United States, 10469