Ivonescimab and ADG126, Alone, and in Combination With Leucovorin and Fluorouracil or FOLFIRI Regimen for the Treatment of Microsatellite Stable Advanced/Metastatic Colorectal Cancer
A Phase I Clinical Trial of Ivonescimab and ADG126, Alone, and in Combination With 5-FU/LV or FOLFIRI in MSS Advanced/Metastatic Colorectal Cancer
Sponsor: City of Hope Medical Center + National Cancer Institute (NCI)
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
Incidence of dose limiting toxicities
Time frame: Up to 6 weeks or 3 doses of ivonescimab, whichever is longer
Secondary Endpoints
Treatment-related adverse event rates
Objective response rate
Duration of response
Eligibility Criteria
Inclusion Criteria: * Documented informed consent of the participant and/or legally authorized representative * Agreement to blood collection for correlative analysis at baseline, 4 weeks, and 8 weeks, and then every subsequent 8 weeks * Age: ≥ 18 years * Eastern Cooperative Oncology Group (ECOG) ≤ 1 * Histologically confirmed advanced/metastatic MSS colorectal cancer. MSS status must have been confirmed by a Clinical Laboratory Improvement Amendments (CLIA) certified assay * Measurable disease by RECIST 1.1 * Fully recovered from the acute, clinically significant, toxic effects (except alopecia) to ≤ grade 1 to prior anti-cancer therapy * ARM A ONLY: Patients should not have evidence of hepatic metastatic disease * ARM A ONLY: Patients should have progressed following irinotecan, oxaliplatin, fluoropyrimidine, and an anti-EGFR if clinically indicated * ARM B ONLY: Patient is eligible for maintenance 5-FU/LV or 5-FU/LV bevacizumab * ARM B ONLY: No history of significant toxicity to 5-…
Read full criteria on CT.gov →✦ Analyst Commentary
Expert commentary on why this trial matters and what to watch for.
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