OncoMatch/Clinical Trials/NCT07244705
A Study of ABT-301 Plus Tislelizumab With Bevacizumab in pMMR/Non-MSI-H Locally Advanced or mCRC
Is NCT07244705 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including ABT-301 and Tislelizumab for colorectal cancer (diagnosis).
Treatment: ABT-301 · Tislelizumab · Bevacizumab (Avastin) — The goal of this clinical trial is to evaluate the safety and tolerability of escalating doses of ABT-301 in combination with fixed doses of tislelizumab 200 mg IV infusion and bevacizumab 7.5 mg/kg IV infusion Q3W, in participants with pMMR/non-MSI-H colorectal cancer (CRC). It will also determine the maximum tolerated dose (MTD) and select the recommended Phase 2 dose (RP2D) of ABT-301. Participants will receive ABT-301 administered once daily (QD ±3 hours) or twice daily (Q12H ±3 hours, at least 9 hours apart) with water in 21-day treatment cycles. Tislelizumab 200 mg IV and bevacizumab 7.5 mg/kg IV Q3W will be given in both parts of the study.
Check if I qualifyExtracted eligibility criteria
Cancer type
Colorectal Cancer
Biomarker criteria
Required: MLH1 proficient MMR
Tumor tissues were identified as pMMR by immunohistochemistry (IHC) method
Required: MSH2 proficient MMR
Tumor tissues were identified as pMMR by immunohistochemistry (IHC) method
Required: MSH6 proficient MMR
Tumor tissues were identified as pMMR by immunohistochemistry (IHC) method
Required: PMS2 proficient MMR
Tumor tissues were identified as pMMR by immunohistochemistry (IHC) method
Allowed: BRAF V600E
Participants with BRAF V600E...may or may not have received relevant targeted therapy and failed
Allowed: HER2 (ERBB2) amplification
Participants with...HER2 amplification...may or may not have received relevant targeted therapy and failed
Allowed: HER2 (ERBB2) mutation
Participants with...HER2...mutation...may or may not have received relevant targeted therapy and failed
Allowed: KRAS G12C
Participants with...KRAS G12C mutation...may or may not have received relevant targeted therapy and failed
Allowed: NTRK1 fusion
Participants with...NTRK gene fusion...may or may not have received relevant targeted therapy and failed
Allowed: NTRK2 fusion
Participants with...NTRK gene fusion...may or may not have received relevant targeted therapy and failed
Allowed: NTRK3 fusion
Participants with...NTRK gene fusion...may or may not have received relevant targeted therapy and failed
Allowed: RET fusion
Participants with...RET fusion...may or may not have received relevant targeted therapy and failed
Disease stage
Required: Stage III, IV
pMMR/non-MSI-H advanced/recurrent histologically confirmed CRC with at least one measurable lesion, per RECIST version 1.1
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: cytotoxic chemotherapy (5-fluorouracil, oxaliplatin, irinotecan)
Participant must have received ≥2 lines of prior systemic therapy (including but not limited to chemotherapeutic agents of 5-fluorouracil, oxaliplatin, irinotecan)
Lab requirements
Blood counts
Absolute neutrophil count ≥1.5 × 10^9/L (1500/μL) without G-CSF support; lymphocyte count >0.5 × 10^9/L (500/µL); platelet count >100 × 10^9/L (100,000/μL) without transfusion; hemoglobin >90 g/L (9 g/dL), may be transfused to meet criterion
Kidney function
Creatinine clearance >60 mL/min
Liver function
AST, ALT, and ALP <2.5 × ULN (≤5 × ULN for participants with liver metastases); total serum bilirubin <1.5 × ULN (<3 × ULN in presence of Gilbert's syndrome or liver metastases)
Adequate hematologic and end-organ function, defined by laboratory data obtained within 7 days prior to the first dose of study intervention
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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