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 (Jun 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
Treatments studied
Immunotherapy
Targeted therapy
Other
Cancer type
Colorectal Cancer
Biomarker criteria
Required: MMR proficient (pMMR by IHC)
Tumor tissues were identified as pMMR by immunohistochemistry (IHC) method
Required: MSI non-MSI-H (non-MSI-H by PCR)
nonMSI-H by polymerase chain reaction (PCR)
Allowed: BRAF V600E
Participants with BRAF V600E ... may or may not have received relevant targeted therapy and failed
Allowed: HER2 (ERBB2) amplification/mutation
Participants with ... HER2 amplification/ 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
Metastatic disease required
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: systemic therapy (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; participant may or may not have received biologic agents such as cetuximab, panitumumab, aflibercept, ramucirumab, bevacizumab; tyrosine kinase inhibitors of regorafenib, fruquintinib)
Cannot have received: immunotherapy
Exception: and has experienced disease progression
Prior treatment with any immunotherapy agent, including CD137 agonists or immune checkpoint blockade therapies (such as anti-CTLA-4, anti-PD-1, and anti-PD-L1 therapeutic antibodies) and has experienced disease progression
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; serum albumin ≥30 g/L (3 g/dL); INR or aPTT <1.5 × ULN
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 the presence of documented Gilbert's syndrome or liver metastases at baseline)
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.
Frequently asked questions
Is NCT07244705 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior immunotherapy disqualifies patients from enrollment.
Does this trial require MMR?
Yes, MMR proficient is a required biomarker for enrollment.
Does this trial require MSI?
Yes, MSI non-MSI-H is a required biomarker for enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages