A Study of ABT-301 Plus Tislelizumab With Bevacizumab in pMMR/Non-MSI-H Locally Advanced or mCRC (NCT07244705) | Clinical Trial Compass
RecruitingPhase 1/2
A Study of ABT-301 Plus Tislelizumab With Bevacizumab in pMMR/Non-MSI-H Locally Advanced or mCRC
Australia66 participantsStarted 2025-11
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
✓. Platelet count \>100 × 109/L (100,000/μL), without transfusion.
✓. Hemoglobin \>90 g/L (9 g/dL), participants may be transfused to meet this criterion.
✓. AST, ALT, and ALP \<2.5 × ULN (must be ≤5 × ULN for participants with liver metastases).
✓. Total serum bilirubin \<1.5 × ULN (\<3 × ULN in the presence of documented Gilbert's syndrome \[unconjugated hyperbilirubinemia\] or liver metastases at baseline).
✓. Creatinine clearance \>60 mL/min.
✓. Serum albumin ≥30 g/L (3 g/dL).
Exclusion criteria
✕. A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval \>450 milliseconds).
What they're measuring
1
Part I - 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 CRC.
Timeframe: From screening to 90 days after last dose
2
Part I - To determine the Maximum tolerated dose (MTD) and select the recommended Phase 2 dose (RP2D) of ABT-301.
Timeframe: From the first dose of ABT-301 to the completion of the first 21-day cycle of ABT-301 treatment in the last cohort.
3
Part II - To evaluate the efficacy of two dosages/schemes of ABT-301 in combination with tislelizumab and bevacizumab.
Timeframe: From baseline until progression of disease or death, whichever occurs first. (up to 28 months)
. A history of additional risk factors for torsades de pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome).
✕. Using concomitant medications that prolong the QT/QTc interval. - Major surgical procedure, other than for diagnosis, within four weeks prior to initiation of study intervention, or anticipation of need for a major surgical procedure during the study.
✕. Participants requiring pain medication must be on a stable regimen at study entry.
✕. Symptomatic lesions (e.g., bone metastases or metastases causing nerve impingement) amenable to palliative radiotherapy should be treated prior to enrollment. Participants should recover from the effects of radiation. There is no required minimum recovery period.
✕. Asymptomatic metastatic lesions that would likely cause functional deficits or intractable pain with further growth (e.g., epidural metastasis that is not currently associated with spinal cord compression) should be considered for loco-regional therapy if appropriate prior to enrollment.
✕. Known to be moderate or strong inhibitors or inducers of CYP3A4 (Appendix 9).
✕. Known to be sensitive or narrow therapeutic index substrates of CYP3A4, CYP2C8, CYP2C9, or CYP2C19 (Appendix 10).