A Study of ABT-301 Plus Tislelizumab With Bevacizumab in pMMR/Non-MSI-H Locally Advanced or mCRC

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.

Trial Details

NCT ID

NCT07244705

Phase

PHASE1 / PHASE2

Sponsor

Anbogen Therapeutics, Inc.

Status

RECRUITING

Cancer Type

Colorectal Cancer

Interventions

ABT-301
Tislelizumab
Bevacizumab (Avastin)

Locations (sample)

Liverpool, New South Wales, Australia|-33.91938,150.92588
Macquarie Park, New South Wales, Australia|-33.78105,151.12757
Randwick, New South Wales, Australia|-33.91439,151.24895
Greenslopes, Queensland, Australia|-27.50815,153.04951
Woodville South, South Australia, Australia|-34.88186,138.53477

Key Eligibility Criteria

Participant must be ≥18 years at the time of signing the informed consent.
Participant with pMMR/non-MSI-H advanced/recurrent histologically confirmed CRC with at least one measurable lesion, per RECIST version 1.1.
Participant must have received ≥2 lines of prior systemic therapy (including but not limited to chemotherapeutic agents of 5-fluorouracil, oxalipla…
NOTE: Participants with BRAF V600E, HER2 amplification/ mutation, KRAS G12C mutation, NTRK gene fusion, RET fusion, may or may not have received re…

For full eligibility, visit ClinicalTrials.gov.

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