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

Sponsor
Anbogen Therapeutics, Inc.
Study ID
NCT07244705
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Colorectal Cancer (CRC)
  • Colorectal Cancer (Diagnosis)
  • Colorectal Cancer Metastatic
  • Immunotherapy

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • ABT-301 — DRUG
    ABT-301 is an oral histone deacetylase inhibitor (HDACi) administered in capsule form once daily (QD ±3 hours) or every 12 hours (Q12H ±3 hours, with at least 9 hours between doses) with water in 21-day treatment cycles. In Part 1 (dose-escalation phase), participants receive escalating doses of ABT-301 (50 mg QD, 100 mg QD, 50 mg Q12H, 150 mg QD, or 75 mg Q12H). Tislelizumab 200 mg and bevacizumab 7.5 mg/kg will be administered through IV infusion on Day 1 of every 21-day treatment cycle. This phase aims to determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of ABT-301 when combined with tislelizumab and bevacizumab. In Part 2 (dose-optimization phase), two ABT-301 doses/schedules will be selected for further evaluation of antitumor activity, safety, and tolerability in adults with pMMR/non-MSI-H colorectal cancer (CRC).
  • Tislelizumab — DRUG
    Tislelizumab is a humanized immunoglobulin G4-variant monoclonal antibody (mAb) blocking programmed cell death protein 1 (PD-1). Tislelizumab 200 mg will be administered through IV infusion on Day 1 of every 21-day treatment cycle in combination with ABT-301 and bevacizumab throughout both parts of the study.
  • Bevacizumab (Avastin) — DRUG
    Bevacizumab (Avastin®) is a recombinant humanized monoclonal IgG1 antibody which binds to and neutralizes VEGF. Neutralization of VEGF by bevacizumab has been shown to inhibit the VEGF-induced proliferation of human endothelial cells in vitro and to decrease micro-vessel density and interstitial pressure in tumor xenografts in vivo. Bevacizumab 7.5 mg/kg will be administered through IV infusion on Day 1 of every 21-day treatment cycle in combination with ABT-301 and tislelizumab, throughout both parts of the study.

Study Details

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.

Key Dates

First listed
Nov 24, 2025
Start date
Nov 30, 2025
Status verified
Nov 2025
Primary completion
Apr 30, 2028
Completion
Jul 31, 2028

Study Design

Enrollment
66 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Part 1 (Dose Escalation Phase)
  • Experimental: Part 2 (Dose Optimization Phase)

Primary Outcome Measure

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. [ Time Frame: From screening to 90 days after last dose ]

Central Contacts

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