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Also known as MPT0E028, Imofinostat
ABT-301 · 1 trial · 4 indications
Endpoints include: Adverse Event will be graded using the NCI CTCAE V5.0.
Endpoints include: Incidence of DLTs during the first cycle of treatment.
Endpoint: ORR per Investigator assessment, according to RECIST version 1.1.
| Arm | Type | Description |
|---|---|---|
| Part 1 (Dose Escalation Phase) | EXPERIMENTAL | - |
| Part 2 (Dose Optimization Phase) | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| 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. |
Inclusion 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...