NCT05501912

A Study of ABM-1310 in Patients With BRAF V600-Mutant Advanced Solid Tumors

A Phase I, Open-Label, Multicenter, Dose Escalation and Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Anti-Cancer Activity of ABM-1310 in Patients With BRAF V600-Mutant Advanced Solid Tumors

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: ABM Therapeutics Shanghai Company Limited · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase I, Open-Label, Multicenter, Dose Escalation and Expansion Study to evaluate the safety, tolerability, pharmacokinetics, and preliminary anti-cancer activity of ABM-1310 in patients with BRAF V600-Mutant advanced solid tumors. This study consists of two stages: dose escalation and dose expansion. During the dose escalation stage, a classic "3+3" design will be used to guide dose escalation to determine MTD and RP2D. The dose expansion stage will be initiated at the MTD or the optimal dose determined by the Safety Monitoring Committee (SMC ) as a fixed dose level (MTD or the optimal dose needs to be reviewed by the SMC and subjects are safe and tolerable at that dose level).

Detailed description

This is a Phase I, Open-Label, Multicenter, Dose Escalation and Expansion Study to evaluate the safety, tolerability, pharmacokinetics, and preliminary anti-cancer activity of ABM-1310 in patients with BRAF V600-Mutant advanced solid tumors. The primary objective of this study is to evaluate the safety and tolerability of ABM-1310 monotherapy, and to determine MTD and RP2D. The study will be conducted in two stages: Dose escalation stage: The dose escalation will be guided by a "3+3" design. In this study, the actual dose escalation will be based on a priming dose one level below the highest safe dose or two levels below the MTD that has been tested in US clinical trials when the enrolment of the China study actually initiates, and subsequent escalated doses may be adjusted as appropriate (e.g., the escalated doses following 150 mg BID in the China study may be adjusted to 200 mg BID, 250 mg BID and 300 mg BID. The actual priming dose and subsequent escalated doses for the China study are determined by the SMC). Dose expansion stage: Subjects will begin to receive oral doses of ABM-1310, BID, for 28-day cycles at a fixed dose level (as determined at the dose escalation stage).The dose expansion stage is expected to include the following two cohorts of advanced solid tumors with BRAF V600 mutations: Cohort 1: primary extracranial solid tumors, subjects with BMs preferentially enrolled, up to 15 patients per tumor type; Cohort 2: primary intracranial solid tumors, N = up to 30 patients.

Conditions

• Advanced Solid Tumor
• BRAF V600 Mutation

Interventions

Type	Name	Description
DRUG	ABM-1310	Dose escalation starting dose will be based on a priming dose one level below the highest safe dose or two levels below the MTD that has been tested in US clinical trials. Dose expansion will be initiated at the MTD or the optimal dose determined by the SMC as a fixed dose level.

Timeline

• Start date: 2022-09-01
• Primary completion: 2024-06-17
• Completion: 2024-06-17
• First posted: 2022-08-16
• Last updated: 2024-11-29

Locations

10 sites across 1 country: China