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

NCT05501912 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2024-11-29

No results posted yet for this study

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).

Conditions

  • Advanced Solid Tumor
  • BRAF V600 Mutation

Interventions

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.

Sponsors & Collaborators

  • ABM Therapeutics Shanghai Company Limited

    lead INDUSTRY

Principal Investigators

  • Jin Li, M.D. · Shanghai East Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-01
Primary Completion
2024-06-17
Completion
2024-06-17

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05501912 on ClinicalTrials.gov