Spots Global Cancer Trial Database for A Study of ABM-1310 in Patients With BRAF V600-Mutant Advanced Solid Tumors
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Trial Identification
Brief Title: A Study of ABM-1310 in Patients With BRAF V600-Mutant Advanced Solid Tumors
Official Title: 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
Study ID: NCT05501912
Interventions
Study Description
Brief 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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Beijing Cancer Hospital, Beijing, Beijing, China
Beijing Tsinghua Changgeng Hospital, Beijing, Beijing, China
Hebei University Affiliated Hospital, Baoding, Hebei, China
Harbin Medical University Affiliated Cancer Hospital, Harbin, Heilongjiang, China
Xuzhou Medical University Affiliated Hospital, Xuzhou, Jiangsu, China
The First Affiliated Hospital of Nanchang University, Nanchang, Jiangxi, China
Jilin Cancer Hospital, Changchun, Jilin, China
Affiliated Cancer Hospital of Shandong First Medical University (Shandong Cancer Institute, Shandong Cancer Hospital), Jinan, Shandong, China
Affiliated hospital of jining medical college, Jining, Shandong, China
Shanghai Chest Hospital, Shanghai, Shanghai, China
Zhongshan Hospital Affiliated to Fudan University, Shanghai, Shanghai, China
Huashan Hospital Affiliated to Fudan University, Shanghai, Shanghai, China
Shanghai East Hospital, Shanghai, Shanghai, China
Shanghai Pulmonary Hospital, Shanghai, Shanghai, China
Shanxi Cancer Hospital, Taiyuan, Shanxi, China
West China Hospital of Sichuan University, Chengdu, Sichuan, China
The Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, Zhejiang, China
Contact Details
Name: Jin Li, M.D.
Affiliation: Shanghai East Hospital
Role: PRINCIPAL_INVESTIGATOR
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