Safety of ABM-1310 Monotherapy in Patients With Advanced Solid Tumors

Summary

Participation Requirements

Description

This is a first-in-human, phase I clinical study with ABM-1310, an investigational, oral, small molecule B-Raf inhibitor in patients with documented BRAF V600 mutation and locally advanced or metastatic solid tumors such as melanoma, colorectal cancer, glioblastoma, cholangiocarcinoma, non-small cel...

This is a first-in-human, phase I clinical study with ABM-1310, an investigational, oral, small molecule B-Raf inhibitor in patients with documented BRAF V600 mutation and locally advanced or metastatic solid tumors such as melanoma, colorectal cancer, glioblastoma, cholangiocarcinoma, non-small cell lung cancer, thyroid cancer, or ovarian carcinoma who have no effective standard treatment options available. The primary objective of this study is to determine the Maximum Tolerated Dose (MTD) and/or the Recommended Phase II Dose (RP2D). The starting dose of ABM-1310 is 25 mg po bid, and dose escalation will be guided by a "3+3" design. ABM-1310 will be administered twice daily on a continuous schedule. Each treatment cycle consists of 28 days. Dose limiting toxicity (DLT) will be evaluated and managed per the pre-defined DLT criteria and rules specified in the protocol. MTD and/or RP2D will be confirmed in a dose confirmation cohort.

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