Advanced Solid Tumor Clinical Trial
Official title:
A Phase 1 Open Label, Multicenter Study of MTB-9655, an Inhibitor of ACSS2, in Patients With Advanced Solid Tumors
MetaboMed is developing MTB-9655, an orally bioavailable, first-in-class small molecule inhibitor of the human Acetyl coenzyme A (Acyl-CoA) synthetase short chain family member 2 (ACSS2) enzyme, as a potential treatment for patients with cancer. This study is a Phase 1,First-in-Human (FIH), open-label dose-escalation study of MTB-9655 given daily as a single oral (PO) agent. Up to 30 patients with locally advanced, unresectable and/or metastatic solid tumor(s) are expected to be enrolled in the dose-escalation portion (Part A). The study will be conducted at 1 to 2 sites in the United States and Israel.
This Phase 1 First-in-Human (FIH) study is to initiate clinical development of MTB-9655 in patients with advanced solid tumors who have failed or refused standard treatment, or who have a tumor for which no therapy of proven efficacy exists. This study of MTB-9655 may consist of 2 parts: a dose-escalation part to establish a safe and tolerable dose of MTB-9655 in patients with advanced or metastatic solid tumors for which no standard therapy is available or standard therapy has failed (Part A), and a dose expansion phase (Part B) which may be initiated at the Sponsor's discretion after the maximum tolerated dose (MTD) (or recommended Phase 2 dose [RP2D]) has been determined in the dose-escalation (Part A), and with approval of an amendment to the protocol. This study will be the basis for future studies. The study will identify the safety and tolerability of MTB-9655 when administered on a continuous dosing schedule (given by mouth on a 21-day schedule). ;
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