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Study of MTB-9655, an Inhibitor of ACSS2, in Patients With Advanced Solid Tumors

NCT04990739 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2021-12-17

No results posted yet for this study

Summary

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.

Conditions

  • Advanced Solid Tumor

Interventions

DRUG

MTB-9655

MTB-9655 is an orally available investigational product that is highly potent as it exhibits selectivity as an ACSS2 inhibitor when tested against a panel of related enzymes. MTB-9655 is formulated as a powder blend in a hydroxypropyl methylcellulose (HPMC) capsule and is presented as 25 mg and 100 mg strengths for oral administration. Patients will receive MTB-9655, by mouth daily in 21-day treatment cycles,either 1 hour before mealtime or 2 hours after mealtime.

Sponsors & Collaborators

  • MetaboMed Inc

    lead OTHER

Principal Investigators

  • Meredith McKean, MD · SCRI Development Innovations, LLC

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-30
Primary Completion
2024-01-31
Completion
2024-01-31
FDA Drug
Yes

Countries

  • United States
  • Israel

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 NCT04990739 on ClinicalTrials.gov