An Open Label, Phase 1, Treatment Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of IDE397 (MAT2A Inhibitor) In Adult Participants With Advanced Solid Tumors

Study Identifier:
IDE397-001
CT.gov Identifier:
NCT04794699
EudraCT Identifier:
2022-002607-37
EU Trial (CTIS) Number:
2024-510995-18-00
Study Contact Information:
N/A
Recruitment Complete

Considering participating in a START clinical trial?

Get Started

Study Summary

This is a Phase 1, open-label, multicenter, dose escalation and expansion study of the safety, PK, PD, and preliminary anti-tumor activity of IDE397 as a single agent and in combination with sacituzumab govitecan (SG), in adult patients with selected advanced or metastatic MTAP-deleted advanced solid tumors who are unresponsive to standard of care therapy. IDE397 is a small molecule inhibitor of methionine adenosyltransferase 2 alpha (MAT2A).

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
  • Solid Tumor
    • Phase
    The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
    I
    Sex
    Female & Male
    Age
    18+ years
    Study Drug
  • Drug: EXPERIMENTAL: Part 1: Dose Escalation Monotherapy (Solid Tumors)
    • Read More
  • Drug: Drug: IDE397
  • Drug: IDE397 dosed orally
  • Drug: EXPERIMENTAL: Part 2: Monotherapy Dose Expansion (NSCLC and Urothelial)
  • Drug: EXPERIMENTAL: Part 5: Combination Dose Escalation with sacituzumab govitecan (SG) (NSCLC and Urothelial)
  • Drug: Drug: Sacituzumab govitecan
  • Drug: Intravenous infusion
  • Drug: EXPERIMENTAL: Part 6: Combination Dose Expansion with sacituzumab govitecan (SG) (NSCLC and Urothelial)
    • Study Status
    Indicates the current recruitment status or the expanded access status
    Recruitment Complete

    Requirements information
    Inclusion criteria
    • * Participant must be at least 18 years of age
    • * Advanced or metastatic solid tumor that has progressed on at least one prior line of treatment or is intolerant to additional effective standard therapy
    • * Have evidence of homozygous loss of MTAP or MTAP deletion
    • * Willing to undergo paired fresh biopsy (pre- and post-treatment) procedure. Exceptions may be made for feasibility and safety concerns
    • * Measurable disease
    • * ECOG performance status <= 1
    • * Adequate organ function
    • * Able to swallow and retain orally administered study treatment
    • * Recovery from acute effects of prior therapy
    • * Able to comply with contraceptive/barrier requirements
    Exclusion criteria
    • Known symptomatic brain metastases
    • * Known primary CNS malignancy
    • * Current active liver or biliary disease
    • * Impairment of gastrointestinal (GI) function
    • * Active uncontrolled infection
    • * Clinically significant cardiac abnormalities
    • * Active second malignancy or history of another malignancy in the past 2 years
    • * Previous treatment with a MAT2A inhibitor and / or PRMT inhibitor or sacituzumab govitecan
    • * Systemic anti-cancer therapy, therapeutic antibody treatment, or major surgery within 4 weeks prior to study entry
    • * Current radiation-related toxicity or radiation therapy within 2 weeks prior to study entry
    • * Small molecule anti-cancer treatment within 2 weeks prior to study entry
    • * Prior irradiation to >25% of the bone marrow
    • * Current use or anticipated need for food or drugs that are known strong CYP3A4/5 inhibitors or inducers
    • * Require concomitant use of proton pump inhibitor
    • * Currently receiving another investigational study drug.
    • * Known or suspected hypersensitivity to IDE397/excipients or components

    Clinical Study Information for Healthcare Providers

    By clicking the button below you will find in-depth information about this clinical trial, including study design, primary and secondary endpoints, and more. This information is intended for healthcare professionals seeking to review the scientific and operational aspects of the study.

    View Study Information

    Study Locations

    Location
    Investigator
    Status
    Condition(s) Treated at Site
    Location
    START Madrid, Spain (CIOCC)
    Madrid, Spain, 28050
    Investigator
    Juan Francisco Rodriguez
    Status
    Recruitment Complete
    Condition(s) Treated at Site
    Solid Tumor