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Purpose

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).

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Part 1: Dose Escalation Monotherapy (Solid Tumors)
  • Drug: IDE397
    IDE397 dosed orally
Experimental
Part 2: Monotherapy Dose Expansion (NSCLC and Urothelial)
  • Drug: IDE397
    IDE397 dosed orally
Experimental
Part 5: Combination Dose Escalation with sacituzumab govitecan (SG) (NSCLC and Urothelial)
  • Drug: IDE397
    IDE397 dosed orally
  • Drug: Sacituzumab govitecan
    Intravenous infusion
Experimental
Part 6: Combination Dose Expansion with sacituzumab govitecan (SG) (NSCLC and Urothelial)
  • Drug: IDE397
    IDE397 dosed orally
  • Drug: Sacituzumab govitecan
    Intravenous infusion

Recruiting Locations

More Details

NCT ID
NCT04794699
Status
Active, not recruiting
Sponsor
IDEAYA Biosciences

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.