Study of IDE397 in Participants With Solid Tumors Harboring MTAP Deletion

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

  • Solid Tumor

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