Study of IDE397 in Participants With Solid Tumors Harboring MTAP Deletion

• Status: Recruiting
• Trial end date: 2024-12-31
• Target enrollment: 0
• Participant gender: All

Summary

This is a Phase 1, open-label, multicenter, multiple dose, dose escalation study of the safety, PK, PD, and anti-tumor activity of IDE397 as a single agent in adult patients with selected advanced or metastatic MTAP-deleted advanced solid tumors who are unresponsive to standard of care therapy or for whom no curative therapy is available.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: IDEAYA Biosciences

Criteria

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 at the DNA or protein level in the participant's tumor tissue

• Measurable disease

• ECOG performance status <= 1 or 2

• Adequate organ function

• Able to swallow and retain orally administered study treatment

• Able to comply with contraceptive/barrier requirements

Exclusion Criteria:

• Known symptomatic brain metastases that are not neurologically stable for 3 months

• Known primary CNS malignancy

• Current active liver or biliary disease

• Active inflammatory gastrointestinal disease, chronic diarrhea, known diverticular disease or previous gastric resection or lap band surgery

• Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of IDE397

• Active, uncontrolled infection including hepatitis B virus, hepatitis C virus, human immunodeficiency virus, or acquired immunodeficiency syndrome related illness

• Baseline 12 lead ECG that demonstrates clinically relevant abnormalities

• Clinically significant cardiac events 6 months before study entry

• Uncontrolled hypertension despite optimal medical therapy

• Previous treatment with a MAT2A inhibitor and / or PRMT inhibitor

• Major surgery within 4 weeks prior to C1D1

• Radiation therapy within 4 weeks prior to C1D1

• Systemic anti-cancer therapy (non-monoclonal antibody) within 4 weeks prior to study entry or within 28 days prior to study entry for an antibody based agent(s) or 5 half-lives (whichever is shorter)

• Have received radioimmunotherapy less than 6 weeks before the first dose of IDE397

• Have received treatment with a therapeutic antibody less than 4 weeks before the first dose of IDE397

• Have received treatment with an investigational small molecule less than 2 weeks before the first dose of IDE397

• Prior irradiation to >25% of the bone marrow

• Current use or anticipated need for food or drugs that are known strong CYP3A4/5 inhibitors

• Current use or anticipated need for food or drugs that are known strong CYP3A4/5 inducers

• Received an investigational product within 28 days prior to first dose of IDE-397 or 5 half-lives (whichever is shorter)

• Exposure to more than 4 investigational medicinal products within 12 months prior to C1D1

• Known or suspected hypersensitivity to IDE397/excipients or components