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 other anticancer agents including taxanes (docetaxel, paclitaxel), or 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 Genders
- 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 - Previous treatment with a MAT2A inhibitor and / or PRMT inhibitor or sacituzumab govitecan - Systemic anti-cancer therapy or major surgery within 4 weeks prior to study entry - Radiation therapy 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 - 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
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Part 1: Dose Escalation Monotherapy (Solid Tumors) |
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Experimental Part 2: Monotherapy Dose Expansion (NSCLC, EG and Urothelial) |
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Experimental Part 3: Combination Dose Escalation with docetaxel or paclitaxel (NSCLC, EG and Urothelial) |
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Experimental Part 4: Combination Dose Expansion with docetaxel or paclitaxel (NSCLC, EG and Urothelial) |
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Experimental Part 5: Combination Dose Escalation with sacituzumab govitecan (SG) (Urothelial) |
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Experimental Part 6: Combination Dose Expansion with sacituzumab govitecan (SG) (Urothelial) |
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Recruiting Locations
University of Arkansas for Medical Sciences
Little Rock, Arkansas 72205
Little Rock, Arkansas 72205
City of Hope
Duarte, California 91010
Duarte, California 91010
Orlando Health Cancer Institute
Orlando, Florida 32806
Orlando, Florida 32806
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland 21287
Baltimore, Maryland 21287
Dana Farber Cancer Institute
Boston, Massachusetts 02115
Boston, Massachusetts 02115
Columbia University Medical Center - Herbert Irving Pavilion
New York, New York 10032
New York, New York 10032
Weill Cornell Medical College
New York, New York 10065
New York, New York 10065
Stephenson Cancer Center
Oklahoma City, Oklahoma 73104
Oklahoma City, Oklahoma 73104
LifeSpan - Brown University
Providence, Rhode Island 02906
Providence, Rhode Island 02906
SCRI Oncology Partners
Nashville, Tennessee 37203
Nashville, Tennessee 37203
Contact:
askSARAH
844-482-4812
askSARAH
844-482-4812
Next Oncology
San Antonio, Texas 78229
San Antonio, Texas 78229
Swedish Cancer Institute
Seattle, Washington 98104
Seattle, Washington 98104
More Details
- NCT ID
- NCT04794699
- Status
- Recruiting
- Sponsor
- IDEAYA Biosciences