Breast Cancer Clinical Trial

Study of IDE397 in Participants With Solid Tumors Harboring MTAP Deletion

Summary

This is a Phase 1, open-label, multicenter, dose escalation and expansion study of the safety, PK, PD, and anti-tumor activity of IDE397 as a single agent and in combination with docetaxel, paclitaxel, gemcitabine/nab-paclitaxel and pemetrexed 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. IDE397 is a small molecule inhibitor of methionine adenosyltransferase 2 alpha (MAT2A).

View Eligibility Criteria

Eligibility 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
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 or 2 after discussion with medical monitor
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
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 is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

382

Study ID:

NCT04794699

Recruitment Status:

Recruiting

Sponsor:

IDEAYA Biosciences

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There are 11 Locations for this study

See Locations Near You

Honor Health Research Institute
Scottsdale Arizona, 85258, United States More Info
Oncology Clinical Trials Nurse Navigator
Contact
480-323-1791
[email protected]
Contact
833-354-6667
City of Hope
Duarte California, 91010, United States More Info
New Patient Services
Contact
800-826-4673
[email protected]
Indiana University Health Hospital
Indianapolis Indiana, 46202, United States More Info
Yvonne LaFary
Contact
[email protected]
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore Maryland, 21287, United States More Info
Carol Goldener
Contact
202-660-5629
[email protected]
Dana Farber Cancer Institute
Boston Massachusetts, 02115, United States More Info
Carolyn Jones
Contact
857-215-1351
[email protected]
Columbia University Medical Center - Herbert Irving Pavilion
New York New York, 10032, United States More Info
Benjamin Herzberg, MD
Contact
646-317-6041
[email protected]
Weill Cornell Medical College
New York New York, 10065, United States More Info
Jessica Wilk
Contact
[email protected]
Stephenson Cancer Center
Oklahoma City Oklahoma, 73104, United States More Info
Christina Seunath
Contact
405-271-8001
[email protected]
The Sarah Cannon Research Institute/Tennessee Oncology
Nashville Tennessee, 37203, United States More Info
askSARAH
Contact
844-482-4812
MD Anderson
Houston Texas, 77030, United States More Info
Jordi Rodon, MD
Contact
713-792-5603
[email protected]
Next Oncology
San Antonio Texas, 78229, United States More Info
Cynthia Deleon
Contact
210-580-9521
[email protected]

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

382

Study ID:

NCT04794699

Recruitment Status:

Recruiting

Sponsor:


IDEAYA Biosciences

How clear is this clinincal trial information?

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