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
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 is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

180

Study ID:

NCT04794699

Recruitment Status:

Recruiting

Sponsor:

IDEAYA Biosciences

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There are 37 Locations for this study

See Locations Near You

Honor Health Research Institute
Scottsdale Arizona, 85258, United States
University of Arkansas for Medical Sciences
Little Rock Arkansas, 72205, United States More Info
Maroof Khan Zafar
Contact
501-686-8274
[email protected]
City of Hope
Duarte California, 91010, United States More Info
New Patient Services
Contact
800-826-4673
[email protected]
Providence Medical Group
Santa Rosa California, 95403, United States More Info
Teresa Lund
Contact
707-521-3830
[email protected]
Advent Health
Celebration Florida, 34747, United States
Orlando Health Cancer Institute
Orlando Florida, 32806, United States More Info
Estefania Bobe Cortes
Contact
321-841-6626
[email protected]
Indiana University Health Hospital
Indianapolis Indiana, 46202, United States
Markey Cancer Center
Lexington Kentucky, 40536, United States More Info
Heather Flynn
Contact
707-521-3830
[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
Kailene Sullivan
Contact
[email protected]
Barbara Ann Karmanos Cancer Institute
Detroit Michigan, 48201, United States More Info
Brandon Smith
Contact
313-576-9681
[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
Alexandra Mavracick
Contact
[email protected]
Stephenson Cancer Center
Oklahoma City Oklahoma, 73104, United States More Info
Christina Seunath
Contact
405-271-8001
[email protected]
LifeSpan - Brown University
Providence Rhode Island, 02906, United States More Info
Benedito Carneiro
Contact
844-222-2881
[email protected]
SCRI Oncology Partners
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
Carmen Gonzalez
Contact
210-580-9521
[email protected]
Swedish Cancer Institute
Seattle Washington, 98104, United States
The Kinghorn Cancer Centre, St Vincent's Health Network Sydney
Darlinghurst New South Wales, 02010, Australia More Info
Southern Oncology Clinical Research Unit
Bedford Park South Australia, 05042, Australia More Info
Ganessan Kichenadasse
Contact
(+61)4 91 679 039
[email protected]
Institut Bergonie
Bordeaux Bordeaux Cedex, 33076, France More Info
Antoine Italiano
Contact
+33 5 56 33 33 33
[email protected]
Institut Claudius Regaud - IUCT-Oncopole
Toulouse Cedex 9, 31059, France More Info
Eulalie Magne
Contact
+33 5 31 15 58 22
[email protected]
Hôpital Timone
Marseille , 13005, France More Info
Laurent Greillier
Contact
+33 4 91 96 59 01
[email protected]
Centre Eugène Marquis
Rennes , 35000, France More Info
Thibault De la Motte Rouge
Contact
+33 2 99 25 29 69
[email protected]
Universitaetsklinikum Hamburg-Eppendorf (UKE)
Hamburg , 20246, Germany More Info
Frank Knauer
Contact
[email protected]
Chungbuk National University Hospital
Cheongju-si Chungcheongbuk-Do, 28644, Korea, Republic of More Info
Ki Hyeong Lee
Contact
82-43-269-6015
[email protected]
National Cancer Center
Goyang-si Gyeonggi, 10408, Korea, Republic of More Info
Ji-Youn Han
Contact
+82-31-920-1154
[email protected]
CHA University - Bundang Medical Center
Seongnam-si Gyeonggi, 28644, Korea, Republic of More Info
Joo-Hang Kim
Contact
[email protected]
Sevrance Hospital
Seoul , 03722, Korea, Republic of More Info
Hye Ryun Kim
Contact
82-2-2228-8125
[email protected]
Asan Medical Center
Seoul , 05505, Korea, Republic of More Info
Changmin Choi
Contact
+82-2-3010-5902
[email protected]
Vall Hebron Institute of Oncology
Barcelona , 08035, Spain More Info
Montserrat Pequera Juvany
Contact
+34 932 54 34 50
[email protected]
Hospital Universitario 12 de Octubre (H12O)
Madrid , 28041, Spain More Info
Elisa Lorente
Contact
+34 91 390 89 22
[email protected]
START Madrid-HM - Centro Integral Oncológico Clara Campal (CIOCC)
Madrid , 28050, Spain More Info
Marta Benitez
Contact
[email protected]
NEXT Madrid, Universitary Hospital QuironSAlud
Madrid , 28223, Spain More Info
Jorge Mercado
Contact
+34 666 209 969
[email protected]
Instituto Valenciano de Oncología (IVO)
Valencia , 46009, Spain More Info
Laura Bailach
Contact
34 663 224 882
[email protected]
National Cheng Kung University Hospital
Tainan , 704, Taiwan More Info
Ya-Zong Hsu
Contact
[email protected]
National Taiwan University Hospital
Taipei , 100, Taiwan More Info
Chia-Chi Lin
Contact
886-223123456
[email protected]

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

180

Study ID:

NCT04794699

Recruitment Status:

Recruiting

Sponsor:


IDEAYA Biosciences

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.