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

ArmDescriptionAssigned Intervention
Experimental
Part 1: Dose Escalation Monotherapy (Solid Tumors)
  • Drug: IDE397
    IDE397 dosed orally
Experimental
Part 2: Monotherapy Dose Expansion (NSCLC, EG and Urothelial)
  • Drug: IDE397
    IDE397 dosed orally
Experimental
Part 3: Combination Dose Escalation with docetaxel or paclitaxel (NSCLC, EG and Urothelial)
  • Drug: IDE397
    IDE397 dosed orally
  • Drug: Docetaxel
    Intravenous infusion
  • Drug: Paclitaxel
    Intravenous infusion
Experimental
Part 4: Combination Dose Expansion with docetaxel or paclitaxel (NSCLC, EG and Urothelial)
  • Drug: IDE397
    IDE397 dosed orally
  • Drug: Docetaxel
    Intravenous infusion
  • Drug: Paclitaxel
    Intravenous infusion
Experimental
Part 5: Combination Dose Escalation with sacituzumab govitecan (SG) (Urothelial)
  • Drug: IDE397
    IDE397 dosed orally
  • Drug: Sacituzumab govitecan
    Intravenous infusion
Experimental
Part 6: Combination Dose Expansion with sacituzumab govitecan (SG) (Urothelial)
  • Drug: IDE397
    IDE397 dosed orally
  • Drug: Sacituzumab govitecan
    Intravenous infusion

Recruiting Locations

University of Arkansas for Medical Sciences
Little Rock, Arkansas 72205
Contact:
Maroof Khan Zafar
501-686-8274
MKZafar@uams.edu

City of Hope
Duarte, California 91010
Contact:
New Patient Services
800-826-4673
newpatientservices3@coh.org

Orlando Health Cancer Institute
Orlando, Florida 32806
Contact:
Estefania Bobe Cortes
321-841-6626
Estefania.BobeCortes@orlandohealth.com

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland 21287
Contact:
Carol Goldener
202-660-5629
cgolden9@jhmi.edu

Dana Farber Cancer Institute
Boston, Massachusetts 02115
Contact:
Kailene Sullivan
dfcicctiexternalreferral@dfci.harvard.edu

Columbia University Medical Center - Herbert Irving Pavilion
New York, New York 10032
Contact:
Benjamin Herzberg, MD
646-317-6041
Boh2109@cumc.columbia.edu

Weill Cornell Medical College
New York, New York 10065
Contact:
Alexandra Mavracick
alm2074@med.cornell.edu

Stephenson Cancer Center
Oklahoma City, Oklahoma 73104
Contact:
Christina Seunath
405-271-8001
Christina-Caldwell@ouhsc.edu

LifeSpan - Brown University
Providence, Rhode Island 02906
Contact:
Benedito Carneiro
844-222-2881
benedito.carneiro@lifespan.org

SCRI Oncology Partners
Nashville, Tennessee 37203
Contact:
askSARAH
844-482-4812

MD Anderson
Houston, Texas 77030
Contact:
Jordi Rodon, MD
713-792-5603
JRodon@mdanderson.org

Next Oncology
San Antonio, Texas 78229
Contact:
Carmen Gonzalez
210-580-9521
NXTSA_Coordinators@nextoncology.com

Swedish Cancer Institute
Seattle, Washington 98104

More Details

NCT ID
NCT04794699
Status
Recruiting
Sponsor
IDEAYA Biosciences

Study Contact

IDEAYA Clinical Trials
+1 650 534 3616
IDEAYAClinicalTrials@ideayabio.com