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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

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
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 4119403, Arkansas 4099753 72205
Contact:
Maroof Khan Zafar
501-686-8274
MKZafar@uams.edu

City of Hope
Duarte 5344147, California 5332921 91010
Contact:
New Patient Services
800-826-4673
newpatientservices3@coh.org

Orlando Health Cancer Institute
Orlando 4167147, Florida 4155751 32806
Contact:
Estefania Bobe Cortes
321-841-6626
Estefania.BobeCortes@orlandohealth.com

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore 4347778, Maryland 4361885 21287
Contact:
Carol Goldener
202-660-5629
cgolden9@jhmi.edu

Dana Farber Cancer Institute
Boston 4930956, Massachusetts 6254926 02115
Contact:
Kailene Sullivan
dfcicctiexternalreferral@dfci.harvard.edu

Columbia University Medical Center - Herbert Irving Pavilion
New York 5128581, New York 5128638 10032
Contact:
Benjamin Herzberg, MD
646-317-6041
Boh2109@cumc.columbia.edu

Weill Cornell Medical College
New York 5128581, New York 5128638 10065
Contact:
Alexandra Mavracick
alm2074@med.cornell.edu

Stephenson Cancer Center
Oklahoma City 4544349, Oklahoma 4544379 73104
Contact:
Christina Seunath
405-271-8001
Christina-Caldwell@ouhsc.edu

LifeSpan - Brown University
Providence 5224151, Rhode Island 5224323 02906
Contact:
Benedito Carneiro
844-222-2881
benedito.carneiro@lifespan.org

SCRI Oncology Partners
Nashville 4644585, Tennessee 4662168 37203
Contact:
askSARAH
844-482-4812

MD Anderson
Houston 4699066, Texas 4736286 77030
Contact:
Jordi Rodon, MD
713-792-5603
JRodon@mdanderson.org

Next Oncology
San Antonio 4726206, Texas 4736286 78229
Contact:
Carmen Gonzalez
210-580-9521
NXTSA_Coordinators@nextoncology.com

Swedish Cancer Institute
Seattle 5809844, Washington 5815135 98104

More Details

NCT ID
NCT04794699
Status
Recruiting
Sponsor
IDEAYA Biosciences

Study Contact

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.