Recruiting
Phase 1

IDE892 & IDE397

Sponsor:

IDEAYA Biosciences

Code:

NCT07277413

Conditions

NSCLC Adenocarcinoma

Gastroesophageal Cancer (GC)

Gastric Adenocarcinoma

Adenocarcinoma of Esophagus

Squamous Cell Car. - Esophagus

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

IDE892

IDE397

Study Details

Brief summary:

This is a multicenter clinical study to evaluate the safety, efficacy, and Pharmacokinetics (PK) of IDE892 as monotherapy and in combination with other agents including IDE397 in participants with methylthioadenosine phosphorylase (MTAP)-deleted advanced solid tumors within indications of interest.

Conditions

NSCLC Adenocarcinoma

Gastroesophageal Cancer (GC)

Gastric Adenocarcinoma

Adenocarcinoma of Esophagus

Squamous Cell Car. - Esophagus

Study ID

NCT07277413

Start date

Mar 4, 2026

Status verified date

Aug, 2026

Completion date

Apr 30, 2028

Anticipated

Primary completion date

Apr 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Are ≥ 18 years of age (or the minimum age of consent in accordance with local regulations) at the time of signing the ICF.
  • Have a histologically confirmed diagnosis of a locally advanced recurrent or metastatic solid tumor type of interest with MTAP deletion (for dose escalation: mesothelioma \[pleural or peritoneal\], gastroesophageal cancers \[squamous and adenocarcinoma of esophagus, gastric adenocarcinoma, gastroesophageal junction cancers\], pancreatic adenocarcinoma and biliary tract carcinomas (intrahepatic and extrahepatic cholangiocarcinoma, and gallbladder cancer), NSCLC \[adenocarcinoma, squamous cell carcinoma, and adeno-squamous\] or UC \[including mixed urothelial-squamous histology\]; for dose expansion: NSCLC that has progressed on at least one prior line of treatment and for which additional effective standard therapy is not available or for which the participant is not a candidate due to intolerance).
  • Are willing and able to provide blood/tumor tissue samples for biomarker testing. An archival tumor tissue specimen must be provided for central confirmation of MTAP loss.
  • Must be willing and able to provide the blood/serum/plasma samples
  • Have evidence of homozygous loss of MTAP or MTAP deletion (pre-screening available after signing pre-screening ICF)
  • Have at least 1 measurable lesion according to RECIST version 1.1
  • Have Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0 or 1
  • Have life expectancy > 3 months
  • Have adequate bone marrow and organ function
  • Able to swallow and retain orally administered study drug/IMP.
  • Are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures
  • Male and female: willing to use contraception

Exclusion Criteria:

  • Known symptomatic brain metastases requiring supraphysiologic doses of systemic corticosteroids
  • Have a known primary central nervous system (CNS) malignancy
  • Have had other malignancies within 2 years prior to the first dose, with some exceptions
  • Impaired cardiac function or clinically significant cardiac diseases
  • Have presence of uncontrolled pleural, peritoneal, or pericardial effusion within 2 weeks before the first study dose, requiring recurrent drainage procedures or an indwelling drainage catheter
  • Have a history of severe infections within 4 weeks prior to the start of study treatment
  • Hypertension (e.g., > 150/100 mmHg) that cannot be controlled by medications despite optimal medical therapy
  • Other acute or chronic medical or psychiatric condition
  • Have a history of immunodeficiency, with a positive human immunodeficiency virus(HIV) test at screening
  • Known or suspected viral hepatitis with a positive test at screening
  • Had an adverse reaction to a previous antitumor treatment that has not recovered to CTCAE Grade ≤ 1
  • Have received chemotherapy within 4 weeks of the first dose of IMP; immunotherapy or biologic targeted antitumor treatments within 2 weeks before the first dose of IMP; small molecule inhibitors within 2 weeks before the first dose of IMP, or other investigational products within 4 weeks
  • Current radiation-related toxicity or radiation therapy within 2 weeks before the first dose of IMP
  • Administration of any of the following within 2 weeks before the first dose of IDE892 as a monotherapy: Strong inhibitors or inducers of cytochrome P450, Strong inhibitors of P-glycoprotein, Narrow therapeutic index and sensitive substrates of multidrug and toxin extrusion (MATE)1 and MATE2-K, Narrow therapeutic index and sensitive substrates of P-gp and breast cancer resistance protein
  • Administration of any of the following within 2 weeks before the first dose of IDE892: Strong inhibitors or inducers of CYP3A4/5, Strong inhibitors of P-gp and/or BCRP, Narrow therapeutic index and sensitive substrates of MATE1 and MATE2-K, Narrow therapeutic index and sensitive substrates of P-gp and BCRP
  • Use of proton pump inhibitors (PPIs) within 7 days prior to the first dose of IMP or planned use during the study
  • Use of drugs with known risk for QT prolongation within 2 weeks prior to the first dose of IDE892
  • Previous treatment with a Amethionine adenosyltransferase 2A (MAT2A) inhibitor and/or Protein arginine N-methyltransferase (PRMT) inhibitor
  • Major surgery within 4 weeks before study entry
  • Prior irradiation to > 25% of the bone marrow
  • Known or suspected hypersensitivity to IDE892

Disease-Specific Eligibility Criteria Eligibility Criteria for Participants with NSCLC (All Parts)

  • Must have histologically confirmed diagnosis of advanced or metastatic NSCLC that has progressed after prior treatment with platinum chemotherapy and a PD-1/PD-L1 inhibitor (unless contraindicated or participant developed intolerance) in the metastatic setting
  • Treatment with no more than 3 prior lines in the setting of advanced or metastatic disease.
  • If considered standard of care and available, participants whose cancers have proven targetable oncogene alterations must have had disease progression on (unless contraindicated or participant developed intolerance) at least 1 prior line containing appropriate targeted therapy.

Eligibility Criteria for Participants with Urothelial Cancer (Bladder and Upper Urinary Tract), Mesothelioma (Pleural or Peritoneal), Pancreatic Adenocarcinoma or Biliary Tract Carcinomas (Intrahepatic and Extrahepatic Cholangiocarcinoma, and Gallbladder Cancer) (Parts 1 and 3)

  • Must have histologically confirmed diagnosis of advanced or metastatic UC, mesothelioma, gastroesophageal cancer or pancreatic and biliary tract tumors
  • Must have progressed following at least 1 prior line of therapy
  • Treatment with no more than 3 prior lines in the setting of advanced or metastatic disease

Study Design

Enrollment

260 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Part 1: IDE892 Monotherapy Dose Escalation (MTAP-deleted advanced solid tumors)

Participants with advanced or metastatic solid tumors harboring MTAP deletion (including mesothelioma, gastroesophageal cancers, pancreatic and biliary tract tumors, non-small cell lung cancer, and urothelial cancer) will receive IDE892. Dose levels will be escalated sequentially using a Bayesian Optimal Interval (BOIN) design to evaluate safety, tolerability, and to determine the maximum tolerated dose and/or recommended dose for expansion. PK and pharmacodynamics (PD) and preliminary antitumor activity will also be assessed.

experimental: Part 2: IDE892 Monotherapy Dose Expansion (MTAP-Deleted NSCLC)

Participants with advanced or metastatic NSCLC with MTAP deletion will receive IDE892. One or more dose levels at or below the maximum tolerated dose from Part 1 will be further evaluated to determine the recommended Phase 2 dose and to assess antitumor activity.

experimental: Part 3: IDE892 + IDE397 Combination Dose Escalation (MTAP-Deleted Solid Tumors)

Participants with advanced or metastatic solid tumors harboring MTAP deletion (including mesothelioma, gastroesophageal cancers, pancreatic and biliary tract tumors, non-small cell lung cancer, and urothelial cancer) will receive IDE892 in combination with IDE397. Dose levels will be escalated using a modified toxicity probability interval (mTPI) design to evaluate safety, tolerability, and to determine the maximum tolerated dose and/or recommended dose for expansion. PK, PD, and preliminary antitumor activity will also be assessed.

experimental: Part 4: IDE892 + IDE397 Combination Dose Expansion (MTAP-Deleted NSCLC)

Participants with advanced or metastatic NSCLC with MTAP deletion will receive IDE892 in combination with IDE397. One or more dose levels at or below the maximum tolerated dose from Part 3 will be further evaluated to determine the recommended Phase 2 dose and to assess antitumor activity.

Interventions

IDE892

IDE892 is an inhibitor of the Protein arginine methyltransferase 5 (PRMT5) that is being developed by IDEAYA Biosciences, Inc. as an anticancer therapeutic for patients with advanced or metastatic cancer harboring MTAP deletions.

IDE397

IDE397 is an oral MAT2A inhibitor that is being developed by IDEAYA Biosciences, Inc. as an anticancer therapeutic for patients with advanced or metastatic cancer harboring MTAP deletions. In this study, IDE397 will be evaluated in combination with IDE892 (Parts 3 and 4) in participants with MTAP-deleted advanced solid tumors.

Primary outcome measure

  • Incidence of Dose-limiting Toxicities (DLTs) of IDE892 (Parts 1 and 3) [ Time Frame: 21 days following the first dose of IDE892 (each cycle is 21 days) ]
  • Incidence of AEs and SAEs (Parts 1, 2, 3, and 4) [ Time Frame: From first dose until 28 days after last dose (each cycle is 21 days) ]
  • Objective response rate (ORR) and duration of response (DOR) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (Parts 2 and 4) [ Time Frame: Approximately 2 years ]

Central Contacts and Locations

Central contacts

IDEAYA Clinical Trials

+1 855 433 2246IDEAYAClinicalTrials@ideayabio.com

Locations

Providence Medical Foundation

Recruiting

Santa Rosa, California, United States, 95403

Contacts

Ian Anderson, MD

707-521-3830ian.anderson@providence.org

Johns Hopkins Sibley Memorial Hospital

Recruiting

Washington D.C., District of Columbia, United States, 20016

Contacts

Solmaz Sahebjam, MD

202-669-6500ssahebj1@jh.edu

Mahlet Atnafu

202-669-6500SibleyOncResReferral@live.johnshopkins.edu

BRCR Global-Coral Springs

Recruiting

Coral Springs, Florida, United States, 33065

Contacts

Alina Quintana

561-447-0614alinaq@brcrglobal.com

Sarah Cannon Research Institute at Florida Cancer Specialists

Recruiting

Orlando, Florida, United States, 32827

Contacts

Elizabeth Gilmore

904-380-2410Elizabeth.Griffith@Scri.com

Moffitt Cancer Center

Recruiting

Tampa, Florida, United States, 33612

Contacts

Mauricio Ribeiro, MD

813-745-3242mauricio.ribeiro@moffitt.org

Anisa Gonzalez

813-745-3874anisa.gonzalez@moffitt.org

Nebraska Cancer Specialists

Recruiting

Omaha, Nebraska, United States, 68130

Contacts

Lindsey Becker, Primary Study Coordinator

402-691-5255lbecker@nebraskacancer.com

START Astera, LLC

Recruiting

East Brunswick, New Jersey, United States, 08816

Contacts

Hope Team Distribution List

hopeteam@startresearch.com

Columbia University Irving Medical Center

Recruiting

New York, New York, United States, 10032

Contacts

Nurse Navigation Team: Contact for All Patient Referrals

212-342-5162cancerclinicaltrials@cumc.columbia.edu

Sidney Kimmel Comprehensive Cancer Center Thomas Jefferson University

Recruiting

Philadelphia, Pennsylvania, United States, 19107

Contacts

askphase1@jefferson.edu

215-586-0199

askphase1@jefferson.edu

Sarah Cannon Research Institute

Recruiting

Nashville, Tennessee, United States, 37203

Contacts

Alydia Miller

615-927-2212alydia.miller@scri.com

Sarah Cannon Institute

844-482-4812asksarah@sarahcannon.com

START Dallas Fort Worth

Recruiting

Fort Worth, Texas, United States, 76104

Contacts

Kasie Newton

682-350-3010kasie.newton@startresearch.com

MD Anderson

Recruiting

Houston, Texas, United States, 77030

Contacts

Jordi Rodon Ahnert, MD, PhD

713-563-1930JRodon@mdanderson.org

NEXT Oncology Houston

Recruiting

Houston, Texas, United States, 77054

Contacts

Emma Morales

832-384-7912emorales@nextoncology.com

NEXT Oncology Dallas

Recruiting

Irving, Texas, United States, 75039

Contacts

Mofopefoluwa Akinwale

972-893-8800fakinwale@nextoncology.com

START Mountain Region, LLC

Recruiting

West Valley City, Utah, United States, 84119

Contacts

Marie Asay, Director, Nursing

801-907-4770marie.asay@startresearch.com

NEXT Oncology Virginia

Recruiting

Fairfax, Virginia, United States, 22031

Contacts

Maybelle De La Rosa

703-783-4518mdelarosa@nextoncology.com

Swedish Cancer Institute

Recruiting

Seattle, Washington, United States, 98104

Contacts

Siddhartha Devarakonda, MD

206-386-2424siddhartha.devarakonda@swedish.org

More Information

Sponsor

IDEAYA Biosciences

Last update posted

Aug 5, 2026

Last verified

Aug, 2026

Keywords

  • MTAP deletion
  • MTAP loss
  • MTAP-deficient tumors
  • homozygous MTAP loss
  • IDE892
  • IDE397
  • MAT2A inhibitor
  • PRMT5
  • advanced solid tumors
  • metastatic cancer
  • recurrent cancer
  • dose escalation
  • dose expansion
  • phase 1 clinical trial
  • ctDNA

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-22. This information was provided to ClinicalTrials.gov by IDEAYA Biosciences on 2026-08-05.