Clinical trial Recruiting at 23 sites Phase 1 Interventional Ages 18 and up

IDE892 alone and with IDE397 for MTAP-deleted advanced solid tumors

Official title: A Multicenter Study Evaluating the Safety, Efficacy, and Pharmacokinetics of IDE892 as Monotherapy and Combination Therapy in Participants With MTAP-Deleted Advanced Solid Tumors

Run by IDEAYA Biosciences · NCT07277413 · Data updated 2026-11-12

This trial tests IDE892 by itself and combined with IDE397 in adults whose advanced solid tumors have MTAP deletion and have progressed after standard treatments.

Quick facts

PhasePhase 1
Study typeInterventional
Ages18 Years and up
SexAll
Enrollment260 (estimated)
SponsorIDEAYA Biosciences
Industry-sponsored
Drugs / interventionschemotherapy, immunotherapy, radiation
Locations23 sites (Goodyear, Arizona and 22 other locations)
StatusRecruiting
StartedMarch 4, 2026
Main results expectedApril 30, 2028
Study endsApril 30, 2028
Registry record updatedSeptember 28, 2026
Trial IDNCT07277413 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults (≥18) with histologically confirmed, locally advanced or metastatic solid tumors that are MTAP-deleted, who have progressed after standard therapies and can provide required tumor tissue and blood samples, are the intended candidates.

Probably not a fit

Patients without MTAP deletion, those who have effective standard treatment options available, or those with medical conditions that make them ineligible for the protocol are unlikely to benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 1, multicenter, dose-escalation and dose-expansion study of IDE892 as monotherapy and in combination with IDE397 in adults with MTAP-deleted advanced solid tumors. Participants must have central confirmation of MTAP loss from tumor tissue and will provide blood and tissue samples for biomarker and pharmacokinetic testing. The primary focus is on safety, tolerability, and defining appropriate dose(s), with secondary assessments of pharmacokinetics and preliminary anti-tumor activity. The combination with IDE397 (a MAT2A inhibitor) is intended to exploit metabolic vulnerabilities caused by MTAP loss while seeking an acceptable therapeutic index.

Why it matters

Potential benefit: If successful, the agents could offer a new targeted treatment option for patients with MTAP-deleted tumors who have limited standard therapies available.

How similar studies have gone: Preclinical studies support targeting MAT2A and exploiting MTAP loss, but clinical evidence for this specific combination is limited and the combination remains largely untested in humans.

Who can join: the full rules

Show full inclusion / exclusion criteria
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

Where it's running

  • City of Hope Cancer Center-Phoenix
    Goodyear, Arizona, United States
    Recruiting
  • Mayo Clinic Arizona
    Phoenix, Arizona, United States
    Recruiting
  • City of Hope Cancer Center-Duarte
    Duarte, California, United States
    Recruiting
  • Providence Medical Foundation
    Santa Rosa, California, United States
    Recruiting
  • Johns Hopkins Sibley Memorial Hospital
    Washington D.C., District of Columbia, United States
    Recruiting
  • BRCR Global-Coral Springs
    Coral Springs, Florida, United States
    Recruiting
Show 17 more locations
  • Mayo Clinic Florida
    Jacksonville, Florida, United States
    Recruiting
  • Sarah Cannon Research Institute at Florida Cancer Specialists
    Orlando, Florida, United States
    Recruiting
  • Moffitt Cancer Center
    Tampa, Florida, United States
    Recruiting
  • City of Hope Cancer Center-Chicago
    Zion, Illinois, United States
    Recruiting
  • Mayo Clinic Rochester
    Rochester, Minnesota, United States
    Recruiting
  • Nebraska Cancer Specialists
    Omaha, Nebraska, United States
    Recruiting
  • START Astera, LLC
    East Brunswick, New Jersey, United States
    Recruiting
  • Columbia University Irving Medical Center
    New York, New York, United States
    Recruiting
  • Sidney Kimmel Comprehensive Cancer Center Thomas Jefferson University
    Philadelphia, Pennsylvania, United States
    Recruiting
  • Sarah Cannon Research Institute
    Nashville, Tennessee, United States
    Recruiting
  • START Dallas Fort Worth
    Fort Worth, Texas, United States
    Recruiting
  • MD Anderson
    Houston, Texas, United States
    Recruiting
  • NEXT Oncology Houston
    Houston, Texas, United States
    Recruiting
  • NEXT Oncology Dallas
    Irving, Texas, United States
    Recruiting
  • START Mountain Region, LLC
    West Valley City, Utah, United States
    Recruiting
  • NEXT Oncology Virginia
    Fairfax, Virginia, United States
    Recruiting
  • Swedish Cancer Institute
    Seattle, Washington, United States
    Recruiting

Study contacts

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.