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
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 260 (estimated) |
| Sponsor | IDEAYA Biosciences Industry-sponsored |
| Drugs / interventions | chemotherapy, immunotherapy, radiation |
| Locations | 23 sites (Goodyear, Arizona and 22 other locations) |
| Status | Recruiting |
| Started | March 4, 2026 |
| Main results expected | April 30, 2028 |
| Study ends | April 30, 2028 |
| Registry record updated | September 28, 2026 |
| Trial ID | NCT07277413 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
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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
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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
- Study coordinator: IDEAYA Clinical Trials
- Email: IDEAYAClinicalTrials@ideayabio.com
- Phone: +1 855 433 2246
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.