A Study of IDE892 for MTAP-deleted Advanced Solid Tumors
This study is testing a new drug called IDE892, by itself and in combination with another drug called IDE397, for people with advanced solid tumors that have a specific genetic change called an MTAP deletion. The study is looking at how safe these drugs are and how well they work. You might be able to join if you are 18 or older and have certain types of advanced solid tumors with an MTAP deletion, such as lung, gastroesophageal, or gastric cancers, that have continued to grow after standard treatments. The researchers will measure side effects (adverse events) and how many people respond to the treatment and for how long. The study aims to enroll about 260 participants.
- Study design
- This is a multi-center interventional study, meaning participants will receive a specific treatment. The study plans to enroll 260 participants.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for side effects from the first dose until 28 days after the last dose. The response to treatment will be measured for approximately 2 years.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT07277413
A Study of IDE892 as Monotherapy and Combination in MTAP-deleted Advanced Solid Tumors
Recruiting
PHASE1Ages 18+InterventionalTreatmentIDEAYA Biosciences
~260 participants
Updated 2026-08-05 on ClinicalTrials.gov
What's tested:IDE892IDE397
At a glance
Recruiting sites
17 of 17 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of Dose-limiting Toxicities (DLTs) of IDE892 (Parts 1 and 3)
Measured over 21 days following the first dose of IDE892 (each cycle is 21 days)
+2 more outcomes measured
Conditions
Where it's being run
17 sites across 12 statesTexas4
Florida3
California1
District of Columbia1
Nebraska1
New Jersey1
New York1
Pennsylvania1
Study leadership
- Edward Chan, MD · STUDY_DIRECTOR · IDEAYA Biosciences
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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
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
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.
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
What this trial measures
- Incidence of Dose-limiting Toxicities (DLTs) of IDE892 (Parts 1 and 3)21 days following the first dose of IDE892 (each cycle is 21 days)
Incidence of DLTs of IDE892 will be determined in Parts 1 and 3
- Incidence of AEs and SAEs (Parts 1, 2, 3, and 4)From first dose until 28 days after last dose (each cycle is 21 days)
Incidence and severity of adverse events (AEs)/serious adverse events (SAEs) (graded based on Common Terminology Criteria for Adverse Events \[CTCAE\] version 5.0) will be determined in Parts 1, 2, 3, and 4.
- Objective response rate (ORR) and duration of response (DOR) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (Parts 2 and 4)Approximately 2 years
Objective response rate (ORR: best objective response of complete response \[CR\] + partial response \[PR\]) and duration of response (DOR) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 as assessed by the Investigator