New drug combo targets Hard-to-Treat cancers with genetic weakness
NCT ID NCT07277413
First seen Jun 25, 2026 · Last updated Aug 06, 2026 · Updated 7 times
Summary
This early-stage trial is testing a new drug called IDE892, alone or with another drug (IDE397), in people with advanced solid tumors that have a specific genetic deletion (MTAP). The study aims to find safe doses and see if the drugs shrink tumors. It includes 260 adults with cancers like lung, stomach, bladder, pancreatic, and mesothelioma.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- IDE892 (a PRMT5 inhibitor) and IDE397 (a MAT2A inhibitor)
- What this could lead to
- If successful, this could point toward a new treatment option for several hard-to-treat cancers that have a specific genetic deletion (MTAP).
- What could go wrong
- This is an early Phase 1 trial, so safety and dosing are still being figured out. It may not work for all cancer types, and side effects are unknown.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 260 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2026
- Expected to finish
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Apr 2028
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
17 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
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Locations
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BRCR Global-Coral Springs
RECRUITINGCoral Springs, Florida, 33065, United States
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Columbia University Irving Medical Center
RECRUITINGNew York, New York, 10032, United States
Contact Email: •••••@•••••
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Johns Hopkins Sibley Memorial Hospital
RECRUITINGWashington D.C., District of Columbia, 20016, United States
Contact Email: •••••@•••••
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MD Anderson
RECRUITINGHouston, Texas, 77030, United States
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Moffitt Cancer Center
RECRUITINGTampa, Florida, 33612, United States
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NEXT Oncology Dallas
RECRUITINGIrving, Texas, 75039, United States
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NEXT Oncology Houston
RECRUITINGHouston, Texas, 77054, United States
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NEXT Oncology Virginia
RECRUITINGFairfax, Virginia, 22031, United States
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Nebraska Cancer Specialists
RECRUITINGOmaha, Nebraska, 68130, United States
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Providence Medical Foundation
RECRUITINGSanta Rosa, California, 95403, United States
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START Astera, LLC
RECRUITINGEast Brunswick, New Jersey, 08816, United States
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START Dallas Fort Worth
RECRUITINGFort Worth, Texas, 76104, United States
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START Mountain Region, LLC
RECRUITINGWest Valley City, Utah, 84119, United States
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Sarah Cannon Research Institute
RECRUITINGNashville, Tennessee, 37203, United States
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Sarah Cannon Research Institute at Florida Cancer Specialists
RECRUITINGOrlando, Florida, 32827, United States
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Sidney Kimmel Comprehensive Cancer Center Thomas Jefferson University
RECRUITINGPhiladelphia, Pennsylvania, 19107, United States
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Swedish Cancer Institute
RECRUITINGSeattle, Washington, 98104, United States
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