RecruitingPhase 1

A Study of IDE892 as Monotherapy and Combination in MTAP-deleted Advanced Solid Tumors

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests IDE892 alone and with other drugs, including IDE397, for certain advanced solid cancers missing the MTAP gene. It looks at safety, how well treatment works, and how the body handles the drug. It is for adults whose cancer meets the study’s testing and prior treatment rules.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be at least 18, or the legal age to consent where you live.
  • Have an advanced cancer missing the MTAP gene, confirmed by tissue testing. Eligible types include certain lung, urinary tract, stomach, esophagus, pancreas, and bile duct cancers, and mesothelioma (cancer of the lining around the lungs or belly).
  • For non-small cell lung cancer: cancer must have worsened after platinum chemotherapy and immune treatment, unless these could not be used or tolerated. Prior targeted treatment is also required when appropriate and available. Have no more than 3 prior treatment courses for advanced cancer.
  • For the lung cancer dose-expansion group: have cancer that worsened after at least 1 treatment, with no further effective standard treatment available or tolerable. For the other listed cancers, have cancer that worsened after at least 1 treatment and no more than 3 prior treatment courses for advanced cancer.
  • Provide blood samples and stored tumor tissue for testing. Have at least 1 tumor that can be measured.
  • Be fully active or able to do light work. Be expected to live more than 3 months and have adequate organ and bone marrow function.
  • Be able to swallow the study drug and keep it down.
  • Be willing and able to follow study visits, tests, treatment, and lifestyle rules, and use birth control.

Who can't join

  • Cancer that started in the brain or spinal cord; cancer spread to the brain causing symptoms and needing high-dose steroids; or another cancer within the past 2 years, with some exceptions.
  • Serious heart problems, high blood pressure not controlled by medicine, or uncontrolled fluid around the lungs, heart, or in the belly needing repeated drainage within 2 weeks before treatment.
  • Severe infection within 4 weeks; a history of weak immune defenses with a positive HIV test; or known or suspected viral hepatitis with a positive test.
  • Other short-term or long-term medical or mental health conditions, or side effects from past cancer treatment that have not improved to mild or less.
  • Recent cancer treatment: chemotherapy or another study drug within 4 weeks; immune treatment, targeted treatment, or radiation within 2 weeks. Ongoing radiation side effects or past radiation to more than 25% of bone marrow also exclude participation.
  • Certain medicines that affect drug processing or heart rhythm within 2 weeks. Proton pump inhibitors, medicines that reduce stomach acid, are not allowed within 7 days before treatment or during the study.
  • Past treatment with MAT2A or PRMT inhibitors, two types of cancer drugs.
  • Major surgery within 4 weeks before study entry, or a known or suspected allergy to IDE892.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility 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

Study sites (23)

AZ

CA

DC

FL

IL

MN

NE

NJ

NY

PA

TN

TX

UT

VA

WA