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

Study Identifier:
IDE892-001
CT.gov Identifier:
NCT07277413
EudraCT Identifier:
N/A
EU Trial (CTIS) Number:
N/A
Study Contact Information:
N/A
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Study Summary

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.

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
  • Non-Small Cell Lung Cancer
  • Gastroesophageal
  • Gastric
  • Esophagus
  • Urinary tract
  • Bladder
  • Mesothelioma
  • Stomach
    • Phase
    The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
    I
    Sex
    Female & Male
    Age
    18+ years
    Study Drug
    N/A
    Study Status
    Indicates the current recruitment status or the expanded access status
    Recruiting

    Requirements information
    Inclusion criteria
    • * Are ≥ 18 years of age 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], NSCLC [adenocarcinoma, squamous cell carcinoma, and adeno-squamous] and 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 retain administered study drug/IMP.
    • * 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
    • * Had an adverse reaction to a previous antitumor treatment that has not recovered to CTCAE Grade ≤ 1
    • * Have received chemotherapy within 3 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 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 NSCLC
    • * 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, including no more than 2 prior lines of chemotherapy.
    • * 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.
    • Urothelial Cancer (Bladder and Upper Urinary Tract), Mesothelioma (Pleural or Peritoneal) and Gastroesophageal Cancers
    • * Must have histologically confirmed diagnosis of advanced or metastatic UC, mesothelioma, or gastroesophageal cancer
    • * Must have progressed following at least 1 prior line of therapy
    • * Treatment with no more than 3 prior lines, including no more than 2 prior lines of chemotherapy

    Clinical Study Information for Healthcare Providers

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    Study Locations

    Location
    Investigator
    Status
    Condition(s) Treated at Site
    Location
    START Dallas Fort Worth
    Fort Worth, TX, United States, 76104
    Investigator
    Henry Xiong
    Status
    Recruiting
    Condition(s) Treated at Site
    Non-Small Cell Lung Cancer
    Gastroesophageal
    Gastric
    Esophagus
    Urinary tract
    Bladder
    Mesothelioma
    Stomach