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:
EudraCT Identifier:
EU Trial (CTIS) Number:
N/A
Study Contact Information:
Recruiting
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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
Esophageal
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.
Phase 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 (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 samplesHave 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 1.1Have Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0 or 1Have life expectancy > 3 monthsHave adequate bone marrow and organ functionAble 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 proceduresMale and female: willing to use contraception
Exclusion criteria
- Known symptomatic brain metastases requiring supraphysiologic doses of systemic corticosteroidsHave a known primary central nervous system (CNS) malignancyHave had other malignancies within 2 years prior to the first dose, with some exceptionsImpaired cardiac function or clinically significant cardiac diseasesHave presence of uncontrolled pleural, peritoneal, or pericardial effusion within 2 weeks before the first study dose, requiring recurrent drainage procedures or an indwelling drainage catheterHave a history of severe infections within 4 weeks prior to the start of study treatmentHypertension (e.g., > 150/100 mmHg) that cannot be controlled by medications despite optimal medical therapyOther acute or chronic medical or psychiatric conditionHave a history of immunodeficiency, with a positive human immunodeficiency virus(HIV) test at screeningKnown or suspected viral hepatitis with a positive test at screeningHad an adverse reaction to a previous antitumor treatment that has not recovered to CTCAE Grade ≤ 1Have 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 weeksCurrent radiation-related toxicity or radiation therapy within 2 weeks before the first dose of IMPAdministration 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 proteinAdministration 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 BCRPUse of proton pump inhibitors (PPIs) within 7 days prior to the first dose of IMP or planned use during the studyUse of drugs with known risk for QT prolongation within 2 weeks prior to the first dose of IDE892Previous treatment with a Amethionine adenosyltransferase 2A (MAT2A) inhibitor and/or Protein arginine N-methyltransferase (PRMT) inhibitorMajor surgery within 4 weeks before study entryPrior irradiation to > 25% of the bone marrowKnown or suspected hypersensitivity to IDE892Disease-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 settingTreatment 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 tumorsMust have progressed following at least 1 prior line of therapyTreatment with no more than 3 prior lines in the setting of advanced or metastatic disease
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
Esophageal
Urinary tract
Bladder
Mesothelioma
Stomach
Location
START Mountain Region
West Valley City, UT, United States, 84119
Investigator
Jose Pacheco
Status
Recruiting
Condition(s) Treated at Site
Non-Small Cell Lung Cancer
Gastroesophageal
Gastric
Esophageal
Urinary tract
Bladder
Mesothelioma
Stomach
Location
START New Jersey
East Brunswick, NJ, United States, 08816
Investigator
Neel Belani
Bruno Fang
Status
Will Be Recruiting
Condition(s) Treated at Site
Non-Small Cell Lung Cancer
Gastroesophageal
Gastric
Esophageal
Urinary tract
Bladder
Mesothelioma
Stomach