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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
IDE892
IDE397
Treatment groups
260 Participants
are divided into 4 treatment groups
Locations
14
California
Providence Medical Foundation95403, Santa Rosa United States
Florida
Sarah Cannon Research Institute at Florida Cancer Specialists32827, Orlando United States
Nebraska
Nebraska Cancer Specialists68130, Omaha United States
New Jersey
START Astera, LLC08816, East Brunswick United States