Clinical Trials

Inclusion Criteria:

• Patients must have documented IDH1-R132 gene-mutated disease as evaluated by site.
• Glioma: Advanced glioma that has recurred or progressed following standard therapy, or that has not responded to standard therapy. 
• Hepatobiliary cancer that is relapsed/refractory or intolerant to approved standard-of-care therapy (included: hepatocellular carcinoma, bile duct carcinoma, intrahepatic cholangiocarcinoma or other hepatobiliary carcinomas).
• Chondrosarcoma that is relapsed or refractory and either locally advanced or metastatic and not amenable to complete surgical excision.
• Intrahepatic cholangiocarcinoma that is advanced nonresectable or metastatic cholangiocarcinoma not eligible for curative resection or transplantation. Phase 1b/Safety Lead-in of Phase 2: relapsed or refractory disease. Combination Phase 2 (beyond Safety Lead-in): have received no more than 1 cycle of gemcitabine/cisplatin therapy.
• Other solid tumors that have relapsed or refractory to standard-of-care therapy with no other available therapeutic options.
• Good performance status.
• Good kidney and liver function.

Exclusion Criteria:

• Prior solid organ or hematopoietic cell transplant.
• Prior treatment with IDH1 inhibitor (Single agent cohorts only).
• Congestive heart failure (New York Heart Association Class III or IV) or unstable angina pectoris. Previous history of myocardial infarction within 1 year prior to study entry, uncontrolled hypertension or uncontrolled arrhythmias.
• Unstable or severe, uncontrolled medical condition (e.g., unstable cardiac function, unstable pulmonary condition including pneumonitis and/or interstitial lung disease, uncontrolled diabetes).
• Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy.
• PD-1 only: active autoimmune disease.