An Early Access Study of Ivosidenib in Patients With a Pretreated Locally Advanced or Metastatic Cholangiocarcinoma

Inclusion Criteria:

• Diagnosis of nonresectable or metastatic Cholangiocarcinoma (CCA), not eligible forcurative-intent resection, transplantation, or ablative therapies

• Have a documented IDH1 R132C, R132L, R132G, R132H, or R132S gene-mutated disease

• Have tried at least 1 prior type of systemic therapy for CCA, and have recoveredfrom any side effects

• Female patients of childbearing potential must have a negative blood pregnancy testprior to starting treatment and must agree to use 2 forms of contraception from thetime they enroll to 1 month after their last dose of study drug

• Male patients with a female partner with childbearing potential must also agree touse 2 forms of contraception from the time they enroll to 1 month after their lastdose of study drug

Exclusion Criteria:

• Received a prior IDH1 inhibitor

• Have received a transplant

• Have received systemic cancer treatment or radiotherapy within 2 weeks prior to Day 1 of Cycle 1

• Have received hepatic radiation, chemoembolization, and radiofrequency ablationwithin 4 weeks prior to Day 1 of Cycle 1

• Have ongoing brain metastases requiring steroids

• Have underwent major surgery within 4 weeks of Day 1 of Cycle 1 prior to C1D1

• Have an active hepatitis B (HBV) or hepatitis C (HCV) infections, known positivehuman immunodeficiency virus (HIV) antibody results, or acquired immunodeficiencysyndrome (AIDS) related illness

• Are pregnant or breastfeeding