Study on XmAb20717 for Advanced Biliary Tract Cancers

Inclusion Criteria

• Must be 18 years or older.
• Have advanced biliary tract cancer, including specific types like intrahepatic, perihepatic, or extrahepatic cholangiocarcinoma, or gallbladder cancer.
• Cancer must have progressed after or been intolerant to gemcitabine-based chemotherapy.
• If the cancer has certain genetic changes (FGFR2 fusion, NTRK fusion, or IDH1 mutation), patients should have tried targeted therapies unless they were not suitable or refused.
• Must have a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities.
• Must have measurable or evaluable disease based on specific criteria.
• Must provide a tumor sample or agree to a biopsy unless it's unsafe.
• Women of childbearing potential must have a negative pregnancy test and agree to use contraception during the study and for 3 months after.
• Men with partners of childbearing potential must use condoms or other contraception during the study and for 4 weeks after.
• Must have adequate organ function as determined by specific tests.

Exclusion Criteria

• Cannot use systemic steroids beyond basic replacement doses.
• Cannot have taken another investigational drug or treatment within 4 weeks before starting the study.
• Cannot have had certain liver treatments or radiation within 4 weeks before starting the study.
• Cannot have had chemotherapy within 3 weeks before starting the study.
• Cannot have stopped PD-1 or PD-L1 inhibitor therapy due to severe side effects.
• Cannot have had CTLA-4 inhibitor treatment.
• Cannot be pregnant or breastfeeding.
• Cannot have allergies to the study drug components.
• Cannot have active brain metastases unless stable after treatment and off steroids for 2 weeks.
• Cannot have substance abuse issues that would interfere with the study.
• Cannot have active infections needing IV treatment within 2 weeks of starting the study.
• Cannot have another primary cancer that could affect study results.
• Cannot have had an organ or bone marrow transplant.
• Cannot have a history of lung diseases like pneumonitis.
• Cannot have active autoimmune diseases, except for certain manageable conditions.
• Cannot have received a live-virus vaccine within 30 days before starting the study.
• Cannot have uncontrolled HIV infection or related complications.
• Cannot have serious medical or psychiatric conditions that would interfere with the study.