Safety and Anti-Tumor Activity of TYRA-200 in Advanced Cholangiocarcinoma With Activating FGFR2 Gene Alterations

Inclusion Criteria

• •Phase 1 Part A
• •Men and women 18 years of age or older.
• •Eastern Cooperative Oncology Group (ECOG) performance status of ≤1.
• •Any histologically confirmed advanced solid tumor with FGFR/FGF pathway alterations including FGFR gene mutations, fusions, and amplifications, as well as gene amplifications of FGFR ligands, who have exhausted or refused approved standard therapies.
• •Evaluable disease according to RECIST v1.1.
• •Phase 1 Part B
• •Men and women 18 years of age or older.
• •Eastern Cooperative Oncology Group (ECOG) performance status of ≤1.
• •Histologically confirmed locally advanced/metastatic intrahepatic cholangiocarcinoma with a previously identified FGFR2 gene mutation or rearrangement.
• •Must have received a prior FGFR inhibitor. Participants may have received more than 1 prior FGFR inhibitor.
• •Presence of an FGFR2 kinase domain mutation that confers resistance to previous/other FGFR inhibitors; resistance mutations should be identified by a US Food and Drug Administration authorized/approved companion diagnostic or a Clinical Laboratory Improvement Amendments (CLIA) validated local test performed in a certified laboratory.
• •At least 1 measurable lesion by RECIST v1.1.