The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary antitumor activity of TYRA-200 in cancers with FGFR2 activating gene alterations, including unresectable locally advanced/metastatic intrahepatic cholangiocarcinoma and other advanced solid tumors.
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.
Discontinued a prior anti-FGFR therapy due to significant toxicity, defined as hepatotoxicity ≥Grade 3 or any Grade 4 toxicity according to CTCAE v5.0.
Has a serum phosphorus level > upper limit of normal (ULN) during screening that remains >ULN despite medical management.
Any ocular condition likely to increase the risk of eye toxicity.
History of or current uncontrolled cardiovascular disease.
Tyra Biosciences, Inc
Lead sponsor