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Safety and Anti-Tumor Activity of TYRA-200 in Advanced Cholangiocarcinoma With Activating FGFR2 Gene Alterations
Trial Status: active
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.
Inclusion Criteria
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.
Exclusion Criteria:
- 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.
- Active, symptomatic, or untreated brain metastases.
- Gastrointestinal disorders that will affect oral administration or absorption of
TYRA-200.
- Females who are pregnant, breastfeeding, or planning to become pregnant and males
who plan to father a child while enrolled in this study.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT06160752.
