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

Launched by TYRA BIOSCIENCES, INC · Nov 29, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called TYRA-200 for patients with advanced cholangiocarcinoma, a type of cancer that affects the bile ducts, particularly when it has specific gene changes known as FGFR2 alterations. The main goal of the study is to find out if TYRA-200 is safe to use and if it can help shrink tumors in patients whose cancer has not responded to other treatments. The trial is currently looking for participants who are at least 18 years old and have already tried standard therapies without success.

To be eligible, patients should have a confirmed diagnosis of advanced cholangiocarcinoma with a specific FGFR2 gene mutation and must have received a prior FGFR inhibitor treatment. Participants will take TYRA-200 and will be monitored for any side effects, as well as how well the treatment is working. It’s important to note that patients with certain health conditions, such as significant liver problems or uncontrolled heart disease, may not be able to join the trial. If you or someone you know is interested and meets the criteria, this study may provide an opportunity to access a new treatment option.

Gender

ALL

Eligibility 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.