Clinical trial · Interventional
Safety and Anti-Tumor Activity of TYRA-200 in Advanced Cholangiocarcinoma With Activating FGFR2 Gene Alterations
A Multicenter, Open-label, First-in-Human Study of TYRA-200 in Advanced Intrahepatic Cholangiocarcinoma and Other Solid Tumors With Activating FGFR2 Gene Alterations (SURF-201)
NCT06160752CI-TRIAL-00120646SURF201active not recruitingPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Intrahepatic Cholangiocarcinoma | Intrahepatic Cholangiocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Locally Advanced Cholangiocarcinoma | Cholangiocarcinoma | CURATED_BROADER | 0.78 |
| Metastatic Cholangiocarcinoma | Cholangiocarcinoma | CURATED_BROADER | 0.78 |
| Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Phase 1 Part A - dose escalation TYRA-200 taken once daily by mouth in 28-day cycles | Drug | — | UNRESOLVED |
| Phase 1 Part B - dose expansion TYRA-200 taken once daily by mouth in 28-day cycles | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Phase 1 Part A and Part B
- description
- TYRA-200 taken once daily by mouth in 28-day cycles
- interventionNames
- Drug: Phase 1 Part A - dose escalation TYRA-200 taken once daily by mouth in 28-day cycles
- Drug: Phase 1 Part B - dose expansion TYRA-200 taken once daily by mouth in 28-day cycles
Primary outcomes (2)
- measure
- Phase 1 Part A: To determine the maximum tolerated dose (MTD) of TYRA-200.
- timeFrame
- Initiation of study treatment through 28 Days
- measure
- Phase 1 Part B: To determine the optimal dose of TYRA-200.
- timeFrame
- Initiation of study treatment through 28 days (up to approximately 18 months
Secondary outcomes (11)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.