Locally Advanced CholangiocarcinomaPhase 1SURF201NCT06160752

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

A Phase 1 study testing Phase 1 Part A - dose escalation TYRA-200 taken once daily by mouth in 28-day cycles and Phase 1 Part B - dose expansion TYRA-200 taken once daily by mouth in 28-day cycles in people with Locally Advanced Cholangiocarcinoma and Intrahepatic Cholangiocarcinoma, run by Tyra Biosciences, Inc at 4 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Locally Advanced Cholangiocarcinoma, Intrahepatic Cholangiocarcinoma, Solid Tumor
What is being tested?: Phase 1 Part A - dose escalation TYRA-200 taken once daily by mouth in 28-day cycles and Phase 1 Part B - dose expansion TYRA-200 taken once daily by mouth in 28-day cycles
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 40 participants
Where: 4 sitesUnited States
Study dates: 22 Nov 2023to Sep 2027
Phase: Phase 1

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

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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.

Who cannot join

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.

Trial locations and contacts

4 sites in 1 country.

United States4 sites

Massachusetts General Hospital
Boston, Massachusetts, 02114
The Ohio State University
Columbus, Ohio, 43210
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
University of California San Francisco (UCSF)
San Francisco, California, 94143

Other trials in United States

About this study

Official title: 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)

Read the detailed description

This is a single arm, multi-part, phase 1 clinical trial studying TYRA-200, a novel, potent fibroblast growth factor receptor (FGFR) 1/2/3 tyrosine kinase inhibitor, in unresectable locally advanced/metastatic intrahepatic cholangiocarcinoma and other advanced solid tumors with activating alterations in FGFR2. Part A is a dose escalation study in participants with any advanced solid tumor with FGFR/FGF pathway alterations who have exhausted approved standard therapies. Part A will evaluate the safety, tolerability, and PK of TYRA-200 to determine the optimal and maximum tolerated dose (MTD). Part B will evaluate the preliminary antitumor activity of TYRA-200 in participants with unresectable locally advanced/metastatic intrahepatic cholangiocarcinoma who have previously received an FGFR inhibitor and have FGFR2 kinase-domain mutations resistant to other FGFR inhibitors.

Conditions: Locally Advanced Cholangiocarcinoma, Intrahepatic Cholangiocarcinoma, Solid Tumor, Metastatic Cholangiocarcinoma
Being tested: Phase 1 Part A - dose escalation TYRA-200 taken once daily by mouth in 28-day cycles, Phase 1 Part B - dose expansion TYRA-200 taken once daily by mouth in 28-day cycles
Keywords: FGFR2 gene activation, FGFR2 gene alterations, FGFR2 gene fusion/rearrangement, FGFR2 gene mutation, FGFR2 gene translocation, FGFR2, Fibroblast growth factor receptor 2 (FGFR2), Fibroblast growth factor receptor 2 alterations, locally advanced cancer, metastatic cancer, solid tumors, cholangiocarcinoma, intrahepatic cholangiocarcinoma, unresectable cholangiocarcinoma, metastatic cholangiocarcinoma, fibroblast growth factor receptor inhibitor
Medical subject headings: Cholangiocarcinoma, Acrocephalosyndactylia, Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Phase 1 Part A - dose escalation TYRA-200 taken once daily by mouth in 28-day cyclesDrug
TYRA-200 is an oral, novel potent FGFR 1/2/3 tyrosine kinase inhibitor that targets tumors that contain activating gene alterations of FGFR2.
Phase 1 Part B - dose expansion TYRA-200 taken once daily by mouth in 28-day cyclesDrug
TYRA-200 is an oral, novel potent FGFR 1/2/3 tyrosine kinase inhibitor that targets tumors that contain activating gene alterations of FGFR2.

Study groups in NCT06160752
Study group	Role	What they receive
Phase 1 Part A and Part B	Experimental	TYRA-200 taken once daily by mouth in 28-day cycles Receives: 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

What is being measured

The primary outcome is the main question the study is designed to answer.

Phase 1 Part A: To determine the maximum tolerated dose (MTD) of TYRA-200.
Measured: Initiation of study treatment through 28 Days
Phase 1 Part B: To determine the optimal dose of TYRA-200.
Measured: Initiation of study treatment through 28 days (up to approximately 18 months

Secondary outcomes (11)

Number of participants with adverse events (AEs) and serious adverse events (SAEs) as a measure of safety and tolerability.
Measured: From day 1 treatment through 28-days post treatment (up to 2 years)
Frequency in changes in laboratory parameters and physical signs of toxicity.
Measured: From day 1 treatment through 28-days post treatment (up to 2 years)
Pharmacokinetics: maximum plasma concentration (Cmax).
Measured: From Day 1 through Cycle 3 Day 1 (each cycle is 28 days)
Pharmacokinetics: time to reach maximum plasma concentration (Tmax).
Measured: From Day 1 through Cycle 3 Day 1 (each cycle is 28 days)
Pharmacokinetics: area under the plasma concentration-time curve (AUC).
Measured: From Day 1 through Cycle 3 Day 1 (each cycle is 28 days)
Pharmacokinetics: half-life of Tyra-200 (t1/2).
Measured: From Day 1 through Cycle 3 Day 1 (each cycle is 28 days)
Overall response rate (ORR) defined as the proportion of participants with complete response (CR) or partial response (PR) as determined by the investigator using RECIST V1.1.
Measured: From enrollment, every 8 or 12 weeks (up to 2 years)
Duration of response defined as the time from the initial CR or PR to the time of relapse or death, whichever occurs first among participant with an objective response.
Measured: From enrollment, every 8 or 12 weeks (up to 5 years)
Disease control rate defined as the proportion of participants having a CR, PR or stable disease (SD) for >12 weeks.
Measured: From enrollment up to 5 years
Time to response defined as time to first CR or PR that is subsequently confirmed according to RECIST v1.1.
Measured: Up to 5 years
Progression-free survival defined as the time from the date of first study drug administration to the earliest date of documented disease progression or death.
Measured: From the date of the first dose of study drug until disease progression or death as assessed up to the last efficacy assessment for disease progression (up to 5 years)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

22 Nov 2023Sep 2027

First posted7 Dec 2023
Study start22 Nov 2023
Primary completionMar 2027 (estimated)
Study completionSep 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Locally Advanced CholangiocarcinomaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Sequential
Masking: None (open label)
Enrolment: 40 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06160752
Sponsor's protocol ID: TYR200-101
Acronym: SURF201
Status last verified: Oct 2026
First submitted: 29 Nov 2023
Last updated: 14 Oct 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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