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Tyrosine Kinase Inhibitor

Phase 1 Part A and Part B for Cholangiocarcinoma (SURF201 Trial)

Phase 1

Recruiting

Research Sponsored by Tyra Biosciences, Inc

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Phase 1 Part A: 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

Phase 1 Part B: 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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from enrollment, every 8 or 12 weeks (up to 5 years)

Awards & highlights

SURF201 Trial Summary

This trial tests a new drug to see if it can safely treat cancers with a specific gene mutation, including liver cancer.

Who is the study for?

Adults with advanced solid tumors, including intrahepatic cholangiocarcinoma with FGFR2 gene alterations who have tried or declined standard treatments. For Part B, they must have had a prior FGFR inhibitor and specific resistance mutations. Exclusions include significant past anti-FGFR therapy toxicity, high serum phosphorus despite treatment, eye conditions increasing risk of toxicity, uncontrolled heart disease, active brain metastases, GI issues affecting drug absorption, and pregnant or breastfeeding women.Check my eligibility

What is being tested?

The trial is testing TYRA-200's safety and effectiveness against tumors with FGFR2 gene changes. Participants take the oral medication daily in 28-day cycles. The study has two parts: dose escalation (Part A) to find a safe dosage and dose expansion (Part B) to further assess its effects at that dosage.See study design

What are the potential side effects?

Potential side effects of TYRA-200 may include liver problems (hepatotoxicity), eye toxicity risks for those predisposed to ocular conditions, gastrointestinal disturbances that could affect the drug's absorption or administration orally.

SURF201 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My advanced cancer has FGFR/FGF alterations and I've tried or refused all standard treatments.

Select...

My cancer has a specific mutation resistant to FGFR inhibitors, confirmed by an approved test.

Select...

I am fully active or can carry out light work.

Select...

My bile duct cancer is advanced, has spread, and has a FGFR2 gene change.

SURF201 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from enrollment, every 8 or 12 weeks (up to 5 years)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from enrollment, every 8 or 12 weeks (up to 5 years)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from enrollment, every 8 or 12 weeks (up to 5 years) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Phase 1 Part A: To determine the maximum tolerated dose (MTD) of TYRA-200.

Phase 1 Part B: To determine the optimal dose of TYRA-200.

Secondary outcome measures

Disease control rate defined as the proportion of participants having a CR, PR or stable disease (SD) for >12 weeks.

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.

Frequency in changes in laboratory parameters and physical signs of toxicity.

+8 more

SURF201 Trial Design

1Treatment groups

Experimental Treatment

Group I: Phase 1 Part A and Part BExperimental Treatment2 Interventions

TYRA-200 taken once daily by mouth in 28-day cycles

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Tyra Biosciences, IncLead Sponsor

2 Previous Clinical Trials

370 Total Patients Enrolled

Hiroomi Tada, M.D., Ph.D.Study ChairTyra Biosciences, Inc

2 Previous Clinical Trials

370 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA granted approval for both segments of Phase 1?

"Our team gave Phase 1 Part A and B a score of 1, as there is minimal evidence backing their safety and efficacy."

Answered by AI

Are new participants currently being sought for this clinical experiment?

"Affirmative. Clinicaltrials.gov displays that this medical experiment, first made public on November 22nd 2023 is at present recruiting individuals for participation. 40 volunteers need to be procured from a single research centre."

Answered by AI

How many volunteers are involved in this experiment?

"Indeed, clinicaltrials.gov reports that this medical trial is actively recruiting participants since its initial posting on November 22nd 2023. The study requires 40 patients to be recruited from a single site and was last updated on November 29th of the same year."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2023. "Safety and Anti-Tumor Activity of TYRA-200 in Advanced Cholangiocarcinoma With Activating FGFR2 Gene Alterations". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06160752.

All > Intrahepatic Cholangiocarcinoma > Cholangiocarcinoma