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Tyrosine Kinase Inhibitor
TYRA-200 for Bile Duct Cancer (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
Must not have
Has a serum phosphorus level > upper limit of normal (ULN) during screening that remains >ULN despite medical management
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
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.
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.
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
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.
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I am fully active or can carry out light work.
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My bile duct cancer is advanced, has spread, and has a FGFR2 gene change.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My blood phosphorus levels are high despite treatment.
Select...
I stopped a previous FGFR-targeted therapy due to severe side effects.
Select...
I do not have stomach or intestine problems affecting medication absorption.
Select...
I have an eye condition that could worsen with treatment.
Select...
I have a history of heart disease that is not under control.
Select...
I have brain metastases that are causing symptoms or haven't been treated.
Select...
I am not pregnant, breastfeeding, nor planning to become pregnant, and I do not plan to father a child while in this study.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
Find a Location
Who is running the clinical trial?
Tyra Biosciences, IncLead Sponsor
2 Previous Clinical Trials
370 Total Patients Enrolled
Doug WarnerStudy ChairTyra Biosciences, Inc
1 Previous Clinical Trials
310 Total Patients Enrolled
Hiroomi Tada, M.D., Ph.D.Study ChairTyra Biosciences, Inc
2 Previous Clinical Trials
370 Total Patients Enrolled