Solid Tumor Clinical Trial
— SURF201Official 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)
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.
Status | Recruiting |
Enrollment | 40 |
Est. completion date | September 2027 |
Est. primary completion date | September 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | The Ohio State University | Columbus | Ohio |
United States | The University of Texas MD Anderson Cancer Center | Houston | Texas |
United States | University of California San Francisco (UCSF) | San Francisco | California |
Lead Sponsor | Collaborator |
---|---|
Tyra Biosciences, Inc |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Phase 1 Part A: To determine the maximum tolerated dose (MTD) of TYRA-200. | Initiation of study treatment through 28 Days | ||
Primary | Phase 1 Part B: To determine the optimal dose of TYRA-200. | Initiation of study treatment through 28 days (up to approximately 18 months | ||
Secondary | Number of participants with adverse events (AEs) and serious adverse events (SAEs) as a measure of safety and tolerability. | From day 1 treatment through 28-days post treatment (up to 2 years) | ||
Secondary | Frequency in changes in laboratory parameters and physical signs of toxicity. | From day 1 treatment through 28-days post treatment (up to 2 years) | ||
Secondary | Pharmacokinetics: maximum plasma concentration (Cmax). | From Day 1 through Cycle 3 Day 1 (each cycle is 28 days) | ||
Secondary | Pharmacokinetics: time to reach maximum plasma concentration (Tmax). | From Day 1 through Cycle 3 Day 1 (each cycle is 28 days) | ||
Secondary | Pharmacokinetics: area under the plasma concentration-time curve (AUC). | From Day 1 through Cycle 3 Day 1 (each cycle is 28 days) | ||
Secondary | Pharmacokinetics: half-life of Tyra-200 (t1/2). | From Day 1 through Cycle 3 Day 1 (each cycle is 28 days) | ||
Secondary | 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. | From enrollment, every 8 or 12 weeks (up to 2 years) | ||
Secondary | 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. | From enrollment, every 8 or 12 weeks (up to 5 years) | ||
Secondary | Disease control rate defined as the proportion of participants having a CR, PR or stable disease (SD) for >12 weeks. | From enrollment up to 5 years | ||
Secondary | Time to response defined as time to first CR or PR that is subsequently confirmed according to RECIST v1.1. | Up to 5 years | ||
Secondary | 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. | 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) |
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