Patients
For patients, caregivers, loved ones, advocates & healthcare specialists
At TYRA, we recognize that patients living with cancer and people living with genetically defined conditions are in desperate need of innovation from new therapies. This reality has inspired us to work “Tyrelessly” to advance next-generation product candidates with the goal to improve patient outcomes and quality of life.
Tyra Biosciences Current Clinical Trials
We are actively recruiting patients to participate in clinical trials to evaluate our therapeutic candidates. If you believe you or a loved one might be a good candidate for our trials, we encourage you to reach out directly through the link below.
Dabogratinib (Formerly TYRA-300)
BEACH301 is a Phase 2, multicenter, open-label, dose-escalation/dose-expansion study evaluating dabogratinib in children ages 3 to 10 with achondroplasia with open growth plates. The study will enroll children who are treatment-naïve (Cohort 1) and those who have received prior growth-accelerating therapy (Cohort 2) at multiple sites across the globe. Each of these cohorts is expected to enroll up to 10 participants per dose level (0.125, 0.25, 0.375, 0.50 mg/kg) for up to 12 months. The study is also enrolling a safety sentinel cohort of up to 3 participants per dose level in children ages 5 to 10.Dabogratinib (Formerly TYRA-300)
SURF302 is an open-label Phase 2 clinical study evaluating the efficacy and safety of dabogratinib in participants with FGFR3-altered low-grade, IR NMIBC. The study will enroll up to 90 participants at multiple sites primarily in the United States. Participants will be randomized initially to treatment with dabogratinib at 50 mg once-daily (QD) (Cohort 1) or treatment with dabogratinib at 60 mg QD (Cohort 2). Following a review of efficacy and safety, an additional dosing cohort may be evaluated. The primary endpoint is complete response (CR) rate at three months. Secondary endpoints include time to recurrence, the median duration of response, recurrence free survival (RFS), progression free survival (PFS), safety and tolerability.
Dabogratinib (Formerly TYRA-300)
Dabogratinib is an investigational FGFR3 inhibitor currently in clinical development initially for patients with locally advanced/metastatic urothelial carcinoma (bladder and urinary tract) and other solid tumors. TYRA is currently enrolling patients in a Phase 1/2 clinical study of dabogratinib, (SURF301), a global study designed to determine the maximum tolerated dose (MTD) and the recommended Phase 2 dose (RP2D) of dabogratinib, as well as to evaluate the preliminary antitumor activity of dabogratinib.
TYRA-430
TYRA-430 is an oral, investigational FGFR4/3-biased inhibitor for FGF19+/FGFR4-driven cancers. The Phase 1 study is a multicenter, open-label, first-in-human study of TYRA-430 in advanced hepatocellular carcinoma (HCC) and other solid tumors with activating FGF/FGFR pathway aberrations (SURF431).
TYRA-200
The SURF201 study is currently enrolling and dosing adults with unresectable locally advanced/metastatic intrahepatic cholangiocarcinoma and other advanced solid tumors with activating FGFR2 gene alterations. The Phase 1 clinical study of TYRA-200, SURF201 (Study in PrevioUsly treated and Resistant FGFR2+ Cholangiocarcinoma and Other Advanced Solid Tumors) (NCT06160752), is a multi-center, open label study designed to evaluate the safety, tolerability, and pharmacokinetics (PK) of TYRA-200 and determine the optimal and maximum tolerated doses (MTD), as well as evaluate the preliminary antitumor activity of TYRA-200.
Expanded
Access Policy
Expanded access (sometimes referred to as “compassionate use”) refers to the use of an investigational medicine to potentially treat a serious or life-threatening condition outside of a clinical trial.
At Tyra Biosciences, Inc. (TYRA), we are focused on developing next-generation precision medicines that target oncology and genetically defined conditions for patients who need improved, precise options for care. We collaborate with clinical investigators to conduct clinical trials with the goal of achieving regulatory approval to make these medicines broadly available to patients as quickly as possible. We believe participation in one of our trials is the most appropriate route to access these investigational medicines. For this reason, TYRA does not currently have an expanded access program for any of our investigational products, nor are we accepting applications for expanded access.
For information about our clinical trials, please visit our website at https://tyra.bio/patients/ or visit www.clinicaltrials.gov and search “Tyra Biosciences” (under Other terms).
If you have questions about our policy, please contact tyraclinicaltrials@tyra.bio. We expect to acknowledge each submitted inquiry within 5 business days from receipt.
Consistent with the 21st Century Cures Act, the posting of this policy does not serve as a guarantee of access to any specific investigational products by any individual patient. TYRA reserves the right to revise this expanded access policy at any time. To the extent we can accommodate expanded access requests at a later date, we will provide general criteria for evaluating such requests. This posting will be updated to reflect any policy change.
Reach Out
For questions or comments please reach out to us directly at tyraclinicaltrials@tyra.bio
