RECRUITING

A Study of TYRA-300 in Children With Achondroplasia: BEACH301

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Conditions

Achondroplasia

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of this study is to evaluate the safety, tolerability, and identify potentially effective dose(s) of TYRA-300 in children with achondroplasia with open growth plates.

Official Title

A Multicenter, Phase 2, Dose-Escalation/Dose-Expansion Study of TYRA-300 in Children With Achondroplasia With Open Growth Plates: BEACH301

Quick Facts

Study Start:2025-03
Study Completion:2030-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06842355

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:3 Years to 10 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * Aged 3 to 10 years old (inclusive) at the time of consent.
  2. * Informed consent provided by parent(s) or legal guardian(s). As study participants are less than 18 years old, participants are willing and able to provide written assent (where applicable and required).
  3. * Molecular diagnosis of achondroplasia (FGFR3 G380R).
  4. * Radiographically confirmed open growth plates at Screening, as determined by bone age X-ray.
  5. * Able to stand and ambulate independently.
  6. * Able to take oral medication.
  7. * Sentinel Safety Cohort only: aged 5 to 10 years old (inclusive).
  8. * Cohort 1 only: aged 3 to 10 years old (inclusive) and are naive to prior growth accelerating therapy.
  9. * Cohort 2 only: aged 3 to 10 years old (inclusive) and have received prior growth accelerating therapy.
  1. * Presence or history of any concurrent disease or condition that would interfere with study participation, safety evaluations, or any uncontrolled or untreated condition that could impact pediatric growth.
  2. * Diagnosis of endocrine condition that alters calcium/phosphate homeostasis.
  3. * Prior limb lengthening surgery or planned or expected to have limb lengthening surgery while enrolled in the study.
  4. * Taking medications that are strong inhibitors or inducers of cytochrome P450 (Cyp) 3A4.
  5. * History or current evidence of corneal or retinal disorder/keratopathy.
  6. * Presence of guided growth hardware/8 plates. Planned or anticipated orthopedic surgeries.

Contacts and Locations

Study Contact

Kate Hogg Call
CONTACT
(619) 728-4805
ACH@tyra.bio

Principal Investigator

Doug Warner, MD
STUDY_CHAIR
Tyra Biosciences

Study Locations (Sites)

Rare Disease Research
Kissimmee, Florida, 34746
United States
Rare Disease Research
Atlanta, Georgia, 30329
United States
Rare Disease Research
Hillsborough, North Carolina, 27278
United States

Collaborators and Investigators

Sponsor: Tyra Biosciences, Inc

  • Doug Warner, MD, STUDY_CHAIR, Tyra Biosciences

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-03
Study Completion Date2030-06

Study Record Updates

Study Start Date2025-03
Study Completion Date2030-06

Terms related to this study

Additional Relevant MeSH Terms

  • Achondroplasia