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NCT05544552 (TYRA-300 in Advanced Urothelial Carcinoma and Other Solid…): BVCT ex-ante prediction vs. reported outcome

On 27 Jul 2024, BioinvestGPT's BVCT predicted technical success and commercial success for this trial. The 25 Oct 2024 readout is classified on the dashboard as True Positive (TP), a correct prediction. Recorded clinical-benefit conclusion: statistically significant (superior in safety) and commercially TBD (OS data not mature).

Clinical Trial

NCTID
NCT05544552
Acronym
SURF301
Drug Name
TYRA-300
Drug MoA
N540K-mutation-specific FGFR3 antagonist
Drug Modality
small molecule
Drug Class
First-In-Class
Therapeutic Area
Neoplasms
Indication
Advanced Urothelial Carcinoma and Other Solid Tumors With FGFR3 Gene Alterations
Human Patients
310
Sponsor
Tyra Biosciences
Phase
Phase 1 Phase 2

Prediction of , index 1700

Prospective Prediction
Prediction Index
1700
Prediction Date
Commercial Prediction
SUCCESS (commercially sufficient clinical benefit in OS/CR superior to erdafitinib)
Technical Prediction
SUCCESS (statistically significant clinical benefit in ORR/PFS with superior-to-erdafitinib safety)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
90 days in advance
Readout Data Interpretation
TYRA300 achieved 54.5% ORR and 10% SAE (Gr3 only no Gr4); superior to erdafitinib's 71% SAE (both Gr3 and Gr4) (Lancet DOI- 10.1016/S1470-2045(21)00660-4)
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically significant (superior in safety) and commercially TBD (OS data not mature)
Prediction Classification
True Positive (TP)

ClinicalTrials.gov record

ClinicalTrials.gov record, retrieved 2026-09-24. Third-party data.

Official title
A Multicenter, Open-label Phase 1/2 Study of TYRA300 in Advanced Urothelial Carcinoma and Other Solid Tumors With Activating FGFR3 Gene Alterations (SURF301)
Phase
Phase 1, Phase 2
Status
Active not recruiting
Enrollment
310
Lead sponsor
Tyra Biosciences, Inc
Conditions
Locally Advanced Urothelial Carcinoma; Metastatic Urothelial Carcinoma; Solid Tumor; Urothelial Carcinoma; Solid Tumor, Adult; Bladder Cancer; Non-muscle-invasive Bladder Cancer; FGFR3 Gene Mutation; FGFR3 Gene Alteration; Advanced Solid Tumor; Advanced Urothelial Carcinoma; Urinary Tract Cancer; Urinary Tract Tumor; Urinary Tract Carcinoma
Interventions
DRUG: TYRA-300
Design
Non randomized · Sequential · None
Primary purpose
Treatment
Start
2022-11-22
Primary completion
2026-11
Completion
2027-06
Primary outcomes
  • Phase 1 Part A: To determine the maximum tolerated doses (MTD). (Initiation of study treatment through 28 days.)
  • Phase 1 Part B: To determine the recommended Phase 2 dose (R2PD). (Initiation of study treatment through 28 days (up to approximately 18 months).)
  • Phase 2: Overall Response Rate (ORR), defined by RECIST v1.1. (Initiation of study treatment until disease progression, death, unacceptable toxicity, or withdrawal (up to 2 years).)

NCT05544552 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

How to read these records: evidence · methodology · all trials