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Efficacy and Safety of TYRA-300 in Participants With FGFR3 Altered Low Grade, Intermediate Risk Non-Muscle Invasive Bladder Cancer

ConditionsLow-grade NMIBCFGFR Gene AmplificationFGFR Gene AlterationsFGFR3 Gene AlterationFGFR3 Gene MutationFGFR3 Gene Fusions
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorTyra Biosciences, Inc

About this trial

Phase 2 Study of TYRA-300 in FGFR3 Altered Low Grade, Intermediate Risk NMIBC

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Participants age 18 and over of informed consent and willing and able to comply with all requires study procedures

Able to understand and given written informed consent

Ta low grade

T1 low grade

Disqualifiers

Current or previous history of muscle invasive bladder cancer

Current or previous history of lymph node positive and/or metastatic bladder cancer

Evidence of pure squamous cell carcinoma, pure adenocarcinoma or pure undifferentiated carcinoma of the bladder

Currently receiving systemic cancer therapy (cytotoxic, immunotherapy, targeted)

Trial design

Design model

Parallel

Treatments tested in this trial

  • TYRA-300 60mg

    Drug

    Self-administered 60mg dose Oral tablet(s) given daily

  • TYRA-300 50mg

    Drug

    Self-administered 50mg dose Oral tablet(s) given daily

  • TYRA-300 Dose TBD

    Drug

    To Be Determined Dose: Self-administered Oral tablet(s) given daily

Treatment groups

90 Participants
are divided into 3 treatment groups
Group A: Dose Cohort A (DCA)Experimental treatment 1 intervention
Group B: Dose Cohort B (DCB)Experimental treatment 1 intervention
Group C: Possible Dose Cohort C (DCC)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

To assess the efficacy of TYRA-300 in LG IR-NMIBC participants

Complete response (CR) rate

Time frame
at 3 months

Secondary outcomes

1

Duration of response (responders only)

Time frame
time from initial response to confirmed recurrence of disease or death, up to 24 months
2

Time to recurrence (responders only)

Time frame
time from start of response to confirmed recurrence of disease, up to 24 months
3

Recurrence-free survival rate (responders only)

Time frame
at 12 months and 24 months
4

Progression-free survival (all participants)

Time frame
time from randomization to the progression of disease or death from any cause, whichever occurs first, up to 24 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Tyra Biosciences, Inc

Lead sponsor

Source ClinicalTrials.gov
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