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Phase 2A/B Efficacy and Safety of Dabogratinib in Participants With Low Grade Upper Tract Urothelial Carcinoma

ConditionLow Grade Upper Tract Urothelial Carcinoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorTyra Biosciences, Inc

About this trial

A Phase 2A/B study of Dabogratinib (TYRA-300) in Low Grade Upper Tract Urothelial Carcinoma

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Participants ≥ 18 years of age at the time of informed consent and willing and able to comply with all required study procedures

Confirmed LOW RISK LG UTUC (both favorable and unfavorable) per AUA

At least 5mm of marker lesion left behind

Participants must have previous genomic report or archival/fresh tissue in addition to urine sample for retrospective genomic testing

Disqualifiers

Evidence or any features of high grade (HG) UTUC

History of carcinoma in situ (CIS)

History of prostatic urethral involvement

Current or previous history of muscle invasive bladder cancer

Trial design

Design model

Parallel

Treatments tested in this trial

  • Dabogratinib (TYRA-300) 60mg

    Drug

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

  • Dabogratinib (TYRA-300) 80mg

    Drug

    Self-administered 80mg dose Oral tablet(s) given daily

  • Dabogratinib (TYRA-300) TBD

    Drug

    To be determined: Self-administered Oral tablet(s) given daily

Treatment groups

230 Participants
are divided into 3 treatment groups
Group A: Study Drug Dose Cohort A (DCA) 60mgExperimental treatment 1 intervention
Group B: Study Drug Dose Cohort B (DCB) 80mgExperimental treatment 1 intervention
Group C: Possible Study Drug Dose Cohort C (DCC) TBD mgExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

To assess the efficacy of Dabogratinib in LG UTUC FGFR3+ participants (proportion of participants with a CR within 6 months out of all LG UTUC FGFR3+ participants)

Complete response (CR) rate

Time frame
within 6 months

Secondary outcomes

1

To assess the efficacy of Dabogratinib in LG UTUC in all participants (proportion of participants with a CR within 6 months out of all LG UTUC participants)

Complete Response (CR) rate

Time frame
at 6 months
2

Duration of Response (DOR)(median time for CR duration in those participants who achieve a CR)

Time frame
up to 36 months
3

Complete Response (proportion of participants who continue to have a CR at 12 and 24 months)

Time frame
at 12 and 24 months
4

Safety and tolerability of dabogratinib

Incidence rate and severity of adverse events

Time frame
Up to 2 years

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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