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SURF301NCT05544552

Safety and Preliminary Anti-Tumor Activity of TYRA-300 in Advanced Urothelial Carcinoma and Other Solid Tumors With FGFR3 Gene Alterations

StatusActive, Not Recruiting
PhasePhase 1/2
Primary completion (estimated)
Track this trial

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Record History

All 15 versions: 14 with changes below, 1 re-verified with no change. See every version on ClinicalTrials.gov ↗

  1. Trial status: Recruiting to Active, Not Recruiting
    • Study sites: 21 to 19
    v15
  2. Eligibility criteria shortened, about 7 words
    • Site details revised at 2 of 21 sites
    v13
  3. Study sites: 20 to 21v12
  4. Study sites: 19 to 20v11
  5. Site details revised at 5 of 19 sitesv10
Show 8 earlier versionsHide 8 earlier versions
  1. Site details revised at 3 of 19 sitesv9
  2. Site details revised at 1 of 19 sitesv8
  3. Site details revised at 1 of 19 sitesv7
  4. Study sites: 21 to 19v6
  5. Site details revised at 2 of 21 sitesv5
  6. Start date changed from estimate of Nov 2022 to Nov 22, 2022
    • Site details revised at 1 of 21 sites
    v4
  7. Start date: Oct 2022 to Nov 2022
    • Site details revised at 2 of 21 sites
    • Study title expanded, about 4 words
    v3
  8. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 21
    • Start date: Sep 2022 to Oct 2022
    v2
  1. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Phase 1 Part A: To determine the maximum tolerated doses (MTD).
Timeframe: Initiation of study treatment through 28 days.
Phase 1 Part B: To determine the recommended Phase 2 dose (R2PD).
Timeframe: Initiation of study treatment through 28 days (up to approximately 18 months).
Phase 2: Overall Response Rate (ORR), defined by RECIST v1.1.
Timeframe: Initiation of study treatment until disease progression, death, unacceptable toxicity, or withdrawal (up to 2 years).

Secondary (11)

Number of participants with adverse events (AEs) and serious adverse events (SAEs) as a measure of safety and tolerability.
Frequency in changes in laboratory parameters and physical signs of toxicity.
Pharmacokinetics: maximum plasma concentration (Cmax).
Pharmacokinetics: time to reach maximum plasma concentration (Tmax).
Pharmacokinetics: area under the plasma concentration-time curve (AUC).
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Pharmacokinetics: half-life of TYRA-300 (t1/2).
ORR is defined as the proportion of participants with complete response (CR) or partial response (PR) as determined by the investigator using RECIST V1.1.
Duration of response will be defined as the time from the initial CR or PR to the time of relapse or death, whichever occurs first among participant with an objective response.
Disease control rate is defined as the proportion of participants having a CR, PR or stable disease (SD) for >12 weeks.
Time to response is defined as time to first CR or PR that is subsequently confirmed according to RECIST v1.1.
Progression-free survival is defined as the time from the date of first study drug administration to the earliest date of documented disease progression or death.

Arms and interventions

Phase 1 Part A - dose escalationExperimental

TYRA-300 taken once daily by mouth in 28-day cycles starting at 10 mg daily.

Phase 1 Part B - dose expansionExperimental

TYRA-300 taken once or twice daily by mouth in 28-day cycles.

Phase 2Experimental

TYRA-300 taken once or twice daily by mouth in 28-day cycles at doses determined during Phase 1.

Drugs: TYRA-300

Sites

19 sites in 4 countries

United States 7, Australia 6, France 3, Spain 3