Fase 2A/B Effektivitet og Sikkerhed af Dabogratinib hos Deltagere med Lavgrads Øvre Urinvejskarcinom (SURF303)
En fase 2A/B, multicenter, åben-label undersøgelse, der evaluerer effektiviteten og sikkerheden af Dabogratinib (TYRA-300) hos deltagere med lavgradet overste urinvejsløbscarcinom (SURF303)
A Phase 2A/B study of Dabogratinib (TYRA-300) in Low Grade Upper Tract Urothelial Carcinoma
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
A Phase 2A/B, Multi-center, Open-Label Study Evaluating the Efficacy and Safety of Dabogratinib (TYRA-300) in Participants with Low Grade Upper Tract Urothelial Carcinoma (SURF303)
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Fase 2
Kontakter og lokationer
Studiekontakt
- Navn: Lara Balick
- Telefonnummer: 929-792-5633
- E-mail: TyraClinicalTrials@tyra.bio
Studiesteder
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California
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Loma Linda, California, Forenede Stater, 92354-3450
- Rekruttering
- Loma Linda University (LLU) - Loma Linda University Medical Center (LLUM)
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Los Angeles, California, Forenede Stater, 90033
- Rekruttering
- USC Norris Comprehensive Cancer Center
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Florida
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Tampa, Florida, Forenede Stater, 33612-9416
- Rekruttering
- Moffitt Cancer Center
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Georgia
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Atlanta, Georgia, Forenede Stater, 30322-1013
- Rekruttering
- The Winship Cancer Institute of Emory University
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Illinois
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Chicago, Illinois, Forenede Stater, 60637
- Rekruttering
- The University of Chicago
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Lisle, Illinois, Forenede Stater, 60532
- Rekruttering
- Duly Health and Care Chicago
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Indiana
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Greenwood, Indiana, Forenede Stater, 46143
- Rekruttering
- Urology of Indiana, LLC
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Indianapolis, Indiana, Forenede Stater, 46202
- Rekruttering
- Indiana University (IU) Health Physicians - Urology
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Jeffersonville, Indiana, Forenede Stater, 47130
- Rekruttering
- First Urology
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Massachusetts
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Plymouth, Massachusetts, Forenede Stater, 02360
- Rekruttering
- Greater Boston Urology - Plymouth Care Center
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Michigan
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Ann Arbor, Michigan, Forenede Stater, 48109-5000
- Rekruttering
- University of Michigan Health System (UMHS)
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Royal Oak, Michigan, Forenede Stater, 48073-0996
- Rekruttering
- Michigan Healthcare Professionals - William Beaumont University Hospital
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Missouri
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St Louis, Missouri, Forenede Stater, 63141
- Rekruttering
- Urology of St. Louis
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New Jersey
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Sewell, New Jersey, Forenede Stater, 08080-2359
- Rekruttering
- Summit Health - Washington Township
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New York
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Albany, New York, Forenede Stater, 12208-3412
- Rekruttering
- Albany Medical College
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Syracuse, New York, Forenede Stater, 13210
- Rekruttering
- Associated Medical Professionals of NY, PLLC
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Ohio
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Cleveland, Ohio, Forenede Stater, 44111
- Rekruttering
- Cleveland Clinic
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Columbus, Ohio, Forenede Stater, 43210-1280
- Rekruttering
- The Ohio State University Wexner Medical Center
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Gahanna, Ohio, Forenede Stater, 43230
- Rekruttering
- Central Ohio Urology Group
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Pennsylvania
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Radnor, Pennsylvania, Forenede Stater, 19087
- Rekruttering
- Penn Medicine Radnor
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South Carolina
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Mt. Pleasant, South Carolina, Forenede Stater, 29464-3771
- Rekruttering
- Medical University of South Carolina (MUSC)
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Tennessee
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Nashville, Tennessee, Forenede Stater, 37209-4035
- Rekruttering
- Urology Associates, P C
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Texas
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Austin, Texas, Forenede Stater, 78705-2009
- Rekruttering
- Urology Austin - Apex Cancer Care - Austin
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Dallas, Texas, Forenede Stater, 75235
- Rekruttering
- The University of Texas Southwestern Medical Center
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Houston, Texas, Forenede Stater, 77030
- Rekruttering
- The University of Texas MD Anderson Cancer Center
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Paris, Frankrig, 75015
- Rekruttering
- Hôpital Européen Georges Pompidou (HEGP)
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Paris, Frankrig, 75013
- Rekruttering
- Hopital Pitie-Salpetriere
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Saint-Etienne, Frankrig
- Rekruttering
- CHU de Saint-Etienne - Hopital Bellevue
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Jerusalem, Israel
- Rekruttering
- Hadassah University Hospital - Ein Kerem
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Kfar Saba, Israel, 4428164
- Rekruttering
- Meir Medical Center
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Tel Aviv
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Holon, Tel Aviv, Israel, 5822012
- Rekruttering
- Edith Wolfson Medical Center
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Ramat Gan, Tel Aviv, Israel
- Rekruttering
- Chaim Sheba Medical Center
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Tel Aviv, Tel Aviv, Israel, 6423906
- Rekruttering
- Tel Aviv Sourasky Medical Center
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Cadiz, Spanien, 11009
- Rekruttering
- Hospital Universitario Puerta del Mar
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Madrid, Spanien, 28041
- Rekruttering
- Hospital Universitario 12 de Octubre
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Valencia
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Valencia, Valencia, Spanien, 46026
- Rekruttering
- Hospital Universitari i Politècnic La Fe
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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Participants ≥ 18 years of age at the time of informed consent and willing and able to comply with all required study procedures
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Confirmed LG UTUC (both favorable and unfavorable) per AUA
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At least 5mm of marker lesion(s) left behind
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Identification of marker lesion(s) within 8 weeks prior to randomization (refer to Inclusion Criterion #2)
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If synchronous NMIBC, NMIBC must be fully resected and low-grade Ta or T1
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No prior BCG administration within 1 year of date of consent.
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No intravesical chemotherapy within 8 weeks prior to C1D1 (including UGN-101).
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No systemic chemotherapy within 3 months prior to C1D1
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ECOG PS 0-2
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Pathology consists of pure urothelial carcinoma
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Adequate bone marrow function:
i. Absolute neutrophil count (ANC) ≥1,500/mm3 ii. Platelet count ≥75,000/mm3 iii. Hemoglobin ≥10.0 g/dL
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Adequate liver function:
i. Total bilirubin ≤ ULN ii. Alanine aminotransferase (ALT) ≤ ULN iii. Aspartate aminotransferase (AST) ≤ ULN
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Adequate renal function:
i. Estimated glomerular filtration rate >30 mL/min ii. Serum Phosphate level ≤ ULN prior to starting treatment iii. International normalized ratio (INR) ≤1.5 × ULN
Exclusion Criteria:
- 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
- Current or previous history of lymph node positive and/or metastatic bladder cancer
- Evidence of squamous cell carcinoma, adenocarcinoma or undifferentiated carcinoma or small cell of the bladder
- Currently receiving systemic cancer therapy (cytotoxic or immunotherapy)
- Current or prior history of pelvic external beam radiotherapy for bladder cancer
- Current or history of receiving a prior FGFR inhibitor
- Systemic immunotherapy within 6 months prior to C1D1
- Treatment with an investigational agent within 30 days or 5 half-lives from C1D1, whichever is shorter; compounds with an unknown half-life will be default to 30 days.
- Prior treatment with an intravesical or intracavitary agent within 8 weeks of C1D1.
- Current evidence of central serous retinopathy or retinal pigmented epithelial detachment of any grade at time of baseline examination.
- Requiring use of medications that are strong and moderate inhibitors or inducers of CYP3A or inhibitors of P-gp and BCRP transporters (prohibited list of medications)
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: Study Drug Dose Cohort A (DCA) 60mg
Dabogratinib (TYRA-300) monotherapy in Participants |
Self-administered 60mg dose Oral tablet(s) given daily
Andre navne:
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Eksperimentel: Study Drug Dose Cohort B (DCB) 80mg
Dabogratinib (TYRA-300) monotherapy in Participants |
Self-administered 80mg dose Oral tablet(s) given daily
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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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)
Tidsramme: within 6 months
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Complete response (CR) rate |
within 6 months
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Varigheden af respons (DOR) (median tid for CR-varighed hos de deltagere, der opnår en CR)
Tidsramme: op til 36 måneder
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op til 36 måneder
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Komplet respons (andel af deltagere, der fortsat har en CR efter 12 og 24 måneder)
Tidsramme: efter 12 og 24 måneder
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efter 12 og 24 måneder
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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)
Tidsramme: at 6 months
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Complete Response (CR) rate |
at 6 months
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Safety and tolerability of dabogratinib
Tidsramme: Up to 2 years
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Incidence rate and severity of adverse events |
Up to 2 years
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Rate of renal preservation after treatment with dabogratinib
Tidsramme: Up to 2 years
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Proportion of participants who did not undergo a nephrectomy or nephroureterectomy |
Up to 2 years
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Change from unresectable UTUC to resectable UTUC
Tidsramme: Up to 2 years
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Proportion of participants with unresectable disease at baseline who convert to resectable disease on dabogratinib, as assessed by the Investigator |
Up to 2 years
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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Studiestol: Doug Warner, Tyra Biosciences, Inc
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- TYR300-203
- 2025-523539-20-00 (Ctis)
- 2025 (U.S. NIH-bevilling/kontrakt)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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