A Study of PYX-201 in Advanced Solid Tumors

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
Pyxis Oncology, Inc
Study ID
NCT05720117
Phase
PHASE1
Status
Recruiting

Conditions

  • Advanced Solid Tumor
  • Solid Tumor

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • PYX-201 — DRUG
    Antibody-Drug Conjugate

Study Details

The primary objectives of this study are to determine the recommended dose(s) of PYX-201 for participants with recurrent/metastatic (R/M) solid tumors, and to determine the objective response rate (ORR) in participants treated with PYX-201 as a single agent.

Key Dates

First listed
Feb 9, 2023
Start date
Mar 14, 2023
Status verified
Jun 2026
Primary completion
Apr 25, 2027
Completion
Jun 30, 2028

Study Design

Enrollment
330 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Dose Escalation
  • Experimental: Dose Expansion Cohort A (HNSCC)
  • Experimental: Dose Expansion Cohort B (TNBC)
  • Experimental: Dose Expansion Cohort C (HR+ HER2- BC)
  • Experimental: Dose Expansion Cohort D (Other Solid Tumor Types)

Primary Outcome Measure

Number of Participants who Experience a Dose-limiting Toxicity (DLT) in Dose Escalation [ Time Frame: Day 1 to Day 21 ]

Central Contacts

Locations (17)

FacilityCityStateZIPSite coordinators
HonorHealth Research InstituteScottsdaleArizona85258-
Ronald Reagan UCLA Medical CenterLos AngelesCalifornia90095-
SCRI - HealthOne DenverDenverColorado80218-
SCRI - Florida Cancer SpecialistsSarasotaFlorida34232-
Winship Cancer Institute, Emory UniversityAtlantaGeorgia30308-
University of Chicago MedicineChicagoIllinois60637-
Dana-Farber Cancer InstituteBostonMassachusetts02215-
Massachusetts General HospitalBostonMassachusetts02114-
Washington University School of MedicineSt LouisMissouri63110-1010-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-
University of Cincinnati Medical CenterCincinnatiOhio45219-
University of Pennsylvania, Abramson Cancer CenterPhiladelphiaPennsylvania19106-
Rhode Island HospitalProvidenceRhode Island02903-
NEXT DallasDallasTexas75231-
The University of Texas MD Anderson Cancer CenterHoustonTexas77030-
NEXT San AntonioSan AntonioTexas78229-
NEXT VirginiaFairfaxVirginia22031-

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