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

Start date
Mar 14, 2023
Status verified
Mar 2026
Primary completion
Jul 31, 2026
Completion
May 31, 2027

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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