Phase 1/2 Study of PYX-201 in Combination With Pembrolizumab in Advanced Solid Tumors

Part of paid clinical trials in San Diego, California.

Sponsor
Pyxis Oncology, Inc
Study ID
NCT06795412
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Advanced Solid Tumors

Eligibility Criteria

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

Interventions

  • PYX-201 — DRUG
    Intravenous (IV) infusion.
  • pembrolizumab — DRUG
    IV infusion.

Study Details

The primary objective of this study is to determine the recommended Phase 2 doses (RP2D(s)) and maximum tolerated dose (MTD) of PYX-201 in combination with pembrolizumab for participants with advanced solid tumors.

Key Dates

Start date
Apr 15, 2025
Status verified
Apr 2026
Primary completion
Dec 6, 2027
Completion
Dec 6, 2027

Study Design

Enrollment
220 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Part 1: Dose Escalation
    Participants will receive escalating doses of PYX-201 to evaluate the safety, tolerability, and preliminary efficacy of PYX-201 in combination with pembrolizumab.
  • Experimental: Part 2: Dose Expansion
    Part 2 dose-expansion cohorts will be opened based on emerging data to further inform the safety, tolerability, and preliminary efficacy determinations as defined.

Primary Outcome Measure

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

Central Contacts

Locations (11)

FacilityCityStateZIPSite coordinators
University of California San DiegoSan DiegoCalifornia92093-
Sarcoma Oncology CenterSanta MonicaCalifornia90403-
Moffitt Cancer CenterTampaFlorida33612-
University of ChicagoChicagoIllinois60637-
Dana-Farber Cancer InstituteBostonMassachusetts02215-
Massachusetts General HospitalBostonMassachusetts02114-
University of PennsylvaniaPhiladelphiaPennsylvania19104-
University of Pittsburgh Medical CenterPittsburghPennsylvania15232-
NEXT Oncology HoustonHoustonTexas77054-
University of Texas - M.D. Anderson Cancer CenterHoustonTexas77030-
NEXT VirginiaFairfaxVirginia22031-

Find similar trials in San Diego, CA

By research site
University of California San Diego· San Diego, CASarcoma Oncology Center· Santa Monica, CAMoffitt Cancer Center· Tampa, FLUniversity of Chicago· Chicago, ILDana-Farber Cancer Institute· Boston, MAMassachusetts General Hospital· Boston, MA

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