PQ203 in Advanced Malignant Tumors Including Triple Negative Breast Cancer

Part of paid clinical trials in Houston, Texas.

Sponsor
ProteinQure Inc.
Study ID
NCT07190469
Phase
PHASE1
Status
Recruiting
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Conditions

  • Advanced Solid Tumors Cancer
  • Triple Negative Breast Cancer (TNBC)

Eligibility Criteria

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

Interventions

  • PQ203 — DRUG
    PQ203 is a peptide drug-conjugate given once weekly by intravenous infusion intended for the treatment of advanced solid tumor cancers including triple negative breast cancer.

Study Details

The primary purposes of this study are to determine the safety and tolerability of PQ203 in patients with advanced solid tumors including triple negative breast cancer (TNBC), and to determine a recommended Phase 2 dose level for future studies in TNBC.

Key Dates

Start date
Sep 16, 2025
Status verified
Feb 2026
Primary completion
Dec 31, 2028
Completion
Feb 28, 2029

Study Design

Enrollment
80 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: PQ203
    A Phase 1, first-in-human (FIH), multiple ascending dose study of the peptide drug-conjugate PQ203 to evaluate the safety, pharmacokinetics, tolerability and preliminary anti-cancer activity in patients with advanced cancers with solid tumors. Comprises up to 7 planned ascending dose cohorts with expansion of doses to identify recommended dose levels for testing in the Phase 1B Dose Optimization study. This is an open label study and all participants will receive PQ203.

Primary Outcome Measure

Incidence of treatment-emergent Adverse Events [ Time Frame: From the time of informed consent until ~28 days after the last dose of PQ203 ]

Locations (3)

FacilityCityStateZIPSite coordinators
MD Anderson Cancer CenterHoustonTexas77030
Desirae Dufner
[email protected]
713-745-7813
Timothy A Yap, MBBS, PhD, FRCP (PRINCIPAL_INVESTIGATOR)
NEXT OncologySan AntonioTexas78229
David Sommerhalder, MD (PRINCIPAL_INVESTIGATOR)
START Mountain RegionWest Valley CityUtah84119
Olivia Darais
[email protected]
801-917-4750

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MD Anderson Cancer Center· Houston, TXNEXT Oncology· San Antonio, TXSTART Mountain Region· West Valley City, UT

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