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OncoMatch/Clinical Trials/NCT07190469

PQ203 in Advanced Malignant Tumors Including Triple Negative Breast Cancer

Is NCT07190469 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies PQ203 for triple negative breast cancer (tnbc).

Phase 1RecruitingProteinQure Inc.NCT07190469Data as of May 2026

Treatment: PQ203The 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.

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Extracted eligibility criteria

Cancer type

Triple-Negative Breast Cancer

Breast Carcinoma

Tumor Agnostic

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Cannot have received: MMAE-containing drug

Any prior receipt of a MMAE-containing drug

Cannot have received: SORT1-targeting medication

Any prior receipt of a SORT1-targeting medication

Cannot have received: chemotherapy or other systemic anti-cancer therapy

Exception: except for Nitrosoureas or mitomycins ≤42 days

Chemotherapy or other systemic anti-cancer therapy ≤14 days or 5 half-lives (whichever is shorter) prior to first dose of study drug except for Nitrosoureas or mitomycins ≤42 days

Lab requirements

Blood counts

Absolute neutrophil count (ANC) ≥ 1.5 × 10e9/L; Platelets > 100 × 10e9/L; Hemoglobin ≥ 9 g/dL

Kidney function

Calculated creatinine clearance of ≥ 60 mL/min by the Cockcroft-Gault equation; Urine protein < 2+

Liver function

AST, alanine transaminase ALT or ALP ≤ 2.5 × upper limit of normal (ULN); if liver metastases, then ≤ 5 × ULN; Bilirubin ≤ 1.5 × ULN (< 2 × ULN if hyperbilirubinemia is due to Gilbert's syndrome); Serum albumin ≥ 35 g/L (3.5 g/dL)

Cardiac function

Left ventricular ejection fraction (LVEF) ≥ 50%; QTc interval using Fridericia's formula (QTcF) ≤ 470 ms; Diastolic blood pressure ≥ 60 mmHg and ≤ 110 mmHg

Adequate organ function confirmed by the following laboratory values obtained within 14 days of the first dose of PQ203: ... (see details above)

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • MD Anderson Cancer Center · Houston, Texas
  • NEXT Oncology · San Antonio, Texas
  • START Mountain Region · West Valley City, Utah

Showing up to 5 US sites. See all sites on ClinicalTrials.gov →

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