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).
Treatment: PQ203 — 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.
Check if I qualifyExtracted 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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