ProteinQure Inc.
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.
This is an open-label, first-in-human study designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of PQ203 in patients with selected advanced solid tumors. PQ203 will be administered as a once-weekly intravenous infusion. The study consists of two parts: Phase 1A (dose escalation/expansion) and Phase 1B (dose optimization). * Phase 1A will employ a dose-escalation design in patients with advanced solid tumors to assess the safety and tolerability of PQ203 as monotherapy and to establish a provisional Recommended Phase 2 Dose (RP2D). A dose-expans…
Inclusion Criteria: * At least 18 years old * Histologically or cytologically documented metastatic or locally advanced solid tumor malignancies having progressed through or being otherwise ineligible to receive approved standard-of-care therapies * Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 * Documented presence of RECIST v1.1 measurable disease * Adequate organ function confirmed by the following laboratory values obtained within 14 days of the first dose of PQ203: Bone Marrow Function * Absolute neutrophil count (ANC) ≥ 1.5 × 10e9/L * Platelets \> 100 × 10e9/L *…
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.
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