NCT07190469

PQ203 in Advanced Malignant Tumors Including Triple Negative Breast Cancer

A Phase 1, Open-label, Multicenter Clinical Trial Evaluating the Safety, Pharmacokinetics, Pharmacodynamics and Anti-Cancer Activity of PQ203 in Patients With Advanced Solid Tumor Malignancies

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: ProteinQure Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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-expansion component will further evaluate the provisional RP2D in one or more selected tumor types. * Phase 1B will assess the provisional RP2D and further characterize safety, pharmacokinetics, and preliminary efficacy. Endpoints: * Primary Endpoints: Incidence of treatment-emergent adverse events (TEAEs) and determination of the RP2D. * Secondary Endpoints: Pharmacokinetic profile of PQ203 and its payload (MMAE), and preliminary evidence of antitumor activity.

Conditions

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

Interventions

Type	Name	Description
DRUG	PQ203	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.

Timeline

• Start date: 2025-09-16
• Primary completion: 2028-12-01
• Completion: 2029-02-01
• First posted: 2025-09-24
• Last updated: 2026-02-23

Locations

4 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study