RecruitingPhase 1NCT07190469

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

Sponsor

ProteinQure Inc.

Enrollment

80 participants

Start Date

Sep 16, 2025

Study Type

INTERVENTIONAL

Conditions

Triple Negative Breast Cancer(TNBC)Advanced Solid Tumors Cancer

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug called PQ203 for people with advanced solid tumors — including triple-negative breast cancer — that have progressed after standard treatments. **You may be eligible if...** - You are 18 or older - You have a confirmed advanced or metastatic solid tumor that has progressed through or is not eligible for standard treatments - You have at least one measurable tumor on imaging - You are well enough to participate (ECOG 0 or 1) - Your blood counts, liver, kidney, and heart function meet minimum thresholds **You may NOT be eligible if...** - You are pregnant or breastfeeding (or plan to become pregnant and are not using effective contraception) - Your blood counts or organ function are below the required levels - Your heart's pumping function (ejection fraction) is below 50% Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPQ203

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.