NCT07190469 PQ203 in Advanced Malignant Tumors Including Triple Negative Breast Cancer
| NCT ID | NCT07190469 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | ProteinQure Inc. |
| Condition | Triple Negative Breast Cancer (TNBC) |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2025-09-16 |
| Primary Completion | 2028-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 80 participants in total. It began in 2025-09-16 with a primary completion date of 2028-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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 * Hemoglobin ≥ 9 g/dL Hepatic 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) Renal Function * Calculated creatinine clearance of ≥ 60 mL/min by the Cockcroft-Gault equation * Urine protein \< 2+ Cardiac Function • Left ventricular ejection fraction (LVEF) ≥ 50% Other * Understand and voluntarily sign an Institutional Review Board (IRB)/Independent Ethics Committee (IEC)/Research Ethics Board (REB)-approved informed consent form prior to any study-specific evaluation. * PT/PTT or INR \<1.2x upper limit of normal * Non-surgically sterile men and women of child bearing potential must agree to use highly effective methods of contraception for at least 4 months beyond the final dose received. * Toxicity of previous antitumor therapy has returned to Grade ≤1 Exclusion Criteria: * Patients with primary central nervous system (CNS) malignancies (Patients with stable brain metastases (≥ 4 weeks after a treatment) not requiring steroids or other treatment will be allowed on study). * Blood transfusion within 14 days of study treatment * Serious comorbid medical conditions such as heart, lung, kidney, liver, and brain disease that, in the opinion of the enrolling investigator, could interfere with study treatment * Subjects with history of severe heart disease * QTc interval using Fridericia's formula (QTcF) \> 470 ms * Estimated or known weight \> 115 kg (253 lbs) * Known/suspected pregnancy and/or lactation * Diastolic blood pressure \< 60 mmHg or \>110 mmHg * Uncontrolled intercurrent illness * Long term care facility resident or prisoner * Any prior receipt of a MMAE-containing drug * Any prior receipt of a SORT1-targeting medication * Participation in another clinical study investigating a drug or medical device or a neuro-interventional or surgical procedure that is not considered as standard care in the 30 days preceding study enrolment * Treatment with any of the following: * 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 * Major surgery ≤28 days from first dose of study drug * Patients with a history of cerebrovascular accident within 6 months of planned first dose. * Patients with clinically symptomatic ocular toxicities * Patients with history of (noninfectious) interstitial lung disease (ILD)/pneumonitis that require steroids, with current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening * Patients with active Grade \>1 peripheral neuropathy
Frequently Asked Questions
Who can join the NCT07190469 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Triple Negative Breast Cancer (TNBC). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07190469 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07190469 currently recruiting?
Yes, NCT07190469 is actively recruiting participants. Visit ClinicalTrials.gov or contact ProteinQure Inc. to inquire about joining.
Where is the NCT07190469 trial being conducted?
This trial is being conducted at Houston, United States, San Antonio, United States, West Valley City, United States, Toronto, Canada.
Who is sponsoring the NCT07190469 clinical trial?
NCT07190469 is sponsored by ProteinQure Inc.. The trial plans to enroll 80 participants.
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