PQ203 for advanced solid 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
This trial will test whether once-weekly intravenous PQ203 is safe and tolerable in adults with advanced solid tumors, including triple negative breast cancer.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | ProteinQure Inc. Industry-sponsored |
| Drugs / interventions | Chemotherapy |
| Locations | 4 sites (Houston, Texas and 3 other locations) |
| Trial ID | NCT07190469 on ClinicalTrials.gov |
What this trial studies
This open-label, first-in-human Phase 1 trial gives PQ203 as a once-weekly IV infusion to adults with selected advanced solid tumors, including TNBC. Phase 1A uses dose escalation with an expansion cohort to establish a provisional recommended Phase 2 dose, while Phase 1B refines the dose and further characterizes safety and pharmacokinetics. Primary endpoints are treatment-emergent adverse events and determination of the RP2D, and secondary endpoints include PK of PQ203 and its MMAE payload plus preliminary antitumor activity. Eligible patients must have measurable disease, ECOG 0-1, and adequate organ function to enroll.
Who should consider this trial
Good fit: Adults (≥18) with histologically confirmed metastatic or locally advanced solid tumors, measurable disease by RECIST v1.1, ECOG performance status 0–1, and adequate organ function who have progressed on or are ineligible for approved therapies.
Not a fit: Patients with poor performance status (ECOG ≥2), significant organ dysfunction, uncontrolled comorbidities, or inability to attend required clinic visits are unlikely to be eligible or to benefit.
Why it matters
Potential benefit: If successful, PQ203 could offer a new targeted treatment option for patients with advanced TNBC and other solid tumors who have exhausted standard therapies.
How similar studies have performed: PQ203 is first-in-human, but antibody-drug conjugates that deliver MMAE have shown meaningful responses in other cancers, so the approach has clinical precedent though PQ203 itself is untested in people.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Houston, Texas and 3 other locations
- MD Anderson Cancer Center — Houston, Texas, United States (Recruiting)
- NEXT Oncology — San Antonio, Texas, United States (Recruiting)
- START Mountain Region — West Valley City, Utah, United States (Recruiting)
- Princess Margaret Cancer Centre — Toronto, Ontario, Canada (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.