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NCT07190469

PQ203 in Advanced Malignant Tumors Including Triple Negative Breast Cancer

Recruiting
PHASE1Ages 18+InterventionalTreatment
ProteinQure Inc.
~80 participants
Updated 2026-02-23 on ClinicalTrials.gov
What's tested:PQ203

At a glance

Recruiting sites
4 of 4 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of treatment-emergent Adverse Events
Measured over From the time of informed consent until ~28 days after the last dose of PQ203
+1 more outcome measured

Conditions

Triple Negative Breast Cancer (TNBC)
Advanced Solid Tumors Cancer

NCT07190469

Where you'd take part

This study runs at 4 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • MD Anderson Cancer Center

    Houston, Texasstudy coordinator listed

    Recruiting

  • NEXT Oncology

    San Antonio, Texasstudy coordinator listed

    Recruiting

  • Princess Margaret Cancer Centre

    Toronto, Ontario, Canadastudy coordinator listed

    Recruiting

  • START Mountain Region

    West Valley City, Utahstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

Desirae Dufner
[email protected]
713-745-7813
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Want this trial checked against your situation?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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:
Absolute neutrophil count (ANC) ≥ 1.5 × 10e9/L
Platelets \> 100 × 10e9/L
Hemoglobin ≥ 9 g/dL
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)
Calculated creatinine clearance of ≥ 60 mL/min by the Cockcroft-Gault equation
Urine protein \< 2+
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

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

What this trial measures

  • Incidence of treatment-emergent Adverse EventsFrom the time of informed consent until ~28 days after the last dose of PQ203

    The incidence and severity of Adverse Events (AEs) will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) to assess safety and tolerability.

  • Objective Response Rate (ORR)From informed consent until ~28 days after the last dose of PQ203

    Tumor growth will be assessed using standard imaging techniques and scored by Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST v1.1). An Objective response rate (ORR), defined as the proportion of patients with a best overall response (BOR) of complete response (CR) or partial response (PR) will be calculated to assess preliminary signals of anti-tumor activity.