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

Study Identifier:
PQ203-001
CT.gov Identifier:
NCT07190469
EudraCT Identifier:
N/A
EU Trial (CTIS) Number:
N/A
Study Contact Information:
(210) 593-5651 or [email protected]
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Study 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. To evaluate the safety, tolerability, and preliminary efficacy of PQ203 in human cancer patients To establish the maximum tolerated dose (MTD) / biologically optimal dose and to assess preliminary anti-cancer activity To evaluate safety and efficacy of PQ203 in patients with triple negative breast cancer To evaluate the safety, tolerability, pharmacokinetics, preliminary activity, and pharmacodynamics of PQ203

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
  • Breast Cancers
  • Solid Tumor
    • Phase
    The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
    I
    Sex
    Female & Male
    Age
    18+ years
    Study Drug
  • Drug: Experimental: PQ203
    • Study Status
    Indicates the current recruitment status or the expanded access status
    Recruiting

    Requirements information
    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

    Clinical Study Information for Healthcare Providers

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    Study Locations

    Location
    Investigator
    Status
    Condition(s) Treated at Site
    Location
    START Mountain Region
    West Valley City, UT, United States, 84119
    Investigator
    Justin Call
    Status
    Recruiting
    Condition(s) Treated at Site
    Breast Cancers
    Solid Tumor