Phase I, Open-label, Dose-escalating, Clinical and Pharmacokinetic Study of PM534 Administered Intravenously to Patients With Advanced Solid Tumors

Study Identifier:
PM534-A002-24
CT.gov Identifier:
NCT05835609
EudraCT Identifier:
2022-002032-31
EU Trial (CTIS) Number:
2024-513056-15-00
Study Contact Information:
N/A
Recruiting

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Study Summary

The goals of this trial are to identify the dose limiting toxicities, to determine the maximum tolerated dose and the recommended dose of PM534 in patients with advanced solid tumors.

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
  • Prostate
  • 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: PM534
    • Study Status
    Indicates the current recruitment status or the expanded access status
    Recruiting

    Requirements information
    Inclusion criteria
    • Voluntarily signed and dated written informed consent, obtained prior to any specific study procedure.
    • Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤1
    • Patients must have:
    • 3.1 Pathologically confirmed diagnosis of advanced solid tumors 3.2 No more than three prior chemotherapy lines.
    • Patients with measurable or non-measurable disease according to the RECIST v.1.1.
    • Recovery to grade ≤1 from drug-related adverse events (AEs) of previous disease treatments, excluding grade 2 alopecia.
    • Laboratory values within seven days prior to first infusion:
    • Absolute neutrophil count (ANC) ≥1.5 x 10⁹/L, platelet count ≥100 x 10⁹/L and hemoglobin ≥9 g/dL
    • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3.0 x upper limit of normal (ULN).
    • Total bilirubin ≤ULN (up to 1.5 x ULN for patients with Gilbert's syndrome).
    • Creatinine clearance ≥30 mL/min or serum creatinine ≤1.5 x ULN.
    • Serum albumin ≥3 g/dL.
    • Serum potassium ≥3.5 mmol/L.
    • Serum magnesium ≥1.6 mg/dL.
    • Wash-out periods:
    • At least three weeks since the last chemotherapy.
    • At least four weeks since the last monoclonal antibody (MAb)-containing therapy.
    • At least two weeks since the last biological/investigational single-agent therapy (excluding MAbs) and/or palliative radiotherapy (RT).
    • In patients with hormone-sensitive breast cancer progressing while on hormone therapy (except for luteinizing hormone-releasing hormone [LHRH] analogues in pre-menopausal women or megestrol acetate), all other hormonal therapies must be stopped at least one week before study treatment start.
    • Castrate-resistant prostate cancer (CRPC) patients may continue receiving hormone therapy prior to and during study treatment.
    • Life expectancy ≥3 months
    Exclusion criteria
    • Concomitant diseases/conditions:
    • Increased cardiac risk:
    • History of long QT syndrome.
    • Corrected QT interval (QTcF, Fridericia correction) ≥450 msec on screening electrocardiogram (ECG).
    • History of or current ischemic heart disease, including myocardial infarction, stable/unstable angina, coronary arteriography or cardiac stress testing with findings consistent with coronary occlusion or infarction or symptomatic arrhythmia.
    • History of heart failure or left ventricular dysfunction (left ventricular ejection fraction [LVEF] ≤50%) by multiple-gated acquisition scan (MUGA) or echocardiography (ECHO).
    • Clinically significant ECG abnormalities, including any of the following: right bundle branch block with left anterior hemiblock, second (Mobitz II) or third degree atrioventricular block and findings suggestive of ischemic heart disease.
    • Symptomatic arrhythmia.
    • Use of a cardiac pacemaker.
    • History of or current peripheral vascular disease or cerebrovascular disease.
    • Presence of:
    • Any grade of peripheral neuropathy (any etiology) at study entry.
    • Prior history of grade ≥ 2 peripheral neuropathy due to any chemotherapeutic or investigational agent.
    • Clinical or radiological signs of subocclusion/bowel obstruction.
    • Active infection requiring systemic treatment.
    • Known human immunodeficiency virus (HIV) or known hepatitis C virus (HCV) infection or active hepatitis B.
    • Any other major illness that, in the Investigator's judgment, will substantially increase the risk associated with the patient's participation in this study
    • Symptomatic, steroid-requiring, central nervous system (CNS) disease.
    • Patients with carcinomatous meningitis.
    • Prior bone marrow or stem cell transplantation.
    • Current treatment with colchicine.
    • Use of (strong or moderate) inhibitors or strong inducers of CYP3A4 activity within two weeks prior to the first infusion of PM534
    • Known hypersensitivity to any of the components of the drug product.
    • Limitation of the patient's ability to comply with the treatment or to follow the protocol procedures.
    • Women who are pregnant or breast feeding and fertile patients (men and women) who are not using an effective method of contraception
    • Patients with pulmonary lymphangitis.
    • Use of medications with known risk of inducing torsades de pointes (TdP) within five half-lives prior to the first infusion of PM534

    Clinical Study Information for Healthcare Providers

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    Study Locations

    Location
    Investigator
    Status
    Condition(s) Treated at Site
    Location
    START La Rioja
    Logroño, La Rioja, Spain, 26006
    Investigator
    Maria de Miguel
    Status
    Recruiting
    Condition(s) Treated at Site
    Breast Cancers
    Prostate
    Solid Tumor