PM534 Administered Intravenously to Patients With Advanced Solid Tumors

NCT05835609 | Recruiting Phase 1 DMC

• 1 other identifier: PM534-A-001-22
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 3

Brief 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. All Patients will receive PM534 via intravenous.

Conditions

Patients With Advanced Solid Tumors

Outcome Measures

Primary Outcomes (1)

• Determination of the Maximum Tolerated Dose and the Recommended Dose

  A fully evaluable patient is a patient evaluable for the primary objective (i.e., determination of the MTD and the RD).

  From the date of first infusion of PM534 to the date of study termination, up to 46 months

Secondary Outcomes (18)

• Safety AEs of PM534

  From the date of first infusion of PM534 to the date of study termination, up to 46 months

• Safety Hb of PM534

  From the date of first infusion of PM534 to the date of study termination, up to 46 months

• Safety neutrophils of PM534

  From the date of first infusion of PM534 to the date of study termination, up to 46 months

• Safety platelets of PM534

  From the date of first infusion of PM534 to the date of study termination, up to 46 months

• Safety BT of PM534

  From the date of first infusion of PM534 to the date of study termination, up to 46 months

Study Arms (1)

PM534

EXPERIMENTAL

Patients will be included in cohorts of a minimum of three or six patients to receive PM534 at successively increasing dose levels.

Drug: PM534

Interventions

PM534 DRUG

PM534 drug product is provided as a powder for concentrate for solution for infusion, is a sterile, preservative-free, lyophilized white cake in a single-dose vial for reconstitution prior to intravenous infusion.

PM534

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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:

You may not qualify if:

• 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.

Sponsors & Collaborators

• PharmaMar: lead

Study Sites (3)

HM Nou Delfos

Barcelona, 08023, Spain

RECRUITING

Hospital Universitario Fundación Jiménez Díaz

Madrid, 28040, Spain

RECRUITING

Hospital Universitario HM Sanchinarro

Madrid, 28050, Spain

RECRUITING

Central Study Contacts

Gaston Federico Boggio, M.D.

CONTACT

+34 91 823 4524; gfboggio@pharmamar.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Sequential Assignment

Study Record Dates

• First Submitted: February 7, 2023
• First Posted: April 28, 2023
• Study Start: December 23, 2022
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: August 22, 2025

Record last verified: 2025-08

Locations

ES (3)