RecruitingPhase 1Phase 2NCT07644039

Study of PM54 in Combination With Immunotherapy in Adult Participants With Advanced Malignancies

A Multicenter, Open-label, Phase 1/2 Safety Run-in and Expansion Study of PM54 in Combination With Immunotherapy Evaluating Safety and Efficacy in Adult Participants Who Were Previously Treated for Advanced Malignancies

Sponsor

PharmaMar

Enrollment

119 participants

Start Date

May 21, 2026

Study Type

INTERVENTIONAL

Conditions

Advanced Malignancies

Summary

The main purpose of the study is to evaluate the safety, tolerability and recommended dose of PM54 in combination with pembrolizumab. To assess the antitumor activity of PM54 in combination with pembrolizumab in terms of clinical benefit rate (CBR) and objective response rate (ORR) based on investigator's assessment in participants in other cohorts.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called PM54 and a drug called Pembrolizumab for people with advanced malignancies. The study is currently recruiting participants at 6 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPembrolizumab

Intravenous infusion.

DRUGPM54

Intravenous infusion.

Locations(11)

START New York

New York, New York, United States

START Dallas

Fort Worth, Texas, United States

The University of Texas MD Anderson Cancer Center

Houston, Texas, United States

NEXT Houston

Houston, Texas, United States

NEXT Dallas

Irving, Texas, United States

NEXT Virginia

Fairfax, Virginia, United States

Institut Català d'Oncologia

Barcelona, Spain

Clinica Universidad de Navarra (CUN)

Madrid, Spain

Hospital General Universitario Gregorio Marañón

Madrid, Spain

START Madrid - Hospital Universitario Fundacion Jimenez D

Madrid, Spain

Clinica Universidad de Navarra (CUN)

Pamplona, Spain

View Full Details on ClinicalTrials.gov

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NCT07644039

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