PM54 + Cytotoxic Agents for Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
The primary purpose of this study is to evaluate the safety, tolerability and recommended dose (RD) of PM54 in combination with cytotoxic and targeted anticancer agents in adult participants with advanced solid tumors. The study will also assess the antitumor activity of PM54 in combination with cytotoxic and targeted anticancer agents in terms of objective response rate (ORR) based on investigator's assessment in participants in other cohorts.
Are You a Good Fit for This Trial?
This trial is for adults with advanced solid tumors (cancers that form lumps in organs or tissues) who may have already tried other treatments. Participants must be healthy enough overall to join and meet specific medical requirements set by the study team.Inclusion Criteria
Exclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- Doxorubicin
- Irinotecan
- PM54
Trial Overview
The study is testing a new drug called PM54 given together with standard chemotherapy drugs like doxorubicin or irinotecan. The main goal is to find out what dose of PM54 is safe when used with these other cancer medicines, and how well this combination works against tumors.
How Is the Trial Designed?
4
Treatment groups
Experimental Treatment
Participants will receive the recommended dose combination of PM54 and Doxorubicin as identified in Part 1 of the study (sub - study 2).
Participants will initially receive a low dose of PM54 in combination with a low dose of Doxorubicin. If the initial dose level is tolerated, the doses of PM54 and Doxorubicin may be escalated to higher dose levels according to the study protocol until a suitable dose for the combination is established, or until clinical or objective disease progression, withdrawal of consent, or unacceptable or cumulative toxicity occurs.
Participants will receive the recommended dose combination of PM54 and Irinotecan as identified in Part 1 of the study (sub- study 1).
Participants will initially receive a low dose of PM54 in combination with a low dose of Irinotecan (sub- study 1). If the initial dose level is tolerated, the doses of PM54 and Irinotecan may be escalated to higher dose levels according to the study protocol until a suitable dose for the combination is established, or until clinical or objective disease progression, withdrawal of consent, or unacceptable or cumulative toxicity occurs.
Find a Clinic Near You
Who Is Running the Clinical Trial?
PharmaMar
Lead Sponsor
José María Fernández de Sousa-Faro
PharmaMar
Chief Executive Officer since 1986
PhD in Biochemistry, Complutense University of Madrid
Carmen Cuevas Marchante
PharmaMar
Chief Medical Officer since 2002
MD, University of Navarra
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