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A study of PM54 and pembrolizumab in adults with advanced cancer

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What is this study about?

This study is being conducted to evaluate the safety and effectiveness of combining the experimental drug PM54 with pembrolizumab in adults with advanced malignancies, which refers to cancers that have spread to other parts of the body. The treatment is administered through an intravenous infusion, a method where medicine is delivered directly into a vein.

The research aims to determine the best dose of the study drugs and how well the combination works in different types of cancer. Participants will receive these medications as part of a structured process to monitor how the body reacts to the treatment. During the study, the focus is on observing how the drugs are tolerated and tracking any side effects that may occur.

Who Can Join the Study?

  • You must have read, understood, and signed the informed consent form, which is a document that explains all the details of the study before you agree to join.
  • Your cancer must have progressed, meaning it has grown or spread, despite having received previous medical treatments.
  • You must have an ECOG performance status of 0 or 1, which is a scale used by doctors to measure how well you can perform daily activities and how much the disease affects your physical function.
  • You must not have any ongoing toxicities, which are harmful side effects from previous cancer treatments, that are rated as moderate or severe, with some exceptions for mild side effects like hair loss.
  • Certain stable conditions from previous immunotherapy, such as issues with the thyroid, blood sugar, or adrenal glands, are allowed if they are managed with a steady dose of medication.
  • If you have metastases in the central nervous system (cancer that has spread to the brain or spinal cord), they must be stable, showing no new symptoms, and not requiring high doses of steroids.
  • If you have had brain radiation, at least 2 weeks must have passed before starting the study.
  • You must not have had a seizure (an uncontrolled electrical disturbance in the brain) in the 4 weeks before starting treatment.
  • Your laboratory parameters, such as blood tests, must show that your organs are functioning well enough to participate.
  • You must have fully recovered from the physical effects of any previous surgeries or radiation treatments.
  • You must be willing to follow all study procedures, including giving biological samples like blood for testing.
  • Women of childbearing potential must provide evidence that they are not pregnant and must agree to use highly effective contraception (birth control) during the study and for 7 months after the last treatment.
  • Male participants with partners who can become pregnant must agree to use condoms during the treatment and for 4 months after.
  • You must be an adult, aged 18 years or older.
  • Your cancer must be advanced, meaning it has spread or returned and cannot be completely removed by surgery or other curative treatments.
  • Your cancer must be measurable, meaning a doctor can clearly see and track the size of the tumors using standard medical imaging.

Who Cannot Join the Study?

  • You cannot participate if you have previously used PM54 or any other ecteinascidin agent, which is a specific class of cancer medication including drugs like ecubectedin, trabectedin, and lurbinectedin.
  • You are excluded if you test positive for the Hepatitis B virus (HBV) with a high level of the virus in your blood (HBV DNA ≥1000 IU/mL). If you have a low level of the virus or a suspected hidden infection, you must take preventive medicine to stop the virus from becoming active again before joining.
  • You cannot join if there is a high risk of physical damage to important body parts, such as major blood vessels, large airways, or the vertebral spine (the bones that make up your backbone).
  • Pregnant women or those who are breastfeeding are not eligible.
  • Men and women who are able to have children and are not using a highly effective method of contraception (birth control to prevent pregnancy) are excluded.
  • You are excluded if you have a history of hypersensitivity, which means an allergic reaction, to PM54, pembrolizumab, or any of the inactive ingredients used to make the medicine.
  • You cannot participate if you have had other types of malignancies (cancer) within the last 3 years, unless it was a skin cancer that was fully removed or a disease that is not likely to return.
  • You are excluded if you have carcinomatous meningitis, which is a condition where cancer spreads to the protective layers covering the brain and spinal cord.
  • You are excluded if you have certain cardiovascular (heart and blood vessel) issues, such as:
    • A history of myocardial infarction (heart attack), CNS infarction (stroke), or other issues with the arteries within the last 6 months.
    • Heart failure that is moderate or severe, or an LVEF (a measurement of how much blood your heart pumps out with each beat) of less than 45%.
    • Arrhythmia (an irregular heartbeat) or other significant ECG (an electrical test of the heart) abnormalities.
    • A QTc interval (a measurement of the time it takes for your heart muscle to recharge between beats) that is longer than the normal range.
  • You are excluded if you have respiratory (lung) issues, such as:
    • A history of ILD (interstitial lung disease, which is scarring of the lung tissue) or pneumonitis (inflammation of lung tissue) that required steroids or other medicines to lower your immune system response.
    • Severe lung disorders like COPD (chronic obstructive pulmonary disease), asthma, or restrictive lung disease, or having extra fluid around the lungs (pleural effusions).
    • A recent or worsening pulmonary embolism (a blood clot in the lung) or deep vein thrombosis (a blood clot in a deep vein, usually in the leg) within the last 2 months.
  • You are excluded if you have a history of autoimmune or connective tissue disease (conditions where the body’s immune system attacks its own healthy tissues) that might get worse with the study medicine or has required high doses of corticosteroids (strong anti-inflammatory medicines) in the last year.
  • You cannot participate if you have an uncontrolled infection or an unexplained fever.
  • You are excluded if you have previously had a bone marrow or stem cell transplantation.
  • You are excluded if you have any other medical, behavioral, or social condition that the doctor believes makes it unsafe for you to take the study medicine or undergo the required procedures.
  • You cannot join if you have recently used other anticancer treatments without waiting for a sufficient washout period (a specific amount of time for the drug to leave your body) before starting the study.
  • You are excluded if you have an active HIV infection, unless you are on proper medicine, have an undetectable viral load (very little virus in the blood), and have a healthy level of CD4+ lymphocytes (a type of white blood cell that helps fight infection).
  • You are excluded if you test positive for HCV RNA, which indicates an active Hepatitis C infection.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Hospital Universitario De Navarra Pamplona Spain
Hospital Clinico San Carlos Madrid Spain

Other Sites

Site Name City Country Status
Hospital General Universitario Gregorio Maranon Madrid Spain
Hospital Universitario Fundacion Jimenez Diaz Madrid Spain
Hospital Universitario Puerta De Hierro De Majadahonda Majadahonda Spain
Iendjxrq Cgcpja Drnjeheushhzksgax L'hospitalet De Llobregat Spain
Fxvkagyzf Pkni Ly Ituacpqaosagc Bpdrbfzfx Dhe Hcjkpzee Urcbvdblqlpsc Lm Pgr Madrid Spain

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Spain Spain
Recruiting
06.04.2026

Trial locations

Investigated drugs:

Pembrolizumab is a type of immunotherapy that helps the body’s immune system recognize and fight cancer cells.

PM54 is an experimental treatment being studied to see if it can work effectively when used together with immunotherapy.

Investigated diseases:

Malignancy – This is a condition where abnormal cells grow uncontrollably and can spread to other parts of the body. These cells often form masses known as tumors. As the condition progresses, the cells may invade nearby tissues and interfere with normal bodily functions. The growth pattern and speed of the cells can vary depending on the specific type of cancer.

Trial ID:
2025-523774-16-00
Protocol code:
PM54-A-003-25
Trial Phase:
Human Pharmacology (Phase I) – Other

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