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A study of RPTR-1-201 and pembrolizumab in patients with advanced solid tumors

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on individuals with Advanced Solid Tumors, which are types of cancer that have formed solid masses in the body and have spread or become more severe. The research aims to evaluate the safety and effectiveness of a new treatment called RPTR-1-201, a type of T Cell Receptor Bispecific Therapy that helps the body's immune system target cancer cells. The study will look at how this new drug works on its own and when used together with pembrolizumab, a medication known as an anti-PD-1 monoclonal antibody that helps the immune system recognize cancer.

During the course of the study, participants may receive the treatments through an intravenous infusion, which means the medicine is delivered directly into a vein. The study is divided into two parts to first determine the safest way to give the medication and then to see how well the combination of drugs can shrink or control the tumors.

The research process

The trial runs in 2 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Participation in phase 1

    The phase 1 stage focuses on determining the safety and how well the body tolerates the study treatments.

    The study involves receiving RPTR-1-201, which is a type of therapy designed to work with immune cells, either by itself or in combination with pembrolizumab (a medication known as an anti-PD-1 monoclonal antibody, which helps the immune system recognize cancer cells).

    The medications are administered through an intravenous infusion, which means the liquid medicine is delivered directly into a vein.

  2. Step 2

    Participation in phase 2

    The phase 2 stage evaluates how effective RPTR-1-201 is at treating advanced solid tumors (growths of cancer cells that have spread or become more complex).

    The treatment continues to be studied either as a single medication or in combination with pembrolizumab through intravenous infusion.

Who can join the trial?

10 criteria

  • You must be at least 18 years old on the day you sign the agreement to join the study.
  • You must undergo HLA testing, which is a blood test that checks for specific markers on your cells to see if they are a match for certain treatments.
  • You must have a confirmed locally advanced or metastatic solid tumor, which means a type of cancer that has grown into nearby tissues or spread to other parts of the body, and cannot be fully cured with current treatments.
  • Your cancer must have shown progression, meaning the disease has grown or spread, after receiving standard medical treatments.
  • There should be no other treatment options available that the doctor believes would be effective in helping you live longer or feel better.
  • You must have received a limited number of previous treatments for your cancer, including the standard medicines usually given for your specific type of cancer.
  • You must have at least one measurable lesion, which is a tumor or area of cancer that is large enough to be clearly seen and measured on medical scans like X-rays or CT scans.
  • Your organ function, such as how well your heart, liver, and kidneys are working, must be healthy enough to meet the study requirements.
  • You must have an ECOG Performance Status of 1 or less, which is a scale used by doctors to measure how well you can perform daily activities; a score of 0 or 1 means you are still quite active and able to do most things.
  • You must be willing and able to follow specific contraceptive guidelines, which are rules about using birth control to prevent pregnancy during the study.

Who cannot join the trial?

8 criteria

  • You have active leptomeningeal disease, which is a condition where cancer spreads to the protective layers covering the brain and spinal cord, or you have brain metastasis, which means cancer has spread to the brain and is not being managed or treated.
  • You have pleural effusion (fluid buildup around the lungs), pericardial effusion (fluid buildup around the heart), or ascites (fluid buildup in the belly area) that cannot be controlled and requires frequent medical drainage.
  • You have received systemic anti-cancer therapy (drugs that travel through the entire body to treat cancer) or radiotherapy (using radiation to kill cancer cells) within the last 2 weeks.
  • You have another type of malignancy (cancer) that is currently growing or has required active treatment within the last three years.
  • You are experiencing toxicities (harmful side effects) from previous cancer treatments that have not yet returned to your normal state or stabilized.
  • You have received a live vaccine (a type of vaccine that uses a weakened form of the germ) within the last 28 days.
  • You are currently participating in another therapeutic clinical trial (a medical study testing a new treatment).
  • You have any medical condition, such as alcohol or drug abuse or dependence, that the study doctors believe would make it unsafe for you to participate or would make it difficult to follow the study rules.
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Investigated drugs

  • Pembrolizumab

    is an immunotherapy medication that helps the body's immune system recognize and attack cancer cells.

  • RPTR-1-201

    is a specialized therapy designed to help immune cells find and destroy certain types of cancer cells in the body.

What is already known about the treatment

  • Pembrolizumab

    This medication is an intravenous solution used to treat various types of advanced cancers. It is an established immunotherapy that works by blocking a specific protein on immune cells, which helps the body's own immune system recognize and attack cancer cells. Scientifically classified as an anti-PD-1 monoclonal antibody, it is widely used in modern cancer treatment to improve the body's natural defense against tumors.

  • RPTR-1-201

    This substance is an experimental liquid medication administered through an intravenous infusion to target advanced solid tumors. It belongs to a new class of drugs called T-cell receptor bispecific therapies, which act like a bridge to connect immune cells directly to cancer cells. Currently being studied in clinical trials, it works at a molecular level by grabbing onto both the immune system and the tumor to trigger a targeted attack.

Investigated diseases

Advanced Solid Tumor - This condition occurs when abnormal cells form a mass in one of the body's tissues and have spread or grown significantly. These tumors consist of a collection of cells that multiply uncontrollably. As the disease moves forward, the tumor can grow larger and potentially affect surrounding organs or tissues. The progression involves the continued development of these cell clusters within the body.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase I/IITrial ID2025-524010-28-00Protocol codeRPTR-1-201-101Estimated enrolment132 patientsSponsorRepertoire Immune Medicines Inc.

sourced from the EU Clinical Trials Register and site verification

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