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Study on the Safety of GRWD5769 Alone and with Cemiplimab for 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 clinical trial is focused on studying the safety and tolerability of a new medication called GRWD5769 in patients with advanced forms of cancer known as solid tumors. Solid tumors are abnormal masses of tissue that usually do not contain cysts or liquid areas. The study will explore how GRWD5769 works when given alone and in combination with another medication called cemiplimab, which is also known by its brand name, Libtayo. Cemiplimab is a type of treatment that helps the immune system fight cancer.

The purpose of this study is to determine how safe and tolerable these treatments are for patients. The study is divided into different parts. In one part, patients will receive GRWD5769 by itself. In another part, patients will receive GRWD5769 along with cemiplimab. The study will involve taking GRWD5769 in capsule form, which means it is taken by mouth, while cemiplimab is given through an intravenous infusion, which means it is delivered directly into the bloodstream through a vein.

Throughout the study, participants will be monitored for any side effects or reactions to the treatments. The study aims to gather information on how the body responds to these medications and to identify any potential risks. This information will help researchers understand the best way to use these treatments in the future for patients with solid tumors. The study is expected to continue until early 2027.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial visit

    Upon joining the study, participants will attend an initial visit. During this visit, participants will receive detailed information about the study, including its purpose, procedures, and potential risks.

    Participants will be asked to provide written informed consent, confirming their understanding and willingness to participate in the study.

  2. Step 2

    Baseline assessments

    Participants will undergo baseline assessments to evaluate their current health status. These assessments may include physical examinations, blood tests, and imaging studies.

    The results of these assessments will help determine eligibility and provide a reference point for future evaluations.

  3. Step 3

    Treatment initiation

    Participants will begin receiving the study medication. In Module 1, participants will receive GRWD5769 as a capsule taken orally.

    In Module 2, participants will receive GRWD5769 in combination with cemiplimab (Libtayo®) 350 mg, administered as an intravenous infusion.

  4. Step 4

    Ongoing treatment and monitoring

    Participants will continue to take the study medication as directed. Regular monitoring will occur to assess the safety and effectiveness of the treatment.

    Participants will attend scheduled visits for physical exams, blood tests, and other necessary evaluations to monitor their response to the treatment.

  5. Step 5

    Follow-up assessments

    At the end of the treatment period, participants will undergo follow-up assessments to evaluate their overall health and the impact of the study medication.

    These assessments will help determine the long-term effects and safety of the treatment.

  6. Step 6

    Study completion

    Upon completion of the study, participants will have a final visit to discuss their experience and any ongoing care needs.

    Participants will receive information about the study results and any further steps if necessary.

Who can join the trial?

11 criteria

  • Must have given written informed consent before any study-related activities are carried out and must be able to understand the full nature and purpose of the trial, including possible risks and adverse effects.
  • Must be at least 18 years old.
  • Must have a type of cancer called solid malignancy that is advanced or has spread to other parts of the body, and for which no standard treatment is available, or the patient has declined or cannot tolerate standard treatment.
  • Must have a measurable disease according to specific medical guidelines (RECIST 1.1/iRECIST).
  • Must have an ECOG performance status of 0 or 1, which means the patient is fully active or has some symptoms but does not require bed rest during the day.
  • Must be able to take oral medications and be willing to record daily adherence to the study drug.
  • Must have an estimated life expectancy of at least 3 months, according to the study doctor.
  • Must be willing and able to comply with all scheduled visits, treatment plans, laboratory tests, and other study procedures.
  • Must be willing to allow access to stored historical tumor tissue and prior tumor radiological assessments and tumor biomarker data, if available.
  • Female participants must be of non-childbearing potential or agree to use effective contraception and have a negative pregnancy test before starting the study drug.
  • Male participants must agree not to donate sperm and use effective contraception if engaging in sexual intercourse with a female partner who could become pregnant.

Who cannot join the trial?

10 criteria

  • Participants cannot have any other serious medical conditions that might interfere with the study.
  • Participants should not have any allergies to the study medications.
  • Participants cannot be pregnant or breastfeeding.
  • Participants should not have participated in another clinical trial recently.
  • Participants must not have any active infections.
  • Participants should not have a history of certain heart conditions.
  • Participants must not have any uncontrolled high blood pressure.
  • Participants should not have any history of drug or alcohol abuse.
  • Participants must not have any mental health conditions that are not well managed.
  • Participants should not have received certain treatments for their cancer recently.
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Investigated drugs

  • GRWD5769

    is a new medication being tested to see if it is safe and well-tolerated by patients with advanced cancers. In this study, researchers are looking at how patients respond to this medication when it is used by itself. The goal is to understand if it can be used safely in people with different types of solid tumors.

  • Cemiplimab (Libtayo®)

    is a medication that helps the body's immune system fight cancer. It is already used to treat certain types of skin cancer and lung cancer. In this study, cemiplimab is being combined with GRWD5769 to see if the two medications together are safe and if they work well in treating patients with solid tumors. The researchers want to find out if this combination can help improve treatment outcomes for patients with advanced cancers.

What is already known about the treatment

  • GRWD5769

    GRWD5769 is an investigational medication currently being studied for its potential use in treating solid tumors, which are a type of cancer. It is administered to patients in a clinical setting, either alone or in combination with another cancer treatment called cemiplimab (Libtayo®). The main goal of the ongoing study is to assess the safety and tolerability of GRWD5769. While the exact mechanism of action at the molecular level is not detailed, it is being explored for its potential effects on cancer cells. GRWD5769 is classified under experimental cancer therapies, as it is still in the early phases of clinical trials.

  • Cemiplimab (Libtayo®)

    Cemiplimab, marketed as Libtayo®, is a medication used in the treatment of certain types of cancer, including skin cancer and lung cancer. It is administered through an intravenous infusion, typically in a hospital or clinical setting. Cemiplimab works by helping the immune system recognize and attack cancer cells, specifically by blocking a protein called PD-1, which can prevent the immune system from effectively targeting tumors. It is classified as an immune checkpoint inhibitor and is approved for use in various cancer treatments.

Investigated diseases

Solid malignancies – Solid malignancies refer to a group of cancers that form solid tumors in various organs or tissues. These tumors arise from abnormal cell growth and can occur in organs such as the breast, lung, prostate, and colon. As the disease progresses, the tumor may grow larger and invade nearby tissues. It can also spread to other parts of the body through the bloodstream or lymphatic system, a process known as metastasis. The progression of solid malignancies varies depending on the type and location of the tumor. Symptoms may include a noticeable lump, pain, or dysfunction of the affected organ.
Trial detailsLast updated 4 Oct 2026
Age18+ yearsPhasePhase I/IITrial ID2023-504845-30-00Protocol codeGRWD5769-ST-01Estimated enrolment300 patientsSponsorGrey Wolf Therapeutics Limited

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