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Study of DYP688 for Patients with Metastatic Uveal Melanoma and Other GNAQ/11 Mutant Melanomas

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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 a type of cancer called metastatic uveal melanoma, which is a form of eye cancer that has spread to other parts of the body. The study also includes other types of skin and mucosal cancers that have specific genetic changes known as GNAQ/11 mutations. The treatment being tested in this study is a medication called DYP688, which is given to patients through an infusion into a vein.

The purpose of the study is to understand how safe and tolerable DYP688 is for patients and to see how well it works against these cancers. The study is divided into two phases. In the first phase, researchers will focus on determining the best dose of DYP688 and observing any side effects. In the second phase, they will evaluate how effective the treatment is in reducing the size of the tumors.

Participants in the study will receive DYP688 and will be monitored closely by the research team. This includes regular check-ups and tests to track their health and the cancer's response to the treatment. Some participants may receive a placebo, which is a substance with no active medication, to compare the effects of DYP688. The study aims to gather important information that could lead to better treatment options for patients with these types of cancers in the future.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, eligibility is confirmed based on age, weight, and health status. Patients must have a confirmed diagnosis of metastatic uveal melanoma or other GNAQ/11 mutant melanomas.

    Patients must be willing to undergo necessary biopsies and have progressed on previous therapies or have no satisfactory alternative treatments.

  2. Step 2

    Phase I treatment

    The initial phase focuses on determining the safety and tolerability of the medication DYP688. This involves monitoring for any dose-limiting toxicities and adverse events.

    The medication is administered as a powder for solution for infusion through intravenous use. The specific dosage and frequency are adjusted based on individual tolerance and response.

  3. Step 3

    Monitoring and adjustments

    Throughout the first 28 days, the incidence and severity of any adverse effects are closely monitored. This includes changes in laboratory values, electrocardiograms, and vital signs.

    Adjustments to the dosage may be made based on the patient's response and any side effects experienced.

  4. Step 4

    Phase II treatment

    In the second phase, the focus shifts to evaluating the anti-tumor activity of DYP688. The overall response rate is assessed using standardized criteria.

    Patients continue to receive the medication as a single agent, with ongoing monitoring for adverse events and any necessary dose adjustments.

  5. Step 5

    Evaluation of outcomes

    The duration of response, progression-free survival, and overall survival are evaluated. The frequency of dose interruptions and any development of anti-DYP688 antibodies are also assessed.

    The study aims to gather comprehensive data on the effectiveness and safety of DYP688 for future treatment considerations.

Who can join the trial?

8 criteria

  • Patients must be at least 18 years old for the first part of the study. In the second part, patients can be 12 years or older, but in some places, only those 18 and older can join. Patients must weigh at least 40 kg. For a specific dose, they cannot weigh more than 115 kg.
  • Patients 18 years or older must have an ECOG performance status of 0 or 1, which means they are fully active or have some symptoms but can still do light work. Patients aged 16 to 18 need a Karnofsky performance status of 70 or more, meaning they can care for themselves but might not be able to do normal activities or work. Patients aged 12 to 16 need a Lansky performance status of 70 or more, indicating they can do most activities but might have some limitations.
  • Patients must be willing and able to have biopsies, which are small samples of tissue taken for testing, if it is safe for them to do so.
  • For the first part of the study with uveal melanoma: Patients must have a confirmed diagnosis of metastatic uveal melanoma, which means the cancer has spread. They can be new to treatment or have had previous treatments but the cancer has worsened.
  • For the first part of the study with other melanomas: Patients must have advanced skin or mucosal melanoma with a confirmed diagnosis of metastatic disease. The cancer must have worsened after all standard treatments or there are no other good treatment options. They must have a specific mutation called GNAQ/11.
  • For the second part of the study, Tebentafusp-naive group: Patients must have a confirmed diagnosis of metastatic uveal melanoma that has worsened after standard treatments or there are no other good treatment options.
  • For the second part of the study, Tebentafusp pre-treated group: Patients must have a confirmed diagnosis of metastatic uveal melanoma. They must have been treated with a drug called tebentafusp and the cancer has worsened.
  • For the second part of the study with other melanomas: Patients must have a confirmed diagnosis of skin or mucosal melanomas with a GNAQ/11 mutation. The cancer must have worsened after all standard treatments or there are no other good treatment options.

Who cannot join the trial?

7 criteria

  • Patients with other types of cancer that are not related to **metastatic uveal melanoma** or **GNAQ/11 mutant melanomas**. **Metastatic uveal melanoma** is a type of eye cancer that has spread to other parts of the body. **GNAQ/11 mutant melanomas** are specific genetic types of skin or mucosal melanoma.
  • Patients who have not recovered from previous cancer treatments. This means if you are still experiencing side effects from past treatments, you may not be eligible.
  • Patients with serious heart problems. This includes conditions like heart failure or recent heart attacks.
  • Patients with uncontrolled infections. If you have an infection that is not being managed well, you may not be able to participate.
  • Patients who are pregnant or breastfeeding. This is to ensure the safety of both the mother and the baby.
  • Patients who are unable to follow the study procedures. This means if you cannot attend appointments or follow instructions, you may not be eligible.
  • Patients with certain other medical conditions that the study doctors believe would make participation unsafe. This is determined on a case-by-case basis.
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Investigated drugs

DYP688 is an investigational medication being studied for its potential to treat metastatic uveal melanoma and other melanomas with specific genetic mutations. The trial aims to understand how safe and tolerable this medication is for patients and to determine the best dose for future studies. Additionally, the trial seeks to evaluate how effective DYP688 is in reducing tumor size or slowing the progression of the disease.

What is already known about the treatment

DYP688 – This medication is administered orally and is currently being studied in clinical trials for its effectiveness in treating metastatic uveal melanoma and other melanomas with GNAQ/11 mutations. It is in the early phases of clinical research, focusing on determining its safety, tolerability, and optimal dosing. The main therapeutic use of DYP688 is to target and reduce tumor growth in these specific types of melanoma. At the molecular level, DYP688 works by interfering with specific pathways that are crucial for the survival and proliferation of cancer cells. It is classified pharmacologically as an anti-cancer agent.

Investigated diseases

  • Metastatic Uveal Melanoma

    This is a type of cancer that originates in the eye's uveal tract and spreads to other parts of the body. It typically begins in the pigmented cells of the eye and can progress to affect organs such as the liver. The disease is characterized by the uncontrolled growth of melanocytes, which are the cells responsible for producing pigment. As it advances, it can lead to symptoms such as vision changes or loss, and eventually, systemic symptoms as it metastasizes. The progression of the disease can vary, but it often involves the spread to distant organs, complicating treatment and management.

  • Other GNAQ/11 Mutant Melanomas

    These are melanomas that occur due to mutations in the GNAQ or GNA11 genes, which are involved in cell signaling pathways. These mutations can lead to abnormal cell growth and the development of melanoma in areas such as the skin or mucosal surfaces. The disease progresses as the mutated cells continue to divide uncontrollably, potentially leading to the formation of tumors. Over time, these melanomas can invade surrounding tissues and may spread to other parts of the body. The progression and behavior of these melanomas can vary depending on the location and extent of the mutation.

Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase I/IITrial ID2023-509451-14-00Protocol codeCDYP688A12101Estimated enrolment76 patientsSponsorNovartis Pharma AG

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