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

Sponsor: Novartis Pharmaceuticals

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT05415072

Provider View

This clinical trial is testing a new drug, DYP688, to see if it is safe and effective in treating patients with metastatic uveal melanoma and other melanomas with specific genetic mutations.

Patient Parameters

Program Overview

This study is testing a new drug called DYP688 to see if it is safe and can help treat patients with metastatic uveal melanoma (a type of eye cancer) and other melanomas with specific genetic changes (GNAQ/11 mutations). The study is being conducted in multiple locations and involves two parts: the first part will determine the best dose of DYP688, and the second part will test its effectiveness in different groups of patients.

Description

This study is the first time DYP688 is being tested in humans. It is divided into two parts: Phase I and Phase II. In Phase I, researchers will find the best dose of DYP688 by gradually increasing the dose in patients with metastatic uveal melanoma and other melanomas with GNAQ/11 mutations. Once the best dose is found, the study will move to Phase II, where the drug's effectiveness will be tested in three groups: patients with uveal melanoma who have not been treated with tebentafusp, those who have been treated with tebentafusp, and patients with other types of melanomas with GNAQ/11 mutations. The study aims to see if DYP688 can help shrink tumors and improve patient outcomes.

Eligibility Criteria

Inclusion Criteria

  • Must be at least 18 years old for Phase I, and at least 12 years old for Phase II (depending on local regulations).
  • Must weigh at least 40 kg.
  • Must be in good general health, with specific performance status scores based on age.
  • Must be willing to undergo necessary biopsies unless medically unfeasible.

For Phase I:

  • Must have metastatic uveal melanoma or other melanomas with GNAQ/11 mutations.
  • Must have either not received treatment or have progressed after previous treatments.

For Phase II:

  • Must have metastatic uveal melanoma, either untreated with tebentafusp or previously treated and progressed.
  • Must have other melanomas with GNAQ/11 mutations that have progressed after standard treatments.

Exclusion Criteria

  • Have another type of cancer besides the one being studied.
  • Have active brain metastases or certain brain conditions.
  • Have active bleeding issues or need long-term blood thinners that interfere with biopsies.
  • Have severe allergic reactions to similar drugs.
  • Have received certain cancer treatments within specific timeframes before starting the study.
  • Have significant heart disease that is not well-controlled.

Other specific criteria may apply.

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