A Phase I/II, Multi-center, Open Label Study of DYP688 in Patients With Metastatic Uveal Melanoma (MUM) and Other GNAQ/11 Mutant Melanomas

Study Identifier:
CDYP688A12101
CT.gov Identifier:
NCT05415072
EudraCT Identifier:
2021-003380-95
EU Trial (CTIS) Number:
2023-509451-14-00
Study Contact Information:
N/A
Recruitment Complete

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Study Summary

To characterize the safety, tolerability, and anti-tumor activity of DYP688 as a single agent in patients with metastatic uveal melanoma (MUM) and other melanomas harboring GNAQ/11 mutations.

To evaluate safety and tolerability, determine recommended dose(s) (RDs) of DYP688 (primary objective), and evaluate antitumor activity, pharmacokinetics (PK), and immunogenicity (secondary objectives)

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
  • Eye
    • Phase
    The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
    I/II
    Sex
    Female & Male
    Age
    18 - 100 Years
    Study Drug
  • Drug: Experimental: Phase I
    • Read More
  • Drug: Experimental: Phase II
  • Drug: Drug: DYP688
  • Drug: Patient treated with DYP688
  • Drug: ASCO 2025
    • Study Status
    Indicates the current recruitment status or the expanded access status
    Recruitment Complete

    Requirements information
    Inclusion criteria
    • Patients in the dose escalation part must be >or=18 years of age at the time of informed consent (ICF) signature. In the phase II part, patients ≥ 12 years of age at the time of informed consent may be eligible for enrollment. Patients must have a minimum weight of 40 kg.
    • ECOG performance status ≤ 1 for patients >or= 18 years of age; Karnofsky performance status ≥ 70 for patients >or= 16 and < 18 years of age; Lansky performance status >or= 70 for patients ≥ 12 and < 16 years of age
    • Patients must be suitable and willing to undergo study required biopsies according to the treating institution's own guidelines and requirements.
    • For all patients in Dose Escalation
    • MUM: uveal melanoma with histologically or cytologically confirmed metastatic disease. Patient must be either treatment naive or have received any number of prior lines and progressed on most recent therapy
    • Non-MUM: advanced cutaneous or mucosal melanoma with histologically or cytologically confirmed metastatic disease that has progressed following standard therapies or that has no satisfactory alternative therapies and has evidence of GNAQ/11 mutation based on local data
    • For patients in Phase II
    • Tebentafusp naïve group: Diagnosis of uveal melanoma with histologically or cytologically confirmed metastatic disease that has progressed following standard therapies or that has no satisfactory alternative therapies
    • Tebentafusp pre-treated group: Diagnosis of uveal melanoma with histologically or cytologically confirmed metastatic disease. Patients must be previously treated with tebentafusp and have progressed
    • Non-MUM: patients with diagnosis of cutaneous or mucosal melanomas harboring GNAQ/11 mutations based on local data, with histologically or cytologically confirmed metastatic disease that has progressed following standard therapies or that has no satisfactory alternative therapies
    Exclusion criteria
    • Malignant disease, other than that being treated in this study.
    • Active brain metastases, i.e. symptomatic brain metastases or known leptomeningeal disease.
    • Evidence of active bleeding or bleeding diathesis or significant coagulopathy (including familial) or a medical condition requiring long term systemic anticoagulation that would interfere with biopsies.
    • History of anaphylactic or other severe hypersensitivity / infusion reactions to ADCs or monoclonal antibodies, which in the opinion of the investigator may pose an increased risk of serious infusion reaction.
    • Treatment with any of the following anti-cancer therapies prior to the first dose of study treatment within the stated timeframes:
    • 2 weeks for fluoropyrimidine therapy
    • 4 weeks for radiation therapy or limited field radiation for palliation within
    • 4 weeks or
    • 6 weeks for cytotoxic agents with major delayed toxicities, such as nitrosoureas and mitomycin C.
    • 4 weeks for immuno-oncologic therapy, such as CTLA-4, PD-1, or PD-L1 antagonists.
    • Clinically significant and / or uncontrolled heart disease such as congestive heart failure requiring treatment (NYHA grade ≥ 2) or clinically significant arrhythmia despite medical treatment.
    • Other protocol-defined inclusion/exclusion criteria may apply.

    Clinical Study Information for Healthcare Providers

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    Study Locations

    Location
    Investigator
    Status
    Condition(s) Treated at Site
    Location
    START Madrid, Spain (CIOCC)
    Madrid, Spain, 28050
    Investigator
    Emiliano Calvo
    Status
    Recruitment Complete
    Condition(s) Treated at Site
    Eye