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

  • STATUS
    Recruiting
  • End date
    Nov 4, 2025
  • participants needed
    124
  • sponsor
    Novartis Pharmaceuticals
Updated on 20 October 2022

Summary

This is a FIH, phase I/II, open label, multi-center study of DYP688 as a single agent. The purpose of this study is 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.

Description

This is a First in Human (FIH), phase I/II, open label, multi-center study of DYP688 as a single agent. There will be two parts to this study: a phase I, dose escalation part followed by a phase II part. Dose escalation will be conducted in patients with MUM and other melanomas harboring GNAQ/11 mutations. Once the MTD and/or RD(s) is determined in the dose escalation part, the study may continue with a phase II part. The phase II part will be conducted in two groups of patients with MUM, a prior tebentafusp-treated group and a tebentafusp-naïve group. In addition to MUM, a third group of patients with non-uveal GNAQ/11 mutant melanomas may also be explored. This cohort may be opened based on emerging data from the dose escalation part of the study.

Details
Condition Metastatic Uveal Melanoma
Treatment DYP688
Clinical Study IdentifierNCT05415072
SponsorNovartis Pharmaceuticals
Last Modified on20 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Patients in the dose escalation part must be ≥ 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 ≥ 18 years of age; Karnofsky performance status ≥ 70 for patients ≥ 16 and < 18 years of age; Lansky performance status ≥ 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
weeks for fluoropyrimidine therapy
weeks for radiation therapy or limited field radiation for palliation within ≤ 2 weeks prior to the first dose of study treatment
weeks or ≤ 5 half-lives (whichever is shorter) for chemotherapy or biological therapy (including monoclonal antibodies) or continuous or intermittent small molecule therapeutics or any other investigational agent
weeks for cytotoxic agents with major delayed toxicities, such as nitrosoureas and mitomycin C
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
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