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Studies

Interventional Active not recruiting Phase 1/Phase 2

NCT05415072 on ClinicalTrials.gov

A Phase I/II Study of DYP688 in Patients With Metastatic Uveal Melanoma and Other GNAQ/11 Mutant Melanomas

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

  • Sponsor: Novartis Pharmaceuticals Corporation
  • Enrollment: 66 (Actual)
  • Study start: 2022-07-04 (Actual)
  • Primary completion: 2027-10-01 (Estimated)
  • Study completion: 2027-10-01 (Estimated)
  • Allocation: Non-Randomized
  • InterventionModel: Sequential
  • Masking: None
  • PrimaryPurpose: Treatment

Brief 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.

Conditions

  • Metastatic Uveal Melanoma

Intervention / Treatment

  • Drug: DYP688

Primary Outcome Measures

  • Phase I (Dose Escalation): Incidence and severity of dose limiting toxicities (DLTs) during the first 28 days of treatment. (28 days)
    A DLT is defined as an adverse event or abnormal laboratory value of Common Terminology Criteria for Adverse Events (CTCAE) grade ≥ 3 assessed as unrelated to disease, disease progression, intercurrent illness, or concomitant medications that occurs within the first cycle of treatment with DYP688. Other clinically significant toxicities may be considered to be DLTs, even if not CTCAE grade 3 or higher.
  • Phase I (Dose Escalation): Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) (9 months)
    Assessment of safety of DYP688 as a single agent
  • Phase I (Dose Escalation): Frequency of dose interruptions, reductions, and discontinuations (9 months)
    Assessment of tolerability of DYP688 as a single agent
  • Phase II: Overall Response rate (ORR) per RECIST 1.1 (17 months)
    ORR in Phase II will be evaluated by central review per RECIST 1.1.

Countries

Australia, France, Germany, Netherlands, Spain, Switzerland, United States

Locations and Investigators

  • Massachusetts General Hospital, Boston, United States
  • Columbia University Medical Center, New York, United States
  • Memorial Sloane Ketterin Cancer Ctr, New York, United States
  • Novartis Investigative Site, Westmead, Australia
  • Novartis Investigative Site, Melbourne, Australia
  • Novartis Investigative Site, Paris, France
  • Novartis Investigative Site, Essen, Germany
  • Novartis Investigative Site, Heidelberg, Germany
  • Novartis Investigative Site, Leiden, Netherlands
  • Novartis Investigative Site, Madrid, Spain
  • Novartis Investigative Site, Zurich, Switzerland