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

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

ClinicalTrials.gov Identifier: NCT05415072

Novartis Reference Number: CDYP688A12101

Last Update: Sep 28, 2022

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All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. 

Study Description

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.

Condition 
Metastatic Uveal Melanoma
Phase 
Phase 1
Phase 2
Overall status 
Recruiting
Start date 
Jul 04, 2022
Completion date 
Nov 04, 2025
Gender 
All
Age(s)
12 Years and older (Child, Adult, Older Adult)

Interventions

Drug
DYP688
Single agent DYP688

Eligibility Criteria

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:

2 weeks for fluoropyrimidine therapy
4 weeks for radiation therapy or limited field radiation for palliation within ≤ 2 weeks prior to the first dose of study treatment.
4 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.
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.

Study Locations

United States
Massachusetts General Hospital Hematology Oncology
Recruiting
Boston, 02114 - Massachusetts
Contact: Brielle Salvo (617-643-3614) - [email protected] - Ryan Sullivan
United States
Columbia University Medical Center- New York Presbyterian Onc Dept
Recruiting
New York, 10032 - New York
Contact: Ellen Alt (212-304-5579) - [email protected] - Richard Carvajal
United States
Memorial Sloane Kettering Cancer Center MSKCC
Recruiting
New York, 10065 - New York
Contact: Shirlanna Station - [email protected] - Alexander Shoushtari
United States
Australia
Novartis Investigative Site
Recruiting
Westmead, 2145
New South Wales
Australia
Novartis Investigative Site
Recruiting
Melbourne, 3000
Victoria
Australia
Switzerland
Novartis Investigative Site
Recruiting
Zuerich, 8091
-
Switzerland

Contacts

Name: 
Novartis Pharmaceuticals
Phone: 
Name: 
Novartis Pharmaceuticals
Phone: 

Have a question?

Call 1-888-669-6682 or email [email protected]