CDYP688A12101
A Phase I/II, Multi-center, Open Label Study of DYP688 in Patients With Metastatic Uveal Melanoma (MUM) and Other GNAQ/11 Mutant Melanomas
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.
Klinische Settings
Indikation: Aderhautmelanom
Therapiesituation: inoperable fortgeschritten, Erstlinie / inoperable fortgeschritten, höhere Therapielinie
Einschlusskriterien
- 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 (not applicable in countries where enrollment is restricted by the local health authority to patients ≥ 18 years of age). 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. If a biopsy is not medically feasible, exceptions may be considered after documented discussion with Novartis.
Ausschlusskriterien
- 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.
- for more visit ClinicalTrial.gov
Links
An der Studie beteiligte Zentren
Zentrum
Hauttumorzentrum am Westdeutschen Tumorzentrum
Universitätsmedizin Essen Hufelandstraße 55
45147 Essen
Deutschland
Kontakt
Herr Prof. Dr. Dirk Schadendorf Hautklinik.Studienzentrum@uk-essen.de
Zentrum
Hauttumorzentrum der Universitäts-Hautklinik und des NCT Heidelberg Im Neuenheimer Feld 440/460 69120 Heidelberg Deutschland
Kontakt
Frau Prof. Dr. Jessica Hassel Hauttumorzentrum@med.uni-heidelberg.de