NL-OMON53721
Recruiting
Phase 2
A Phase I/II, multi-center, open label study of DYP688 in patients with MUM and other GNAQ/11 mutant melanomas (study CDYP688A12101) - CDYP688A12101
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- ovartis
- Enrollment
- 7
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
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 Il part, patients \>\=12 years of
- •age at the time of informed consent may be eligible for enrollment (for
- •Netherlands only \>\=18 years of age are eligible). Patients must have a minimum
- •weight of 40 kg.
- •ECOG performance status \<\=1 for patients \>\=18 years of age; Karnofsky
- •performance status \>\=70
- •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:
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 antibody\-drug conjugate 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
Outcomes
Primary Outcomes
Not specified
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