A Study of DEDN6526A in Patients With Metastatic or Unresectable Melanoma
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This multicenter, open-label study will assess the safety and pharmacokinetics of DEDN6526A in patients with metastatic or unresectable melanoma. Cohorts of patients will receive escalating doses of DEDN6526A by intravenous infusion on Day 1 of each 21-day cycle. In the absence of disease progression or unacceptable toxicity, patients may continue to receive DEDN6552A for up to 17 cycles (1 year).
Safety: Incidence of adverse events [ Time Frame: assessed on an ongoing basis and up to 90 days following last dose of study treatment ]
Maximum tolerated dose/dose-limiting toxicities [ Time Frame: approximately one year after study start ]
Determination of recommended Phase II dose [ Time Frame: approximately 2 years ]
Secondary Outcome Measures :
Pharmacokinetics: Area under the concentration-time curve [ Time Frame: Pre-dose, 30 min. and 4, 24, 48 hours post-dose and Days 7, 10, 15, 17 Cycles 1-4, pre-dose and 30 min. post-dose Cycle 5 and every other cycle thereafter ]
Anti-therapeutic antibody (ATA) levels [ Time Frame: Pre-dose Day 1 Cycles 1-4, and within 30 days post last dose ]
Tumor response (tumor assessments according to RECIST criteria) [ Time Frame: up to approximately 1 year ]
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Ages Eligible for Study:
18 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Adult patients, >/= 18 years of age
Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
Prior failure of >/= 1 prior treatment regimens for metastatic or unresectable melanoma due to disease progression or unacceptable toxicity and for whom no standard therapy is available
Measurable disease according to RECIST criteria
Adequate bone marrow, liver and renal function
Female patients of childbearing potential and male patients with female partners of childbearing potential must agree to use one highly effective form of non-hormonal contraception or two effective forms of non-hormonal contraception through the course of the study treatment and for 6 months after the last dose of study treatment
Treatment with cytotoxic or antibody based therapy within 21 days prior to first dose of study treatment, or with any other anti-cancer therapy within 5 half-lives of the therapy prior to first dose of study treatment
Known active infection (including HIV and atypical mycobacterial disease, but excluding fungal infection of the nail beds)
Current Grad >/= 2 toxicity (except alopecia or anorexia) from prior therapy
Grade >/= 2 peripheral neuropathy
History of severe allergic or anaphylactic reactions to monoclonal antibody therapies (or recombinant antibody-related fusion proteins)
Clinically significant history of liver disease, including viral or other hepatitis, current alcohol abuse, or cirrhosis
Untreated or active central nervous system (CNS) metastases (progressing or requiring anticonvulsants or corticosteroids for symptomatic control)
Evidence of significant uncontrolled concomitant disease or disorder
Pregnant or lactating women
Prior treatment with any other antibody-drug conjugate (ADC) compound containing monomethyl auristatin E (MMAE) for the treatment of melanoma
Previous participation in a clinical trial within 30 days of the day of first study drug administration (Cycle 1, Day 1)