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A Phase I, Open-Label Study of the Safety and Pharmacokinetics of Escalating Doses of DEDN6526A in Patients With Metastatic or Unresectable Melanoma

Phase 1
18 Years
Open (Enrolling)
Malignant Melanoma

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Trial Information

A Phase I, Open-Label Study of the Safety and Pharmacokinetics of Escalating Doses of DEDN6526A in Patients With Metastatic or Unresectable Melanoma

Inclusion Criteria:

- Adult patients, >/= 18 years of age

- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

- Histologically confirmed metastatic melanoma (AJCC stage IV) or unresectable melanoma
(AJCC Stage III)

- 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

Exclusion Criteria:

- 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)

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety: Incidence of adverse events

Outcome Time Frame:

assessed on an ongoing basis and up to 90 days following last dose of study treatment

Safety Issue:


Principal Investigator

Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:



United States: Food and Drug Administration

Study ID:




Start Date:

March 2012

Completion Date:

March 2015

Related Keywords:

  • Malignant Melanoma
  • Melanoma



Fountain Valley, California  92708
Nashville, Tennessee  37203-1632
Flint, Michigan  48532