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A Phase 1 Study of the Safety, Tolerability, Pharmacokinetics and Radiologic Distribution of Ascending Single-Dose Radiolabeled MORAb-028 in Subjects With Metastatic Melanoma


Phase 1
18 Years
N/A
Not Enrolling
Both
Metastatic Melanoma, Malignant Metastatic Melanoma, Advanced Melanoma, Melanoma

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Trial Information

A Phase 1 Study of the Safety, Tolerability, Pharmacokinetics and Radiologic Distribution of Ascending Single-Dose Radiolabeled MORAb-028 in Subjects With Metastatic Melanoma


Melanoma is a serious form of skin cancer. If untreated, the melanoma can spread beyond the
original affected tissue and invade distant tissue and organs. Treatment for metastatic
melanoma includes medical treatments (chemotherapy or immunotherapy), surgery, or radiation
therapy. MORAb-028 is a recombinant human immunoglobulin M (IgM) monoclonal antibody that
recognizes a cell surface diacyl ganglioside named disialoganglioside (GD2). GD2 is
overexpressed in tumors of neuro-ectodermal origin such as melanomas, neuroblastomas,
small-cell lung carcinomas, and many sarcomas, while absent in most normal tissues. GD2
expression has been demonstrated in human melanoma and small cell lung cancer by thin layer
chromatography and radiolabeled anti-GD2 antibody detection. It is hypothesized that one
mode of action of MORAb-028 is complement-dependent cytotoxicity. Complement-dependent
cytotoxicity is a mechanism for killing tumor cells in which an antibody bound to the target
cell surface fixes complement, which results in assembly of the complement membrane attack
complex that punches holes in the target cell membrane resulting in subsequent cell lysis.
IgMs strongly bind to C1Q and robustly activate complement-dependent cytotoxicity.
MORAb-028 is being developed as a potential therapy for GD2-positive tumors.


Inclusion Criteria:



- Measurable metastatic melanoma that has failed standard therapy

- Males and females greater than or equal to 18 years of age

- Life expectancy of greater than or equal to 3 months

Exclusion Criteria:

- Significant cardiovascular impairment

- Clinically significant illness, medical condition, surgical history, or laboratory
abnormality that could affect the safety of the subject or negatively impact the
study results

- Chemotherapy, radiotherapy, or immunotherapy within 3 weeks prior to administration
to MORAb-028

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Safety of single dose radio labeled MORAb-028 in subjects with metastatic melanoma

Outcome Time Frame:

Daily for 7 days followed by weekly for 2 weeks, then biweekly for 4 weeks

Safety Issue:

Yes

Principal Investigator

Christina Coughlin, MD, PhD

Investigator Role:

Study Director

Investigator Affiliation:

Morphotek

Authority:

United States: Food and Drug Administration

Study ID:

MORAb-028-001

NCT ID:

NCT01212276

Start Date:

December 2010

Completion Date:

September 2012

Related Keywords:

  • Metastatic Melanoma
  • Malignant Metastatic Melanoma
  • Advanced Melanoma
  • Melanoma
  • Melanoma

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021