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A Phase 1 Dose Escalation Study of CMD-193 in Subjects With Advanced Malignant Tumors.

Phase 1
18 Years
Not Enrolling

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Trial Information

A Phase 1 Dose Escalation Study of CMD-193 in Subjects With Advanced Malignant Tumors.

Inclusion Criteria:

- Histologically confirmed malignant solid tumor that has progressed following standard
therapy, or for which no standard effective treatment is available

- Tumor expression of Lewis Y antigen ( > or = 20% tumor cells positive for Lewis Y by
immunohistochemistry assay)

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

Exclusion Criteria:

- Chemotherapy, radiation therapy, other cancer therapy, or investigational agents
within 21 days of the first dose of CMD-193 (42 days if the previous chemotherapy
included nitrosoureas or mitomycin C)

- Symptomatic or clinically active CNS metastases. Subjects who have had prior
treatment with radiotherapy or surgical resection for CNS metastases will be
permitted if CNS metastases have remained stable and have not required any treatment
for at least 3 months prior to the first dose of CMD-193.

- Significant prior allergic reaction to recombinant human or murine proteins

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:

Physical examinations

Principal Investigator

Medical Monitor

Investigator Role:

Study Director

Investigator Affiliation:

Wyeth is now a wholly owned subsidiary of Pfizer


United States: Food and Drug Administration

Study ID:




Start Date:

November 2004

Completion Date:

July 2007

Related Keywords:

  • Neoplasms
  • Malignant Tumors
  • Neoplasms



Philadelphia, Pennsylvania  19104
Nashville, Tennessee  37203-1632
Lebanon, New Hampshire