CDX-011: Clinical Program

TREATMENT FOR METASTATIC BREAST CANCER AND ADVANCED MELANOMA

Our first antibody-drug conjugate (ADC) product candidate, CDX-011, formerly CR011-vcMMAE, is in development for the treatment of locally advanced or metastatic breast cancer and stage III and IV melanoma. CDX-011 is a fully-human monoclonal ADC that targets glycoprotein NMB, also known as osteoactivin, a protein overexpressed on the surface of cancer cells, including melanoma, breast cancer and gliomas. The antibody, CDX-011, is linked to a potent chemotherapeutic, monomethyl auristatin E (MMAE), using Seattle Genetics’ proprietary technology. The ADC is designed to be stable in the bloodstream, but to release MMAE upon internalization into GPNMB-expressing tumor cells, resulting in a targeted cell-killing effect.

Closed to enrollment
Phase 1/2: Locally Advanced or Metastatic Breast Cancer
Phase 1/2: Unresectable Stage III or Stage IV Melanoma

Phase 1/2: Locally Advanced or Metastatic Breast Cancer

This study is evaluating the safety and tolerability of CDX-011 in patients with locally advanced and metastatic breast cancer. CDX-011 is administered intravenously once every 3 weeks to cohorts of 3-6 patients to confirm the maximum tolerated dose (MTD) in breast cancer patients. Once the MTD is confirmed, up to 25 patients with locally advanced or metastatic breast cancer will be enrolled into the Phase 2 portion of the trial to further evaluate the safety and efficacy of CDX-011.

Patient Eligibility

To be eligible for the trial, patients must have:

  • locally advanced or metastatic breast cancer
  • received at least two prior chemotherapeutic regimens for breast cancer, as follows:
    • At least one regimen must have been for locally advanced or metastatic disease
    • Must have received an anthracycline, a taxane, and capecitabine in any combination unless the patient was intolerant to or not a candidate for any of these agents
    • Hormonal therapy, biologic therapy (such as trastuzumab or bevacizumab), or immunotherapy do not count as one of the 2 regimens
    • Patients with HER2/neu overexpressing tumors must have been treated with trastuzumab except in situations where the patient was intolerant to or not a candidate for trastuzumab
  • Documented progressive disease within 6 months of the last regimen
  • Adequate bone marrow, renal and liver function

Please click here for more information about this trial, including a list of clinical trial sites and contact information for prospective patients.

Phase 1/2: Unresectable Stage III or Stage IV Melanoma

This study is evaluating the safety, tolerability and pharmacokinetics of CDX-011 in patients who have unresectable stage III or stage IV melanoma. CDX-011 is administered intravenously at various dosing schedules until the maximum tolerated dose (MTD) is reached. Once the MTD for each schedule is defined, additional patients are enrolled to further evaluate the safety and efficacy of CDX-011.

Patient Eligibility

To be eligible for the trial, patients must have:

  • Progressive or new metastatic melanoma, stage III or IV
  • Measurable disease by CT / MRI
  • Failure of no more than 1 line of prior cytotoxic therapy
  • Adequate bone marrow, renal and hepatic function

Please click here for more information about this trial, including a list of clinical trial sites and contact information for prospective patients.

Print Page