Phase I, Open-Label, Multicenter, Dose-Escalation, Multidose Study of BMS-936559 (MDX-1105) Administered Every 14 Days in Subjects with Selected Advanced or Recurrent Solid Tumors (CA210001 (MDX1105-01))
Title Phase I, Open-Label, Multicenter, Dose-Escalation, Multidose Study of BMS-936559 (MDX-1105) Administered Every 14 Days in Subjects with Selected Advanced or Recurrent Solid Tumors (CA210001 (MDX1105-01))
Contact AW
Principal Investigator Adekunle Odunsi, MD PhD
Study Number 144908
Phase1
Summary
This is a Phase I, open-label, multicenter, dose-escalation, and multidose study of MDX-1105 a fully human monoclonal IgG4 antibody targeting the Programmed Death - Ligand 1. Up to 40 subjects with measurable advanced or recurrent solid tumors, non-small cell lung cancer (NSCLC), malignant melanoma (MEL), colorectal cancer (CRC) or epithelial ovarian cancer (epOC) will be enrolled in the study.
The study will consist of 3 periods: Screening (up to 28 days), Treatment (up to 16 6-week cycles) and follow-up (up to 6 months). Each cycle is comprised of 3 doses of study drug administered on Days 1, 15, and 29 with a response assessment between Days 38 and 42. The response assessment must be completed before the first dose in the next cycle.
Eligibility
- Adults at least 18 years of age.
- FOR RCC: Subjects must have a histologically confirmed diagnosis of renal cell carcinoma with advanced or recurrent disease that is not amenable to sure by surgery or other means and must have failed at least 1 previous systemic therapy including, but not limited to, treatment with sunitinib, temsirolimus, sorafenib, interleukin-2 and/or chemotherapy
- FOR CRC: Subjects must have a histologically or cytologically confirmed recurrent or refractory colorectal carcinoma with tumor progression after prior therapy for colorectal cancer such as fluoroipyrimidine (5-FU) or capcitabine), irinotecan, oxaplatin or cetuximab.
- FOR NSCLC: Subjects must have refractory or recurrent histologically or cytologically confirmed advanced NSCLC. The malignancy must be deemed unresectable, and subjects must have failed at least 1 prior systemic taxane-based therapy.
- FOR MEL: Subjects must have a histologically confirmed diagnosis of melanoma with advanced disease; disease no longer controlled by surgery, chemotherapy, or radiotherapy; and disease refractory to or relapsed after at least 1 prior standard therapy. All melanomas regardless of primary site of disease will be allowed
- FOR epOC: Subjects must have a histologically confirmed diagnosis of epithelial ovarian cancer with advanced or recurrent disease that is not amendable to cury by surgery or other means and must have failed at least 1 prior systemic platinum-based therapy.
