A Safety Study Of A Monoclonal Antibody Against A5B1 Integrin In Solid Tumors

A Phase 1 Safety, Pharmacokinetic And Pharmacodynamic Study Of The Anti-A5B1 Integrin Monoclonal Antibody PF-04605412 Administered Intravenously To Adult Patients With Advanced Or Metastatic Solid Tumors

Dose finding study of the MoaB PF-04605412 directed against the alpha5beta1 integrin. Main objective is to define the MTD (maximum tolerated dose) or MAD (maximum administrable dose) in cancer patients pre treated or unresponsive to standard therapies.

Inclusion Criteria:

• Histologically or cytologically confirmed advanced measurable or evaluable solid tumors unresponsive to currently available therapies, or for which there is no curative therapy
• Eastern Cooperative Oncology Group (ECOG) performance status 0 and 1
• Life expectancy more than12 weeks
• Adequate bone marrow, liver and renal function

Exclusion Criteria:

• Known brain metastasis
• Chemotherapy, radiotherapy, or any investigational cancer therapy within 4 weeks of start of screening procedures
• Major surgical procedure within 4 weeks of start of screening procedures
• Active bleeding disorder, including gastrointestinal bleeding, as evidenced by hematemesis, significant hemoptysis or melena in the past 6 months