Study of Dalotuzumab (MK-0646) in Adults With Solid Tumors (MK-0646-009)

A Phase I Study of MK-0646 in Patients With Relapsed or Refractory Locally Advanced or Metastatic Solid Tumors

This clinical study evaluates the safety, tolerability, pharmacokinetics, and immunogenicity of dalotuzumab (MK-0646) in participants with relapsed or refractory locally advanced or metastatic solid tumors using once weekly and once every other week dose infusion regimens.

The primary study hypothesis is that administration of dalotuzumab as a once weekly and an every other week infusion will be generally safe and well tolerated

Inclusion Criteria:

• Has histologically- or cytologically-confirmed metastatic or locally advanced solid tumor(s) that has (have) failed to respond to standard therapy, or for which adequate standard therapy does not exist
• Has tumor(s) associated with insulin-like growth factor 1 receptor (IGF-1R) expression in the literature (e.g. prostate, pancreatic, colon, lung and breast)
• Has Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1
• Demonstrates adequate organ function

Exclusion Criteria:

• Has had chemotherapy, radiotherapy, or biological therapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to registration
• Is concurrently using growth hormone (GH), or growth hormone inhibitor
• Has any active central nervous system (CNS) metastases and/or carcinomatous meningitis
• Has any primary CNS tumor - any symptomatic ascites or plural effusion
• Has a history or current evidence of any clinically significant disease that might confound the results of the study, complicate the interpretation of the study results, interfere with the participant's participation, or pose an additional risk to the participant
• Is pregnant or breast-feeding