A Study of IMC-RON8 in Advanced Solid Tumors

Inclusion Criteria:

• The patient has histologically-confirmed advanced primary or recurrent solid tumors that have not responded to standard therapy or for which no standard therapy is available
• The patient has measurable or non-measurable disease
• The patient has not received major surgery, prior chemotherapy, prior treatment with an investigational agent or device, or prior radiation therapy within 28 days prior to the first dose of study therapy
• The patient has an Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0-2
• The patient has adequate hematologic function
• The patient has adequate renal function as defined by serum creatinine ≤ 1.5 x the institutional ULN
• The patient has a life expectancy > 3 months

Exclusion Criteria:

• The patient has received chemotherapy or therapeutic radiation therapy within 28 days prior to the first dose of study therapy
• The patient has ongoing toxicities of > Grade 1 associated with any prior treatment
• The patient has a known sensitivity to monoclonal antibodies or other therapeutic agents, or to agents of similar biologic composition as IMC-RON8
• The patient has received treatment with any monoclonal antibodies within 6 weeks prior to first dose of study therapy
• The patient has received treatment with agents specifically targeting the Ron ligand or receptor within 6 weeks prior to first dose of study therapy
• The patient has undergone a major surgical procedure, open biopsy, or experienced a significant traumatic injury within 28 days prior to the first dose of study therapy
• The patient has an ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, serious cardiac arrhythmia (well controlled atrial fibrillation is permitted), psychiatric illness/social situations, active bleeding, or any other serious uncontrolled medical disorders in the opinion of the investigator
• The patient has known or suspected brain or leptomeningeal metastases (patients with a history of brain metastases must have received definitive surgery or radiotherapy, be clinically stable, and may not be taking steroids; patients receiving anticonvulsants are eligible)
• The patient has a serious or nonhealing active wound, ulcer, or bone fracture
• The patient is currently using or has received a thrombolytic agent within 28 days prior to first dose of study therapy
• The patient is receiving full-dose warfarin (patients receiving low-dose warfarin to maintain the patency of permanent, indwelling intravenous catheters are eligible if the international normalized ratio is < 1.5)
• The patient is receiving intravenous heparin