A Study of IMC-RON8 in Advanced Solid Tumors

Lilly

Status and phase: Completed; Phase 1

Conditions: Cancer

Treatments: Biological: IMC-RON8

Study type: Interventional

Funder types: Industry

Identifiers

NCT01119456

13958

I5D-IE-JRCA (Other Identifier)

CP21-0901 (Other Identifier)

Details and patient eligibility

About

A dose escalation study to determine the maximum tolerated dose of IMC-RON8 in participants with solid tumors. Participants can either be dosed once a week, or once every other week.

Enrollment: 39 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• The participant 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 participant has measurable or non-measurable disease
• The participant 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 participant has an Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0-2
• The participant has adequate hematologic function
• The participant has adequate renal function as defined by serum creatinine ≤1.5 times the institutional upper limit of normal (ULN)
• The participant has a life expectancy >3 months

Exclusion criteria

• The participant has received chemotherapy or therapeutic radiation therapy within 28 days prior to the first dose of study therapy
• The participant has ongoing toxicities of >Grade 1 associated with any prior treatment
• The participant has a known sensitivity to monoclonal antibodies or other therapeutic agents, or to agents of similar biologic composition as IMC-RON8
• The participant has received treatment with any monoclonal antibodies within 6 weeks prior to first dose of study therapy
• The participant has received treatment with agents specifically targeting the RON ligand or receptor within 6 weeks prior to first dose of study therapy
• The participant 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 participant 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 participant has known or suspected brain or leptomeningeal metastases (participants with a history of brain metastases must have received definitive surgery or radiotherapy, be clinically stable, and may not be taking steroids; participants receiving anticonvulsants are eligible)
• The participant has a serious or nonhealing active wound, ulcer, or bone fracture
• The participant is currently using or has received a thrombolytic agent within 28 days prior to first dose of study therapy
• The participant is receiving full-dose warfarin (participants receiving low-dose warfarin to maintain the patency of permanent, indwelling intravenous catheters are eligible if the international normalized ratio is <1.5)
• The participant is receiving intravenous heparin

Trial design

39 participants in 1 patient group

IMC-RON8

Experimental group

Description:

A monoclonal antibody to human macrophage-stimulating 1-receptor-8 (RON8).

Treatment:

Biological: IMC-RON8

Biological: IMC-RON8

Biological: IMC-RON8

Biological: IMC-RON8

Biological: IMC-RON8

Biological: IMC-RON8

Biological: IMC-RON8

Biological: IMC-RON8