A Study of IMC-RON8 in Advanced Solid Tumors

Summary

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.

Conditions

• Cancer

Interventions

BIOLOGICAL

IMC-RON8

5 milligrams per kilogram (mg/kg) intravenously (IV) Once a week for each 4-week treatment cycle, for a total of four doses per cycle. The initial 4-week treatment cycle will be followed by a 2-week observation period. Cohort 1

BIOLOGICAL

IMC-RON8

10 mg/kg IV Once a week for each 4-week treatment cycle, for a total of four doses per cycle. The initial 4-week treatment cycle will be followed by a 2-week observation period. Cohort 2

BIOLOGICAL

IMC-RON8

15 mg/kg IV Once a week for each 4-week treatment cycle, for a total of four doses per cycle. The initial 4-week treatment cycle will be followed by a 2-week observation period. Cohort 3

BIOLOGICAL

IMC-RON8

15 mg/kg IV Once every 2 weeks for each 4-week treatment cycle, for a total of two doses per cycle. Cohort 4

BIOLOGICAL

IMC-RON8

20 mg/kg IV Once every 2 weeks for each 4-week treatment cycle, for a total of two doses per cycle. Cohort 5

BIOLOGICAL

IMC-RON8

25 or 30 mg/kg IV Once every 2 weeks for each 4-week treatment cycle, for a total of two doses per cycle. Cohort 6

BIOLOGICAL

IMC-RON8

30, 35, or 40 mg/kg IV Once every 2 weeks for each 4-week treatment cycle, for a total of two doses per cycle. Cohort 7

BIOLOGICAL

IMC-RON8

20 or 25 mg/kg IV Once every week for each 4-week treatment cycle, for a total of four doses per cycle. Cohort 8

Sponsors & Collaborators

• Eli Lilly and Company

  lead INDUSTRY

Principal Investigators

• Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) · Eli Lilly and Company

Study Design

Purpose

TREATMENT

Masking

NONE

Model

SEQUENTIAL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2010-05-31

Primary Completion

2013-11-30

Completion

2013-11-30

Countries

• United States

Study Locations