A Study of IMC-RON8 in Advanced Solid Tumors

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Study Completion Date

2013-11-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Cancer

Study Design

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Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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IMC-RON8

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

Group Type EXPERIMENTAL

IMC-RON8

Intervention Type BIOLOGICAL

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

IMC-RON8

Intervention Type BIOLOGICAL

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

IMC-RON8

Intervention Type BIOLOGICAL

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

IMC-RON8

Intervention Type BIOLOGICAL

15 mg/kg IV

Once every 2 weeks for each 4-week treatment cycle, for a total of two doses per cycle.

Cohort 4

IMC-RON8

Intervention Type BIOLOGICAL

20 mg/kg IV

Once every 2 weeks for each 4-week treatment cycle, for a total of two doses per cycle.

Cohort 5

IMC-RON8

Intervention Type BIOLOGICAL

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

IMC-RON8

Intervention Type BIOLOGICAL

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

IMC-RON8

Intervention Type BIOLOGICAL

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

Interventions

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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

Intervention Type 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

Intervention Type 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

Intervention Type 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

Intervention Type 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

Intervention Type 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

Intervention Type 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

Intervention Type 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

Intervention Type BIOLOGICAL

Other Intervention Names

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Narnatumab LY3012219 Narnatumab LY3012219 Narnatumab LY3012219 Narnatumab LY3012219 Narnatumab LY3012219 Narnatumab LY3012219 Narnatumab LY3012219 Narnatumab LY3012219

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No