A Study of IMC-CS4 in Subjects With Advanced Solid Tumors

Study Overview
=================
Brief Summary
-----------------
A dose escalation study to establish the safety profile and characterize the pharmacokinetic profile of IMC-CS4 in the treatment of subjects with advanced solid tumors refractory to standard therapy or for which no standard therapy is available.

Official Title
-----------------
Phase 1 Study of IMC-CS4, a Monoclonal Antibody Targeted to the CSF-1 Receptor (CSF-1R), In Subjects With Advanced Solid Tumors Refractory to Standard Therapy or for Which No Standard Therapy is Available

Conditions
-----------------
Neoplasms

Intervention / Treatment
-----------------
* Biological: IMC-CS4


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject has histologic or cytologic confirmation of advanced solid tumors that is refractory to standard therapy or for which no standard therapy is available Subject has measurable or nonmeasurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 Subject has resolution to grade ≤1 by NCI-CTCAE (Common Toxicity Criteria for Adverse Effects) Version 4.03 of all clinically significant toxic effects of prior treatment Subject has an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 Subject has adequate hematologic, hepatic, renal, and coagulation function Subject has a life expectancy greater than 3 months Subject agrees to use adequate contraception during the study period and for 12 weeks after last dose of study therapy Subject must undergo mandatory biopsies, including one pretreatment and one post treatment tumor biopsy procedure Exclusion Criteria: Subject has experienced acute pathologic fracture or spinal cord compression within 28 days prior to first dose of study therapy Subject has a known hypersensitivity to monoclonal antibodies or to agents of similar biologic composition as IMC-CS4. Subject has received treatment with any monoclonal antibodies within 4 weeks prior to first dose of study therapy Subject has undergone a major surgical procedure, open biopsy, radiofrequency ablation or has experienced a significant injury within 28 days prior to enrollment Subject has a concurrent active malignancy other than adequately treated nonmelanomatous skin cancer or in situ neoplasm Subject has an ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, active bleeding or any other serious uncontrolled medical disorder Subject has known or suspected primary brain or leptomeningeal metastases Subject has leukemia or lymphoma Subject is know to have active tuberculosis, leishmaniasis, or listeriosis Subjects with known history, or clinical or laboratory evidence of liver disease Subject has a known active hepatitis B or C infection, Human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS) Subject if female, is pregnant or breastfeeding Subject has received an organ transplant

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IMC-CS4 Weight Based Dosing<br>Participants receiving IMC-CS4 intravenously (weight based dosing) | Biological: IMC-CS4<br> <br> * Other names: LY3022855;|
| Experimental: IMC-CS4 Non-Weight Based Dosing<br>Participants receiving IMC-CS4 intravenously (non-weight based dosing) | Biological: IMC-CS4<br> <br> * Other names: LY3022855;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics - Maximum concentration (Cmax) of IMC-CS4 |  | Up to Week 36 | 
| Pharmacokinetics - Minimum concentration (Cmin) of IMC-CS4 |  | Up to Week 36 | 
| Pharmacokinetics - Area Under the Curve (AUC) of IMC-CS4 |  | Up to Week 36 | 
| Pharmacokinetics - Volume of distribution at steady state (Vss) of IMC-CS4 |  | Up to Week 36 | 
| Pharmacokinetics -Clearance (Cl) of IMC-CS4 |  | Up to Week 36 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recommend Phase 2 Dose (RP2D) of IMC-CS4 |  | Approximately 6 Months | 
| Anti-IMC-CS4 Antibody Assessment |  | Approximately 6 Months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Advanced Solid Tumors