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

Lilly

Status and phase: Completed; Phase 1

Conditions: Neoplasms

Treatments: Biological: IMC-CS4

Study type: Interventional

Funder types: Industry

Identifiers

NCT01346358

I5F-IE-JSCA (Other Identifier)

14311

CP24-1001 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 52 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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52 participants in 2 patient groups

IMC-CS4 Weight Based Dosing

Experimental group

Description:

Participants received 2.5 mg/kg once weekly (QW), 0.3 mg/kg QW, 0.6 mg/kg QW, 1.25 mg/kg every two weeks (Q2W) and1.25 mg/kg QW of IMC CS4 by intravenous infusion in Part A.

Treatment:

Biological: IMC-CS4

IMC-CS4 Non-Weight Based Dosing

Experimental group

Description:

Participants received 100 mg QW, 100 mg QW on weeks 1, 2, 4 and 5 and 150 mg QW of IMC CS4 by intravenous infusion in Part B.

Treatment:

Biological: IMC-CS4