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

NCT01346358 | Completed Phase 1 Results

• 3 other identifiers: 14311CP24-1001I5F-IE-JSCA
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 6

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.

Conditions

Neoplasms

Keywords

Advanced Solid Tumors

Outcome Measures

Primary Outcomes (5)

• Pharmacokinetics (PK) - Maximum Concentration (Cmax) of IMC-CS4

  Pharmacokinetics (PK) - Maximum concentration (Cmax) of IMC-CS4.

  Predose, 1, 2, 4 and 8 hours post dose of Cycle 1 Day 1, Cycle 1 Day 15, Cycle 1 Day 22 and Cycle 3 Day 1

• Pharmacokinetics - Minimum Concentration (Cmin) of IMC-CS4

  Pharmacokinetics - Minimum concentration (Cmin) of IMC-CS4.

  Predose, 1, 2, 4 and 8 hours post dose of Cycle 1 Day 1, Cycle 1 Day 15, Cycle 1 Day 22 and Cycle 3 Day 1

• Pharmacokinetics - Area Under the Curve (AUC) of IMC-CS4

  Pharmacokinetics - Area Under the Curve (AUC) of IMC-CS4.

  Predose, 1, 2, 4 and 8 hours post dose of Cycle 1 Day 1, Cycle 1 Day 15, Cycle 1 Day 22 and Cycle 3 Day 1

• Pharmacokinetics - Volume of Distribution at Steady State (Vss) of IMC-CS4

  Pharmacokinetics - Volume of distribution at steady state (Vss) of IMC-CS4.

  Predose, 1, 2, 4 and 8 hours post dose of Cycle 1 Day 1, Cycle 1 Day 15, Cycle 1 Day 22 and Cycle 3 Day 1

• Pharmacokinetics -Clearance (Cl) of IMC-CS4

  Pharmacokinetics -Clearance (Cl) of IMC-CS4.

  Predose, 1, 2, 4 and 8 hours post dose of Cycle 1 Day 1, Cycle 1 Day 15, Cycle 1 Day 22 and Cycle 3 Day 1

Secondary Outcomes (2)

• Recommend Phase 2 Dose (RP2D) of IMC-CS4

  Cycle 1 (6 Days)

• Percentage of Participants With Anti-IMC-CS4 Antibody Assessment

  Up To 6 Months

Study Arms (2)

IMC-CS4 Weight Based Dosing

EXPERIMENTAL

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.

Biological: IMC-CS4

IMC-CS4 Non-Weight Based Dosing

EXPERIMENTAL

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.

Biological: IMC-CS4

Interventions

IMC-CS4 BIOLOGICAL

Also known as: LY3022855

IMC-CS4 Non-Weight Based Dosing; IMC-CS4 Weight Based Dosing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (6)

The Angeles Clinic & Research Institute

Los Angeles, California, 90025, United States

Location

Univ of California San Francisco

San Francisco, California, 94115, United States

Location

Emory University

Atlanta, Georgia, 30322, United States

Location

Columbia University College of Phys & Surgeons

New York, New York, 10032, United States

Location

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106-5055, United States

Location

Ohio State University Medical Center

Columbus, Ohio, 43210, United States

Location

Related Publications (1)

• Dowlati A, Harvey RD, Carvajal RD, Hamid O, Klempner SJ, Kauh JSW, Peterson DA, Yu D, Chapman SC, Szpurka AM, Carlsen M, Quinlan T, Wesolowski R. LY3022855, an anti-colony stimulating factor-1 receptor (CSF-1R) monoclonal antibody, in patients with advanced solid tumors refractory to standard therapy: phase 1 dose-escalation trial. Invest New Drugs. 2021 Aug;39(4):1057-1071. doi: 10.1007/s10637-021-01084-8. Epub 2021 Feb 23.

  PMID: 33624233 DERIVED

MeSH Terms

Conditions

Neoplasms

Interventions

LY3022855

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

ClinicalTrials.gov@lilly.com

800-545-5979

Study Officials

• 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 DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2011
• First Posted: May 3, 2011
• Study Start: June 15, 2011
• Primary Completion: May 31, 2018
• Study Completion: May 31, 2018
• Last Updated: September 19, 2024
• Results First Posted: September 19, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)