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Completed

NCT Number: NCT01346358

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

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.

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Key information

Conditions

Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

The Angeles Clinic & Research Institute, Los Angeles, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

IMC-CS4

Biological

Other names: LY3022855

Primary outcomes

  1. Pharmacokinetics (PK) - Maximum Concentration (Cmax) of IMC-CS4

    Time frame: 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 (PK) - Maximum concentration (Cmax) of IMC-CS4.

  2. Pharmacokinetics - Minimum Concentration (Cmin) of IMC-CS4

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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.

  5. Pharmacokinetics -Clearance (Cl) of IMC-CS4

    Time frame: 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.

Secondary outcomes

  1. Recommend Phase 2 Dose (RP2D) of IMC-CS4

    Time frame: Cycle 1 (6 Days)

    The recommended Phase 2 dose was the highest dose where less than 1/3 of participants experienced dose limiting toxicities (DLTs). A DLT is defined as an adverse event (AE) occurring during Cycle 1 that fulfilled 1 of the following criteria: Any Common Terminology Criteria for Adverse Events (CTCAE), version (v) 4.0 Grade 4 neutropenia lasting ≥ 7 days, Grade 3 or 4 neutropenia complicated by fever ≥38.0°C or infection, Grade 4 thrombocytopenia, Grade 3 thrombocytopenia complicated by hemorrhage, Grade 3 or 4 anemia, Grade ≥3 AST/ALT elevation, Grade ≥2 AST/ALT elevation and Grade ≥2 bilirubin elevation and Grade 3 or 4 nonhematologic toxicity. A summary of other nonserious AEs and all Serious Adverse Events (SAE), regardless of causality is located in the Reported Adverse Event section.

  2. Percentage of Participants With Anti-IMC-CS4 Antibody Assessment

    Time frame: Up To 6 Months

    The overall percentage of participants with treatment-emergent positive for anti-IMC-CS4 antibodies during the study. Participants were considered positive for anti-IMC-CS4 antibodies if they exhibited a post-treatment antibody level that exceeded the positive upper cut point determined from the normal anti-IMC-CS4 level seen in healthy untreated individuals.

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2018
Study completion
2018
First posted
May 3, 2011
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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