A Study of IMC-CS4 in Subjects With Advanced Solid Tumors | NCT01346358

NCT01346358

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module

ID	Type	Description	Link
CP24-1001	Other Identifier	ImClone Systems
I5F-IE-JSCA	Other Identifier	Eli Lilly and Company

Status Module

Oversight Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
IMC-CS4	Biological		IMC-CS4 Non-Weight Based Dosing IMC-CS4 Weight Based Dosing	LY3022855

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Recommend Phase 2 Dose (RP2D) of IMC-CS4	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.

Eligibility Module

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

Name	Affiliation	Role
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

Facility	Status	City	State	ZIP	Country	Contacts
The Angeles Clinic & Research Institute		Los Angeles	California	90025	United States
Univ of California San Francisco

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
33624233	Derived	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.

Arm/Group Information

ID	Title	Description
FG000	Cohort 1 (2.5 Milligram Per Kilogram (mg/kg) QW)	Participants received 2.5 milligram per kilogram (mg/kg) of IMC-CS4 once weekly (QW) by intravenous infusion.
FG001	Cohort 2 (0.3 mg/kg QW)	Participants received 0.3 mg/kg of IMC-CS4 once weekly by intravenous infusion.
FG002	Cohort 3 (0.6 mg/kg QW)	Participants received 0.6 mg/kg of IMC-CS4 once weekly by intravenous infusion.
FG003	Cohort 4 (1.25 mg/kg Q2W)	Participants received 1.25 mg/kg of IMC-CS4 every two weeks (Q2W) by intravenous infusion.
FG004	Cohort 4 Expanded (1.25 mg/kg Q2W)	Participants received 1.25 mg/kg of IMC-CS4 every two weeks by intravenous infusion on weeks 1, 2, 4 and 5.
FG005	Cohort 5 (1.25 mg/kg QW)	Participants received 1.25 mg/kg of IMC-CS4 weekly once by intravenous infusion.
FG006	Cohort 6a (100 mg QW)	Participants received 100 mg of IMC-CS4 weekly once by intravenous infusion.
FG007	Cohort 6a Expanded (100 mg QW)	Participants received 100 mg of IMC-CS4 weekly once by intravenous infusion on weeks 1, 2, 4 and 5.
FG008	Cohort 7a (150 mg QW)	Participants received 150 mg of IMC-CS4 weekly once by intravenous infusion.

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	Cohort 1 (2.5 Milligram Per Kilogram (mg/kg) QW)	Participants received 2.5 milligram per kilogram (mg/kg) of IMC-CS4 once weekly by intravenous infusion.
BG001	Cohort 2 (0.3 mg/kg QW)

Units	Counts
Participants	BG000

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Continuous			Mean

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

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

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

All enrolled participants who received at least one dose of study drug and have evaluable PK data for Cmax.

Posted

Geometric Mean

Geometric Coefficient of Variation

Microgram/milliliters (µg/mL)

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

ID	Title	Description
OG000	2.5 mg/kg of IMC-CS4 QW	Participants received 2.5 milligram per kilogram (mg/kg) of IMC-CS4 once weekly by intravenous infusion.
OG001	0.3 mg/kg of IMC-CS4 QW	Participants received 0.3 mg/kg of IMC-CS4 once weekly by intravenous infusion.

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Cohort 1 (2.5 mg/kg QW)	Participants received 2.5 milligram per kilogram (mg/kg) of IMC-CS4 once weekly by intravenous infusion.

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Sep 3, 2015	Feb 25, 2019	Prot_000.pdf
SAP	No	Yes	No	Statistical Analysis Plan	Oct 19, 2012	Feb 25, 2019	SAP_001.pdf