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IMC-CS4

Phase 1

Neoplasms | Monoclonal antibody | Oncology |Eli Lilly and Company|Last Updated: Sep 19, 2024

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment52

FDA Designations

No designations recorded

Clinical trial landscape

IMC-CS4 · 1 trial · 1 indication

Phase 1 1
NCT01346358A Study of IMC-CS4 in Subjects With Advanced Solid TumorsNeoplasms
COMPLETED52 Analytics
PHASE1COMPLETED
A Study of IMC-CS4 in Subjects With Advanced Solid Tumors
NeoplasmsUnlock trial analytics

Study Endpoints

Primary Endpoints

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 (PK) - Maximum concentration (Cmax) 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 - Minimum concentration (Cmin) 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 - Area Under the Curve (AUC) 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 - Volume of distribution at steady state (Vss) 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

Pharmacokinetics -Clearance (Cl) of IMC-CS4.

Secondary Endpoints

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
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
IMC-CS4 Weight Based DosingEXPERIMENTALParticipants 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.
IMC-CS4 Non-Weight Based DosingEXPERIMENTALParticipants 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.

Interventions

NameTypeDescription
IMC-CS4BIOLOGICAL -
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites6

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) V...

Countries:United States
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Frequently asked questions about IMC-CS4

What is IMC-CS4 used for?

IMC-CS4 is an investigational monoclonal antibody being studied for the treatment of neoplasms, which are abnormal growths of tissue that can be benign or malignant. It is being developed as a potential oncology therapy for patients with advanced solid tumors.

Who makes IMC-CS4?

IMC-CS4 is being developed by Eli Lilly and Company, a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol LLY. The company is conducting clinical research to evaluate the safety and efficacy of this investigational monoclonal antibody in oncology.

What phase is IMC-CS4 in?

IMC-CS4 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still undergoing clinical trials to assess its safety and potential effectiveness in treating neoplasms.

What clinical trials is IMC-CS4 in?

IMC-CS4 has been studied in one clinical trial with the identifier NCT01346358, titled 'A Study of IMC-CS4 in Subjects With Advanced Solid Tumors.' This Phase 1 trial was completed and enrolled 52 participants in the United States, with a minimum age of 18 years.

Is IMC-CS4 a monoclonal antibody?

Yes, IMC-CS4 is a monoclonal antibody, a type of biologic drug designed to bind to specific targets in the body. It is being investigated as a potential treatment for neoplasms, including advanced solid tumors, in the field of oncology.