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IMC-3C5

Phase 1

Neoplasms | Monoclonal antibody | Oncology |Eli Lilly and Company|Trials Updated: Jun 17, 2019

IMC-3C5 development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Feb 2011

IMC-3C5 target and mechanism

Molecular targetFLT4
Target classInhibitor
ModalityMonoclonal antibody

Also known as LY3022856

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment44

FDA Designations

No designations recorded

IMC-3C5 clinical trials

IMC-3C5 · 1 trial · 1 indication

Phase 1 1
NCT01288989A Study of Anti-VEGFR-3 Monoclonal Antibody IMC-3C5 in Subjects With Advanced Solid TumorsNeoplasms
COMPLETED44 Analytics
PHASE1COMPLETED
A Study of Anti-VEGFR-3 Monoclonal Antibody IMC-3C5 in Subjects With Advanced Solid Tumors
NeoplasmsUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of Participants With Adverse Events (AEs)
Baseline up to 46 months

AEs include serious AEs (SAEs). AEs do not distinguish whether the events are treatment-emergent. A summary of serious and other non-serious AEs, regardless of causality, is presented in the Reported Adverse Event module.

Number of Participants Reporting Dose-Limiting Toxicity (DLT)
Baseline up to 16 Months

A DLT was defined as any adverse event (National Cancer Institute \[NCI\]-Common Terminology Criteria for Adverse Events \[CTCAE\], Version 4.0) considered by the investigator to be definitely, probably, or possibly related to IMC-3C5, that occurred during the DLT Assessment Period (weeks 1 through 6) as follows: * Any Grade 3 or 4 hematologic toxicity * Any Grade 3 or 4 nonhematologic toxicity (excluding fatigue or anorexia lasting \<7 days, or Grade 3 nausea and/or vomiting that persisted for \<2 days following appropriate supportive care intervention)

Secondary Endpoints

Antitumor Activity of Single Agent IMC-3C5: Best Overall Response (BOR)
Baseline up to 46 Months
Maximum Concentration (Cmax) of IMC-3C5 - First Infusion
Prior to 1st infusion (Day 1 of Cycle 1), immediately after, 0.5, 1, 2, 4, 8, 24, 48, 96, 168 hours post infusion for cohorts 1-4. Prior to 1st infusion and 1 hour post infusion for cohort 5. (Cycle 1 = 4 - 6 weeks.)
Area Under the Concentration-Time Curve From Time Zero to Last Quantifiable Drug Concentration (AUC 0-tlast) of IMC-3C5 - First Infusion
Prior to 1st infusion (Day 1 of Cycle 1), immediately after, 0.5, 1, 2, 4, 8, 24, 48, 96, 168 hours post infusion for cohorts 1-4. (Cycle 1 = 6 weeks.)
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
IMC-3C5EXPERIMENTALParticipants receiving IMC-3C5 intravenously

Interventions

NameTypeDescription
IMC-3C5BIOLOGICALEscalating doses of IMC-3C5 administered intravenously (i.v.), weekly or every other week
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites4

Inclusion Criteria: 1. Participant has histologic or cytologic confirmation of cancer 2. Participant has an advanced solid tumor that is refractory to standard therapy or for which no standard therapy is available 3. Participant has measurable or nonmeasurable disease according to Response Evaluati...

Countries:United States
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Frequently asked questions about IMC-3C5

What is IMC-3C5?

IMC-3C5 is an investigational monoclonal antibody being developed by Eli Lilly and Company for the treatment of advanced solid tumors. It is designed to target FLT4, also known as VEGFR-3, a receptor involved in tumor biology. IMC-3C5 has been studied in a Phase 1 clinical trial in patients with neoplasms.

What does IMC-3C5 target?

IMC-3C5 targets FLT4, also known as VEGFR-3. It is a monoclonal antibody that acts as an inhibitor of this receptor. FLT4 is a vascular endothelial growth factor receptor, and targeting it is the intended mechanism of action for this investigational oncology agent.

Who is developing IMC-3C5?

IMC-3C5 is being developed by Eli Lilly and Company, which trades on the New York Stock Exchange under the ticker symbol LLY. The company is the sponsor of the clinical program evaluating this monoclonal antibody in patients with advanced solid tumors.

What phase is IMC-3C5 in?

IMC-3C5 is in Phase 1 clinical development. It is an investigational agent and has not been approved by the FDA. The Phase 1 trial evaluating IMC-3C5 in subjects with advanced solid tumors has been completed.

What clinical trials is IMC-3C5 in?

IMC-3C5 has been evaluated in one clinical trial, NCT01288989, titled "A Study of Anti-VEGFR-3 Monoclonal Antibody IMC-3C5 in Subjects With Advanced Solid Tumors." This Phase 1 trial enrolled 44 participants, was conducted in the United States, and has been completed.

What is IMC-3C5 used for?

IMC-3C5 is being studied for the treatment of neoplasms, specifically advanced solid tumors. It is an investigational monoclonal antibody in Phase 1 development and is not approved for any indication. The completed Phase 1 trial enrolled 44 adult patients with advanced solid tumors.