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IMC-3C5

Phase 1

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

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment44

FDA Designations

No designations recorded

Clinical trial landscape

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 used for?

IMC-3C5 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 for use in oncology, specifically for patients with advanced solid tumors.

What does IMC-3C5 target?

IMC-3C5 targets VEGFR-3, a receptor involved in the growth of lymphatic vessels. By binding to VEGFR-3, the antibody aims to interfere with signaling pathways that may contribute to tumor growth and spread. This mechanism is being explored in the context of advanced solid tumors.

Who makes IMC-3C5?

IMC-3C5 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 drug.

What phase is IMC-3C5 in?

IMC-3C5 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still being studied in clinical trials to assess its safety, tolerability, and potential efficacy in patients with advanced solid tumors.

What clinical trials is IMC-3C5 in?

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

Is IMC-3C5 the same as anti-VEGFR-3 monoclonal antibody?

IMC-3C5 is an anti-VEGFR-3 monoclonal antibody, as described in the clinical trial title. The drug is referred to by its code name IMC-3C5, and its mechanism involves targeting the VEGFR-3 receptor. No other alternative names have been established in the available information.