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IMC-3G3

Phase 1

Solid Tumors | Monoclonal antibody | Oncology |Eli Lilly and Company|Last Updated: Jun 28, 2011

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment20

FDA Designations

No designations recorded

Clinical trial landscape

IMC-3G3 · 1 trial · 1 indication

Phase 1 1
NCT00768391Study of IMC-3G3 in Patients With Tumors That Are Not Responding to Standard Therapies or No Therapy is AvailableSolid Tumors
COMPLETED20 Analytics
PHASE1COMPLETED
Study of IMC-3G3 in Patients With Tumors That Are Not Responding to Standard Therapies or No Therapy is Available
Solid TumorsUnlock trial analytics

Study Endpoints

Primary Endpoints

Summary of Participants Reporting Adverse Events
Approximately 36 months
Maximum Tolerated Dose (MTD)
Approximately 36 months

After all patients complete a cohort, toxicity data is reviewed before the next cohort of patients is treated at the next higher dose level

Secondary Endpoints

Pharmacokinetics
6 weeks
Anti-IMC-3G3 Antibody Assessment
Approximately 36 months
Antitumor Activity of IMC-3G3 as Monotherapy
6 weeks
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP

Treatment Arms

ArmTypeDescription
IMC-3G3EXPERIMENTALAll patients will receive intravenous infusions of IMC-3G3, with the dose depending on which cohort they are enrolled into.

Interventions

NameTypeDescription
IMC-3G3BIOLOGICALIntravenously, once every week for Cohorts 1 through 3 and once every other week for Cohorts 4 and 5. Starting dose will be 4mg/kg in Cohort 1, with dose doubling between cohorts. Dose escalation of 100% (2 x previous dose) Dose escalation increment reduced to 33% (1.33 x previous dose). Cohorts 4 and 5 will receive 15mg/kg and 20mg/kg, intravenously, once every other week.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: 1. Histopathological-documented, measurable, or non measurable, advanced primary tumor or recurrent solid tumor or lymphoma unresponsive to standard therapy or for which there is no standard therapy available. 2. Eastern Cooperative Oncology Group (ECOG) performance status score...

Countries:United States
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Competitive Landscape -Other Solid Tumors 9 trials (matched to "Solid Tumors")

Frequently asked questions about IMC-3G3

What is IMC-3G3 used for?

IMC-3G3 is an investigational monoclonal antibody being developed for the treatment of solid tumors. It is intended for patients whose tumors are not responding to standard therapies or for whom no standard therapy is available. The drug is currently in Phase 1 clinical development.

Who makes IMC-3G3?

IMC-3G3 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 patients with solid tumors.

What phase is IMC-3G3 in?

IMC-3G3 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. The Phase 1 trial has been completed, and the drug remains under investigation for the treatment of solid tumors.

What clinical trials is IMC-3G3 in?

IMC-3G3 has been studied in one clinical trial with the identifier NCT00768391. This Phase 1 trial, titled 'Study of IMC-3G3 in Patients With Tumors That Are Not Responding to Standard Therapies or No Therapy is Available,' enrolled 20 participants with solid tumors in the United States. The trial has been completed.

Is IMC-3G3 FDA approved?

IMC-3G3 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. The completed Phase 1 trial evaluated the drug in 20 patients with solid tumors, but further clinical studies would be needed to establish safety and efficacy before any regulatory approval could be considered.