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IMC-18F1

Phase 1

Advanced Solid Tumors | Monoclonal antibody | Oncology |Eli Lilly and Company|Last Updated: Sep 30, 2010

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMC
Total Trials1
Total Enrollment27

FDA Designations

No designations recorded

Clinical trial landscape

IMC-18F1 · 1 trial · 1 indication

Phase 1 1
NCT00782002Safety Study of IMC-18F1,to Treat Advanced Solid Tumors in Subjects That no Longer Respond to Standard TherapyAdvanced Solid Tumors
COMPLETED27 Analytics
PHASE1COMPLETED
Safety Study of IMC-18F1,to Treat Advanced Solid Tumors in Subjects That no Longer Respond to Standard Therapy
Advanced Solid TumorsUnlock trial analytics

Study Endpoints

Primary Endpoints

Maximum Tolerated Dose
6 weeks

Secondary Endpoints

Pharmacokinetics
6 weeks
Antitumor Activity of IMC-18F1 Monotherapy
6 Weeks
Pharmacodynamics
6 Weeks
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
IMC-18F1EXPERIMENTAL -

Interventions

NameTypeDescription
IMC-18F1BIOLOGICALCohorts 1-4 will receive IMC-18F1 intravenously for 4 weekly infusions, followed by a 2-week observation period. Cohort 5 will receive IMC-18F1 intravenously every other week for the first 6 weeks of therapy. Cohort 6 will receive IMC-18F1 every 3 weeks for the first 6 weeks for therapy. The starting dose in Cohort 1 will be 2mg/kg. The maximum dose of IMC-18F1 will not exceed 16mg/kg administered every week, 15mg/kg administered every other week, and 20mg/kg administered every 3 weeks. Dose escalation of 100% (2 x previous dose) if no dose limiting toxicities (DLTs) are observed in the first three patients within a cohort during the initial 6-week therapy period. Dose escalation increment will be reduced to 50% (1.5 x previous dose) following the occurrence of either grade 2 or higher AEs in 2 or more patients that are possibly, probably, or definitely-related to study medication or one DLT during the initial 6-week therapy period. No intrapatient dose escalation is allowed.
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Eligibility Criteria

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

Inclusion Criteria: 1. Patients with histopathologically-documented, measurable or non measurable {evaluable}, advanced solid tumors refractory to standard therapy or for which no standard therapy is available (see Section 10.2, Tumor Response, for the definition of measurable and non measurable {e...

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

Frequently asked questions about IMC-18F1

What is IMC-18F1 used for?

IMC-18F1 is a monoclonal antibody being developed for the treatment of advanced solid tumors. It is intended for patients whose tumors no longer respond to standard therapy. The drug is currently in clinical development and has not been approved by regulatory authorities.

What does IMC-18F1 target?

IMC-18F1 is a monoclonal antibody, but its specific molecular target has not been disclosed. The drug is being studied in oncology for advanced solid tumors, and its mechanism of action is not publicly detailed in available information.

Who makes IMC-18F1?

IMC-18F1 is being developed by Eli Lilly and Company, a pharmaceutical company listed on the stock exchange under the ticker symbol LLY. The company is conducting clinical research on this investigational drug for advanced solid tumors.

What phase is IMC-18F1 in?

IMC-18F1 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA or any other regulatory agency. The Phase 1 trial has been completed, and the drug remains in early-stage clinical research.

What clinical trials is IMC-18F1 in?

IMC-18F1 has been studied in one clinical trial with the identifier NCT00782002. This was a Phase 1 safety study conducted in the United States, enrolling 27 adult patients with advanced solid tumors who no longer responded to standard therapy. The trial has been completed.

Is IMC-18F1 the same as any other drug?

IMC-18F1 is the primary name for this investigational monoclonal antibody. No alternative names have been identified for this drug in available information. It is a distinct asset being developed by Eli Lilly and Company for advanced solid tumors.