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IMC-TR1

Phase 1

Neoplasms | Monoclonal antibody | Oncology |Eli Lilly and Company|Last Updated: Jan 18, 2019

Success Probability

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment14

FDA Designations

No designations recorded

Clinical trial landscape

IMC-TR1 · 1 trial · 2 indications

Phase 1 1
NCT01646203A Study of IMC-TR1 in Participants With Advanced Solid TumorsNeoplasms
COMPLETED14 Analytics
PHASE1COMPLETED
A Study of IMC-TR1 in Participants With Advanced Solid Tumors
NeoplasmsUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of Participants With Dose-Limiting Toxicities (DLTs)
First Dose Up to 6 Weeks

A DLT was defined as an AE occurring during Cycle 1(first 6 weeks of treatment) that was considered at least possibly related to study drug, was considered dose-dependent, and fulfilled a criteria selected (using the National Cancer Institute Common Terminology Criteria for Adverse Events,version 4.0 \[NCI-CTCAE v 4.0\] \[NCI 2009\]):Grade(Gr)≥3 nonhematological toxicity,Gr4 thrombocytopenia lasting at least 5 days and/or complicated with bleeding,Gr≥3 febrile neutropenia(ntr),Gr4 ntr of \>5 days' duration,increase(incr)of at least 1 gr from a preexisting Gr1 valvular insufficiency or any new Gr≥2 valvular toxicity,left ventricular(vtr) ejection fraction decrease of 10% in absolute value or 16% in relative value,incr in right vtr systolic pressure dysfunction from mild to moderate(mod) or from mod to severe,incr in left atrial or ventricular chamber size of ≥2 cm and ≥1cm respectively,any other life-threatening toxicity,significant morphologic on cardiac echocardiogram,any major ocular.

Secondary Endpoints

Maximum Tolerated Dose (MTD) of IMC-TR1
First Dose through Cycle 1 (6 Weeks)
Maximum Tolerated Dose (MTD) of IMC-TR1 (1.25 mg/kg LY3022859 ) for Participants Receiving a Weight-Based Dose
First Dose through Cycle 1 (6 Weeks)
Number of Dose-Limiting Toxicities (DLTs)
First Dose through Cycle 1 (6 Weeks)
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Study Design & Arms

MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
IMC-TR1EXPERIMENTALPart A - Dose Escalation: Cohort 1A: 1.25 mg/kg, intravenously (IV), every 2 weeks of the 6-week treatment cycle Cohorts 1B-9: Dose Escalation from 12.5 mg to 1600 mg (flat dose), intravenously (IV), every 2 weeks of the 6-week treatment cycles Cohorts 10-12: Dose escalation from 800 mg to 1600 mg (flat dose), intravenously (IV), weekly during the 6-week treatment cycles Part B - Disease Specific Cohort Expansion: Participants will be enrolled into each of three tumor-specific cohort expansions. Participants will be treated with recommended Phase 2 dose.

Interventions

NameTypeDescription
IMC-TR1BIOLOGICALAdministered intravenously
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites3

Inclusion Criteria: * Part A and Part B: Participants must be appropriate candidates for experimental therapy, with a solid tumor that has failed standard therapy or for which no standard therapy is available, and evidence of progressive disease * Part A only: Participants must have histological...

Countries:United States
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Frequently asked questions about IMC-TR1

What is IMC-TR1 used for?

IMC-TR1 is an investigational monoclonal antibody being studied for the treatment of neoplasms, which are tumors. It was evaluated in a Phase 1 clinical trial in participants with advanced solid tumors. The drug is being developed by Eli Lilly and Company for use in oncology.

What does IMC-TR1 target?

The specific molecular target of IMC-TR1 has not been disclosed in available information. As a monoclonal antibody, it is designed to interact with a specific protein involved in tumor growth, but the exact target is not publicly detailed. The drug is being investigated for its potential anti-tumor activity in advanced solid tumors.

Who makes IMC-TR1?

IMC-TR1 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 conducted a Phase 1 clinical trial to evaluate the safety and tolerability of IMC-TR1 in patients with advanced solid tumors.

What phase is IMC-TR1 in?

IMC-TR1 is in Phase 1 of clinical development. The Phase 1 trial, which has been completed, was an uncontrolled, non-randomized study that enrolled 14 participants with advanced solid tumors. The drug is investigational and has not been approved by regulatory authorities.

What clinical trials is IMC-TR1 in?

IMC-TR1 has been studied in one clinical trial, identified as NCT01646203, titled "A Study of IMC-TR1 in Participants With Advanced Solid Tumors." This Phase 1 trial was completed in the United States and enrolled 14 participants aged 18 years and older with neoplasms or tumors.

Is IMC-TR1 the same as any other drug?

No alternative names for IMC-TR1 have been disclosed. The drug is known only by its code name IMC-TR1 in clinical trial records. It is a distinct investigational monoclonal antibody being developed by Eli Lilly and Company for the treatment of advanced solid tumors.