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NCT01646203 · ClinicalTrials.gov registry record · Phase 1
A Study of IMC-TR1 in Participants With Advanced Solid Tumors
A Phase 1 study, sponsored by Eli Lilly and Company.
- Completed
- Registry status
- Phase 1
- Development phase
- 14
- Enrollment target
NCT01646203: Completed Phase 1 study, sponsored by Eli Lilly and Company.
NCT01646203 is a Phase 1 study that has completed, run by Eli Lilly and Company. The registered enrollment target is 14 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01646203, a Phase 1 study, has completed, sponsored by Eli Lilly and Company.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 14 participants
- Enrollment target
Study Summary
A study to evaluate the safety and tolerability of anti-TGFβRII monoclonal antibody (IMC-TR1) in participants with advanced solid tumors, as well as gather evidence of anti-tumor activity.
Primary Outcome
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 day
Interventions
- BIOLOGICAL IMC-TR1
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2012-07 |
| Est. Completion | 2014-10 |
| Phase | Phase 1 |
What the finished NCT01646203 record still lists
NCT01646203 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (77% lower).
The record links to 0 conditions, and to 1 intervention - of which IMC-TR1 is the first listed.
NCT01646203 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01646203 about?
NCT01646203 is a clinical study titled "A Study of IMC-TR1 in Participants With Advanced Solid Tumors". A study to evaluate the safety and tolerability of anti-TGFβRII monoclonal antibody (IMC-TR1) in participants with advanced solid tumors, as well as gather evidence of anti-tumor activity.
What is the current status of trial NCT01646203?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 14 participants. The study started on 2012-07. Estimated completion is 2014-10.
What interventions are being tested in trial NCT01646203?
The interventions under investigation include: IMC-TR1 (BIOLOGICAL).
Who is sponsoring clinical trial NCT01646203?
This trial is sponsored by Eli Lilly and Company, which has 1,341 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01646203's enrollment target sits among peer trials
14 1844th of 2000 higher than 154 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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