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NCT03099109 · ClinicalTrials.gov registry record · Phase 1

A Study of LY3321367 Alone or With LY3300054 in Participants With Advanced Relapsed/Refractory Solid Tumors

A Phase 1 study, sponsored by Eli Lilly and Company.

Completed
Registry status
Phase 1
Development phase
209
Enrollment target

NCT03099109: Completed Phase 1 study, sponsored by Eli Lilly and Company.

NCT03099109 is a Phase 1 study that has completed, run by Eli Lilly and Company. The registered enrollment target is 209 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (248% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03099109, a Phase 1 study, has completed, sponsored by Eli Lilly and Company.

COMPLETED
Registry status
Phase 1
Development phase
209 participants
Enrollment target

Study Summary

The purpose of this study is to evaluate the safety of the study drug known as LY3321367, an anti-T-cell immunoglobulin and mucin-domain domain-containing molecule-3 (TIM-3) antibody administered alone or in combination with LY3300054, an anti-programmed death ligand 1 (PD-L1) antibody, in participants with advanced relapsed/refractory solid tumors.

Primary Outcome

Dose Limiting Toxicity (DLT) is defined as an adverse event (AE) that meets protocol defined DLT criteria during cycle 1 and is at least possibly related to study drug.

Interventions

  • DRUG LY3300054
  • DRUG LY3321367

Trial Details

FieldValue
Enrollment Target 209 participants
Start Date 2017-04-12
Est. Completion 2023-08-30
Phase Phase 1
Eli Lilly and Company

1,341 total trials

What the finished NCT03099109 record still lists

NCT03099109 is an interventional study that assigns participants to a tested intervention. The registered 209 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (248% higher).

The record links to 0 conditions, and to 2 interventions - of which LY3300054 is the first listed.

NCT03099109 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03099109 about?

NCT03099109 is a clinical study titled "A Study of LY3321367 Alone or With LY3300054 in Participants With Advanced Relapsed/Refractory Solid Tumors". The purpose of this study is to evaluate the safety of the study drug known as LY3321367, an anti-T-cell immunoglobulin and mucin-domain domain-containing molecule-3 (TIM-3) antibody administered alone or in combination with LY3300054, an anti-programmed death ligand 1 (PD-L1) antibody, in participa...

What is the current status of trial NCT03099109?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 209 participants. The study started on 2017-04-12. Estimated completion is 2023-08-30.

What interventions are being tested in trial NCT03099109?

The interventions under investigation include: LY3300054 (DRUG), LY3321367 (DRUG).

Who is sponsoring clinical trial NCT03099109?

This trial is sponsored by Eli Lilly and Company, which has 1,341 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03099109's enrollment target sits among peer trials

209 250th of 2000 higher than 1,751 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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Source: ClinicalTrials.gov NCT03099109, the US trial registry maintained by the National Library of Medicine. NCT03099109 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.