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NCT04580485 · ClinicalTrials.gov registry record · Phase 1
INCB106385 Alone or in Combination With Immunotherapy in Advanced Solid Tumors
A Phase 1 study of Non-Small Cell Lung Cancer and Colorectal Cancer, sponsored by Incyte Corporation.
- Completed
- Registry status
- Phase 1
- Development phase
- 54
- Enrollment target
- 20
- Study locations
NCT04580485: Completed Phase 1 study of Non-Small Cell Lung Cancer and Colorectal Cancer, sponsored by Incyte Corporation.
NCT04580485 is a Phase 1 study of Non-Small Cell Lung Cancer and Colorectal Cancer that has completed, run by Incyte Corporation. The registered enrollment target is 54 participants, below the 652-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (92% lower). The trial reports 20 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04580485, a Phase 1 study of Non-Small Cell Lung Cancer and Colorectal Cancer, has completed, sponsored by Incyte Corporation.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 54 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a multicenter, open-label, dose-escalation/dose-expansion Phase 1 clinical study to investigate the safety, tolerability, PK profile, pharmacodynamics, and preliminary clinical efficacy of INCB106385 when given as monotherapy or in combination with INCMGA00012 in participants with selected CD8 T-cell-positive advanced solid tumors including SCCHN, NSCLC, ovarian cancer, CRPC, TNBC, bladder cancer, and specified GI malignancies (defined as CRC, gastric/GEJ cancer, HCC, PDAC, or SCAC)
Primary Outcome
Defined as any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study drug up to 90 days after last dose of study drug.
Conditions Studied
Interventions
- DRUG INCMGA00012
- DRUG INCB106385
Study Locations (20)
Other
- Cliniques Universitaires Ucl Saint-Luc - Brussels
- Universitaire Ziekenhuis Leuven - Gasthuisberg - Leuven
- Institut Bergonie - Bordeaux
- Universitaire Du Cancer de Toulouse Institut Claudius Regaud Iuct-Oncopole - Toulouse
- Institut Gustave Roussy - Villejuif
- A.O.U. Di Modena - Policlinico - Modena
- Istituto Nazionale Tumori Irccs Fondazione Pascale - Naples
- Irccs Istituto Clinico Humanitas - Rozzano
- Azienda Ospedaliera Universitaria Integrata Verona (Ospedale Borgo Roma) - Verona
- Hospital General Universitario Vall D Hebron - Barcelona
- Fundacion Jimenez Diaz University Hospital - Madrid
- Hospital Universitario 12 de Octubre - Madrid
New York
- Roswell Park Cancer Institute - Buffalo
- Columbia University Medical Center - New York
Texas
- Md Anderson Cancer Center - Houston
- South Texas Accelerated Research Therapeutics - San Antonio
California
- Cedars-Sinai Medical Center - West Hollywood
Maryland
- University of Maryland-Greenebaum Cancer Center - Baltimore
Massachusetts
- Dana Farber Cancer Institute - Boston
Pennsylvania
- University of Pittsburgh - Pittsburgh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 54 participants |
| Start Date | 2021-02-03 |
| Est. Completion | 2024-01-22 |
| Phase | Phase 1 |
What the finished NCT04580485 record still lists
NCT04580485 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 54 participants, a relatively small participant target, below the 652-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (92% lower).
The record links to 10 conditions, with Non-Small Cell Lung Cancer appearing as the primary indexed condition, and to 2 interventions - of which INCMGA00012 is the first listed.
NCT04580485 names 20 study sites across 7 states, led by Other, New York, Texas.
Frequently Asked Questions
What is clinical trial NCT04580485 about?
NCT04580485 is a clinical study titled "INCB106385 Alone or in Combination With Immunotherapy in Advanced Solid Tumors". This is a multicenter, open-label, dose-escalation/dose-expansion Phase 1 clinical study to investigate the safety, tolerability, PK profile, pharmacodynamics, and preliminary clinical efficacy of INCB106385 when given as monotherapy or in combination with INCMGA00012 in participants with selected C...
What is the current status of trial NCT04580485?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 54 participants. The study started on 2021-02-03. Estimated completion is 2024-01-22.
What conditions does trial NCT04580485 study?
This clinical trial studies the following conditions: Non-Small Cell Lung Cancer, Colorectal Cancer, Ovarian Cancer, Bladder Cancer, Hepatocellular Carcinoma.
What interventions are being tested in trial NCT04580485?
The interventions under investigation include: INCMGA00012 (DRUG), INCB106385 (DRUG).
Who is sponsoring clinical trial NCT04580485?
This trial is sponsored by Incyte Corporation, which has 239 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04580485 being conducted?
This trial has 20 study locations across California, Maryland, Massachusetts, New York, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04580485's enrollment target sits among peer trials
54 327th of 454 higher than 127 of 454 other Non-Small Cell Lung Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Non-Small Cell Lung Cancer 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.
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