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NCT03829436 · ClinicalTrials.gov registry record · Phase 1
TPST-1120 as Monotherapy and in Combination With Nivolumab in Subjects With Advanced Cancers
A Phase 1 study of Non-Small Cell Lung Cancer and Colorectal Cancer, sponsored by Tempest Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 38
- Enrollment target
- 11
- Study locations
NCT03829436: Completed Phase 1 study of Non-Small Cell Lung Cancer and Colorectal Cancer, sponsored by Tempest Therapeutics.
NCT03829436 is a Phase 1 study of Non-Small Cell Lung Cancer and Colorectal Cancer that has completed, run by Tempest Therapeutics. The registered enrollment target is 38 participants, below the 652-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (94% lower). The trial reports 11 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03829436, a Phase 1 study of Non-Small Cell Lung Cancer and Colorectal Cancer, has completed, sponsored by Tempest Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 38 participants
- Enrollment target
- 11
- Study locations
Study Summary
This is a phase 1/1b open label, multicenter dose escalation and dose expansion study to investigate the safety, tolerability and anti-tumor activity of TPST-1120, a small molecule selective antagonist of PPARα (peroxisome proliferator activated receptor alpha) as monotherapy and in combination with a systemic anticancer agent, nivolumab, an anti-PD1 antibody, in subjects with advanced solid tumors.
Primary Outcome
Incidence of dose limiting toxicities (DLTs) of TPST-1120 as a single agent and in combination with nivolumab.
Conditions Studied
Interventions
- DRUG Part 1 TPST-1120
- DRUG Part 2 TPST-1120 + nivolumab
- DRUG Part 3 TPST-1120
- DRUG Part 4 TPST-1120 + nivolumab
Study Locations (11)
Pennsylvania
- University of Pennsylvania Perelman School of Medicine - Philadelphia
- Thomas Jefferson University Hospital - Philadelphia
- UPMC Hillman Cancer Center - Pittsburgh
California
- University of California - San Francisco - San Francisco
Florida
- Miami Cancer Institute - Miami
Maryland
- Johns Hopkins University - Baltimore
Michigan
- University of Michigan Rogel Cancer Center - Ann Arbor
New York
- Columbia University Medical Center - New York
North Carolina
- Carolina BioOncology Institute - Huntersville
Oklahoma
- Stephenson Cancer Center - Oklahoma City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 38 participants |
| Start Date | 2019-03-20 |
| Est. Completion | 2022-09-07 |
| Phase | Phase 1 |
What the finished NCT03829436 record still lists
NCT03829436 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 38 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 (94% lower).
The record links to 10 conditions, with Non-Small Cell Lung Cancer appearing as the primary indexed condition, and to 4 interventions - of which Part 1 TPST-1120 is the first listed.
NCT03829436 lists 11 locations in 9 states (Pennsylvania, California, Florida).
Frequently Asked Questions
What is clinical trial NCT03829436 about?
NCT03829436 is a clinical study titled "TPST-1120 as Monotherapy and in Combination With Nivolumab in Subjects With Advanced Cancers". This is a phase 1/1b open label, multicenter dose escalation and dose expansion study to investigate the safety, tolerability and anti-tumor activity of TPST-1120, a small molecule selective antagonist of PPARα (peroxisome proliferator activated receptor alpha) as monotherapy and in combination with...
What is the current status of trial NCT03829436?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 38 participants. The study started on 2019-03-20. Estimated completion is 2022-09-07.
What conditions does trial NCT03829436 study?
This clinical trial studies the following conditions: Non-Small Cell Lung Cancer, Colorectal Cancer, Hepatocellular Carcinoma, Renal Cell Carcinoma, Triple Negative Breast Cancer.
What interventions are being tested in trial NCT03829436?
The interventions under investigation include: Part 1 TPST-1120 (DRUG), Part 2 TPST-1120 + nivolumab (DRUG), Part 3 TPST-1120 (DRUG), Part 4 TPST-1120 + nivolumab (DRUG).
Who is sponsoring clinical trial NCT03829436?
This trial is sponsored by Tempest Therapeutics, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03829436 being conducted?
This trial has 11 study locations across California, Florida, Maryland, Michigan, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03829436's enrollment target sits among peer trials
38 373rd of 454 higher than 79 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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