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NCT04344795 · ClinicalTrials.gov registry record · Phase 1
Phase 1a/1b Study of TPST-1495 as a Single Agent and in Combination With Pembrolizumab in Subjects With Solid Tumors
A Phase 1 study, sponsored by Tempest Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 89
- Enrollment target
NCT04344795: Completed Phase 1 study, sponsored by Tempest Therapeutics.
NCT04344795 is a Phase 1 study that has completed, run by Tempest Therapeutics. The registered enrollment target is 89 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (48% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04344795, a Phase 1 study, has completed, sponsored by Tempest Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 89 participants
- Enrollment target
Study Summary
This is a first-in-human Phase 1a/1b, multicenter, open-label, dose-escalation, dose and schedule optimization, and expansion study of TPST-1495 as a single agent and in combination with pembrolizumab to determine its maximum tolerated dose (MTD) and or recommended Phase 2 dose (RP2D), safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary anti-tumor activity in subjects with advanced solid tumors. Subjects with all histologic types of solid tumors are eligible for the escalation and dose-finding portions of the study. However, the preferred tumor types for enrollment are colorectal cancer (CRC), non-small cell lung cancer (NSCLC), squamous cell carcinoma of the head and neck (SCCHN), urothelial cancer, endometrial cancer, and gastroesophageal junction (GEJ) or gastric adenocarcinoma. Enrollment in the expansion cohorts is limited to the following tumor types: endometrial, SCCHN, CRC, and a basket cohort in subjects selected for an activating mutation in PIK3Ca.
Primary Outcome
Determination of maximum tolerated dose and/or recommended Phase 2 dose (RP2D) and optimum dose schedule for TPST-1495 as a single agent and in combination with pembrolizumab based on dose limiting toxicities
Interventions
- DRUG Pembrolizumab
- DRUG TPST-1495 twice daily
- DRUG TPST-1495 once daily or on intermittent schedule
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 89 participants |
| Start Date | 2020-05-06 |
| Est. Completion | 2024-09-25 |
| Phase | Phase 1 |
What the finished NCT04344795 record still lists
NCT04344795 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 89 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (48% higher).
The record links to 0 conditions, and to 3 interventions - of which Pembrolizumab is the first listed.
NCT04344795 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04344795 about?
NCT04344795 is a clinical study titled "Phase 1a/1b Study of TPST-1495 as a Single Agent and in Combination With Pembrolizumab in Subjects With Solid Tumors". This is a first-in-human Phase 1a/1b, multicenter, open-label, dose-escalation, dose and schedule optimization, and expansion study of TPST-1495 as a single agent and in combination with pembrolizumab to determine its maximum tolerated dose (MTD) and or recommended Phase 2 dose (RP2D), safety, toler...
What is the current status of trial NCT04344795?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 89 participants. The study started on 2020-05-06. Estimated completion is 2024-09-25.
What interventions are being tested in trial NCT04344795?
The interventions under investigation include: Pembrolizumab (DRUG), TPST-1495 twice daily (DRUG), TPST-1495 once daily or on intermittent schedule (DRUG).
Who is sponsoring clinical trial NCT04344795?
This trial is sponsored by Tempest Therapeutics, which has 2 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04344795's enrollment target sits among peer trials
89 649th of 2000 higher than 1,351 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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