Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 is a Phase 1 study that has completed, run by Tempest Therapeutics. The registered enrollment target is 89 participants.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04344795
The ClinicalTrials.gov registry entry for NCT04344795 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 89 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Tempest Therapeutics, which has 2 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Pembrolizumab is the first listed.
NCT04344795 reports 0 study locations.
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
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.