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NCT06480552 · ClinicalTrials.gov registry record · Phase 1
An Open-label Dose Escalation/Expansion Trial to Evaluate the Safety and Anti-tumor Activity of TEV-56278 Alone or in Combination With Pembrolizumab in Participants With Advanced or Metastatic Solid Tumors
A Phase 1 study of Advanced Solid Tumors, sponsored by Teva Branded Pharmaceutical Products R&D.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 240
- Enrollment target
- 11
- Study locations
NCT06480552 is a Phase 1 study of Advanced Solid Tumors that is actively recruiting participants, run by Teva Branded Pharmaceutical Products R&D. The registered enrollment target is 240 participants, above the 197-participant average among 144 other Advanced Solid Tumors trials with a reported enrollment target (22% higher). The trial reports 11 study locations across 11 states.
The verdict
NCT06480552, a Phase 1 study of Advanced Solid Tumors, is actively recruiting participants, sponsored by Teva Branded Pharmaceutical Products R&D.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 240 participants
- Enrollment target
- 11
- Study locations
Study Summary
The primary objectives of this trial are to: * Characterize the safety and tolerability of TEV-56278 * Determine the Recommended Phase 2 Dose (RP2D) * Evaluate antitumor activity of TEV-56278 * Determine the safety and tolerability of TEV-56278 in combination with pembrolizumab * Determine a RP2D of TEV-56278 in combination with pembrolizumab The secondary objectives of this trial are to: * Characterize the serum pharmacokinetics of TEV-56278 * Evaluate the antitumor activity of TEV-56278 * Determine the safety and tolerability of TEV-56278 * Evaluate other measures of antitumor activity of TEV-56278 * Evaluate anti-tumor activity Participants will be treated up to 12 months with a follow-up period of up to 12 months after last infusion. The total duration of the trial will be up to 25 months for individual participants.
Conditions Studied
Interventions
- DRUG Pembrolizumab
- DRUG TEV-56278
Study Locations (11)
California
- Teva Investigational Site 12017 - Los Angeles
Florida
- Teva Investigational Site 12021 - Lake Mary
Illinois
- Teva Investigational Site 12016 - Chicago
Michigan
- Teva Investigational Site 12015 - Detroit
North Carolina
- Teva Investigational Site 12014 - Huntersville
Ohio
- Teva Investigational Site 12023 - Cincinnati
Pennsylvania
- Teva Investigational Site 12058 - Pittsburgh
Tennessee
- Teva Investigational Site 12019 - Nashville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 240 participants |
| Start Date | 2024-07-22 |
| Est. Completion | 2031-02-25 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06480552
The ClinicalTrials.gov registry entry for NCT06480552 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 240 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 197-participant average among 144 other Advanced Solid Tumors trials with a reported enrollment target (22% higher). The listed sponsor is Teva Branded Pharmaceutical Products R&D, which has 167 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Advanced Solid Tumors appearing as the primary indexed condition, and to 2 interventions - of which Pembrolizumab is the first listed.
NCT06480552 reports 11 study locations spanning 11 distinct geographic areas - top geographies include California, Florida, Illinois.
Frequently Asked Questions
What is clinical trial NCT06480552 about?
NCT06480552 is a clinical study titled "An Open-label Dose Escalation/Expansion Trial to Evaluate the Safety and Anti-tumor Activity of TEV-56278 Alone or in Combination With Pembrolizumab in Participants With Advanced or Metastatic Solid Tumors". The primary objectives of this trial are to: * Characterize the safety and tolerability of TEV-56278 * Determine the Recommended Phase 2 Dose (RP2D) * Evaluate antitumor activity of TEV-56278 * Determine the safety and tolerability of TEV-56278 in combination with pembrolizumab * Determine a RP2D o...
What is the current status of trial NCT06480552?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 240 participants. The study started on 2024-07-22. Estimated completion is 2031-02-25.
What conditions does trial NCT06480552 study?
This clinical trial studies the following conditions: Advanced Solid Tumors.
What interventions are being tested in trial NCT06480552?
The interventions under investigation include: Pembrolizumab (DRUG), TEV-56278 (DRUG).
Who is sponsoring clinical trial NCT06480552?
This trial is sponsored by Teva Branded Pharmaceutical Products R&D, which has 167 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06480552 being conducted?
This trial has 11 study locations across California, Florida, Illinois, Michigan, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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