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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
Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
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.
Official title: A Phase 1a/1b Open-Label, Multicenter, Dose Escalation, and Dose Expansion Trial to Evaluate the Safety and Activity of TEV-56278, as a Monotherapy and in Combination With Pembrolizumab in Participants With Selected Locally Advanced or Metastatic Solid Tumors
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
240
Start Date
2024-07-22
Completion Date
2031-02-25
Last Updated
2026-02-05
Healthy Volunteers
No
Conditions
Interventions
TEV-56278
Administered intravenously
Pembrolizumab
Administered intravenously
Locations (11)
Teva Investigational Site 12017
Los Angeles, California, United States
Teva Investigational Site 12021
Lake Mary, Florida, United States
Teva Investigational Site 12016
Chicago, Illinois, United States
Teva Investigational Site 12015
Detroit, Michigan, United States
Teva Investigational Site 12014
Huntersville, North Carolina, United States
Teva Investigational Site 12023
Cincinnati, Ohio, United States
Teva Investigational Site 12058
Pittsburgh, Pennsylvania, United States
Teva Investigational Site 12019
Nashville, Tennessee, United States
Teva Investigational Site 12018
Fairfax, Virginia, United States
Teva Investigational Site 12025
Milwaukee, Wisconsin, United States
Teva Investigational Site 11282
Toronto, Ontario, Canada