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RECRUITING
NCT06480552
PHASE1

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.

View on ClinicalTrials.gov

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

Interventions

DRUG

TEV-56278

Administered intravenously

DRUG

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