Actively Recruiting

Phase 1
Age: 18Years +
All Genders
NCT06480552

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

Led by Teva Branded Pharmaceutical Products R&D LLC · Updated on 2026-05-04

240

Participants Needed

12

Research Sites

344 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Have an established histological diagnosis of selected solid tumor and must have received and progressed on established standard therapies or have been intolerant to such therapy or have been considered by the Investigator as ineligible for approved standard therapy
  • Have a life expectancy≥12 weeks at the time of the screening
  • Women of childbearing potential must agree to use highly effective methods of contraception for the course of the trial through 120 days after the last dose of trial medication
  • Males who are sexually active with women of childbearing potential must agree to use condoms and refrain from donating sperm for the course of the trial through 120 days after the last dose of trial medication

NOTE- Additional criteria apply, please contact the investigator for more information

Not Eligible

You will not qualify if you...

  • Has a history of systemic treatment therapy for cancer (including chemotherapy, immunotherapy, radiotherapy, or other investigational drug) or surgery within 4 weeks prior to baseline
  • Is currently receiving or has received hematopoietic colony-stimulating growth factors within 2 weeks before screening or transfusion support 4 weeks prior to screening
  • Has a diagnosis of immunodeficiency
  • Has active known autoimmune disease.
  • Has a history of or known active brain metastases and/or carcinomatous meningitis and/or leptomeningeal metastasis
  • Has active or uncontrolled serious infections requiring systemic therapy within 14 days prior to baseline
  • Has a history of clinically significant cardiovascular or cerebrovascular disease in previous 6 months prior to screening
  • Has evidence of clinically significant interstitial lung disease or active, noninfectious pneumonitis
  • Has a seizure disorder requiring therapy (such as steroids or antiepileptics)

NOTE- Additional criteria apply, please contact the investigator for more information

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 12 locations

1

Teva Investigational Site 12017

Los Angeles, California, United States, 90025

Actively Recruiting

2

Teva Investigational Site 12021

Lake Mary, Florida, United States, 32746

Completed

3

Teva Investigational Site 12016

Chicago, Illinois, United States, 60611

Actively Recruiting

4

Teva Investigational Site 12015

Detroit, Michigan, United States, 48201

Actively Recruiting

5

Teva Investigational Site 12014

Huntersville, North Carolina, United States, 28078

Actively Recruiting

6

Teva Investigational Site 12023

Cincinnati, Ohio, United States, 45219

Actively Recruiting

7

Teva Investigational Site 12058

Pittsburgh, Pennsylvania, United States, 15232

Actively Recruiting

8

Teva Investigational Site 12019

Nashville, Tennessee, United States, 37203

Actively Recruiting

9

Teva Investigational Site 12024

Nashville, Tennessee, United States, 37232

Actively Recruiting

10

Teva Investigational Site 12018

Fairfax, Virginia, United States, 22031

Actively Recruiting

11

Teva Investigational Site 12025

Milwaukee, Wisconsin, United States, 53226

Actively Recruiting

12

Teva Investigational Site 11282

Toronto, Ontario, Canada, M5G 2M9

Actively Recruiting

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Research Team

T

Teva U.S. Medical Information

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

3

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