Actively Recruiting
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
Eligibility Criteria
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
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
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
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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