Evaluating TEV-56278 alone or with Pembrolizumab for advanced solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This trial aims to assess the safety and effectiveness of TEV-56278, both as a standalone treatment and in combination with Pembrolizumab, for patients with advanced or metastatic solid tumors. It will involve dose escalation to determine the optimal dosage and evaluate the anti-tumor activity of the treatments. Participants will receive treatment for up to 12 months, followed by a follow-up period of up to 12 months, making the total duration of the trial for each participant up to 25 months.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Where it's running

• Teva Investigational Site 12017
  Los Angeles, California, United States Recruiting
• Teva Investigational Site 12016
  Chicago, Illinois, United States Recruiting
• Teva Investigational Site 12015
  Detroit, Michigan, United States Recruiting
• Teva Investigational Site 12014
  Huntersville, North Carolina, United States Recruiting
• Teva Investigational Site 12023
  Cincinnati, Ohio, United States Recruiting
• Teva Investigational Site 12058
  Pittsburgh, Pennsylvania, United States Recruiting

Study contacts

• Study coordinator: Teva U.S. Medical Information
• Email: USMedInfo@tevapharm.com
• Phone: 1-888-483-8279

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.