Evaluating TEV-56278 alone or with Pembrolizumab for advanced solid tumors
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
This study is testing a new treatment called TEV-56278, both alone and with another drug called Pembrolizumab, to see if it helps people with advanced solid tumors.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 240 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Teva Branded Pharmaceutical Products R&D, Inc. Industry-sponsored |
| Drugs / interventions | chemotherapy, immunotherapy, pembrolizumab |
| Locations | 12 sites (Los Angeles, California and 11 other locations) |
| Trial ID | NCT06480552 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are patients with advanced solid tumors who have progressed on standard therapies or are intolerant to them.
Not a fit: Patients who have not received prior systemic treatment for cancer may not benefit from this study.
Why it matters
Potential benefit: If successful, this trial could provide a new treatment option for patients with advanced solid tumors who have not responded to standard therapies.
How similar studies have performed: Other studies have shown promise in using combination therapies for advanced solid tumors, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Los Angeles, California and 11 other locations
- Teva Investigational Site 12017 — Los Angeles, California, United States (Recruiting)
- Teva Investigational Site 12021 — Lake Mary, Florida, United States (Completed)
- 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)
- Teva Investigational Site 12019 — Nashville, Tennessee, United States (Recruiting)
- Teva Investigational Site 12024 — Nashville, Tennessee, United States (Recruiting)
- Teva Investigational Site 12018 — Fairfax, Virginia, United States (Recruiting)
- Teva Investigational Site 12025 — Milwaukee, Wisconsin, United States (Recruiting)
- Teva Investigational Site 11282 — Toronto, Ontario, Canada (Recruiting)
Study contacts
- Study coordinator: Teva U.S. Medical Information
- Email: USMedInfo@tevapharm.com
- Phone: 1-888-483-8279
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.