NCT06480552 · Teva Branded Pharmaceutical Products R&D LLC
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
What this study is about
The primary objectives of this trial are to: * Characterize the safety and how well patients handle the treatment of TEV-56278 * Determine the Recommended Phase 2 Dose (RP2D) * Evaluate antitumor activity of TEV-56278 (Part 2 only) * Determine the safety and how well patients handle the treatment 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 how the drug moves through the body of TEV-56278 * Evaluate the antitumor activity of TEV-56278 * Determine the safety and how well patients handle the treatment 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. Participants who exhibit a favorable benefit risk profile at the end of the 12 month trial treatment period may be offered an opportunity for an extended treatment period in which they can be treated for a maximum of 12 additional months (up to 26 additional cycles of TEV-56278).
View original scientific description
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 (Part 2 only) * 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. Participants who exhibit a favorable benefit risk profile at the end of the 12 month trial treatment period may be offered an opportunity for an extended treatment period in which they can be treated for a maximum of 12 additional months (up to 26 additional cycles of TEV-56278).
Interventions
DRUG
TEV-56278
Administered intravenously
DRUG
Pembrolizumab
Administered intravenously
Primary outcome measures
Incidence of AEs with CTCAE Grade≥3 in the escalation phase
Time frame: Up to 15 months after 1st infusion in the escalation phase
CTCAE: Common Terminology Criteria for Adverse Events
Incidence of SAEs in the escalation phase
Time frame: Up to 15 months after 1st infusion in the escalation phase
Incidence of AEs meeting protocol-defined DLT criteria in the escalation phase
Time frame: Up to 28 days after 1st infusion in the escalation phase
DLT: dose-limiting toxicity
Incidence of dose modifications due to AEs in the escalation phase
Time frame: Up to 12 months after 1st infusion in the escalation phase
Incidence of AEs leading to discontinuation in the escalation phase
Time frame: Up to 12 months after 1st infusion in the escalation phase
Recommended Phase 2 dose as monotherapy
Time frame: Up to 24 months after 1st infusion
Objective Response Rate (ORR) based on RECIST (v 1.1) criteria in the expansion phase
Time frame: Up to 24 months after the 1st dose in the expansion phase
RECIST: Response Evaluation Criteria in Solid Tumors.
Duration of Response (DOR) in the expansion phase
Time frame: Up to 24 months after the 1st dose in the expansion phase
Recommended Phase 2 dose in combination with Pembrolizumab
Time frame: Up to 24 months after 1st dose
Incidence of AEs with CTCAE Grade≥3 in the combination phase
Time frame: Up to 15 months after 1st infusion in the combination phase
Incidence of SAEs in the combination phase
Time frame: Up to 15 months after 1st infusion in the combination phase
Incidence of AEs meeting protocol-defined DLT criteria in the combination phase
Time frame: Up to 28 days after 1st infusion in the combination phase
Incidence of dose modifications due to AEs in the combination phase
Time frame: Up to 12 months after 1st infusion in the combination phase
Incidence of AEs leading to discontinuation in the combination phase
Time frame: Up to 12 months after 1st infusion in the combination phase
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Los Angeles, California
- Lake Mary, Florida
- Chicago, Illinois
- Detroit, Michigan
- Huntersville, North Carolina
- Cincinnati, Ohio
- Pittsburgh, Pennsylvania
- Nashville, Tennessee
- Fairfax, Virginia
- Milwaukee, Wisconsin
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 4, 2026 · Source of record for eligibility and locations