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
- Registration Number
- NCT06480552
- Lead Sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 240
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description TEV-56278 in Combination with Pembrolizumab; Dose Escalation TEV-56278 - TEV-56278 Monotherapy; Dose Escalation TEV-56278 - TEV-56278 Monotherapy; Dose Expansion TEV-56278 - TEV-56278 in Combination with Pembrolizumab; Dose Escalation Pembrolizumab -
- Primary Outcome Measures
Name Time Method Incidence of SAEs in the escalation phase Up to 15 months after 1st infusion in the escalation phase Incidence of AEs meeting protocol-defined DLT criteria in the escalation phase Up to 28 days after 1st infusion in the escalation phase DLT: dose-limiting toxicity
Incidence of AEs leading to discontinuation in the escalation phase Up to 12 months after 1st infusion in the escalation phase Duration of Response (DOR) in the expansion phase Up to 24 months after the 1st dose in the expansion phase Incidence of AEs with CTCAE Grade≥3 in the escalation phase Up to 15 months after 1st infusion in the escalation phase CTCAE: Common Terminology Criteria for Adverse Events
Incidence of dose modifications due to AEs in the escalation phase Up to 12 months after 1st infusion in the escalation phase Recommended Phase 2 dose as monotherapy Up to 24 months after 1st infusion Objective Response Rate (ORR) based on RECIST criteria in the expansion phase Up to 24 months after the 1st dose in the expansion phase RECIST: Response Evaluation Criteria in Solid Tumors.
Recommended Phase 2 dose in combination with Pembrolizumab Up to 24 months after 1st dose Incidence of AEs with CTCAE Grade≥3 in the combination phase Up to 15 months after 1st infusion in the combination phase Incidence of SAEs in the combination phase Up to 15 months after 1st infusion in the combination phase Incidence of AEs meeting protocol-defined DLT criteria in the combination phase Up to 28 days after 1st infusion in the combination phase Incidence of AEs leading to discontinuation in the combination phase Up to 12 months after 1st infusion in the combination phase Incidence of dose modifications due to AEs in the combination phase Up to 12 months after 1st infusion in the combination phase
- Secondary Outcome Measures
Name Time Method Incidence of AEs with CTCAE Grade≥3 in the expansion phase Up to 24 months after 1st infusion in the expansion phase Incidence of AEs leading to discontinuation in the expansion phase Up to 12 months after 1st infusion in the expansion phase Disease Control Rate (DCR) according to RECIST (v1.1) criteria Up to 24 months after 1st infusion Time to Respond (TTR) according to RECIST (v1.1) criteria Up to 24 months after 1st infusion AUC0-last Predose up to Day 8 Area under the serum concentration-time curve from time 0 to last measurable drug concentration
tmax Predose up to Day 8 Time to maximum observed drug concentration
Incidence of dose modifications due to AEs in the expansion phase Up to 12 months after 1st infusion in the expansion phase Objective Response Rate (ORR) based on RECIST criteria in the escalation phase Up to 24 months after 1st infusion in the escalation phase Incidence of SAEs in the expansion phase Up to 15 months after 1st infusion in the expansion phase Objective Response Rate (ORR) based on RECIST criteria in the combination phase Up to 24 months after 1st infusion in the combination phase Cmax Predose up to Day 8 Maximum observed concentration
Trial Locations
- Locations (10)
Teva Investigational Site 12017
🇺🇸Los Angeles, California, United States
Teva Investigational Site 12021
🇺🇸Lake Mary, Florida, United States
Teva Investigational Site 12016
🇺🇸Chicago, Illinois, United States
Teva Investigational Site 12015
🇺🇸Detroit, Michigan, United States
Teva Investigational Site 12014
🇺🇸Huntersville, North Carolina, United States
Teva Investigational Site 12058
🇺🇸Pittsburgh, Pennsylvania, United States
Teva Investigational Site 12019
🇺🇸Nashville, Tennessee, United States
Teva Investigational Site 12018
🇺🇸Fairfax, Virginia, United States
Teva Investigational Site 11282
🇨🇦Toronto, Ontario, Canada
Teva Investigational Site 12023
🇺🇸Cincinnati, Ohio, United States