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
NCT ID: NCT06480552
Last Updated: 2026-02-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
240 participants
INTERVENTIONAL
2024-07-22
2031-02-25
Brief Summary
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* 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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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TEV-56278 in Combination with Pembrolizumab; Dose Escalation
TEV-56278
Administered intravenously
Pembrolizumab
Administered intravenously
TEV-56278 Monotherapy; Dose Escalation
TEV-56278
Administered intravenously
TEV-56278 Monotherapy; Dose Expansion
TEV-56278
Administered intravenously
Interventions
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TEV-56278
Administered intravenously
Pembrolizumab
Administered intravenously
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Teva Branded Pharmaceutical Products R&D, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Teva Medical Expert, MD
Role: STUDY_DIRECTOR
Teva Branded Pharmaceutical Products R&D, Inc.
Locations
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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 12023
Cincinnati, Ohio, 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 12025
Milwaukee, Wisconsin, United States
Teva Investigational Site 11282
Toronto, Ontario, Canada
Countries
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Central Contacts
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Other Identifiers
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TV56278-ONC-10203
Identifier Type: -
Identifier Source: org_study_id
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