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Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
Randomized
Intervention Model
Sequential Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
TEV-56278 Monotherapy; Dose Escalation
  • Drug: TEV-56278
    Administered intravenously
Experimental
TEV-56278 Monotherapy; Dose Expansion
  • Drug: TEV-56278
    Administered intravenously
Experimental
TEV-56278 in Combination with Pembrolizumab; Dose Escalation
  • Drug: TEV-56278
    Administered intravenously
  • Drug: Pembrolizumab
    Administered intravenously
    Other names:
    • KEYTRUDA®

Recruiting Locations

Teva Investigational Site 12017
Los Angeles 5368361, California 5332921 90025

Teva Investigational Site 12016
Chicago 4887398, Illinois 4896861 60611

Teva Investigational Site 12015
Detroit 4990729, Michigan 5001836 48201

Teva Investigational Site 12014
Huntersville 4472370, North Carolina 4482348 28078

Teva Investigational Site 12023
Cincinnati 4508722, Ohio 5165418 45219

Teva Investigational Site 12058
Pittsburgh 5206379, Pennsylvania 6254927 15232

Teva Investigational Site 12019
Nashville 4644585, Tennessee 4662168 37203

Teva Investigational Site 12018
Fairfax 4758023, Virginia 6254928 22031

Teva Investigational Site 12025
Milwaukee 5263045, Wisconsin 5279468 53226

More Details

Status
Recruiting
Sponsor
Teva Branded Pharmaceutical Products R&D, Inc.

Study Contact

Teva U.S. Medical Information
1-888-483-8279
USMedInfo@tevapharm.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.