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

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 (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).

Condition

  • Advanced Solid Tumors

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
Non-Randomized
Intervention Model
Sequential Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Part 1: TEV-56278 Monotherapy Dose Escalation 		Part 1 will be initiated first and will evaluate dose escalation of TEV-56278 as a monotherapy in selected solid tumors
  • Drug: TEV-56278
    Administered intravenously
Experimental
Part 2: Cohort A -TEV-56278 Monotherapy Dose Expansion in Malignant Melanoma Primary Resistance 		Part 2 Cohort A will consist of TEV-56278 monotherapy dose expansion in malignant melanoma (primary and secondary resistance to anti-PD-(L)1) and in non-small cell lung carcinoma (NSCLC) (primary and secondary resistant to anti-PD-(L)1). EU participants will only be included in Part 2.
  • Drug: TEV-56278
    Administered intravenously
Experimental
Part 2: Cohort B- TEV-56278 Monotherapy Dose Expansion in Malignant Melanoma Secondary Resistance 		Part 2 Cohort B will consist of TEV-56278 monotherapy dose expansion in malignant melanoma (primary and secondary resistance to anti-PD-(L)1) and in NSCLC (primary and secondary resistant to anti-PD-(L)1) Only Cohort B will be randomized
  • Drug: TEV-56278
    Administered intravenously
Experimental
Part 2: Cohort C - TEV-56278 Monotherapy Dose Expansion in NSCLC Primary Resistance 		Part 2 Cohort C will consist of TEV-56278 monotherapy dose expansion in malignant melanoma (primary and secondary resistance to anti-PD-(L)1) and in NSCLC (primary and secondary resistant to anti-PD-(L)1)
  • Drug: TEV-56278
    Administered intravenously
Experimental
Part 2: Cohort D - TEV-56278 Monotherapy Dose Expansion in NSCLC Secondary Resistance 		Part 2 Cohort D will consist of TEV-56278 monotherapy dose expansion in malignant melanoma (primary and secondary resistance to anti-PD-(L)1) and in NSCLC (primary and secondary resistant to anti-PD-(L)1)
  • Drug: TEV-56278
    Administered intravenously
Experimental
Part 3: TEV-56278 and Pembrolizumab Combination Dose Escalation 		Part 3 will be initiated at the discretion of the Sponsor, after some or all of the dose levels in Part 1 have been explored. Part 3 will evaluate escalating doses of TEV-56278 in combination with a fixed dose of pembrolizumab (400 mg Q6W) and include dose escalation in selected solid tumors (same indications as in Part 1)
  • Drug: Pembrolizumab
    Administered intravenously
    Other names:
    • KEYTRUDA®

Recruiting Locations

Teva Investigational Site 12017
Los Angeles, California 90025

Teva Investigational Site 12016
Chicago, Illinois 60611

Teva Investigational Site 12015
Detroit, Michigan 48201

Teva Investigational Site 12014
Huntersville, North Carolina 28078

Teva Investigational Site 12023
Cincinnati, Ohio 45219

Teva Investigational Site 12058
Pittsburgh, Pennsylvania 15232

Teva Investigational Site 12019
Nashville, Tennessee 37203

Teva Investigational Site 12024
Nashville, Tennessee 37232

Teva Investigational Site 12018
Fairfax, Virginia 22031

Teva Investigational Site 12025
Milwaukee, Wisconsin 53226

More Details

Status
Recruiting
Sponsor
Teva Branded Pharmaceutical Products R&D LLC

Study Contact

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