Recruiting
Phase 1

TEV-56278 & Pembrolizumab

Sponsor:

Teva Branded Pharmaceutical Products R&D LLC

Code:

NCT06480552

Conditions

Advanced Solid Tumors

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

TEV-56278

Pembrolizumab

Study Details

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 (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).

Conditions

Advanced Solid Tumors

Study ID

NCT06480552

Start date

Jul 22, 2024

Status verified date

Jun, 2026

Completion date

Feb 25, 2031

Anticipated

Primary completion date

May 26, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

240 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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

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.

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

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)

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)

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)

Interventions

TEV-56278

Administered intravenously

Pembrolizumab

Administered intravenously

Primary outcome measure

  • Incidence of AEs with CTCAE Grade≥3 in the escalation phase [ Time Frame: Up to 15 months after 1st infusion in the escalation phase ]
  • 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 ]
  • 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 ]
  • 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 ]

Central Contacts and Locations

Central contacts

Teva U.S. Medical Information

1-888-483-8279USMedInfo@tevapharm.com

Locations

Teva Investigational Site 12017

Recruiting

Los Angeles, California, United States, 90025

Teva Investigational Site 12016

Recruiting

Chicago, Illinois, United States, 60611

Teva Investigational Site 12015

Recruiting

Detroit, Michigan, United States, 48201

Teva Investigational Site 12014

Recruiting

Huntersville, North Carolina, United States, 28078

Teva Investigational Site 12023

Recruiting

Cincinnati, Ohio, United States, 45219

Teva Investigational Site 12058

Recruiting

Pittsburgh, Pennsylvania, United States, 15232

Teva Investigational Site 12019

Recruiting

Nashville, Tennessee, United States, 37203

Teva Investigational Site 12024

Recruiting

Nashville, Tennessee, United States, 37232

Teva Investigational Site 12018

Recruiting

Fairfax, Virginia, United States, 22031

Teva Investigational Site 12025

Recruiting

Milwaukee, Wisconsin, United States, 53226

Teva Investigational Site 11282

Recruiting

Toronto, Ontario, Canada, M5G 2M9

More Information

Sponsor

Teva Branded Pharmaceutical Products R&D LLC

Last update posted

Jun 4, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Teva Branded Pharmaceutical Products R&D LLC on 2026-06-04.