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

June 2, 2026 updated by: Teva Branded Pharmaceutical Products R&D LLC

A Phase 1a/1b Open-Label, Multicenter, Dose Escalation, and Dose Expansion Trial to Evaluate the Safety and Activity of TEV-56278, as a Monotherapy and in Combination With Pembrolizumab in Participants With Selected Locally Advanced or Metastatic Solid Tumors

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
240

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 2M9
        • Recruiting
        • Teva Investigational Site 11282
  • United States
    • California
      • Los Angeles, California, United States, 90025
        • Recruiting
        • Teva Investigational Site 12017
    • Florida
      • Lake Mary, Florida, United States, 32746
        • Completed
        • Teva Investigational Site 12021
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Recruiting
        • Teva Investigational Site 12016
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Recruiting
        • Teva Investigational Site 12015
    • North Carolina
      • Huntersville, North Carolina, United States, 28078
        • Recruiting
        • Teva Investigational Site 12014
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Recruiting
        • Teva Investigational Site 12023
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15232
        • Recruiting
        • Teva Investigational Site 12058
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Recruiting
        • Teva Investigational Site 12019
      • Nashville, Tennessee, United States, 37232
        • Recruiting
        • Teva Investigational Site 12024
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Recruiting
        • Teva Investigational Site 12018
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Recruiting
        • Teva Investigational Site 12025

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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®

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Incidence of AEs with CTCAE Grade≥3 in the escalation phase
Time Frame: Up to 15 months after 1st infusion in the escalation phase
CTCAE: Common Terminology Criteria for Adverse Events
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
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
DLT: dose-limiting toxicity
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
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
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
Up to 24 months after 1st infusion
Duration of Response (DOR) in the expansion phase
Time Frame: Up to 24 months after the 1st dose in the expansion phase
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
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
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
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
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
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
Up to 12 months after 1st infusion in the combination phase
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
RECIST: Response Evaluation Criteria in Solid Tumors.
Up to 24 months after the 1st dose in the expansion phase

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
AUC0-last
Time Frame: Predose up to Day 8
Area under the serum concentration-time curve from time 0 to last measurable drug concentration
Predose up to Day 8
Cmax
Time Frame: Predose up to Day 8
Maximum observed concentration
Predose up to Day 8
tmax
Time Frame: Predose up to Day 8
Time to maximum observed drug concentration
Predose up to Day 8
Incidence of SAEs in the expansion phase
Time Frame: Up to 15 months after 1st infusion in the expansion phase
Up to 15 months after 1st infusion in the expansion phase
Incidence of dose modifications due to AEs in the expansion phase
Time Frame: Up to 12 months after 1st infusion in the expansion phase
Up to 12 months after 1st infusion in the expansion phase
Incidence of AEs leading to discontinuation in the expansion phase
Time Frame: Up to 12 months after 1st infusion 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
Time Frame: Up to 24 months after 1st infusion
Up to 24 months after 1st infusion
Time to Respond (TTR) according to RECIST (v1.1) criteria
Time Frame: Up to 24 months after 1st infusion
Up to 24 months after 1st infusion
Objective Response Rate (ORR) based on RECIST criteria in the combination phase
Time Frame: Up to 24 months after 1st infusion in the combination phase
Up to 24 months after 1st infusion in the combination phase
Objective Response Rate (ORR) based on RECIST (v1.1) criteria in the escalation phase
Time Frame: Up to 24 months after 1st infusion in the escalation phase
Up to 24 months after 1st infusion in the escalation phase
Incidence of AEs with CTCAE (v5.0) Grade≥3 in the expansion phase
Time Frame: Up to 24 months after 1st infusion in the expansion phase
Up to 24 months after 1st infusion in the expansion phase

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Teva Branded Pharmaceutical Products R&D LLC

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Teva Medical Expert, MD, Teva Branded Pharmaceutical Products R&D LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 22, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 26, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 25, 2031

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 10, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 24, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 28, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 4, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 2, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TV56278-ONC-10203
  • 2026-525954-12-00 (Ctis)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Qualified researchers may request access to patient level data and related study documents including the study protocol and the statistical analysis plan. Requests will be assessed for scientific merit, product approval status, and conflicts of interest. If the request is approved, patient level data will be de-identified and study documents will be redacted to protect the privacy of trial participants and to protect commercially confidential information. Please email USMedInfo@tevapharm.com to make your request.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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