RECRUITING

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-07-22

Study Completion:2031-02-25

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06480552

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.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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)

Inclusion Criteria

Exclusion 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

* 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)

Contacts and Locations

Study Contact

Teva U.S. Medical Information

CONTACT

1-888-483-8279

USMedInfo@tevapharm.com

Principal Investigator

Teva Medical Expert, MD

STUDY_DIRECTOR

Teva Branded Pharmaceutical Products R&D, Inc.

Study Locations (Sites)

Teva Investigational Site 12014

Huntersville, North Carolina, 28078

United States

Teva Investigational Site 12018

Fairfax, Virginia, 22031

United States

Collaborators and Investigators

Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.

Teva Medical Expert, MD, STUDY_DIRECTOR, Teva Branded Pharmaceutical Products R&D, Inc.

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 Registration Dates

Study Start Date2024-07-22

Study Completion Date2031-02-25

Study Record Updates

Study Start Date2024-07-22

Study Completion Date2031-02-25

Terms related to this study

Additional Relevant MeSH Terms

Advanced Solid Tumors