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NCT06480552PHASE1Recruiting

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

Teva Branded Pharmaceutical Products R&D LLC

Start Date

7/22/2024

Completion Date

2/25/2031

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).

Eligibility Criteria

Age Range: 18 years to No maximum

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

Interventions

DRUG

TEV-56278

DRUG

Pembrolizumab

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Conditions

Advanced Solid Tumors

Locations

Teva Investigational Site 12017

Los Angeles, California 90025

United States

Teva Investigational Site 12021

Lake Mary, Florida 32746

United States

Teva Investigational Site 12016

Chicago, Illinois 60611

United States

Teva Investigational Site 12015

Detroit, Michigan 48201

United States

Teva Investigational Site 12014

Huntersville, North Carolina 28078

United States

Teva Investigational Site 12023

Cincinnati, Ohio 45219

United States

Teva Investigational Site 12058

Pittsburgh, Pennsylvania 15232

United States

Teva Investigational Site 12019

Nashville, Tennessee 37203

United States

Teva Investigational Site 12024

Nashville, Tennessee 37232

United States

Teva Investigational Site 12018

Fairfax, Virginia 22031

United States

Teva Investigational Site 12025

Milwaukee, Wisconsin 53226

United States

Teva Investigational Site 11282

Toronto, Ontario M5G 2M9

Canada