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

NCT06480552 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: TV56278-ONC-10203
• Study Type: interventional
• Target: 240
• Locations: 2 countries
• Sites: 12

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
• 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.

Conditions

Advanced Solid Tumors

Outcome Measures

Primary Outcomes (14)

• Incidence of AEs with CTCAE Grade≥3 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

  Up to 15 months after 1st infusion in the escalation phase

• Incidence of AEs meeting protocol-defined DLT criteria 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

  Up to 12 months after 1st infusion in the escalation phase

• Incidence of AEs leading to discontinuation in the escalation phase

  Up to 12 months after 1st infusion in the escalation phase

• Recommended Phase 2 dose as monotherapy

  Up to 24 months after 1st infusion

• Objective Response Rate (ORR) based on RECIST criteria in the expansion phase

  RECIST: Response Evaluation Criteria in Solid Tumors.

  Up to 24 months after the 1st dose in the expansion phase

• Duration of Response (DOR) in the expansion phase

  Up to 24 months after the 1st dose in the expansion phase

• Recommended Phase 2 dose in combination with Pembrolizumab

  Up to 24 months after 1st dose

• Incidence of AEs with CTCAE Grade≥3 in the combination phase

  Up to 15 months after 1st infusion in the combination phase

• Incidence of SAEs 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

  Up to 28 days after 1st infusion in the combination phase

• Incidence of dose modifications due to AEs 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

  Up to 12 months after 1st infusion in the combination phase

Secondary Outcomes (11)

• AUC0-last

  Predose up to Day 8

• Cmax

  Predose up to Day 8

• tmax

  Predose up to Day 8

• Objective Response Rate (ORR) based on RECIST criteria in the escalation phase

  Up to 24 months after 1st infusion in the escalation phase

• Incidence of AEs with CTCAE Grade≥3 in the expansion phase

  Up to 24 months after 1st infusion in the expansion phase

Study Arms (3)

TEV-56278 Monotherapy; Dose Escalation

EXPERIMENTAL

Drug: TEV-56278

TEV-56278 Monotherapy; Dose Expansion

EXPERIMENTAL

Drug: TEV-56278

TEV-56278 in Combination with Pembrolizumab; Dose Escalation

EXPERIMENTAL

Drug: TEV-56278; Drug: Pembrolizumab

Interventions

TEV-56278 DRUG

Administered intravenously

TEV-56278 Monotherapy; Dose Escalation; TEV-56278 Monotherapy; Dose Expansion; TEV-56278 in Combination with Pembrolizumab; Dose Escalation

Pembrolizumab DRUG

Administered intravenously

Also known as: KEYTRUDA®

TEV-56278 in Combination with Pembrolizumab; Dose Escalation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Teva Branded Pharmaceutical Products R&D LLC: lead

Study Sites (12)

Teva Investigational Site 12017

Los Angeles, California, 90025, United States

RECRUITING

Teva Investigational Site 12021

Lake Mary, Florida, 32746, United States

COMPLETED

Teva Investigational Site 12016

Chicago, Illinois, 60611, United States

RECRUITING

Teva Investigational Site 12015

Detroit, Michigan, 48201, United States

RECRUITING

Teva Investigational Site 12014

Huntersville, North Carolina, 28078, United States

RECRUITING

Teva Investigational Site 12023

Cincinnati, Ohio, 45219, United States

RECRUITING

Teva Investigational Site 12058

Pittsburgh, Pennsylvania, 15232, United States

RECRUITING

Teva Investigational Site 12019

Nashville, Tennessee, 37203, United States

RECRUITING

Teva Investigational Site 12024

Nashville, Tennessee, 37232, United States

RECRUITING

Teva Investigational Site 12018

Fairfax, Virginia, 22031, United States

RECRUITING

Teva Investigational Site 12025

Milwaukee, Wisconsin, 53226, United States

RECRUITING

Teva Investigational Site 11282

Toronto, Ontario, M5G 2M9, Canada

RECRUITING

MeSH Terms

Interventions

pembrolizumab

Study Officials

• Teva Medical Expert, MD

  Teva Branded Pharmaceutical Products R&D LLC

  STUDY DIRECTOR

Central Study Contacts

Teva U.S. Medical Information

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2024
• First Posted: June 28, 2024
• Study Start: July 22, 2024
• Primary Completion (Estimated): May 26, 2029
• Study Completion (Estimated): February 25, 2031
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

US (11); CA (1)