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

Phase 1RecruitingNCT06480552

Teva Branded Pharmaceutical Products R&D, Inc.240 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

240

Conditions

Advanced Solid Tumors

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (11)

Teva Investigational Site 12017

Los Angeles, California, United States

RECRUITING

Teva Investigational Site 12021

Lake Mary, Florida, United States

COMPLETED

Teva Investigational Site 12016

Chicago, Illinois, United States

RECRUITING

Teva Investigational Site 12015

Detroit, Michigan, United States

RECRUITING

Teva Investigational Site 12014

Huntersville, North Carolina, United States

RECRUITING

Teva Investigational Site 12023

Cincinnati, Ohio, United States

RECRUITING

Teva Investigational Site 12058

Pittsburgh, Pennsylvania, United States

RECRUITING

Teva Investigational Site 12019

Nashville, Tennessee, United States

RECRUITING

Teva Investigational Site 12018

Fairfax, Virginia, United States

RECRUITING

Teva Investigational Site 12025

Milwaukee, Wisconsin, United States

RECRUITING

...and 1 more locations

Outcomes

Primary Outcomes

Incidence of AEs with CTCAE Grade≥3 in the escalation phase

CTCAE: Common Terminology Criteria for Adverse Events

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

DLT: dose-limiting toxicity

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 criteria in the expansion phase

RECIST: Response Evaluation Criteria in Solid Tumors.

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

Secondary Outcomes

AUC0-last

Area under the serum concentration-time curve from time 0 to last measurable drug concentration

Time frame: Predose up to Day 8

Cmax

Maximum observed concentration

Time frame: Predose up to Day 8

tmax

Time to maximum observed drug concentration

Time frame: Predose up to Day 8

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

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

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

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

Incidence of SAEs in the expansion phase

Time frame: 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

Incidence of AEs leading to discontinuation in the expansion phase

Time frame: 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

Time to Respond (TTR) according to RECIST (v1.1) criteria

Time frame: Up to 24 months after 1st infusion

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

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

Overview

Conditions

Interventions

Eligibility

Locations (11)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts