← Back to Search

Monoclonal Antibodies

TEV-56278 + Pembrolizumab for Cancer

Phase 1
Recruiting
Research Sponsored by Teva Branded Pharmaceutical Products R&D, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Must not have
Has a diagnosis of immunodeficiency
Has a seizure disorder requiring therapy (such as steroids or antiepileptics)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 28 days after 1st infusion in the escalation phase
Awards & highlights

Summary

This trial aims to test the safety, effectiveness, and recommended dosage of a drug called TEV-56278 for treating tumors. The study will also look at how well TEV-56278 works

Who is the study for?
This trial is for people with advanced or metastatic solid tumors. Participants will be treated and followed up for a total of up to 25 months. Specific eligibility details are not provided, but typically include factors like age, health status, type of tumor, and prior treatments.
What is being tested?
The trial is testing TEV-56278 alone and in combination with Pembrolizumab to see how safe they are and how well they work against tumors. The study aims to find the best dose that's effective yet tolerable.
What are the potential side effects?
While specific side effects aren't listed here, common ones from drugs like these may include fatigue, nausea, skin reactions, immune-related conditions or infusion reactions.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have been diagnosed with an immune system disorder.
Select...
I am on medication for seizures.
Select...
I have or had cancer spread to my brain or its coverings.
Select...
I have a serious lung condition not caused by an infection.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 28 days after 1st infusion in the escalation phase
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 28 days after 1st infusion in the escalation phase for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Incidence of AEs meeting protocol-defined DLT criteria in the escalation phase
Incidence of AEs with CTCAE Grade≥3 in the escalation phase
Objective Response Rate (ORR) based on RECIST criteria in the expansion phase
Secondary study objectives
AUC0-last
Cmax
tmax

Trial Design

3Treatment groups
Experimental Treatment
Group I: TEV-56278 in Combination with Pembrolizumab; Dose EscalationExperimental Treatment2 Interventions
Group II: TEV-56278 Monotherapy; Dose ExpansionExperimental Treatment1 Intervention
Group III: TEV-56278 Monotherapy; Dose EscalationExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 2
~2070

Find a Location

Who is running the clinical trial?

Teva Branded Pharmaceutical Products R&D, Inc.Lead Sponsor
253 Previous Clinical Trials
3,485,578 Total Patients Enrolled
Teva Medical Expert, MDStudy DirectorTeva Branded Pharmaceutical Products R&D, Inc.
94 Previous Clinical Trials
38,781 Total Patients Enrolled
~160 spots leftby May 2029
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top