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Immunotherapy

INBRX-106 + Pembrolizumab for Breast Cancer

Phase 2
Recruiting
Led By David Page, MD
Research Sponsored by Providence Health & Services
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new treatment combination using pembrolizumab and INBRX-106 to see if it can be used instead of chemotherapy before surgery. One group will be studied to compare

Who is the study for?
This trial is for patients with Stage II Triple Negative Breast Cancer (TNBC) who are looking into treatment options that do not involve chemotherapy. Specific eligibility criteria details are not provided, but typically participants would need to meet certain health standards and have no conflicting medical conditions.
What is being tested?
The trial is testing a combination of INBRX-106, an experimental drug designed to stimulate the immune system, with Pembrolizumab, an existing immunotherapy medication. It's a Phase II study focusing on the effects of these drugs given together before any surgery without using chemotherapy.
What are the potential side effects?
While specific side effects for INBRX-106 aren't detailed here, Pembrolizumab can cause immune-related reactions such as skin rash, colitis, hepatitis, endocrine disorders like thyroid dysfunction and potential infusion-related symptoms.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Pathological response (post-IO)
Secondary study objectives
Event free survival
IO-path response assessed prior to Cycle 2
Overall survival
+3 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Pembrolizumab + INBRX-106Experimental Treatment2 Interventions
Patients will be given pembrolizumab at a dose of 200mg IV in combination with INBRX-106 at a dose of 0.1mg/kg IV every 3 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 3
~2810

Find a Location

Who is running the clinical trial?

Inhibrx Biosciences, IncIndustry Sponsor
6 Previous Clinical Trials
1,061 Total Patients Enrolled
Providence Health & ServicesLead Sponsor
123 Previous Clinical Trials
823,765 Total Patients Enrolled
7 Trials studying Breast Cancer
4,608 Patients Enrolled for Breast Cancer
Inhibrx, Inc.Industry Sponsor
8 Previous Clinical Trials
1,595 Total Patients Enrolled
~8 spots leftby Jun 2027
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