RecruitingPhase 2NCT06353997

Neoadjuvant INBRX-106 in Combination With Pembrolizumab for Stage II/III TNBC Patients

A Phase II, Single-arm, Multi-center, Open-label Study of Neoadjuvant INBRX-106 (Hexavalent OX40 Agonist) in Combination With Pembrolizumab as an Induction Immunotherapy for Stage II/III TNBC Patients

Sponsor

Providence Health & Services

Enrollment

12 participants

Start Date

Sep 5, 2024

Study Type

INTERVENTIONAL

Conditions

Triple-Negative Breast Cancer

Summary

This is a Phase II trial to assess efficacy and feasibility of pembrolizumab + INBRX-106 as an induction therapy preceding neoadjuvant therapy.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a drug called INBRX-106 added to the standard immunotherapy (pembrolizumab) given before surgery for Stage II or III triple-negative breast cancer (TNBC) — a type of breast cancer that lacks common hormone receptors. The goal is to see if this combination increases the chance of eliminating the tumor before surgery. **You may be eligible if...** - You are 18 or older (any gender) with a confirmed diagnosis of triple-negative breast cancer - Your breast tumor is at least 1 cm and measurable by ultrasound - You have not previously received any treatment for this breast cancer - You are planning to receive standard pre-surgery chemotherapy with pembrolizumab - You are willing to have biopsies and blood draws during the study **You may NOT be eligible if...** - You have received any prior therapy for triple-negative breast cancer - Your blood counts or organ function are not adequate for treatment - You have conditions that would make it unsafe to participate Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPembrolizumab

Drug will be delivered per standard-of-care as established by trial Keynote-522.

DRUGINBRX-106

INBRX-106 is a hexavalent, recombinant humanized IgG1, OX40 agonist antibody that targets the human OX40 receptor (TNFRSF4, UniProtKB: P43489). INBRX-106 is based on a sdAb platform and, in detail, 3 identical humanized camelid heavy chain-only antibody binding domains (VHHs) targeting OX40 are joined end-to-end and with an Fc based on human IgG1 to create a molecule that homo-dimerizes into an antibody targeting a total of 6 OX40 receptors.