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

Conditions

Pembrolizumab — DRUG
Drug will be delivered per standard-of-care as established by trial Keynote-522.
INBRX-106 — DRUG
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.

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

Experimental: Pembrolizumab + INBRX-106
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.

Volumetric Response [ Time Frame: At the end of Cycle 2 (each cycle is 21 days) ]

Facility	City	State	ZIP	Site coordinators
Ellison Institute of Technology (EITM)	Los Angeles	California	90064	Reva Basho, MD 310-272-7640
Providence Portland Cancer Institute - Franz Clinic	Portland	Oregon	97213	Nicole Moxon, RN [email protected] 503-215-1979 Alison Conlin, MD (SUB_INVESTIGATOR) Evelyn Brosnan, MD (SUB_INVESTIGATOR) Evie Hobbs, MD (SUB_INVESTIGATOR) Rui Li, MD, PhD (SUB_INVESTIGATOR) Sasha Stanton, MD, PhD (SUB_INVESTIGATOR) Zheng Topp, MD (SUB_INVESTIGATOR) Amy Hartman, NP (SUB_INVESTIGATOR) Kathleen Dronkowski, NP (SUB_INVESTIGATOR) Kimberlie Dame, NP (SUB_INVESTIGATOR) Molly Davis, NP (SUB_INVESTIGATOR) RaYoung Chung, NP (SUB_INVESTIGATOR) Roxanne Griswold, NP (SUB_INVESTIGATOR)
Providence St. Vincent Medical Center	Portland	Oregon	97225	Nicole Moxon, RN [email protected] 503-215-1979 David Page, MD (PRINCIPAL_INVESTIGATOR)
Swedish Cancer Institute	Seattle	Washington	98104	Danielle File, MD 206-386-3900

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