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
Providence Health & Services
Summary
This is a Phase II trial to assess efficacy and feasibility of pembrolizumab + INBRX-106 as an induction therapy preceding neoadjuvant therapy.
Description
A Simon 2-stage design is implemented to minimize exposure if the treatment regimen is not feasible or if no response. If feasibility is established with responses exceeding futility parameters, study will expand to stage 2. Additional arms may be introduced in a protocol amendment. Below shows the sample size required using Simon's 2-stage design, 80% power and 5% one-sided significance level: * Null hypothesis: \<5% week 6 US response * Alternative hypothesis: \>35% week 6 US response * Stage I n (r\*): 6 (0) * Stage I + II total n (r): 12 (2) * Criteria: Minimax * Minimum responses to pro…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Age ≥ 18 years, inclusive of all genders. 2. Have an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 2. 3. Patients must have histologically confirmed TNBC (ER/PR ≤ 10% allowed, HER2- as defined by ASCO guidelines). HER2 negative permitted to enroll as IHC 0, 1, or 2+ with negative ISH. 4. Primary breast tumor measurable by ultrasound and at least 1cm. 5. Clinically appropriate to receive neoadjuvant pembrolizumab plus chemotherapy (e.g. Keynote-522) planned for curative intent per standard of care (as indicated following study therapy however…
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.
Locations (4)
- Ellison Institute of Technology (EITM)Los Angeles, California
- Providence Portland Cancer Institute - Franz ClinicPortland, Oregon
- Providence St. Vincent Medical CenterPortland, Oregon
- Swedish Cancer InstituteSeattle, Washington