Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06353997 | Neoadjuvant INBRX-106 in Combination With Pembrolizumab for Stage II/III TNBC Patients | PHASE2 | RECRUITING | 12 | — | — | Sep 5, 2024 | Jun 1, 2029 | Jan 15, 2026 | 4 | United States |
Patients achieving (\>30%) reduction in ultrasound estimate of breast mass volume (mL) at the end of 2 cycles investigational therapy
| Arm | Type | Description |
|---|---|---|
| Pembrolizumab + INBRX-106 | EXPERIMENTAL | 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. |
| Name | Type | Description |
|---|---|---|
| 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. |
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 ...