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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05271604 | A Phase 2 Open Label Study of BA3021 in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck | PHASE2 | COMPLETED | 42 | — | — | Dec 13, 2022 | Sep 22, 2025 | Sep 26, 2025 | 7 | United States |
Proportion of patients who achieve a confirmed CR or PR according to RECIST v1.1
Measured by frequency and severity of adverse events as assessed by CTCAE v5
| Arm | Type | Description |
|---|---|---|
| Cohort M1 | EXPERIMENTAL | Monotherapy BA3021 Q2W dosing regimen |
| Cohort M2 | EXPERIMENTAL | Monotherapy BA3021 2Q3W dosing regimen |
| Cohort N1 | EXPERIMENTAL | Neoadjuvant/induction setting combination therapy of BA3021 2Q3W dosing regimen, pembrolizumab Q3W dosing regimen, and BA3071 Q3W dosing regimen prior to surgery. |
| Cohort C1 | EXPERIMENTAL | Combination therapy of BA3021 2Q3W dosing regimen, pembrolizumab Q3W dosing regimen, and BA3071 Q3W dosing regimen |
| Cohort C2 | EXPERIMENTAL | Combination therapy of BA3021 2Q3W dosing regimen, and pembrolizumab Q3W dosing regimen |
| Cohort C3 | EXPERIMENTAL | Combination therapy of BA3021 2Q3W dosing regimen and cetuximab QW dosing regimen |
| Name | Type | Description |
|---|---|---|
| Ozuriftamab Vedotin | BIOLOGICAL | Conditionally active biologic anti-ROR2 antibody drug conjugate |
| Pembrolizumab | BIOLOGICAL | PD-1 inhibitor |
| Evalstotug (BA3071) | BIOLOGICAL | Conditionally active biologic anti-CTLA-4 checkpoint blockade antibody |
| Cetuximab | BIOLOGICAL | Epidermal growth factor receptor (EGFR) antagonist |
Inclusion Criteria: * The eligible primary tumor locations are oropharynx, oral cavity, hypopharynx, and larynx. Patients may not have a primary tumor site of nasopharynx (any histology). * Neoadjuvant/induction setting (Cohort N1): Patient with newly diagnosed Stage III SCCHN who are eligible for ...