Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Ozuriftamab Vedotin · 1 trial · 5 indications
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 ...
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Ozuriftamab Vedotin is an investigational antibody-drug conjugate developed by BioAtla, Inc. for the treatment of head and neck cancer. It is being studied in patients with recurrent or metastatic squamous cell carcinoma of the head and neck. The drug has received Fast Track designation from the FDA.
Ozuriftamab Vedotin is being developed for head and neck cancer, specifically recurrent or metastatic squamous cell carcinoma of the head and neck. It is an investigational therapy and is not yet approved for commercial use. The clinical program has focused on patients with these advanced forms of the disease.
Ozuriftamab Vedotin is developed by BioAtla, Inc., a clinical-stage biopharmaceutical company. BioAtla trades on the Nasdaq under the ticker symbol BCAB. The company is responsible for the clinical development of the antibody-drug conjugate.
Ozuriftamab Vedotin is in Phase 2 clinical development. A Phase 2 trial has been completed, and the drug remains investigational. It has not been approved by the FDA for any indication. The program has received Fast Track designation from the FDA for its development in head and neck cancer.
Ozuriftamab Vedotin has been evaluated in a Phase 2 open-label study, NCT05271604, titled A Phase 2 Open Label Study of BA3021 in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck. The trial enrolled 42 patients in the United States and has been completed.
Yes, Ozuriftamab Vedotin is also known as BA3021. The Phase 2 clinical trial for this antibody-drug conjugate was conducted under the name BA3021. Both names refer to the same investigational therapy developed by BioAtla, Inc. for head and neck cancer.