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 monoclonal antibody being studied for the treatment of head and neck cancer, specifically recurrent or metastatic squamous cell carcinoma of the head and neck. It is currently in Phase 2 clinical development and has not been approved by the FDA.
Ozuriftamab Vedotin is being developed by BioAtla, Inc., a biopharmaceutical company traded on Nasdaq under the ticker symbol BCAB. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with head and neck cancer.
Ozuriftamab Vedotin is in Phase 2 clinical development. It has received Fast Track designation from the FDA, which is intended to expedite the development and review of drugs that treat serious conditions and fill an unmet medical need. The drug is investigational and not yet approved.
Ozuriftamab Vedotin is being evaluated in a Phase 2 open-label study with the identifier NCT05271604. This trial enrolled 42 patients with recurrent or metastatic squamous cell carcinoma of the head and neck and has been completed. The study was conducted in the United States.
Yes, Ozuriftamab Vedotin is also known as BA3021. The Phase 2 clinical trial NCT05271604, which evaluated the drug in patients with recurrent or metastatic squamous cell carcinoma of the head and neck, used the name BA3021 in its title.