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Ozuriftamab Vedotin

Phase 2

Head and Neck Cancer | Monoclonal antibody | Oncology |BioAtla, Inc.|Last Updated: Sep 26, 2025

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLEDDMC
Total Trials1
Total Enrollment42

FDA Designations

FAST_TRACK

Clinical trial landscape

Ozuriftamab Vedotin · 1 trial · 5 indications

Phase 2 1
NCT05271604A Phase 2 Open Label Study of BA3021 in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and NeckHead and Neck Cancer
COMPLETED42 Analytics
PHASE2COMPLETED
A Phase 2 Open Label Study of BA3021 in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck
Head and Neck CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Confirmed Objective Response Rate (ORR) per RECIST v1.1
Up to 24 months

Proportion of patients who achieve a confirmed CR or PR according to RECIST v1.1

Incidence of Adverse Events or Serious Adverse Events as assessed by CTCAE v5
Up to 24 months

Measured by frequency and severity of adverse events as assessed by CTCAE v5

Secondary Endpoints

Duration of response (DOR)
Up to 24 months
Progression-free survival (PFS)
Up to 24 months
Best overall response (BOR)
Up to 24 months
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Cohort M1EXPERIMENTALMonotherapy BA3021 Q2W dosing regimen
Cohort M2EXPERIMENTALMonotherapy BA3021 2Q3W dosing regimen
Cohort N1EXPERIMENTALNeoadjuvant/induction setting combination therapy of BA3021 2Q3W dosing regimen, pembrolizumab Q3W dosing regimen, and BA3071 Q3W dosing regimen prior to surgery.
Cohort C1EXPERIMENTALCombination therapy of BA3021 2Q3W dosing regimen, pembrolizumab Q3W dosing regimen, and BA3071 Q3W dosing regimen
Cohort C2EXPERIMENTALCombination therapy of BA3021 2Q3W dosing regimen, and pembrolizumab Q3W dosing regimen
Cohort C3EXPERIMENTALCombination therapy of BA3021 2Q3W dosing regimen and cetuximab QW dosing regimen

Interventions

NameTypeDescription
Ozuriftamab VedotinBIOLOGICALConditionally active biologic anti-ROR2 antibody drug conjugate
PembrolizumabBIOLOGICALPD-1 inhibitor
Evalstotug (BA3071)BIOLOGICALConditionally active biologic anti-CTLA-4 checkpoint blockade antibody
CetuximabBIOLOGICALEpidermal growth factor receptor (EGFR) antagonist
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites7

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 ...

Countries:United States
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Frequently asked questions about Ozuriftamab Vedotin

What is Ozuriftamab Vedotin used for?

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.

Who is developing Ozuriftamab Vedotin?

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.

What phase is Ozuriftamab Vedotin in?

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.

What clinical trials is Ozuriftamab Vedotin in?

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.

Is Ozuriftamab Vedotin the same as BA3021?

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.