CompletedNCT05271604Updated Sep 26, 2025

A Phase 2 Open Label Study of BA3021 in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck

A Phase 2 interventional study of Ozuriftamab Vedotin and Pembrolizumab in Head and Neck Cancer, Squamous Cell Carcinoma of Head and Neck and Recurrent Squamous Cell Carcinoma of the Head and Neck, sponsored by BioAtla, Inc.. Completed at 7 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-26.

Sponsored by BioAtla, Inc. · Phase 2, Interventional, and Treatment

From the registry’s dates

Primary completion was Sep 2025, 1 year ago, and no results have been posted to the registry.

Phase: Phase 2
Study type: Interventional
Enrollment: 42
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study summary

This is a multi-center, open-label Phase 2 study designed to evaluate the efficacy and safety of BA3021 as monotherapy and combination therapy in patients with recurrent or metastatic squamous cell carcinoma of the head and neck.

Conditions studied

Head and Neck Cancer
Squamous Cell Carcinoma of Head and Neck
Recurrent Squamous Cell Carcinoma of the Head and Neck
Metastatic Cancer
Metastatic Squamous Cell Carcinoma of the Head and Neck

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Keywords

Cancer

In context

Head and Neck Neoplasms

2,344 studies on the registry are indexed under Head and Neck Neoplasms; 551 are open to participants now.

This study's enrollment of 42 is below the median of 47 across 1,751 interventional studies indexed under Head and Neck Neoplasms.

Browse Head and Neck Neoplasms studies →

Lead sponsor

BioAtla, Inc. is the lead sponsor of 6 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

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 induction therapy with resectable tumors. No prior treatments, including surgery, radiation, or systemic treatment, for SCCHN are allowed.
Recurrent or metastatic setting: Histologically or cytologically confirmed recurrent or metastatic SCCHN Stage III/IV and not amenable to local therapy with curative intent (surgery or radiation therapy with or without chemotherapy).
First-line - Combination Cohorts (C1 and C2): Patients must have NO prior systemic therapy administered in the locally recurrent or metastatic setting. Previous treatments with PD-1/L1 inhibitor or anti-CTLA-4 treatment are not allowed.
Second-line (Combination Cohort C3) and Second-line+ (Monotherapy Cohorts M1 and M2): Patients must have documented treatment failure of no more than one approved PD-1/L1 inhibitor either administered alone or in combination.

Patients must have measurable disease.

Age ≥ 18 years
Adequate renal function
Adequate liver function
Adequate hematological function
Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

Exclusion criteria

Exclusion Criteria:

Patients must not have a history of ≥ Grade 3 allergic reactions to mAb therapy as well as known or suspected allergy or intolerance to any agent given during this study.
Patients must not have known human immunodeficiency virus (HIV) infection, active hepatitis B and/or hepatitis C.
Patients must not be women who are pregnant or are breast feeding.

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single group
Masking: None (open label)
Enrollment: 42 participants (actual)

Study arms

Experimental
Cohort M1
Monotherapy BA3021 Q2W dosing regimen
Biological: Ozuriftamab Vedotin
Experimental
Cohort M2
Monotherapy BA3021 2Q3W dosing regimen
Biological: Ozuriftamab Vedotin
Experimental
Cohort N1
Neoadjuvant/induction setting combination therapy of BA3021 2Q3W dosing regimen, pembrolizumab Q3W dosing regimen, and BA3071 Q3W dosing regimen prior to surgery.
Biological: Ozuriftamab Vedotin · Biological: Pembrolizumab · Biological: Evalstotug (BA3071)
Experimental
Cohort C1
Combination therapy of BA3021 2Q3W dosing regimen, pembrolizumab Q3W dosing regimen, and BA3071 Q3W dosing regimen
Biological: Ozuriftamab Vedotin · Biological: Pembrolizumab · Biological: Evalstotug (BA3071)
Experimental
Cohort C2
Combination therapy of BA3021 2Q3W dosing regimen, and pembrolizumab Q3W dosing regimen
Biological: Ozuriftamab Vedotin · Biological: Pembrolizumab
Experimental
Cohort C3
Combination therapy of BA3021 2Q3W dosing regimen and cetuximab QW dosing regimen
Biological: Ozuriftamab Vedotin · Biological: Cetuximab

Interventions

BiologicalOzuriftamab Vedotin
Conditionally active biologic anti-ROR2 antibody drug conjugate
BiologicalPembrolizumab
PD-1 inhibitor
BiologicalEvalstotug (BA3071)
Conditionally active biologic anti-CTLA-4 checkpoint blockade antibody
BiologicalCetuximab
Epidermal growth factor receptor (EGFR) antagonist
Also known as: Erbitux

What researchers measure

Primary outcomes

Confirmed Objective Response Rate (ORR) per RECIST v1.1
Proportion of patients who achieve a confirmed CR or PR according to RECIST v1.1
Time frame: Up to 24 months
Incidence of Adverse Events or Serious Adverse Events as assessed by CTCAE v5
Measured by frequency and severity of adverse events as assessed by CTCAE v5
Time frame: Up to 24 months

Secondary outcomes

Duration of response (DOR)
Time from the first documented OR until the first documented disease progression or death (due to any cause), whichever occurs first
Time frame: Up to 24 months
Progression-free survival (PFS)
Time from the first dose of IP until the first documentation of disease progression or death due to any cause, whichever occurs first.
Time frame: Up to 24 months
Best overall response (BOR)
All post-baseline disease assessments that occur prior to the initiation of subsequent anticancer therapy
Time frame: Up to 24 months
Disease control rate (DCR)
Proportion of patients with a best overall response of confirmed CR, confirmed PR, or stable disease (SD) ≥ 12 weeks.
Time frame: Up to 24 months
Time to response (TTR)
Time from the first dose of investigational product until the first documentation of OR.
Time frame: Up to 24 months
Overall survival (OS)
Time from the first dose of BA3021 treatment until death due to any cause.
Time frame: Up to 24 months
Complete response (CR)
Proportion of patients with a best overall response of confirmed CR
Time frame: Up to 24 months

Study locations

7 sites

USC Norris Comprehensive Cancer Center
Los Angeles, California 90033, United States
Christiana Care Helen Graham Cancer Center
Newark, Delaware 19713, United States
Northwestern University
Chicago, Illinois 60611, United States
Norton Cancer Institute
Louisville, Kentucky 40202, United States
Washington University Medical Siteman Cancer Center
St Louis, Missouri 63110, United States
Memorial Sloan-Kettering Cancer Center
New York, New York 10065, United States
Huntsman Cancer Institute
Salt Lake City, Utah 84112, United States

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Sep 26, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT05271604
Lead sponsor: BioAtla, Inc.
Responsible party: Sponsor
First posted: Mar 9, 2022
Start date: Dec 13, 2022
Primary completion: Sep 22, 2025
Completion: Sep 22, 2025
Last update: Sep 26, 2025

Oversight

Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.

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