Head and Neck CancerPhase 2NCT05271604
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 study testing Ozuriftamab Vedotin, Pembrolizumab and Evalstotug (BA3071) in people with Head and Neck Cancer and Squamous Cell Carcinoma of Head and Neck, run by BioAtla, Inc. at 7 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer, Squamous Cell Carcinoma of Head and Neck, Recurrent Squamous Cell Carcinoma of the Head and Neck
- What is being tested?
- Ozuriftamab Vedotin, Pembrolizumab and Evalstotug (BA3071)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 7 sitesUnited States
- Study dates
- 13 Dec 2022to 22 Sep 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Northwestern University
Chicago, Illinois, 60611
USC Norris Comprehensive Cancer Center
Los Angeles, California, 90033
Norton Cancer Institute
Louisville, Kentucky, 40202
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065
Christiana Care Helen Graham Cancer Center
Newark, Delaware, 19713
Huntsman Cancer Institute
Salt Lake City, Utah, 84112
Washington University Medical Siteman Cancer Center
St Louis, Missouri, 63110
About this study
Official title: A Phase 2 Open-Label Study of Ozuriftamab Vedotin (BA3021) in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck
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
- 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
- Being tested
- Ozuriftamab Vedotin, Pembrolizumab, Evalstotug (BA3071), Cetuximab
- Keywords
- Cancer
- Medical subject headings
- Head and Neck Neoplasms, Squamous Cell Carcinoma of Head and Neck, Neoplasm Metastasis, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ozuriftamab VedotinBiological
Conditionally active biologic anti-ROR2 antibody drug conjugate
PembrolizumabBiological
PD-1 inhibitor
Evalstotug (BA3071)Biological
Conditionally active biologic anti-CTLA-4 checkpoint blockade antibody
CetuximabBiological
Also called Erbitux
Epidermal growth factor receptor (EGFR) antagonist
| Study group | Role | What they receive |
|---|---|---|
| Cohort M1 | Experimental | Monotherapy BA3021 Q2W dosing regimen Receives: Biological: Ozuriftamab Vedotin |
| Cohort M2 | Experimental | Monotherapy BA3021 2Q3W dosing regimen Receives: Biological: Ozuriftamab Vedotin |
| 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. Receives: Biological: Ozuriftamab Vedotin; Biological: Pembrolizumab; Biological: Evalstotug (BA3071) |
| Cohort C1 | Experimental | Combination therapy of BA3021 2Q3W dosing regimen, pembrolizumab Q3W dosing regimen, and BA3071 Q3W dosing regimen Receives: Biological: Ozuriftamab Vedotin; Biological: Pembrolizumab; Biological: Evalstotug (BA3071) |
| Cohort C2 | Experimental | Combination therapy of BA3021 2Q3W dosing regimen, and pembrolizumab Q3W dosing regimen Receives: Biological: Ozuriftamab Vedotin; Biological: Pembrolizumab |
| Cohort C3 | Experimental | Combination therapy of BA3021 2Q3W dosing regimen and cetuximab QW dosing regimen Receives: Biological: Ozuriftamab Vedotin; Biological: Cetuximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Confirmed Objective Response Rate (ORR) per RECIST v1.1
Proportion of patients who achieve a confirmed CR or PR according to RECIST v1.1
Measured: 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
Measured: Up to 24 months
Secondary outcomes (7)
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
Measured: 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.
Measured: Up to 24 months
Best overall response (BOR)
All post-baseline disease assessments that occur prior to the initiation of subsequent anticancer therapy
Measured: 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.
Measured: Up to 24 months
Time to response (TTR)
Time from the first dose of investigational product until the first documentation of OR.
Measured: Up to 24 months
Overall survival (OS)
Time from the first dose of BA3021 treatment until death due to any cause.
Measured: Up to 24 months
Complete response (CR)
Proportion of patients with a best overall response of confirmed CR
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2022
- Study start13 Dec 2022
- Primary completion22 Sep 2025
- Study completion22 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- BioAtla, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05271604
- Sponsor's protocol ID
- BA3021-002
- Status last verified
- Sep 2025
- First submitted
- 28 Feb 2022
- Last updated
- 26 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Open-Label Study of Ozuriftamab Vedotin (BA3021) in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck
- ClinicalTrials.gov ID
- NCT05271604
- Acronym / sponsor ID
- BA3021-002
- Conditions
- 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
- Keywords
- Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- BioAtla, Inc.Industry (pharma, biotech, devices)
- Study start
- 13 Dec 2022 (actual)
- Primary completion
- 22 Sep 2025 (actual)
- Study completion
- 22 Sep 2025 (actual)
- First posted
- 9 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Cohort M1 | Experimental | Biological: Ozuriftamab VedotinMonotherapy BA3021 Q2W dosing regimen |
| Cohort M2 | Experimental | Biological: Ozuriftamab VedotinMonotherapy BA3021 2Q3W dosing regimen |
| Cohort N1 | Experimental | Biological: Ozuriftamab Vedotin, Biological: Pembrolizumab, Biological: Evalstotug (BA3071)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 | Biological: Ozuriftamab Vedotin, Biological: Pembrolizumab, Biological: Evalstotug (BA3071)Combination therapy of BA3021 2Q3W dosing regimen, pembrolizumab Q3W dosing regimen, and BA3071 Q3W dosing regimen |
| Cohort C2 | Experimental | Biological: Ozuriftamab Vedotin, Biological: PembrolizumabCombination therapy of BA3021 2Q3W dosing regimen, and pembrolizumab Q3W dosing regimen |
| Cohort C3 | Experimental | Biological: Ozuriftamab Vedotin, Biological: CetuximabCombination therapy of BA3021 2Q3W dosing regimen and cetuximab QW dosing regimen |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ozuriftamab VedotinConditionally active biologic anti-ROR2 antibody drug conjugate | Biological | Cohort C1, Cohort C2, Cohort C3, Cohort M1, Cohort M2, Cohort N1 |
| PembrolizumabPD-1 inhibitor | Biological | Cohort C1, Cohort C2, Cohort N1 |
| Evalstotug (BA3071)Conditionally active biologic anti-CTLA-4 checkpoint blockade antibody | Biological | Cohort C1, Cohort N1 |
| CetuximabAlso: ErbituxEpidermal growth factor receptor (EGFR) antagonist | Biological | Cohort C3 |
Primary outcome
Confirmed Objective Response Rate (ORR) per RECIST v1.1
Time frame: 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
Time frame: Up to 24 months
Measured by frequency and severity of adverse events as assessed by CTCAE v5
7 secondary outcomes
Duration of response (DOR)
Time frame: Up to 24 months
Progression-free survival (PFS)
Time frame: Up to 24 months
Best overall response (BOR)
Time frame: Up to 24 months
Disease control rate (DCR)
Time frame: Up to 24 months
Time to response (TTR)
Time frame: Up to 24 months
Overall survival (OS)
Time frame: Up to 24 months
Complete response (CR)
Time frame: Up to 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ozuriftamab Vedotin, Pembrolizumab and Evalstotug (BA3071) in people with Head and Neck Cancer and Squamous Cell Carcinoma of Head and Neck, run by BioAtla, Inc. at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Confirmed Objective Response Rate (ORR) per RECIST v1.1 (time frame: Up to 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2025.