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 Open-Label Study of Ozuriftamab Vedotin (BA3021) in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck
1 other identifier
interventional
42
1 country
7
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 head-and-neck-cancer
Started Dec 2022
Shorter than P25 for phase_2 head-and-neck-cancer
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 28, 2022
CompletedFirst Posted
Study publicly available on registry
March 9, 2022
CompletedStudy Start
First participant enrolled
December 13, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 22, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
September 22, 2025
CompletedSeptember 26, 2025
September 1, 2025
2.8 years
February 28, 2022
September 23, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Confirmed Objective Response Rate (ORR) per RECIST v1.1
Proportion of patients who achieve a confirmed CR or PR according to RECIST v1.1
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
Up to 24 months
Secondary Outcomes (7)
Duration of response (DOR)
Up to 24 months
Progression-free survival (PFS)
Up to 24 months
Best overall response (BOR)
Up to 24 months
Disease control rate (DCR)
Up to 24 months
Time to response (TTR)
Up to 24 months
- +2 more secondary outcomes
Study Arms (6)
Cohort M1
EXPERIMENTALMonotherapy BA3021 Q2W dosing regimen
Cohort M2
EXPERIMENTALMonotherapy BA3021 2Q3W dosing regimen
Cohort N1
EXPERIMENTALNeoadjuvant/induction setting combination therapy of BA3021 2Q3W dosing regimen, pembrolizumab Q3W dosing regimen, and BA3071 Q3W dosing regimen prior to surgery.
Cohort C1
EXPERIMENTALCombination therapy of BA3021 2Q3W dosing regimen, pembrolizumab Q3W dosing regimen, and BA3071 Q3W dosing regimen
Cohort C2
EXPERIMENTALCombination therapy of BA3021 2Q3W dosing regimen, and pembrolizumab Q3W dosing regimen
Cohort C3
EXPERIMENTALCombination therapy of BA3021 2Q3W dosing regimen and cetuximab QW dosing regimen
Interventions
Conditionally active biologic anti-ROR2 antibody drug conjugate
Conditionally active biologic anti-CTLA-4 checkpoint blockade antibody
Epidermal growth factor receptor (EGFR) antagonist
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- BioAtla, Inc.lead
Study Sites (7)
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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 28, 2022
First Posted
March 9, 2022
Study Start
December 13, 2022
Primary Completion
September 22, 2025
Study Completion
September 22, 2025
Last Updated
September 26, 2025
Record last verified: 2025-09