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

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 Overview

• Status: Completed
• Conditions: Head and Neck Cancer; Metastatic Cancer; Squamous Cell Carcinoma of Head and Neck; Recurrent Squamous Cell Carcinoma of the Head and Neck; Metastatic Squamous Cell Carcinoma of the Head and Neck
• Intervention / Treatment: Biological: Ozuriftamab Vedotin; Biological: Pembrolizumab; Biological: Evalstotug (BA3071); Biological: Cetuximab

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Phase 2

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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:

• 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort M1; Monotherapy BA3021 Q2W dosing regimen	Biological: Ozuriftamab Vedotin; Conditionally active biologic anti-ROR2 antibody drug conjugate
Experimental: Cohort M2; Monotherapy BA3021 2Q3W dosing regimen	Biological: Ozuriftamab Vedotin; Conditionally active biologic anti-ROR2 antibody drug conjugate
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; Conditionally active biologic anti-ROR2 antibody drug conjugate; Biological: Pembrolizumab; PD-1 inhibitor; Biological: Evalstotug (BA3071); Conditionally active biologic anti-CTLA-4 checkpoint blockade antibody
Experimental: Cohort C1; Combination therapy of BA3021 2Q3W dosing regimen, pembrolizumab Q3W dosing regimen, and BA3071 Q3W dosing regimen	Biological: Ozuriftamab Vedotin; Conditionally active biologic anti-ROR2 antibody drug conjugate; Biological: Pembrolizumab; PD-1 inhibitor; Biological: Evalstotug (BA3071); Conditionally active biologic anti-CTLA-4 checkpoint blockade antibody
Experimental: Cohort C2; Combination therapy of BA3021 2Q3W dosing regimen, and pembrolizumab Q3W dosing regimen	Biological: Ozuriftamab Vedotin; Conditionally active biologic anti-ROR2 antibody drug conjugate; Biological: Pembrolizumab; PD-1 inhibitor
Experimental: Cohort C3; Combination therapy of BA3021 2Q3W dosing regimen and cetuximab QW dosing regimen	Biological: Ozuriftamab Vedotin; Conditionally active biologic anti-ROR2 antibody drug conjugate; Biological: Cetuximab; Epidermal growth factor receptor (EGFR) antagonist; Other Names: Erbitux

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	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.	Up to 24 months
Time to response (TTR)	Time from the first dose of investigational product until the first documentation of OR.	Up to 24 months
Overall survival (OS)	Time from the first dose of BA3021 treatment until death due to any cause.	Up to 24 months
Best overall response (BOR)	All post-baseline disease assessments that occur prior to the initiation of subsequent anticancer therapy	Up to 24 months
Complete response (CR)	Proportion of patients with a best overall response of confirmed CR	Up to 24 months

Collaborators and Investigators

• Sponsor: BioAtla, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): December 13, 2022
• Primary Completion (Actual): September 22, 2025
• Study Completion (Actual): September 22, 2025

Study Registration Dates

• First Submitted: February 28, 2022
• First Submitted That Met QC Criteria: February 28, 2022
• First Posted (Actual): March 9, 2022

Study Record Updates

• Last Update Posted (Estimated): September 26, 2025
• Last Update Submitted That Met QC Criteria: September 23, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Cancer
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms by Site; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Neoplastic Processes; Carcinoma; Carcinoma, Squamous Cell; Pathological Conditions, Signs and Symptoms; Squamous Cell Carcinoma of Head and Neck; Neoplasms; Neoplasm Metastasis; Head and Neck Neoplasms; Amino Acids, Peptides, and Proteins; Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Serum Globulins; Globulins; Cetuximab; pembrolizumab
• Other Study ID Numbers: BA3021-002

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No