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

BioAtla

Status and phase: Enrolling; Phase 2

Conditions: Metastatic Cancer; Recurrent Squamous Cell Carcinoma of the Head and Neck; Metastatic Squamous Cell Carcinoma of the Head and Neck; Squamous Cell Carcinoma of Head and Neck; Head and Neck Cancer

Treatments: Biological: Cetuximab; Biological: Evalstotug (BA3071); Biological: Ozuriftamab Vedotin; Biological: Pembrolizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT05271604

BA3021-002

Details and patient eligibility

About

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.

Enrollment: 290 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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290 participants in 6 patient groups

Cohort M1

Experimental group

Description:

Monotherapy BA3021 Q2W dosing regimen

Treatment:

Biological: Ozuriftamab Vedotin

Cohort M2

Experimental group

Description:

Monotherapy BA3021 2Q3W dosing regimen

Treatment:

Biological: Ozuriftamab Vedotin

Cohort N1

Experimental group

Description:

Neoadjuvant/induction setting combination therapy of BA3021 2Q3W dosing regimen, pembrolizumab Q3W dosing regimen, and BA3071 Q3W dosing regimen prior to surgery.

Treatment:

Biological: Pembrolizumab

Biological: Evalstotug (BA3071)

Biological: Ozuriftamab Vedotin

Cohort C1

Experimental group

Description:

Combination therapy of BA3021 2Q3W dosing regimen, pembrolizumab Q3W dosing regimen, and BA3071 Q3W dosing regimen

Treatment:

Biological: Pembrolizumab

Biological: Evalstotug (BA3071)

Biological: Ozuriftamab Vedotin

Cohort C2

Experimental group

Description:

Combination therapy of BA3021 2Q3W dosing regimen, and pembrolizumab Q3W dosing regimen

Treatment:

Biological: Pembrolizumab

Biological: Ozuriftamab Vedotin

Cohort C3

Experimental group

Description:

Combination therapy of BA3021 2Q3W dosing regimen and cetuximab QW dosing regimen

Treatment:

Biological: Ozuriftamab Vedotin

Biological: Cetuximab