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: Ozuriftamab Vedotin; Biological: PD-1 inhibitor

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 in PD-1/L1 failure patients with ROR-2 expression in recurrent or metastatic squamous cell carcinoma of the head and neck.

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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). The eligible primary tumor locations are oropharynx, oral cavity, hypopharynx, and larynx. Patients may not have a primary tumor site of nasopharynx (any histology).
• 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 breast feeding.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

80 participants in 2 patient groups

BA3021 Q2W dosing

Experimental group

Description:

BA3021 Q2W dosing regimen

Treatment:

Biological: PD-1 inhibitor

Biological: Ozuriftamab Vedotin

BA3021 2Q3W dosing

Experimental group

Description:

BA3021 2Q3W dosing regimen

Treatment:

Biological: PD-1 inhibitor

Biological: Ozuriftamab Vedotin