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

Study Overview
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Brief Summary
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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.

Official Title
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A Phase 2 Open-Label Study of Ozuriftamab Vedotin (BA3021) in PD-1/L1 Failure Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck

Conditions
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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

Intervention / Treatment
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* Biological: Ozuriftamab Vedotin
* Biological: PD-1 inhibitor


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BA3021 Q2W dosing<br>BA3021 Q2W dosing regimen | Biological: Ozuriftamab Vedotin<br>* Conditionally active biologic anti-ROR2 antibody drug conjugate<br>Biological: PD-1 inhibitor<br>* PD-1 inhibitor<br>|
| Experimental: BA3021 2Q3W dosing<br>BA3021 2Q3W dosing regimen | Biological: Ozuriftamab Vedotin<br>* Conditionally active biologic anti-ROR2 antibody drug conjugate<br>Biological: PD-1 inhibitor<br>* PD-1 inhibitor<br>|

What is the study measuring?
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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 | 
| Best overall response (OR) | All post-baseline disease assessments that occur prior to the initiation of subsequent anticancer therapy | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cancer