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

Head and Neck Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05271604
• Other study ID #: BA3021-002
• Status: Recruiting
• Phase: Phase 2
• Start date: December 13, 2022
• Est. completion date: December 2024

Study information

• Verified date: September 2023
• Source: BioAtla, Inc.
• Contact: BioAtla Medical Affairs
• Phone: 858-558-0708
• Email: medicalaffairs[@]bioatla.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Head and Neck Cancer
• Metastatic Cancer
• Recurrence
• Squamous Cell Carcinoma of Head and Neck

Intervention

Biological:
• Ozuriftamab Vedotin
Conditionally active biologic anti-ROR2 antibody drug conjugate
• PD-1 inhibitor
PD-1 inhibitor

Locations

Country	Name	City	State
United States	Northwestern University	Chicago	Illinois
United States	USC Norris Comprehensive Cancer Center	Los Angeles	California
United States	Norton Cancer Institute	Louisville	Kentucky
United States	Memorial Sloan-Kettering Cancer Center	New York	New York
United States	Christiana Care Helen Graham Cancer Center	Newark	Delaware
United States	Oregon Health & Science University	Portland	Oregon
United States	Washington University Medical Siteman Cancer Center	Saint Louis	Missouri
United States	Huntsman Cancer Institute	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
BioAtla, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	Best overall response (OR)	All post-baseline disease assessments that occur prior to the initiation of subsequent anticancer therapy	Up to 24 months
Secondary	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
Secondary	Time to response (TTR)	Time from the first dose of investigational product until the first documentation of OR.	Up to 24 months
Secondary	Overall survival (OS)	Time from the first dose of BA3021 treatment until death due to any cause.	Up to 24 months