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

Sponsor

BioAtla, Inc. (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05271604

Collaborator

(none)

Enrollment

Arm

Anticipated Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
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	Biological: Ozuriftamab Vedotin Biological: PD-1 inhibitor	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Anticipated Study Start Date :

Aug 1, 2022

Anticipated Primary Completion Date :

Dec 1, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: BA3021 BA3021 alone in PD-1/L1 failure patients	Biological: Ozuriftamab Vedotin Conditionally active biologic anti-ROR2 antibody drug conjugate Biological: PD-1 inhibitor PD-1 inhibitor

Arm

Intervention/Treatment

Experimental: BA3021

BA3021 alone in PD-1/L1 failure patients

Biological: Ozuriftamab Vedotin

Conditionally active biologic anti-ROR2 antibody drug conjugate

Biological: PD-1 inhibitor

PD-1 inhibitor

Outcome Measures

Primary Outcome Measures

Confirmed Objective Response Rate (ORR) per RECIST v1.1 [Up to 24 months]
Proportion of patients who achieve a confirmed CR or PR according to RECIST v1.1
Incidence of Adverse Events or Serious Adverse Events as assessed by CTCAE v5 [Up to 24 months]
Measured by frequency and severity of adverse events as assessed by CTCAE v5

Secondary Outcome Measures

Duration of response (DOR) [Up to 24 months]
Time from the first documented OR until the first documented disease progression or death (due to any cause), whichever occurs first
Progression-free survival (PFS) [Up to 24 months]
Time from the first dose of IP until the first documentation of disease progression or death due to any cause, whichever occurs first.
Best overall response (OR) [Up to 24 months]
All post-baseline disease assessments that occur prior to the initiation of subsequent anticancer therapy
Disease control rate (DCR) [Up to 24 months]
Proportion of patients with a best overall response of confirmed CR, confirmed PR, or stable disease (SD) ≥ 12 weeks.
Time to response (TTR) [Up to 24 months]
Time from the first dose of investigational product until the first documentation of OR.
Overall survival (OS) [Up to 24 months]
Time from the first dose of BA3021 treatment until death due to any cause.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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 PD-1/L1 inhibitor either administered alone or in combination with Platinum (with and without 5FU) 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 clinically significant cardiac disease.
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.