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

Phase 2

Recruiting

• Conditions: Metastatic Cancer; Head and Neck Cancer; Squamous Cell Carcinoma of Head and Neck; Metastatic Squamous Cell Carcinoma of the Head and Neck; Recurrent Squamous Cell Carcinoma of the Head and Neck
• Interventions: Biological: Ozuriftamab Vedotin; Biological: Cetuximab; Biological: Pembrolizumab; Biological: Evalstotug (BA3071)

• Registration Number: NCT05271604
• Lead Sponsor: BioAtla, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-02-28
• Study First Submitted QC: 2022-02-28
• Study First Posted: 2022-03-09
• Study Start: 2022-12-13
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-27
• Last Update Posted: 2023-09-29
• Primary Completion: 2024-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cohort C2	Ozuriftamab Vedotin	Combination therapy of BA3021 2Q3W dosing regimen, and pembrolizumab Q3W dosing regimen
Cohort M1	Ozuriftamab Vedotin	Monotherapy BA3021 Q2W dosing regimen
Cohort M2	Ozuriftamab Vedotin	Monotherapy BA3021 2Q3W dosing regimen
Cohort N1	Ozuriftamab Vedotin	Neoadjuvant/induction setting combination therapy of BA3021 2Q3W dosing regimen, pembrolizumab Q3W dosing regimen, and BA3071 Q3W dosing regimen prior to surgery.
Cohort N1	Evalstotug (BA3071)	Neoadjuvant/induction setting combination therapy of BA3021 2Q3W dosing regimen, pembrolizumab Q3W dosing regimen, and BA3071 Q3W dosing regimen prior to surgery.
Cohort C1	Evalstotug (BA3071)	Combination therapy of BA3021 2Q3W dosing regimen, pembrolizumab Q3W dosing regimen, and BA3071 Q3W dosing regimen
Cohort C3	Cetuximab	Combination therapy of BA3021 2Q3W dosing regimen and cetuximab QW dosing regimen
Cohort N1	Pembrolizumab	Neoadjuvant/induction setting combination therapy of BA3021 2Q3W dosing regimen, pembrolizumab Q3W dosing regimen, and BA3071 Q3W dosing regimen prior to surgery.
Cohort C1	Pembrolizumab	Combination therapy of BA3021 2Q3W dosing regimen, pembrolizumab Q3W dosing regimen, and BA3071 Q3W dosing regimen
Cohort C1	Ozuriftamab Vedotin	Combination therapy of BA3021 2Q3W dosing regimen, pembrolizumab Q3W dosing regimen, and BA3071 Q3W dosing regimen
Cohort C2	Pembrolizumab	Combination therapy of BA3021 2Q3W dosing regimen, and pembrolizumab Q3W dosing regimen
Cohort C3	Ozuriftamab Vedotin	Combination therapy of BA3021 2Q3W dosing regimen and cetuximab QW dosing regimen

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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 (BOR)	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.
Complete response (CR)	Up to 24 months	Proportion of patients with a best overall response of confirmed CR

Trial Locations

Locations (8)

USC Norris Comprehensive Cancer Center; 🇺🇸 Los Angeles, California, United States

Christiana Care Helen Graham Cancer Center; 🇺🇸 Newark, Delaware, United States

Northwestern University; 🇺🇸 Chicago, Illinois, United States

Norton Cancer Institute; 🇺🇸 Louisville, Kentucky, United States

Washington University Medical Siteman Cancer Center; 🇺🇸 Saint Louis, Missouri, United States

Memorial Sloan-Kettering Cancer Center; 🇺🇸 New York, New York, United States

Oregon Health & Science University; 🇺🇸 Portland, Oregon, United States

Huntsman Cancer Institute; 🇺🇸 Salt Lake City, Utah, United States