Back to results

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

Primary Purpose

Head and Neck Cancer, Squamous Cell Carcinoma of Head and Neck, Recurrent Squamous Cell Carcinoma of the Head and Neck

Status

Recruiting

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Ozuriftamab Vedotin

PD-1 inhibitor

About this trial

This is an interventional treatment trial for Head and Neck Cancer focused on measuring Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

USC Norris Comprehensive Cancer CenterRecruiting
Christiana Care Helen Graham Cancer CenterRecruiting
Northwestern UniversityRecruiting
Norton Cancer InstituteRecruiting
Washington University Medical Siteman Cancer CenterRecruiting
Memorial Sloan-Kettering Cancer CenterRecruiting
Oregon Health & Science UniversityRecruiting
Huntsman Cancer InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

BA3021 Q2W dosing

BA3021 2Q3W dosing

Arm Description

BA3021 Q2W dosing regimen

BA3021 2Q3W dosing regimen

Outcomes

Primary Outcome Measures

Confirmed Objective Response Rate (ORR) per RECIST v1.1

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

Measured by frequency and severity of adverse events as assessed by CTCAE v5

Secondary Outcome Measures

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

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.

Best overall response (OR)

All post-baseline disease assessments that occur prior to the initiation of subsequent anticancer therapy

Disease control rate (DCR)

Proportion of patients with a best overall response of confirmed CR, confirmed PR, or stable disease (SD) ≥ 12 weeks.

Time to response (TTR)

Time from the first dose of investigational product until the first documentation of OR.

Overall survival (OS)

Time from the first dose of BA3021 treatment until death due to any cause.

Full Information

NCT ID

NCT05271604

First Posted

February 28, 2022

Last Updated

September 27, 2023

Sponsor

BioAtla, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT05271604

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Recruiting

Study Start Date

December 13, 2022 (Actual)

Primary Completion Date

December 2024 (Anticipated)

Study Completion Date

December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

BioAtla, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

BA3021 Q2W dosing

Arm Type

Experimental

Arm Description

BA3021 Q2W dosing regimen

Arm Title

BA3021 2Q3W dosing

Arm Type

Experimental

Arm Description

BA3021 2Q3W dosing regimen

Intervention Type

Biological

Intervention Name(s)

Ozuriftamab Vedotin

Intervention Description

Conditionally active biologic anti-ROR2 antibody drug conjugate

Intervention Type

Biological

Intervention Name(s)

PD-1 inhibitor

Intervention Description

PD-1 inhibitor

Primary Outcome Measure Information:

Title

Confirmed Objective Response Rate (ORR) per RECIST v1.1

Description

Proportion of patients who achieve a confirmed CR or PR according to RECIST v1.1

Time Frame

Up to 24 months

Title

Incidence of Adverse Events or Serious Adverse Events as assessed by CTCAE v5

Description

Measured by frequency and severity of adverse events as assessed by CTCAE v5

Time Frame

Up to 24 months

Secondary Outcome Measure Information:

Title

Duration of response (DOR)

Description

Time from the first documented OR until the first documented disease progression or death (due to any cause), whichever occurs first

Time Frame

Up to 24 months

Title

Progression-free survival (PFS)

Description

Time from the first dose of IP until the first documentation of disease progression or death due to any cause, whichever occurs first.

Time Frame

Up to 24 months

Title

Best overall response (OR)

Description

All post-baseline disease assessments that occur prior to the initiation of subsequent anticancer therapy

Time Frame

Up to 24 months

Title

Disease control rate (DCR)

Description

Proportion of patients with a best overall response of confirmed CR, confirmed PR, or stable disease (SD) ≥ 12 weeks.

Time Frame

Up to 24 months

Title

Time to response (TTR)

Description

Time from the first dose of investigational product until the first documentation of OR.

Time Frame

Up to 24 months

Title

Overall survival (OS)

Description

Time from the first dose of BA3021 treatment until death due to any cause.

Time Frame

Up to 24 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

BioAtla Medical Affairs

Phone

858-558-0708

Ext

3333

medicalaffairs@bioatla.com

Facility Information:

Facility Name

USC Norris Comprehensive Cancer Center

City

Los Angeles

State/Province

California

ZIP/Postal Code

90033

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Azucena Vera

Azucena.Vera@med.usc.edu

First Name & Middle Initial & Last Name & Degree

Jacob Thomas, MD

Facility Name

Christiana Care Helen Graham Cancer Center

City

Newark

State/Province

Delaware

ZIP/Postal Code

19713

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Denise DeMaio

Denise.a.demaio@christianacare.org

First Name & Middle Initial & Last Name & Degree

Jamal Misleh, MD

Facility Name

Northwestern University

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60611

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Briana Porwisz

briana.porwisz@northwestern.edu

First Name & Middle Initial & Last Name & Degree

Jochen Lorch, MD

Facility Name

Norton Cancer Institute

City

Louisville

State/Province

Kentucky

ZIP/Postal Code

40202

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Gracie Smith

gracie.smith@nortonhealthcare.org

First Name & Middle Initial & Last Name & Degree

Jaspreet Grewal, MD

Facility Name

Washington University Medical Siteman Cancer Center

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63110

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Justin Alberti

jalberti@wustl.edu

First Name & Middle Initial & Last Name & Degree

Douglas Adkins, MD

Facility Name

Memorial Sloan-Kettering Cancer Center

City

New York

State/Province

New York

ZIP/Postal Code

10065

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Diana Frias

friasd1@mskcc.org

First Name & Middle Initial & Last Name & Degree

Winston Wong, MD

Facility Name

Oregon Health & Science University

City

Portland

State/Province

Oregon

ZIP/Postal Code

97239

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

OHSU Knight Cancer Institute Clinical Trials

trials@ohsu.edu

First Name & Middle Initial & Last Name & Degree

Jeremy Cetnar, MD

Facility Name

Huntsman Cancer Institute

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84112

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Kaitlin Stephens

Kaitlin.stephens@hci.utah.edu

First Name & Middle Initial & Last Name & Degree

Jeffrey Russell, MD

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs