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Monoclonal Antibodies

Ozuriftamab Vedotin for Head and Neck Cancer

Phase 2

Recruiting

Research Sponsored by BioAtla, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

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) with eligible primary tumor locations of oropharynx, oral cavity, hypopharynx, and larynx (excluding nasopharynx)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 24 months

Awards & highlights

Study Summary

This trialtests a drug to treat head and neck cancer in people who haven't responded to other treatments.

Who is the study for?

This trial is for adults over 18 with recurrent or metastatic squamous cell carcinoma of the head and neck, who have failed one PD-1/L1 inhibitor treatment. They should not be candidates for curative surgery or radiation, must have measurable disease, good organ function, and an ECOG status of 0 or 1. Excluded are those with HIV, hepatitis B/C, pregnant/breastfeeding women, significant heart issues, or severe allergies to monoclonal antibodies.Check my eligibility

What is being tested?

The study tests BA3021 in patients whose cancer has returned or spread and expresses ROR-2 after failing treatments that block PD-1/L1 proteins. It's a Phase 2 trial where all participants receive the same experimental therapy without being compared to another group.See study design

What are the potential side effects?

Potential side effects may include reactions related to immune system activation such as inflammation in various organs (similar to other PD-1 inhibitors), infusion-related reactions from the antibody drug conjugate Ozuriftamab Vedotin, fatigue, liver issues due to toxin release from tumor breakdown.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am fully active or can carry out light work.

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My cancer is in the throat or mouth, can't be removed by surgery or cured with radiation, and has spread.

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I have tried one PD-1/L1 inhibitor treatment without success.

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I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

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

Secondary outcome measures

Best overall response (OR)

Disease control rate (DCR)

Duration of response (DOR)

+3 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: BA3021 Q2W dosingExperimental Treatment2 Interventions

BA3021 Q2W dosing regimen

Group II: BA3021 2Q3W dosingExperimental Treatment2 Interventions

BA3021 2Q3W dosing regimen

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

BioAtla, Inc.Lead Sponsor

6 Previous Clinical Trials

1,328 Total Patients Enrolled

Media Library

Ozuriftamab Vedotin (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05271604 — Phase 2

Head and Neck Cancers Research Study Groups: BA3021 Q2W dosing, BA3021 2Q3W dosing

Head and Neck Cancers Clinical Trial 2023: Ozuriftamab Vedotin Highlights & Side Effects. Trial Name: NCT05271604 — Phase 2

Ozuriftamab Vedotin (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05271604 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is BA3021 a secure option for human use?

"Currently, there is no data validating BA3021's efficacy; however, safety has been demonstrated in some clinical trials. Therefore our team at Power placed the agent on a rating of 2."

Answered by AI

What is the cut-off number of participants for this clinical trial?

"The study necessitates 40 suitable participants, and BioAtla, Inc. will be administering it in several places including the Christiana Care Helen Graham Cancer Center of Newark, Delaware and Norton Cancer Institute in Louisville, Kentucky."

Answered by AI

Are there multiple sites administering this research endeavor?

"This research is being conducted through several medical sites, including Christiana Care Helen Graham Cancer Center (Newark, Delaware), Norton Cancer Institute (Louisville, Kentucky) and Washington University Medical Siteman Cancer Centre (Saint Louis, Missouri)."

Answered by AI

Are there any available openings to enroll in this research initiative?

"Indeed, clinicaltrials.gov data shows that this investigation is currently recruiting participants. The research began registration on December 13th 2022 and was last updated February 6th 2023; approximately 40 patients are required to be recruited from 4 distinct medical centres."

Answered by AI

What core aims are investigators attempting to realize with this clinical trial?

"Ultimately, this trial seeks to determine the incidence of adverse and serious adverse events over a 24-month period. Secondary goals include assessing time to response, disease control rate, and best overall response before any subsequent anti-cancer treatments are initiated."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2022. "A Phase 2 Open Label Study of BA3021 in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05271604.

All > Hnscc > Squamous Cell Carcinoma