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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 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

Find a Location

Who is running the clinical trial?

BioAtla, Inc.Lead Sponsor
6 Previous Clinical Trials
1,508 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
~21 spots leftby Dec 2024
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