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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)

Must not have

Patients must not be women who are pregnant or breast feeding

Patients must not have known human immunodeficiency virus (HIV) infection, active hepatitis B and/or hepatitis C

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 24 months

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not pregnant or breastfeeding.

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I do not have HIV, active hepatitis B, or hepatitis C.

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I have never had a severe allergic reaction to antibody treatments.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

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

Secondary study objectives

Best overall response (BOR)

Complete response (CR)

Disease control rate (DCR)

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

6Treatment groups

Experimental Treatment

Group I: Cohort N1Experimental Treatment3 Interventions

Neoadjuvant/induction setting combination therapy of BA3021 2Q3W dosing regimen, pembrolizumab Q3W dosing regimen, and BA3071 Q3W dosing regimen prior to surgery.

Group II: Cohort M2Experimental Treatment1 Intervention

Monotherapy BA3021 2Q3W dosing regimen

Group III: Cohort M1Experimental Treatment1 Intervention

Monotherapy BA3021 Q2W dosing regimen

Group IV: Cohort C3Experimental Treatment2 Interventions

Combination therapy of BA3021 2Q3W dosing regimen and cetuximab QW dosing regimen

Group V: Cohort C2Experimental Treatment2 Interventions

Combination therapy of BA3021 2Q3W dosing regimen, and pembrolizumab Q3W dosing regimen

Group VI: Cohort C1Experimental Treatment3 Interventions

Combination therapy of BA3021 2Q3W dosing regimen, pembrolizumab Q3W dosing regimen, and BA3071 Q3W dosing regimen

Treatment

First Studied