290 Participants Needed

Ozuriftamab Vedotin for Head and Neck Cancer

Recruiting at 6 trial locations
JH
HB
JB
BM
Overseen ByBioAtla Medical Affairs
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This is a multi-center, open-label Phase 2 study designed to evaluate the efficacy and safety of BA3021 as monotherapy and combination therapy in patients with recurrent or metastatic squamous cell carcinoma of the head and neck.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What is known about the safety of PD-1 inhibitors for head and neck cancer?

PD-1 inhibitors, used in head and neck cancer treatment, generally have an acceptable safety profile. Common side effects include diarrhea, low thyroid function, and skin rash, with rare cases of serious lung inflammation.12345

How is the drug Ozuriftamab Vedotin different from other treatments for head and neck cancer?

Ozuriftamab Vedotin is unique because it combines an antibody-drug conjugate (a targeted therapy that links an antibody to a drug) with a PD-1 inhibitor, which helps the immune system attack cancer cells. This dual approach may offer a novel way to treat head and neck cancer compared to existing treatments that typically use either PD-1 inhibitors or other forms of therapy separately.46789

What data supports the effectiveness of the drug Ozuriftamab Vedotin for head and neck cancer?

Research on similar treatments, like atezolizumab and nivolumab, which target the PD-1/PD-L1 pathway, shows promise in treating head and neck cancer by enhancing the immune system's ability to fight the cancer. These drugs have shown clinical activity and safety in trials, suggesting that Ozuriftamab Vedotin, which also involves PD-1 inhibitors, may be effective as well.5681011

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am fully active or can carry out light work.
My liver is working well.
My cancer is in the throat or mouth, can't be removed by surgery or cured with radiation, and has spread.
See 4 more

Exclusion Criteria

I am not pregnant or breastfeeding.
I do not have HIV, active hepatitis B, or hepatitis C.
I have never had a severe allergic reaction to antibody treatments.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive BA3021 as monotherapy or in combination therapy with pembrolizumab, cetuximab, or BA3071

Up to 24 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-8 weeks

Open-label extension (optional)

Participants may opt into continuation of treatment long-term

Long-term

What Are the Treatments Tested in This Trial?

Interventions

  • Ozuriftamab Vedotin
  • PD-1 inhibitor
Trial Overview 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.
How Is the Trial Designed?
6Treatment groups
Experimental Treatment
Group I: Cohort N1Experimental Treatment3 Interventions
Group II: Cohort M2Experimental Treatment1 Intervention
Group III: Cohort M1Experimental Treatment1 Intervention
Group IV: Cohort C3Experimental Treatment2 Interventions
Group V: Cohort C2Experimental Treatment2 Interventions
Group VI: Cohort C1Experimental Treatment3 Interventions

Ozuriftamab Vedotin is already approved in United States for the following indications:

🇺🇸
Approved in United States as Ozuriftamab vedotin for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

BioAtla, Inc.

Lead Sponsor

Trials
7
Recruited
1,500+

Published Research Related to This Trial

In a phase Ia clinical trial involving 32 patients with advanced head and neck cancer, atezolizumab demonstrated a tolerable safety profile, with 66% of patients experiencing treatment-related adverse events, but no grade 5 events reported.
The treatment showed promising efficacy, with 22% of patients achieving objective responses and a median overall survival of 6.0 months, indicating potential benefits regardless of HPV status or PD-L1 expression levels.
Safety and clinical activity of atezolizumab in head and neck cancer: results from a phase I trial.Colevas, AD., Bahleda, R., Braiteh, F., et al.[2022]
In a phase 3 trial involving 361 patients with recurrent squamous-cell carcinoma of the head and neck, nivolumab significantly improved overall survival compared to standard therapy, with a median survival of 7.5 months versus 5.1 months.
Nivolumab also had a better safety profile, with fewer severe treatment-related adverse events (13.1% vs. 35.1% in standard therapy), and patients reported stable quality of life compared to those receiving standard treatment.
Nivolumab for Recurrent Squamous-Cell Carcinoma of the Head and Neck.Ferris, RL., Blumenschein, G., Fayette, J., et al.[2022]
The 22C3 laboratory developed test (LDT) for PD-L1 expression in head and neck squamous cell carcinoma (HNSCC) shows almost perfect concordance with the standardized 22C3 pharmDx assay, indicating it can reliably identify patients who may benefit from pembrolizumab treatment.
Both assays demonstrated substantial interobserver agreement and similar levels of intratumor heterogeneity, confirming that the LDT is a safe and effective alternative to the pharmDx assay for patient selection.
Inter-assay reliability of programmed cell death-ligand 1 in head and neck squamous cell carcinoma.Hempenius, MA., Bisheshar, SK., Slagter-Menkema, L., et al.[2022]

Citations

Safety and clinical activity of atezolizumab in head and neck cancer: results from a phase I trial. [2022]
Nivolumab for Recurrent Squamous-Cell Carcinoma of the Head and Neck. [2022]
Inter-assay reliability of programmed cell death-ligand 1 in head and neck squamous cell carcinoma. [2022]
Zalutumumab plus best supportive care versus best supportive care alone in patients with recurrent or metastatic squamous-cell carcinoma of the head and neck after failure of platinum-based chemotherapy: an open-label, randomised phase 3 trial. [2022]
First-line cetuximab + platinum-based therapy for recurrent/metastatic head and neck squamous cell carcinoma: A real-world observational study-ENCORE. [2023]
Safety evaluation of pembrolizumab for treating recurrent head and neck squamous cell carcinoma. [2022]
Safety profile of immune checkpoint inhibitors: An analysis of the Italian spontaneous reporting system database. [2021]
Pembrolizumab versus methotrexate, docetaxel, or cetuximab for recurrent or metastatic head-and-neck squamous cell carcinoma (KEYNOTE-040): a randomised, open-label, phase 3 study. [2019]
The effects and safety of PD-1/PD-L1 inhibitors on head and neck cancer: A systematic review and meta-analysis. [2021]
[The research progress of PD-1/L1 inhibitors application in the treatment of head and neck squamous cell carcinoma]. [2023]
Investigation of the Efficacy and Safety of Nivolumab in Recurrent and Metastatic Nasopharyngeal Carcinoma. [2021]
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