NT219 for Head and Neck Cancer

Recruiting at 1 trial location

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: University of Colorado, Denver

Must not be taking: Immunosuppressants, Corticosteroids

Disqualifiers: Unknown origin cancer, Active HIV, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 228

Duration: Until progression or unacceptable toxicity

29 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial protocol does not specify if you must stop taking your current medications. However, there are washout periods for certain treatments, like prior anti-cancer biologic agents, chemotherapy, and radiation therapy, which must be stopped a few weeks before starting the trial.

What is the purpose of this trial?

Fixed dose NT219 weekly plus pembrolizumab every 3 weeks or cetuximab weekly to be continued until progression, unacceptable toxicity, or investigator or participant decision.

Research Team

Alice Weaver, MD, PhD

Principal Investigator

University of Colorado, Denver

Eligibility Criteria

Adults over 18 with incurable head and neck squamous cell carcinoma that's not caused by EBV can join. They should have recovered from previous cancer treatments, have measurable disease, and good organ/marrow function. Specific groups include those who've benefited from anti-PD-1 therapy or are new to it, as well as candidates for cetuximab after PD-1 inhibitors didn't work.

Inclusion Criteria

I can have biopsies on my cancer that's not being targeted by current treatments.

I have benefited from anti-PD-1 therapy for at least 6 months or achieved partial/complete response without disease progression.

I have recovered from major side effects of my last cancer treatment.

Exclusion Criteria

I have received an organ transplant.

My cancer is squamous type but its origin is unknown.

My cancer is linked to the Epstein-Barr virus.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive NT219 weekly plus pembrolizumab every 3 weeks or cetuximab weekly until progression, unacceptable toxicity, or decision to discontinue

Until progression or unacceptable toxicity

Weekly visits for NT219 and cetuximab, every 3 weeks for pembrolizumab

Follow-up

Participants are monitored for safety and effectiveness after treatment

9 weeks

Tumor assessments every 9 weeks

Dose-limiting Toxicity Assessment

Assessment of dose-limiting toxicities within the first 21-day cycle for NT219 plus pembrolizumab

3 weeks

Treatment Details

Interventions

• NT219

Trial Overview The trial tests NT219 combined with pembrolizumab every three weeks or weekly cetuximab until the cancer progresses, side effects become too much, or the participant/investigator decides to stop. The goal is to see if this combo helps control the cancer better than current treatments.

Participant Groups

Group I: Cohort 2 NT219 plus cetuximab Experimental Treatment 1 Intervention

Cohort 2 will enroll patients who had progression of disease without clinical benefit from PD-1 inhibition or have received 2 or more lines of therapy and are good candidates for cetuximab. Patients will be treated with NT219 100mg/kg once weekly plus cetuximab given as an initial loading dose of 400 mg/m2 followed by maintenance dosing of 250 mg/m2 once weekly.

Group II: Cohort 1 NT219 plus pembrolizumab Experimental Treatment 1 Intervention

Cohort 1 will enroll patients who have not received PD-1 inhibition in the relapsed/metastatic setting or have received and derived significant clinical benefit from PD-1 inhibition as their first line of therapy. Patients will be treated with NT219 100 mg/kg once weekly plus pembrolizumab 200 mg once every three weeks. The first 6 patients will be required to clear a DLT window of 21 days as an abbreviated safety lead-in.

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials

1,842

Recruited

3,028,000+

Purple Biotech Ltd.

Industry Sponsor