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Monoclonal Antibodies

Enoblituzumab for Head and Neck Cancers

Phase 2
Waitlist Available
Research Sponsored by MacroGenics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up cycle 1 day 1: pre-infusion, end of infusion (eoi [1 hour]), 4 hours after eoi; cycle 1 days 2, 3, 8 and 15 at any time; on day 1 of cycles 2, 3, 4, 5 and 6: pre-infusion and eoi (each cycle is 21 days)
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a combination of drugs that help the immune system fight cancer. It targets patients whose head and neck cancer has come back or spread. The treatment aims to make the body's defenses better at finding and destroying cancer cells. The study established the use of a specific drug, with or without additional treatment, for eligible patients with advanced head and neck cancer.

Eligible Conditions
  • Head and Neck Cancers
  • Head and Neck Squamous Cell Carcinoma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 16.5 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 16.5 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
ORR of Enoblituzumab Plus Tebotelimab
Overall Response Rate (ORR) of Enoblituzumab Plus Retifanlimab
Secondary study objectives
Best Overall Response (BOR)
Disease-control Rate (DCR)
Duration of Response
+8 more

Side effects data

From 2022 Phase 1 trial • 3 Patients • NCT04630769
100%
Weight loss
100%
Hypocalcemia
100%
Hypoalbuminemia
100%
Hyperglycemia
100%
Anorexia
100%
Abdominal pain
100%
Pain
100%
Chills
100%
Alanine aminotransferase increased
100%
Alkaline phosphatase increased
100%
Bloating
100%
Lymphocyte count decreased
100%
Neoplasms benign, malignant and
100%
Anemia
100%
Vomiting
100%
Flatulence
100%
Fatigue
100%
Fever
100%
Platelet count decreased
100%
White blood cell decreased
100%
Aspartate aminotransferase increased
100%
Proteinuria
100%
Dyspnea
100%
Pruritus
100%
Constipation
100%
Nausea
100%
Hyponatremia
100%
Myalgia
100%
Headache
100%
Insomnia
100%
Hematoma
100%
Hypotension
100%
80%
60%
40%
20%
0%
Study treatment Arm
Monotherapy: IP FT516 at 9 x 10^8 Cells/Dose on Day 1, 8, and 15
Monotherapy: IP FT516 at 9 x 10^7 Cells/Dose on Day 1, 8, and 15
Monotherapy: IP FT516 at 3 x 10^8 Cells/Dose on Day 1, 8, and 15

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Tebotelimab CohortExperimental Treatment2 Interventions
Enoblituzumab 15 mg/kg every 3 weeks plus tebotelimab 600 mg every 3 weeks for up to 35 cycles
Group II: Retifanlimab CohortExperimental Treatment2 Interventions
Enoblituzumab 15 mg/kg every 3 weeks plus retifanlimab 375 mg every 3 weeks for up to 35 cycles
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Enoblituzumab
2021
Completed Phase 1
~180
Retifanlimab
2018
Completed Phase 2
~430

Find a Location

Who is running the clinical trial?

MacroGenicsLead Sponsor
48 Previous Clinical Trials
5,070 Total Patients Enrolled
Chet Bohac, MD, PharmD, MScStudy DirectorMacroGenics
Chet Bohac, MD PharmD MScStudy DirectorMacroGenics
2 Previous Clinical Trials
303 Total Patients Enrolled
~13 spots leftby Dec 2025
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