← Back to Search

Monoclonal Antibodies

Combination cohort 1 for Oral Squamous Cell Carcinoma

Phase 1
Waitlist Available
Led By Bradley Sumrow, MD
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 throughout the study, up to 4 years.
Awards & highlights

Study Summary

This trial is testing a new cancer drug to see how safe and effective it is.

Eligible Conditions
  • Oral Squamous Cell Carcinoma
  • Bile Duct Cancer
  • Blood Cancers
  • Solid Tumors
  • Ovarian Cancer
  • Non-Small Cell Lung Cancer
  • Small Cell Lung Cancer
  • Squamous Cell Carcinoma
  • Cervical Cancer
  • Breast Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~throughout the study, up to 4 years.
This trial's timeline: 3 weeks for screening, Varies for treatment, and throughout the study, up to 4 years. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of participants with Treatment-Emergent Adverse Events (TEAE) as assessed by CTCAE v4.03 (tebotelimab monotherapy)
Number of participants with Treatment-Emergent Adverse Events as assessed by CTCAE v4.03 (tebotelimab plus margetuximab)
Secondary outcome measures
Apparent volume of distribution at steady state (Vss) of tebotelimab
Area Under the Plasma Concentration versus Time Curve (AUC) of tebotelimab
Maximum Plasma Concentration (Cmax) of tebotelimab and tebotelimab plus margetuximab
+9 more

Trial Design

12Treatment groups
Experimental Treatment
Group I: Tebotelimab: 800 mgExperimental Treatment1 Intervention
Group II: Tebotelimab: 600 mgExperimental Treatment1 Intervention
Group III: Tebotelimab: 400 mgExperimental Treatment1 Intervention
Group IV: Tebotelimab: 30 mgExperimental Treatment1 Intervention
Group V: Tebotelimab: 1200 mgExperimental Treatment1 Intervention
Group VI: Tebotelimab: 120 mgExperimental Treatment1 Intervention
Group VII: Tebotelimab: 10 mgExperimental Treatment1 Intervention
Group VIII: Tebotelimab: 1 mgExperimental Treatment1 Intervention
Group IX: Tebotelimab 3 mgExperimental Treatment1 Intervention
Group X: Monotherapy Cohort ExpansionExperimental Treatment1 Intervention
Monotherapy expansion at 600 mg
Group XI: Combination cohort 1Experimental Treatment2 Interventions
Tebotelimab and margetuximab
Group XII: Combination Cohort 2Experimental Treatment2 Interventions
Tebotelimab and margetuximab
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
tebotelimab 800 mg
2017
Completed Phase 1
~280
tebotelimab 3 mg
2017
Completed Phase 1
~280
margetuximab
2017
Completed Phase 1
~350
tebotelimab 1 mg
2017
Completed Phase 1
~280
tebotelimab 10 mg
2017
Completed Phase 1
~280
tebotelimab 30 mg
2017
Completed Phase 1
~280
tebotelimab 1200 mg
2017
Completed Phase 1
~280
tebotelimab 120 mg
2017
Completed Phase 1
~280
tebotelimab 300 mg
2017
Completed Phase 1
~280
tebotelimab 400 mg
2017
Completed Phase 1
~280
tebotelimab 600 mg
2017
Completed Phase 1
~280

Find a Location

Who is running the clinical trial?

MacroGenicsLead Sponsor
48 Previous Clinical Trials
5,099 Total Patients Enrolled
Bradley Sumrow, MDPrincipal InvestigatorMacroGenics
1 Previous Clinical Trials
162 Total Patients Enrolled
Ashley Ward, MDStudy DirectorMacroGenics
2 Previous Clinical Trials
54 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current scope of this trial's implementation?

"This clinical trial is being conducted in UPMC Hillman Cancer Center, Pittsburgh; Massachusetts General Hospital and Dana-Farber Cancer Institute, Boston; UCLA Hematology & Oncology Clinic, Los Angeles; as well as 15 other medical centres."

Answered by AI

What is the current enrolment count for this trial?

"Currently this medical trial is not enrolling new participants. It was first published on August 18th 2017 and last updated June 15th 2022. If in search of other studies, there are 7897 trials actively recruiting for oral squamous cell carcinoma patients and 3 clinical trials admitting enrollees for tebotelimab treatment."

Answered by AI

What outcomes are researchers hoping to ascertain from this experiment?

"This 24 month clinical trial has the primary objective of determining Maximum Tolerated Dose. Secondary objectives include evaluating Terminal half-life (t1/2), Area Under the Plasma Concentration versus Time Curve (AUC) and Preliminary anti-tumor activity of MGD013 in combination with margetuximab."

Answered by AI

Are there any extant assessments of tebotelimab's efficacy?

"Currently, 3 clinical trials involving tebotelimab are in the midst of being conducted with one trial having reached Phase 3. These research sites span 132 locations across America, mainly situated within Washington D.C.."

Answered by AI

What makes this particular trial unique?

"At present, there are 3 active clinical trials of tebotelimab taking place across 57 cities and 15 countries. MacroGenics initiated the first study in 2017 with 353 participants that successfully managed to pass through Phase 1 drug approval stage. Since then, a further 5 studies have been completed."

Answered by AI

How perilous is the use of tebotelimab to patients?

"Since tebotelimab is currently in its first clinical trial, Power rated it as a 1 on the safety scale - meaning there exists only limited data supporting efficacy and security."

Answered by AI

Is enrollment for this research project still available?

"The information on clinicaltrials.gov displays that this trial, initially posted on August 18th 2017 and last updated June 15th 2022, is not presently seeking participants for enrollment. However, there are 7900 other trials in progress which might be a suitable alternative for prospective patients."

Answered by AI
~36 spots leftby Apr 2025