← Back to Search

Monoclonal Antibodies

NT219 + Cetuximab for Head and Neck Cancer

Phase 1 & 2
Waitlist Available
Research Sponsored by TyrNovo Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
ECOG performance status score of 0 or 1
Subject with previously treated advanced solid tumors (Portion 1) or recurrent and/or metastatic squamous cell carcinoma of the head and neck (Portion 2 and 3) or colorectal adenocarcinoma, stage III/IV (Portion 2) that must have failed or not be a candidate for available standard of care therapies with documented progression/intolerance following the most recent prior regimen;
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 months
Awards & highlights

Study Summary

This trial is testing a new drug, NT219, to see if it is safe and effective against solid tumors. The trial will have two parts, first testing different doses of NT219 to see what is safe, then testing NT219 with another drug, ERBITUX, to see if it is more effective than ERBITUX alone.

Who is the study for?
Adults with advanced solid tumors, head and neck cancer, or colorectal cancer that's worsened after treatment can join. They must have at least one measurable tumor lesion, be in fairly good health (ECOG score of 0 or 1), and not have had recent major surgery or other treatments. Women who can bear children must test negative for pregnancy and agree to use birth control.Check my eligibility
What is being tested?
The trial is testing NT219 alone and combined with ERBITUX® (Cetuximab) in a two-part study: first to find the right dose (dose escalation) then to see how well it works (expansion phase). It aims to evaluate safety, tolerability, how the body processes the drugs, their effects on tumors, and overall effectiveness.See study design
What are the potential side effects?
Possible side effects include reactions related to drug infusion, changes in liver enzymes which may indicate liver issues, fatigue from low red blood cell counts (anemia), potential kidney function changes indicated by creatinine clearance levels, as well as general risks associated with chemotherapy such as nausea.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am fully active or restricted in physically strenuous activity but can do light work.
Select...
My advanced cancer has not improved with standard treatments.
Select...
I haven't taken any cancer treatment drugs or experimental agents for at least 4 weeks, or 6 weeks for specific immunotherapies, and any side effects I had are now minimal.
Select...
My brain cancer has not grown or spread recently.
Select...
I have at least one tumor that can be measured and has grown since my last cancer treatment.
Select...
I am fully active or restricted in physically strenuous activity but can do light work.
Select...
My kidneys work well, with a creatinine clearance over 60 mL/min.
Select...
I have advanced cancer that standard treatments no longer control.
Select...
I have at least one tumor that can be measured and has grown since my last cancer treatment.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Part 1: Incidence of treatment emergent adverse events
Part 2: Incidence of treatment emergent adverse events
Part 3: Objective Response Rate
Secondary outcome measures
Area under the plasma concentration curve [AUC]
Disease Control Rate when NT219 is used as monotherapy
Disease Control Rate when NT219 is used in combination with ERBITUX®
+16 more

Side effects data

From 2013 Phase 2 trial • 86 Patients • NCT01256385
75%
Fatigue
65%
Anemia
48%
Hyperglycemia
43%
Lymphocyte count decreased
38%
Anorexia
35%
Platelet count decreased
35%
Constipation
35%
Cough
35%
Nausea
30%
Pain
30%
Mucositis oral
28%
Dyspnea
28%
White blood cell decreased
28%
Hypoalbuminemia
25%
Alanine aminotransferase increased
25%
Cholesterol high
25%
Hypertriglyceridemia
23%
Dysphagia
20%
Depression
20%
Fever
20%
Hypophosphatemia
20%
Weight loss
18%
Non-cardiac chest pain
18%
Alkaline phosphatase increased
18%
Aspartate aminotransferase increased
18%
Insomnia
18%
Headache
18%
Hyponatremia
18%
Hypocalcemia
18%
Hypokalemia
15%
Edema face
15%
Vomiting
15%
Creatinine increased
15%
Neck pain
15%
Peripheral sensory neuropathy
13%
Infections and infestations - Other
13%
Diarrhea
13%
Dysgeusia
13%
Rash acneiform
13%
Rash maculo-papular
10%
Neutrophil count decreased
10%
Dizziness
10%
Arthralgia
10%
Edema limbs
8%
Anxiety
8%
Oral dysesthesia
8%
Respiratory failure
8%
Pneumonitis
8%
Pruritus
8%
Facial pain
8%
Back pain
8%
Dry mouth
8%
Dry skin
8%
Hypertension
8%
INR increased
8%
Neck edema
5%
Allergic rhinitis
5%
Pleural effusion
5%
General disorders and administration site conditions - Other
5%
Hypernatremia
5%
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other
5%
Skin infection
5%
Dyspepsia
5%
Ear pain
5%
Epistaxis
5%
Gastroesophageal reflux disease
5%
Generalized muscle weakness
5%
Hypomagnesemia
5%
Leukocytosis
5%
Lung infection
5%
Lymphedema
5%
Sore throat
5%
Tumor pain
5%
Urinary frequency
5%
Hearing impaired
5%
Sinusitis
5%
Chills
5%
Dehydration
5%
Hypercalcemia
5%
Hyperkalemia
5%
Myalgia
5%
Papulopustular rash
3%
Tracheostomy site bleeding
3%
Vertigo
3%
Alopecia
3%
Oral pain
3%
Pharyngeal hemorrhage
3%
Laryngeal obstruction
3%
Anorectal infection
3%
Hypoxia
3%
Pleural infection
3%
Pleuritic pain
3%
Pneumothorax
3%
Respiratory, thoracic and mediastinal disorders - Other
3%
Stridor
3%
Postnasal drip
3%
Skin and subcutaneous tissue disorders - Other
3%
Skin ulceration
3%
Eye disorders - Other
3%
Heart failure
3%
Tracheal hemorrhage
3%
Blurred vision
3%
Hypotension
3%
Palmar-plantar erythrodysesthesia syndrome
3%
Peripheral motor neuropathy
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm B (Temsirolimus)
Arm A (Cetuximab and Temsirolimus)

Trial Design

3Treatment groups
Experimental Treatment
Group I: Expansion cohort of NT219 in combination with ERBITUX®Experimental Treatment1 Intervention
Group II: Dose escalation of NT219 in combination with ERBITUX®Experimental Treatment1 Intervention
Group III: Dose escalation of NT219 as a single agentExperimental Treatment1 Intervention

Find a Location

Who is running the clinical trial?

TyrNovo Ltd.Lead Sponsor
Michael Schickler, PhDStudy DirectorTyrNovo Ltd.
1 Previous Clinical Trials
79 Total Patients Enrolled

Frequently Asked Questions

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

How many health care facilities are administering this experiment?

"For this trial, patients can be enrolled at Stephenson Cancer Center in Oklahoma City, Ochsner Clinic Foundation in New Orleans and UCSD Moores Cancer Center in San Diego. In addition to these sites, 7 other locations are available for enrollment."

Answered by AI

Is enrollment for this research endeavor presently available to participants?

"Affirmative. According to clinicaltrials.gov, this experimental therapy is currently looking for participants, with the trial being first posted on September 3rd 2020 and last updated on May 2nd 2022. A total of 83 subjects are needed at 7 different sites."

Answered by AI

What is the predominant purpose for which doctors prescribe NT219?

"The go-to pharmacotherapy for NT219 is treating the aforementioned conditions. It can be useful in managing regionally advanced squamous cell carcinoma of the head and neck, metastatic squamous cell carcinoma of that same area, as well as other forms of squamous cell carcinoma."

Answered by AI

What has been the cumulative enrollment of this research trial?

"Correct. According to the clinicaltrials.gov website, this medical trial's recruitment process is ongoing and began on September 3rd 2020 with an update issued in May 2022. A total of 83 trials participants must be recruited from 7 different sites."

Answered by AI

Is there evidence of prior experiments that have included NT219?

"Presently, 121 clinical trials for NT219 are ongoing. Of those active projects, 30 entail Phase 3 studies and have locations in Dresden as well as Arizona. Across the globe, 5333 sites are participating in these medical tests."

Answered by AI

Who else is applying?

What state do they live in?
Oklahoma
How old are they?
18 - 65
What site did they apply to?
Stephenson Cancer Center
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
A Study to Evaluate NT219 Alone and in Combination With ERBITUX® (Cetuximab) in Adults With Advanced Solid Tumors and Head and Neck Cancer
2020. "A Study to Evaluate NT219 Alone and in Combination With ERBITUX® (Cetuximab) in Adults With Advanced Solid Tumors and Head and Neck Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04474470.
All > Colorectal Cancer San Diego > Head And Neck Cancer
~2 spots leftby Jun 2024
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top