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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
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I am fully active or restricted in physically strenuous activity but can do light work.
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My advanced cancer has not improved with standard treatments.
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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.
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My brain cancer has not grown or spread recently.
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I have at least one tumor that can be measured and has grown since my last cancer treatment.
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I am fully active or restricted in physically strenuous activity but can do light work.
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My kidneys work well, with a creatinine clearance over 60 mL/min.
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I have advanced cancer that standard treatments no longer control.
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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%
Arthralgia
10%
Neutrophil count decreased
10%
Dizziness
10%
Edema limbs
8%
Oral dysesthesia
8%
Anxiety
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%
Alopecia
3%
Oral pain
3%
Tracheostomy site bleeding
3%
Vertigo
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

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for colorectal cancer often target key signaling pathways involved in cancer cell growth and survival. NT219, for example, modulates signaling pathways such as IRS1/2 and STAT3, which are crucial for cancer cell proliferation and resistance to apoptosis. Similarly, other treatments like cetuximab target the epidermal growth factor receptor (EGFR) pathway, which is often overactive in colorectal cancer cells, leading to uncontrolled growth. Chemotherapy agents like oxaliplatin and fluorouracil disrupt DNA replication and repair, causing cancer cell death. Understanding these mechanisms is vital for colorectal cancer patients as it helps in selecting the most effective treatment based on the specific molecular characteristics of their tumors, potentially improving outcomes and reducing resistance to therapy.

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
~23 spots leftby Jun 2025
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