A Study to Evaluate NT219 Alone and in Combination With ERBITUX® (Cetuximab) in Adults With Advanced Solid Tumors and Head and Neck Cancer
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT04474470 |
Recruitment Status :
Recruiting
First Posted : July 16, 2020
Last Update Posted : December 14, 2022
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Solid Tumor, Adult Squamous Cell Carcinoma of Head and Neck Colorectal Adenocarcinoma Metastatic Solid Tumor Recurrent Solid Tumor Head and Neck Cancer | Drug: NT219 Drug: NT219 and ERBITUX® - Dose Escalation Drug: NT219 and ERBITUX® - Expansion | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 75 participants |
Allocation: | Non-Randomized |
Intervention Model: | Sequential Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase 1/2 Study With Open-Label, Dose Escalation Phase Followed by Single-Arm Expansion at the Maximum Tolerated Dose to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of NT219 Injection Alone and in Combination With ERBITUX® (Cetuximab) in Adults With Advanced Solid Tumors and Head and Neck Cancer |
Actual Study Start Date : | September 3, 2020 |
Estimated Primary Completion Date : | June 2023 |
Estimated Study Completion Date : | September 2023 |

Arm | Intervention/treatment |
---|---|
Experimental: Dose escalation of NT219 as a single agent |
Drug: NT219
Dose escalation of NT219 as a single agent in adult subjects with recurrent and/or metastatic solid tumors |
Experimental: Dose escalation of NT219 in combination with ERBITUX® |
Drug: NT219 and ERBITUX® - Dose Escalation
Dose escalation of NT219 in combination with standard dose ERBITUX® in adult subjects with recurrent and/or metastatic squamous cell carcinoma of the head and neck and colorectal adenocarcinoma |
Experimental: Expansion cohort of NT219 in combination with ERBITUX® |
Drug: NT219 and ERBITUX® - Expansion
Expansion cohort of NT219 at its RP2D in combination with standard dose ERBITUX® in adult patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck |
- Part 1: Incidence of treatment emergent adverse events [ Time Frame: Up to 24 months ]Incidence of treatment emergent adverse events with single agent NT219
- Part 2: Incidence of treatment emergent adverse events [ Time Frame: Up to 24 months ]Incidence of treatment emergent adverse events with NT219 administered in combination with ERBITUX®
- Part 3: Objective Response Rate [ Time Frame: Up to 24 months ]Objective Response Rate when phase 2 dose of NT219 is used in combination with ERBITUX® in adults with recurrent and/or metastatic SCCHN
- Area under the plasma concentration curve [AUC] [ Time Frame: Up to 45 days after first study drug administration ]Area under the plasma concentration curve [AUC] of NT219
- Maximum plasma concentration [Cmax] [ Time Frame: Up to 45 days after first study drug administration ]Maximum plasma concentration [Cmax] of NT219
- Volume of distribution at stead-state [Vss] [ Time Frame: Up to 45 days after first study drug administration ]Volume of distribution at stead-state [Vss] of NT219
- Plasma half-life [t1/2] [ Time Frame: Up to 45 days after first study drug administration ]Plasma half-life [t1/2] of NT219
- Plasma clearance [Cl] [ Time Frame: Up to 45 days after first study drug administration ]Plasma clearance [Cl] of NT219
- Objective Response Rate when NT219 is used as monotherapy [ Time Frame: Up to 24 months ]
- Duration of Response when NT219 is used as monotherapy [ Time Frame: Up to 24 months ]
- Time to Response when NT219 is used as monotherapy [ Time Frame: Up to 24 months ]
- Disease Control Rate when NT219 is used as monotherapy [ Time Frame: Up to 24 months ]
- Progression Free Survival when NT219 is used as monotherapy [ Time Frame: Up to 24 months ]
- Time to Progression when NT219 is used as monotherapy [ Time Frame: Up to 24 months ]
- Overall Survival when NT219 is used as monotherapy [ Time Frame: Up to 24 months ]
- Objective Response Rate when NT219 is used in combination with ERBITUX® [ Time Frame: Up to 24 months ]
- Duration of Response when NT219 is used in combination with ERBITUX® [ Time Frame: Up to 24 months ]
- Time to Response when NT219 is used in combination with ERBITUX® [ Time Frame: Up to 24 months ]
- Disease Control Rate when NT219 is used in combination with ERBITUX® [ Time Frame: Up to 24 months ]
- Progression Free Survival when NT219 is used in combination with ERBITUX® [ Time Frame: Up to 24 months ]
- Time to Progression when NT219 is used in combination with ERBITUX® [ Time Frame: Up to 24 months ]
- Overall Survival when NT219 is used in combination with ERBITUX® [ Time Frame: Up to 24 months ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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 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;
- Must have at least 1 measurable lesion per RECIST1.1 with progressing or new lesions since last antitumor therapy;
- ECOG performance status score of 0 or 1 at screening and baseline
-
Adequate safety lab results:
- Albumin ≥3 g/dL;
- Bilirubin ≤1.5 times the upper limit of normal (ULN) or <3 times the ULN in the case of Gilbert Syndrome;
- Aspartate aminotransaminase (AST), alanine aminotransaminase (ALT), and alkaline phosphatase <3 times the ULN;
- Creatinine clearance >60 mL/minute based on the Cockcroft-Gault equation [creatinine clearance in mL/min = (140 - age in years) x body weight (kg)/72 x serum creatinine (mg/dL); multiplied by 0.85 for women];
- White blood cell (WBC) count ≥2000/uL; hemoglobin ≥9 g/dL;
- Stable brain metastases
- Subjects must have a "wash out" period of at least 4 weeks prior to first study drug administration from all previous chemotherapy and experimental agents except for anti-CTLA4, anti-PD-L1, anti-PD-1 antibodies and IL-2 which must have a "wash out" period of at least 6 weeks prior to first study drug administration, and all adverse events (AEs) have either returned to baseline or stabilized at Grade 1 or less.
- WCBP must have a negative serum pregnancy test at Screening and a negative urine pregnancy test, WCBP must agree to abstain from sex or use an adequate method of contraception, males must abstain from sex with WCBP or use an adequate method of contraception
Exclusion Criteria:
- Any invasive cancer (other than non-melanoma skin cancer) different from the current disease within 3 years of Screening;
- Known hypersensitivity to epidermal growth factor receptor (EGFR), Janus kinase (JAK), or signal transducer and activator of transcription (STAT) antagonists/inhibitors, or inactive ingredients of NT219.
- Radiation or major surgery within 4 weeks prior to the first dose of NT219;
- Treatment with another investigational therapy within 30 days or 5 halflives of the drug prior to Screening, whichever is longer
- Active, untreated central nervous system (CNS) metastases;
- Severely immunocompromised as defined by white blood cell (WBC) count <2000/mm3 and or CD4+ lymphocyte count ≤200/mm3;
- Major surgery within 4 weeks of study administration;
- Any condition which, in the opinion of the PI, places the subject at unacceptable risk if he/she were to participate in the study;
- History of weight loss >10% over the 2 months prior to Screening;
-
Clinically relevant serious co-morbid medical conditions, including:
- Active infection; history of active or latent tuberculosis infection
- Cardiovascular (e.g., History of long QT syndrome, NYHA) Class III or IV cardiac disease)
- Pulmonary (e.g., GOLD score ≥3, chronic obstructive, chronic restrictive pulmonary disease)
- Active CNS disease including carcinomatous meningitis;
- Psychiatric illness/social situation that would limit compliance with study requirements;
- Prior organ allograft;
- Subjects with active, known or suspected autoimmune disease
- History of active or latent tuberculosis infection
- Uncontrolled infection HIV, HBV or HCV
- Pregnant or lactating women;
- Use of known UGT inhibitors within 14 days prior to first dose of study treatment

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04474470
Contact: Michael Schickler, PhD | +972 3 933 3121 | trials@purple-biotech.com | |
Contact: Yifat Zaik, MSc | +972 54 5216 996 | trials@purple-biotech.com |
United States, California | |
California Cancer Associates for Research and Excellence | Recruiting |
Encinitas, California, United States, 92024 | |
Contact: Christina Spencer 760-452-3909 CSpencer@ccare.com | |
The Angeles Clinic and Research Institute | Active, not recruiting |
Los Angeles, California, United States, 90025 | |
UCSD Moores Cancer Center | Recruiting |
San Diego, California, United States, 92037 | |
Contact: Nidhi Patel 858-822-1962 nidpatel@health.ucsd.edu | |
Contact: Jona Plevin +1-858-246-3253 jplevin@health.ucsd.edu | |
United States, District of Columbia | |
MedStar Georgetown University Hospital | Recruiting |
Washington, District of Columbia, United States, 20007 | |
Contact: Jennifer Montcalm 202-687-8974 jem257@georgetown.edu | |
Contact: Christina Benedict +1-202-687-9861 cnb54@georgetown.edu | |
United States, Illinois | |
The University of Chicago and Biological Sciences | Recruiting |
Chicago, Illinois, United States, 60637 | |
Contact: Jeffery Chin 773-834-5004 jchin18@medicine.bsd.uchicago.edu | |
Contact: Varsha Yarra +1-773-702-7166 vyarra@bsd.uchicago.edu | |
United States, Louisiana | |
Ochsner Clinic Foundation | Recruiting |
New Orleans, Louisiana, United States, 70121 | |
Contact: Morgan Smith 504-703-7216 morgan.smith@ochsner.org | |
Contact: Amanda Woolery +1-504-842-0275 Amanda.woolery@ochsner.org | |
United States, Oklahoma | |
Stephenson Cancer Center | Recruiting |
Oklahoma City, Oklahoma, United States, 73117 | |
Contact: Christina Caldwell 405-271-8001 ext 48171 christina-caldwelL@ouhsc.edu | |
Israel | |
Hadassah University Medical Center | Recruiting |
Jerusalem, Israel | |
Contact: Nechana Busheri +972-54-5250296 nechamas@hadassah.org.il | |
Rabin Medical Center | Recruiting |
Petah tikva, Israel | |
Contact: Chen Meir +972-50-7189660 chenme3@clalit.org.il | |
Contact: Liad Carmel +972-54-4594048 liadca@clalit.org.il | |
Sourasky Medical Center | Recruiting |
Tel Aviv, Israel | |
Contact: Aleksandra Kunin +972-54-8066902 aleksandraku@tlvmc.gov.il |
Study Director: | Michael Schickler, PhD | TyrNovo Ltd. |
Responsible Party: | TyrNovo Ltd. |
ClinicalTrials.gov Identifier: | NCT04474470 |
Other Study ID Numbers: |
TYR-219-01 |
First Posted: | July 16, 2020 Key Record Dates |
Last Update Posted: | December 14, 2022 |
Last Verified: | December 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
NT219 ERBITUX Cetuximab |
Neoplasms Head and Neck Neoplasms Squamous Cell Carcinoma of Head and Neck Carcinoma, Squamous Cell Carcinoma Neoplasms, Glandular and Epithelial |
Neoplasms by Histologic Type Neoplasms by Site Cetuximab Antineoplastic Agents, Immunological Antineoplastic Agents |