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A Study to Evaluate NT219 Alone and in Combination With ERBITUX® (Cetuximab) in Adults With Advanced Solid Tumors and Head and Neck Cancer

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ClinicalTrials.gov Identifier: NCT04474470
Recruitment Status : Recruiting
First Posted : July 16, 2020
Last Update Posted : March 9, 2021
Sponsor:
Information provided by (Responsible Party):
Purple Biotech Ltd. ( TyrNovo Ltd. )

Study Description
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Brief Summary:
This is a phase 1/2, multi-center study with an open-label, dose escalation phase followed by a single-arm expansion phase to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of NT219 alone and in combination with ERBITUX® (cetuximab) in adults with recurrent and/or metastatic solid tumors.

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 83 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

Resource links provided by the National Library of Medicine

Drug Information available for: Cetuximab

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Part 1: Incidence of treatment emergent adverse events [ Time Frame: Up to 24 months ]
    Incidence of treatment emergent adverse events with single agent NT219

  2. 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®

  3. 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


Secondary Outcome Measures :
  1. 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

  2. Maximum plasma concentration [Cmax] [ Time Frame: Up to 45 days after first study drug administration ]
    Maximum plasma concentration [Cmax] of NT219

  3. 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

  4. Plasma half-life [t1/2] [ Time Frame: Up to 45 days after first study drug administration ]
    Plasma half-life [t1/2] of NT219

  5. Plasma clearance [Cl] [ Time Frame: Up to 45 days after first study drug administration ]
    Plasma clearance [Cl] of NT219

  6. Objective Response Rate when NT219 is used as monotherapy [ Time Frame: Up to 24 months ]
  7. Duration of Response when NT219 is used as monotherapy [ Time Frame: Up to 24 months ]
  8. Time to Response when NT219 is used as monotherapy [ Time Frame: Up to 24 months ]
  9. Disease Control Rate when NT219 is used as monotherapy [ Time Frame: Up to 24 months ]
  10. Progression Free Survival when NT219 is used as monotherapy [ Time Frame: Up to 24 months ]
  11. Time to Progression when NT219 is used as monotherapy [ Time Frame: Up to 24 months ]
  12. Overall Survival when NT219 is used as monotherapy [ Time Frame: Up to 24 months ]
  13. Objective Response Rate when NT219 is used in combination with ERBITUX® [ Time Frame: Up to 24 months ]
  14. Duration of Response when NT219 is used in combination with ERBITUX® [ Time Frame: Up to 24 months ]
  15. Time to Response when NT219 is used in combination with ERBITUX® [ Time Frame: Up to 24 months ]
  16. Disease Control Rate when NT219 is used in combination with ERBITUX® [ Time Frame: Up to 24 months ]
  17. Progression Free Survival when NT219 is used in combination with ERBITUX® [ Time Frame: Up to 24 months ]
  18. Time to Progression when NT219 is used in combination with ERBITUX® [ Time Frame: Up to 24 months ]
  19. Overall Survival when NT219 is used in combination with ERBITUX® [ Time Frame: Up to 24 months ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  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;
  2. Must have at least 1 measurable lesion per RECIST1.1 with progressing or new lesions since last antitumor therapy;
  3. ECOG performance status score of 0 or 1

  4. Adequate safety lab results:

    1. Albumin ≥3 g/dL;
    2. Bilirubin ≤1.5 times the upper limit of normal (ULN) or <3 times the ULN in the case of Gilbert Syndrome;
    3. Aspartate aminotransaminase (AST), alanine aminotransaminase (ALT), and alkaline phosphatase <3 times the ULN;
    4. 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];
    5. White blood cell (WBC) count ≥2000/uL; hemoglobin ≥9 g/dL;
  5. Stable brain metastases
  6. 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.
  7. 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:

  1. Any invasive cancer (other than non-melanoma skin cancer) different from the current disease within 3 years of Screening;
  2. 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.
  3. Radiation or major surgery within 4 weeks prior to the first dose of NT219;
  4. Treatment with another investigational therapy within 30 days or 5 halflives of the drug prior to Screening, whichever is longer
  5. Active, untreated central nervous system (CNS) metastases;
  6. Severely immunocompromised as defined by white blood cell (WBC) count <2000/mm3 and or CD4+ lymphocyte count ≤200/mm3;
  7. Major surgery within 4 weeks of study administration;
  8. Any condition which, in the opinion of the PI, places the subject at unacceptable risk if he/she were to participate in the study;
  9. History of weight loss >10% over the 2 months prior to Screening;

  10. 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
    • Uncontrolled infection HIV, HBV or HCV
  11. Pregnant or lactating women;
  12. Use of known UGT inhibitors within 14 days prior to first dose of study treatment
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Michael Schickler, PhD +972 3 933 3121 trials@purple-biotech.com
Contact: Naomi Yama, RN, BSN +972 3 933 3121 trials@purple-biotech.com

Locations
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United States, California
California Cancer Associates for Research and Excellence Recruiting
Encinitas, California, United States, 92024
Contact: Daniela Slavin    760-452-3909    dslavin@ccare.com   
The Angeles Clinic and Research Institute Recruiting
Los Angeles, California, United States, 90025
Contact: Saba Mukarram    310-231-2181    smukarram@theangelesclinic.org   
UCSD Moores Cancer Center Recruiting
San Diego, California, United States, 92037
Contact: Ashley Weaver    858-822-1962    aweaver@health.ucsd.edu   
United States, District of Columbia
MedStar Georgetown University Hospital Not yet recruiting
Washington, District of Columbia, United States, 20007
Contact: Stephanie Wagner    202-687-9782    sw1095@georgetown.edu   
United States, Illinois
The University of Chicago and Biological Sciences Not yet recruiting
Chicago, Illinois, United States, 60637
Contact: Katherine Rouse    773-702-8133    krouse@bsd.uchicago.edu   
United States, Louisiana
Ochsner Clinic Foundation Recruiting
New Orleans, Louisiana, United States, 70121
Contact: Mia Saponara    504-842-6729    mia.saponara@ochsner.org   
Sponsors and Collaborators
TyrNovo Ltd.
Investigators
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Study Director: Michael Schickler, PhD TyrNovo Ltd.
More Information
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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: March 9, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Purple Biotech Ltd. ( TyrNovo Ltd. ):
NT219
ERBITUX
Cetuximab
Additional relevant MeSH terms:
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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