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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Recruiting
participants needed

83
sponsor

TyrNovo Ltd.

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Updated on 19 February 2024

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cancer

serum pregnancy test

measurable disease

metastasis

solid tumour

gilbert's syndrome

squamous cell carcinoma of head and neck

squamous cell carcinoma

adenocarcinoma

brain metastases

carcinoma

solid tumors

cetuximab

metastases

head and neck cancer

pd-l1

neck cancer

head and neck carcinoma

metastatic squamous cell carcinoma

erbitux

colorectal adenocarcinoma

interleukin-2

squamous cell carcinoma of the head and neck

brain metastasis

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.

Details

Condition	Squamous cell carcinoma, Squamous cell carcinoma, head and neck cancer, head and neck cancer, Metastatic Solid Tumor, Colorectal Adenocarcinoma, Solid Tumor, Adult, Recurrent Solid Tumor
Age	18-100 years
Treatment	NT219, NT219 and ERBITUX® - Dose Escalation, NT219 and ERBITUX® - Expansion
Clinical Study Identifier	NCT04474470
Sponsor	TyrNovo Ltd.
Last Modified on	19 February 2024

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Eligibility		Yes	No	Not Sure
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 (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
	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
	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
	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

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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