This is a Phase 2, open-label, multicenter, single-arm study of NRC-2694-A in combination with paclitaxel in patients with R/M HNSCC with progression on or after ICI therapy.
A total of approximately 46 male and female patients will be enrolled. This sample size is based on Simon's 2-stage design with historical control ORR of 30% and a target ORR of 50%.
Is willing and capable of understanding the written informed consent, provides signed and witnessed written informed consent, and agrees to comply with protocol requirements.
Is male or female aged 18 years or older at the time of consent.
Has histologically confirmed unresectable R/M HNSCC (oral cavity, oropharynx, hypopharynx, and larynx).
Has documented progressive disease assessed by the principal investigator according to RECIST v1.1.
Has cardiac, hepatic, endocrine, pulmonary, or autoimmune disease, interstitial lung disease, renal or psychiatric disorders, not controlled with therapy corresponding to the illness or a condition that contraindicates the use of a taxane or an EGFR inhibitor.
Has Cirrhosis of liver at a level of Child-Pugh B (or worse).
Has uncontrolled brain metastases. Patients are allowed if brain metastasis has been previously treated with surgery, whole brain irradiation, and/or stereotactic radiosurgery and are considered controlled (controlled by the dose ≤10 mg/day of prednisone or equivalent) at the time of the first dose of investigational product. Radiological evaluation of brain metastasis will be performed only if the patient has symptoms. For asymptomatic patients, brain imaging during screening is not required.
Has baseline prolongation of QT/QTc interval (eg, repeated demonstration of a QTc interval >480 milliseconds [CTCAE Grade 1] using Fredericia's QT correction formula).
Single group
NRC-2694-A
Drug300 mg orally once daily
Paclitaxel
Drug175 mg/m² IV infusion over approximately 3 hours
To determine if NRC-2694-A administered orally in combination with paclitaxel demonstrates objective response in patients with R/M HNSCC, who have had radiological progression on or after treatment with ICI therapies like pembrolizumab or nivolumab
Objective response in terms of CR/PR per RECIST v1.1
Progression-free survival
defined as the interval of time between the date of enrollment to the earliest date of disease progression, as determined by local radiologic assessment per RECIST v1.1, or death due to any cause, whichever occurs first
Overall survival
defined as the time from the date of enrollment to the date of death due to any cause
Duration of response
defined as the time from first confirmed objective response to disease progression
Clinical benefit response
defined as CR + PR + SD for ≥ 6 months
To determine the association between NRC-2694-A activity and biomarkers in blood samples using Epidermal growth factor receptor status in EGFR (epidermal growth factor receptor) gene
as determined by NeoLAB® NGS platform biomarker assessment
To determine the association between NRC-2694-A activity and biomarkers in blood samples using downstream signaling in EGFR gene
as determined by NeoLAB® NGS platform biomarker assessment
To determine the association between NRC-2694-A activity and biomarkers in blood samples using mutations in EGFR gene
as determined by NeoLAB® NGS platform biomarker assessment
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