A Phase 2 Multicenter, Open-Label, Single-Arm Study to Evaluate the Safety and Efficacy of Oral NRC-2694-A in Combination With Paclitaxel in Patients With Recurrent and/or Metastatic Head and Neck Squamous Cell Carcinoma, Who Progressed on or After Immune Checkpoint Inhibitor Therapy
NATCO Pharma Ltd.
Summary
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%.
Description
Patients with recurrent and/or metastatic unresectable Head and Neck Cancer have a poor prognosis and limited treatment options. Pembrolizumab and Nivolumab, both ICIs (Immune Checkpoint Inhibitors), are approved therapies for this condition. However, no approved treatment options exist for patients who progress on ICI therapies. Hence, there is an unmet medical need post-failure of ICI therapy. NRC-2694-A is an orally administered small-molecule tyrosine kinase inhibitor. It was discovered and developed by NATCO Pharma Ltd. NRC-2694-A demonstrated response in HNSCC patients in a Phase-I study…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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 a measurable lesion per RECIST v1.1. * Has ECOG performance status score of ≤2. * Must have progressed during or after re…
Interventions
- DrugNRC-2694-A
300 mg orally once daily
- DrugPaclitaxel
175 mg/m² IV infusion over approximately 3 hours
Locations (13)
- Providence Medical Foundation -FullertonFullerton, California
- Los Angeles Hematology Oncology Medical GroupLos Angeles, California
- Lynn Cancer CenterBoca Raton, Florida
- Miami Cancer CenterMiami, Florida
- Norton Cancer Institute - DowntownLouisville, Kentucky
- University of Maryland Greenebaum Cancer CenterBaltimore, Maryland