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

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%.

Trial Details

NCT ID
NCT05283226
Phase
PHASE2
Sponsor
NATCO Pharma Ltd.
Status
RECRUITING
Cancer Type
Head and Neck Cancer
Interventions
  • NRC-2694-A
  • Paclitaxel
Locations (sample)
  • Fullerton, California, United States|33.87029,-117.92534
  • Los Angeles, California, United States|34.05223,-118.24368
  • Boca Raton, Florida, United States|26.35869,-80.0831
  • Miami, Florida, United States|25.77427,-80.19366
  • Louisville, Kentucky, United States|38.25424,-85.75941

Key Eligibility Criteria

  • Is willing and capable of understanding the written informed consent, provides signed and witnessed written informed consent, and agrees to comply …
  • 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.

For full eligibility, visit ClinicalTrials.gov.

Check If You May Be Eligible

Trialify translates complex eligibility criteria into plain yes-or-no questions to help you understand if this trial might be right for you.

Find Head and Neck Cancer Trials on Trialify →