Clinical Trials Logo

Clinical Trial 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%.


Clinical Trial 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 as a monotherapy. This was further substantiated in a Phase-II study in combination with cisplatin/carboplatin and paclitaxel. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05283226
Study type Interventional
Source NATCO Pharma Ltd.
Contact Praveen Myneni, MBBS
Phone +91 40 23547532
Email drpraveen@natcopharma.co.in
Status Recruiting
Phase Phase 2
Start date September 30, 2022
Completion date January 2, 2025

See also
  Status Clinical Trial Phase
Active, not recruiting NCT04362072 - Study of Lorlatinib In People With ALK-positive Non-small Cell Lung Cancer Phase 4
Completed NCT04033991 - Study of Patients With Metastatic and/or Advanced Renal Cell Carcinoma, Treated With Sunitinib/Axitinib.
Recruiting NCT02292641 - Beyond TME Origins N/A
Not yet recruiting NCT02907606 - Urinary Circulating Tumor DNA Detection in Non-small Cell Lung Cancer: a Prospective Study N/A
Completed NCT02507544 - A Safety and Pharmacokinetic Study of TRX-818 Administered Orally to Patients With Advanced Cancer Phase 1
Completed NCT01942200 - A Non Interventional Study With Oxaliplatin Onkovis (Oxaliplatin) Utilized for the Treatment of Cancer
Completed NCT01061645 - Study of MOC31-PE in Antigen Positive Carcinomas Phase 1
Completed NCT00532155 - A Study of Aflibercept Versus Placebo in Patients With Second-Line Docetaxel for Locally Advanced or Metastatic Non-Small-Cell Lung Cancer Phase 3
Terminated NCT00557596 - A Phase 1-2, XIAP Antisense AEG35156 With Gemcitabine in Patients With Advanced Pancreatic Cancer Phase 1/Phase 2
Completed NCT00216372 - Efficacy and Safety of Lanreotide Microparticles as Palliative Treatment in Peritoneal Carcinomatosis Phase 3
Recruiting NCT06022757 - Study of XNW5004 Tablet in Combination With KEYTRUDA® (Pembrolizumab) in Subjects With Advanced Solid Tumors Who Failed Standard Treatments (KEYNOTE F19) Phase 1/Phase 2
Recruiting NCT05520281 - Short-term Psychodynamic Psychotherapy in Serious Physical Illness N/A
Recruiting NCT05752357 - The Role of Pre-operative and Post-operative Circulating Tumor Cells in Gastric Cancer.
Not yet recruiting NCT05023928 - Tumor Antigen-sensitized DC Vaccine as an Adjuvant Therapy for Esophagus Cancer Phase 1
Completed NCT00446446 - PRISM (Panitumumab Regimen In Second-line Monotherapy of Head and Neck Cancer) Phase 2
Recruiting NCT04566952 - Anlotinib Combined With Dose-reduced Olaparib in Patients With Platinum-Sensitive Recurrent Ovarian Cancer Phase 2
Not yet recruiting NCT06112041 - The Prospective Clinical Study of Precision PRaG Therapy in Elderly Patients With Advanced Solid Malignant Tumors (PRaG9.0) Phase 2
Completed NCT03562897 - Evaluation of Ocoxin-Viusid® in Advanced or Metastatic Ovarian Epithelial Cancer Phase 2
Recruiting NCT06013111 - An Exploratory Clinical Study Evaluating the Safety and Efficacy of Anti-CEA-CAR-T Cells Injection in Patients With CEA+ Locally Advanced and/or Metastatic Solid Tumors Phase 1
Active, not recruiting NCT04600206 - Existential Distress in Patients With Advanced Cancer and Their Caregivers