Ongoing Clinical trials

Ongoing Clinical trials approved by VIEC since January 2023

1. Open Label First In Human Study Investigating the Safety, Tolerability, Pharmacokinetics, and Preliminary Anti-tumor Activity of HPK1 Inhibitor GRC 54276 Alone and in Combination With Anti-PD-1 Monoclonal Antibody Pembrolizumab or Anti-PD-L1 Atezolizumab in Subjects With Advanced Solid Tumors and Lymphomas.
   Protocol Number: GRC 54276-101_Protocol Version 3.0_dated 18-Oct-2022
   Principal Investigator: Dr. Manjunath. Department of Medical Oncology.
2.  A Phase IIb/III, Randomized, Double-blind, Placebo-controlled, Multi centre, Study of CA-170 in Combination with Chemotherapy in Patients with Stage IV Non-Squamous Non-Small Cell Lung Cancer (ASIAD-3)
   Protocol No: CA-170-302
   Principal Investigator: Dr. Shashidhar Karpurnath, Department of Medical Oncology
3. A randomized, double blind, placebo-controlled, multi-center phase III study to evaluate the efficacy and safety of ABX464 once daily for induction treatment in subjects with moderately to severely active ulcerative colitis.
   Protocol no.106
   Principal Investigator: Dr. Praveen Mathew, Department of Medical Gastroenterology
4. A randomized, double blind, multi-center phase III study to evaluate the long term efficacy and safety of ABX464 25mg or 50mg once daily as a maintenance therapy in subjects with moderately to severely active ulcerative colitis.
   Protocol no.107,
   Principal Investigator: Dr. Praveen Mathew, Department of Medical Gastroenterology
5. A phase 1, open label, dose escalation, dose expansion, multi-center, first in human study evaluating the safety, pharmacokinetics and pharmacodynamics of oral AUR 107 in patients with relapsed advanced malignancies.
   Protocol version 2.0,
   Principal Investigator: Dr. Shashidhar Karpurnath, Department of Medical Oncology
6. A randomized, double-blind, multi-center phase 3 study in patients with moderately to severely active ulcerative colitis (UC) to compare the efficacy, safety and immunogenicity of PB016 and Entyvio® for the induction and maintenance of clinical response and remission. (UCESIVE)
   Principal Investigator: Dr. Praveen Mathew, Department of Medical Gastroenterology
7. A Multi center, Double-blind, Randomized, Parallel-group, Phase 3 Study to Compare the Efficacy and Safety of the Proposed Bio-similar PERT-IJS and EU-Perjeta® along with Trastuzumab and Chemotherapy (Carboplatin and Docetaxel) as Neoadjuvant Treatment in Patients with Hormone Receptor Negative (HR-ve) Human Epidermal Growth Factor Receptor 2 (HER2)-positive Early Stage or Locally Advanced Breast Cancer
   Principal Investigator: Dr. Manjunath, Department of Medical Oncology
8. A Phase I, Open Label, Dose-Escalation, First in Human (FIH) study evaluating the Safety, Pharmacokinetics, Pharmacodynamics and Efficacy of AUR106 in patients with select relapsed advanced malignancies.
   Protocol version 2.0
   Principal Investigator: Dr. Shashidhar Karpurnath, Department of Medical Oncology
9. Neoadjuvant chemotherapy followed by Surgery versus Surgery followed by adjuvant chemotherapy for resectable Gastric adenocarcinoma-Phase 3. Metacentric Randomized Controlled trial
   Principal Investigator: Dr. Shashidhar Karpurnath, Department of Medical Oncology
10. A Randomized, Double-blind, Placebo-controlled Phase 3 Study to evaluate Dostarlimab as Sequential Therapy after Chemo radiation in Participants with locally Advanced unrestricted head and neck squamous cell carcinoma.
    Principal Investigator: Dr. Shashidhar Karpurnath, Department of Medical Oncology
11. A Phase IV, Multi-centric, Post-Marketing Study Evaluating the Safety, Immunogenicity and Efficacy of the Marketed Formulation of Hetero-Trastuzumab in Female Patients with HER2+ Breast Cancer
    Protocol No: HCR/IV/TRUMAB/05/2022
    Principal Investigator: Dr. Veerendra Angadi, Department of Medical Oncology