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Ph2 Study NKT2152 With Palbociclib & Sasanlimab in Subjects With Advanced Clear Cell Renal Cell Carcinoma (ccRcc)

Neoplasms Clinical Trial

Official title:
A Phase 2 Trial to Evaluate the Safety and Efficacy of NKT2152 in Combination With Palbociclib (Doublet) and With Palbociclib and Sasanlimab (Triplet) in Subjects With Advanced or Metastatic Clear Cell Renal Cell Carcinoma

Clinical Trial Summary

The goal of the Lead-in phase of the study is to evaluate the safety, efficacy, pharmacokinetics (PK) and determine recommended dose for expansion (RDE) of NKT2152 in combination with palbociclib (Doublet) and with palbociclib and sasanlimab (Triplet) in subjects with advanced or metastatic clear cell renal cell carcinoma (ccRCC) who received prior therapy. The goal of the Expansion phase of the study is to evaluate the safety, efficacy, PK at the selected RDE and identify the RP2D for NKT2152 in combination with palbociclib (Doublet) and with palbociclib and sasanlimab (Triplet) in subjects with advanced or metastatic clear cell renal cell carcinoma (ccRCC) who received prior therapy.

Clinical Trial Description

This is a Phase 2 open-label, multicenter, global study of NKT2152. This study is designed as two phases: a Lead-in phase and an Expansion phase. Patients must be 18 years or older, with advanced or metastatic clear cell renal cell carcinoma (ccRCC). Eligible patients must have progressed or relapsed after at least 1 prior anti-vascular endothelial growth factor (VEGF)/VEGF receptor (VEGFR) systemic therapy and 1 immune checkpoint inhibitor (ICI) for advanced or metastatic ccRCC alone or in combination. The Lead-in phase is designed as a dose escalation phase to evaluate the safety, efficacy, pharmacokinetics (PK) and determine recommended dose for expansion (RDE) of NKT2152 in combination with palbociclib and sasanlimab in advanced or metastatic ccRCC patients who received prior therapy. The subsequent Expansion phase will evaluate the safety, efficacy, PK at the selected RDE and identify the RP2D for NKT2152 in combination with palbociclib and sasanlimab in advanced or metastatic ccRCC patients who received prior therapy. ;

Study Design

Related Conditions & MeSH terms

  • Adenocarcinoma
  • Advanced Renal Cell Carcinoma
  • Carcinoma
  • Carcinoma, Renal Cell
  • ccRCC
  • Clear Cell Renal Cell Carcinoma
  • Kidney Cancer
  • Kidney Diseases
  • Kidney Neoplasms
  • Metastatic Renal Cell Carcinoma
  • Neoplasm by Histology
  • Neoplasms
  • Neoplasms by Site
  • Neoplasms, Glandular and Epithelial
  • Recurrent Renal Cell Carcinoma
  • Refractory Renal Cell Carcinoma
  • Renal Cancer
  • Renal Neoplasms
  • Urogenital Neoplasms
  • Urologic Diseases
  • Urologic Neoplasms
Clinical Trial Details
NCT number NCT05935748
Study type Interventional
Source NiKang Therapeutics, Inc.
Contact Joanna Dojillo, M.Sc.
Phone 3024155127
Email clinicaltrials@nikangtx.com
Status Recruiting
Phase Phase 2
Start date July 28, 2023
Completion date September 2026
View Details
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