NCT05935748

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

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: NiKang Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• ccRCC
• Clear Cell Renal Cell Carcinoma
• Kidney Cancer
• Kidney Neoplasms
• Renal Cancer
• Renal Neoplasms
• Recurrent Renal Cell Carcinoma
• Metastatic Renal Cell Carcinoma
• Refractory Renal Cell Carcinoma
• Advanced Renal Cell Carcinoma
• Carcinoma
• Neoplasms
• Carcinoma, Renal Cell
• Neoplasms, Glandular and Epithelial
• Neoplasm by Histology
• Adenocarcinoma
• Urologic Neoplasms
• Urogenital Neoplasms
• Neoplasms by Site
• Kidney Diseases
• Urologic Diseases

Interventions

Type	Name	Description
DRUG	NKT2152	Oral HIF2a inhibitor
DRUG	palbociclib	a cyclin-dependent kinases (CDK) 4 and 6 inhibitor
OTHER	sasanlimab	an immunoglobulin G4 (IgG4) monoclonal antibody that blocks PD-1; a solution for injection for subcutaneous administration

Timeline

• Start date: 2023-07-28
• Primary completion: 2025-06-30
• Completion: 2025-09-04
• First posted: 2023-07-07
• Last updated: 2025-11-12

Locations

8 sites across 1 country: United States

Regulatory

• FDA-regulated drug study