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

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.

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

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

Sponsors & Collaborators

• Pfizer

  collaborator INDUSTRY

• NiKang Therapeutics, Inc.

  lead INDUSTRY

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-07-28

Primary Completion

2025-06-30

Completion

2025-09-04

FDA Drug

Yes

Countries

• United States

Study Locations