This study is in progress, not accepting new patients

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

a study on CcRCC Kidney Cancer Renal Cell Carcinoma Kidney Neoplasm Carcinoma Neoplasms Neoplasms, Glandular and Epithelial Neoplasm by Histology Adenocarcinoma Urologic Neoplasms Urogenital Neoplasms Kidney Disease

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCSD
Dates
study started
completion around

Description

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.

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

Details

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.

Keywords

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, HIF2a, Hypoxia-inducible factor 2alpha, CDK4 inhibitor, CDK6 inhibitor, PD-1, immune checkpoint inhibitors, Renal Cell Carcinoma, Glandular and Epithelial Neoplasms, Palbociclib, NKT2152, sasanlimab

Eligibility

You can join if…

Open to people ages 18 years and up

  • Must have locally advanced or metastatic ccRCC and have progressed or relapsed after at least 1 prior anti-VEGF/VEGFR systemic therapy and 1 ICI.
  • Measurable disease per the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1)
  • KPS score of at least 70%
  • Able to swallow oral medications.

You CAN'T join if...

  • Active CNS metastases and/or carcinomatous meningitis
  • Has had any major cardiovascular event within 6 months or clinically significant cardiovascular disease
  • Major surgery (eg, GI surgery, removal or biopsy of brain metastasis) within 3 months before administration of study drug.
  • Has known HIV
  • History of hepatitis B or known active hepatitis C infection
  • Has received prior treatment with NKT2152, other HIF2α inhibitors, other CDK 4/6 inhibitors, palbociclib, or sasanlimab
  • Radiation therapy for bone metastasis within 2 weeks, or any other external radiation therapy within 4 weeks before administration of the first dose of study treatment
  • Corrected QT interval calculated by Fridericia formula (QTcF) > 480 ms within 28 days prior to first dose
  • Hypoxia or requires intermittent or chronic supplemental oxygen or any chronic lung condition which has required supplemental oxygen in the past
  • Has a history of interstitial lung disease
  • Has any active or recent history of a known or suspected autoimmune disease

Locations

  • University of California San Diego
    La Jolla California 92093 United States
  • UT Southwestern Medical Center
    Dallas Texas 75390-9324 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
NiKang Therapeutics, Inc.
ID
NCT05935748
Phase
Phase 2 research study
Study Type
Interventional
Participants
Expecting 172 study participants
Last Updated