Phase 2 Study of NKT2152 with Palbociclib and Sasanlimab for Advanced Clear Cell Kidney Cancer

Sponsor: NiKang Therapeutics, Inc.

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05935748

Provider View

This clinical trial is testing a new combination of drugs, NKT2152 with palbociclib and sasanlimab, to see if they are safe and effective for treating advanced clear cell kidney cancer in patients who have already tried other treatments.

Patient Parameters

Program Overview

The study aims to find out if a new combination of drugs, NKT2152 with palbociclib and sasanlimab, can safely and effectively treat advanced clear cell kidney cancer. It will also determine the best dose to use in future studies. The trial is divided into two parts: the Lead-in phase, which tests different doses to find the safest and most effective one, and the Expansion phase, which further evaluates the chosen dose in more patients.

Description

This Phase 2 study is open to adults with advanced clear cell kidney cancer who have already tried other treatments. The study has two parts: the Lead-in phase and the Expansion phase. In the Lead-in phase, researchers will test different doses of the drug combination to find the safest and most effective one. In the Expansion phase, they will use the chosen dose to see how well it works in a larger group of patients. Participants must have advanced kidney cancer that has worsened after at least one previous treatment targeting blood vessels and one immune therapy. They must be able to swallow pills and have a performance status score of at least 70%, meaning they can care for themselves but may not be able to carry out normal activities or work.

Eligibility Criteria

Inclusion Criteria

  • Have advanced or metastatic clear cell kidney cancer that has worsened after at least one previous treatment targeting blood vessels and one immune therapy.
  • Have measurable cancer according to specific medical criteria.
  • Have a performance status score of at least 70%, meaning they can care for themselves but may not be able to carry out normal activities or work.
  • Be able to swallow pills.

Exclusion Criteria

  • Have active cancer spread to the brain or spinal fluid.
  • Have had a major heart problem in the last 6 months or significant heart disease.
  • Have had major surgery within 3 months before starting the study treatment.
  • Have known HIV infection.
  • Have a history of hepatitis B or active hepatitis C infection.
  • Have previously been treated with NKT2152, other similar drugs, or the study drugs palbociclib or sasanlimab.
  • Have had recent radiation therapy to bones or other areas within specified timeframes before starting the study treatment.
  • Have a specific heart rhythm problem as measured by an ECG.
  • Have low oxygen levels or need oxygen therapy due to lung conditions.
  • Have a history of lung disease affecting the tissue between the air sacs.
  • Have an active or recent autoimmune disease.

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