Ph2 Study NKT2152 With Palbociclib & Sasanlimab in Subjects With Advanced Clear Cell Renal Cell Carcinoma (ccRcc)
Reason given: This study was terminated as a result of Sponsor portfolio reprioritization.
Key facts
- Where
- Ann Arbor, Boston, Charlottesville, Chicago, Dallas, La Jolla, New York, and Omaha, United StatesSee the 8 sites
- Phase
- Phase 2
Where in United States
- University of Michigan Rogel Cancer CenterAnn Arbor, United StatesNo longer taking part
- Dana-Farber Cancer InstituteBoston, United StatesNo longer taking part
- University of Virginia Health SystemCharlottesville, United StatesNo longer taking part
- Northwestern University Feinberg School of MedicineChicago, United StatesNo longer taking part
- UT Southwestern Medical CenterDallas, United StatesNo longer taking part
- University of California San DiegoLa Jolla, United StatesNo longer taking part
- Memorial Sloan-Kettering Cancer CenterNew York, United StatesNo longer taking part
- Nebraska Cancer SpecialistsOmaha, United StatesNo longer taking part
Trial details
- Who runs it
- NiKang Therapeutics, Inc.
- Trial code
- NCT05935748
- Record updated
- 12 November 2025
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: 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.
Exclusion: Major surgery (eg, GI surgery, removal or biopsy of brain metastasis) within 3 months before administration of study drug; 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; Has had any major cardiovascular event within 6 months or clinically significant cardiovascular disease; Has known HIV; History of hepatitis B or known active hepatitis C infection; 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; Corrected QT interval calculated by Fridericia formula (QTcF) > 480 ms within 28 days prior to first dose; Active CNS metastases and/or carcinomatous meningitis.