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

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.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 afte

Trial Eligibility

Inclusion Criteria: * 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 Criteria: * 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

Study Info

Interventions

Locations Recruiting

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