Ph2 Study NKT2152 With Palbociclib & Sasanlimab in Subjects With Advanced Clear Cell Renal Cell Carcinoma (ccRcc)
ccRCC, Clear Cell Renal Cell Carcinoma, Kidney Cancer
About this trial
This is an interventional treatment trial for ccRCC focused on measuring HIF2a, Hypoxia-inducible factor 2alpha, CDK4 inhibitor, CDK6 inhibitor, PD-1, immune checkpoint inhibitors
Eligibility Criteria
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
Sites / Locations
- Dana-Farber Cancer InstituteRecruiting
- Nebraska Cancer SpecialistsRecruiting
- University of Virginia Health SystemRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Experimental
Experimental
Lead-in Doublet combination
Lead-in Triplet combination
Expansion Doublet combination
Expansion Triplet combination
Lead-in Doublet assesses safety of oral dosing NKT2152 at increasing dosage levels in combination with palbociclib to determine a recommended dose for expansion (RDE).
Lead-in Triplet assesses the safety of two doses of NKT2152 identified in the Doublet arm (RDE and RDE-1) by orally dosing ccRCC patients with NKT2152 in combination with palbociclib and sasanlimab
Subjects randomized to Arm 1 will receive the Doublet combination (NKT2152 in combination with palbociclib) to provide an assessment of anti-tumor activity and to determine the RP2D.
Subjects randomized to Arm 2 will receive the Triplet therapy (NKT2152 in combination with palbociclib and sasanlimab) to provide an assessment of anti-tumor activity and to determine the RP2D.