Trial Title:
Ph2 Study NKT2152 with Palbociclib & Sasanlimab in Subjects with Advanced Clear Cell Renal Cell Carcinoma (ccRcc)
NCT ID:
NCT05935748
Condition:
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
Conditions: Official terms:
Carcinoma
Neoplasms
Carcinoma, Renal Cell
Kidney Neoplasms
Neoplasms by Site
Urogenital Neoplasms
Urologic Neoplasms
Neoplasms, Glandular and Epithelial
Kidney Diseases
Urologic Diseases
Palbociclib
Conditions: Keywords:
HIF2a
Hypoxia-inducible factor 2alpha
CDK4 inhibitor
CDK6 inhibitor
PD-1
immune checkpoint inhibitors
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Active, not recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
Lead-in/Dose Escalation (doublet & triplet combination) and Dose Expansion (doublet &
triplet combination)
Primary purpose:
Treatment
Masking:
None (Open Label)
Masking description:
Randomization during Expansion phase
Intervention:
Intervention type:
Drug
Intervention name:
NKT2152
Description:
Oral HIF2a inhibitor
Arm group label:
Expansion Doublet combination
Arm group label:
Expansion Triplet combination
Arm group label:
Lead-in Doublet combination
Arm group label:
Lead-in Triplet combination
Intervention type:
Drug
Intervention name:
palbociclib
Description:
a cyclin-dependent kinases (CDK) 4 and 6 inhibitor
Arm group label:
Expansion Doublet combination
Arm group label:
Expansion Triplet combination
Arm group label:
Lead-in Doublet combination
Arm group label:
Lead-in Triplet combination
Other name:
IBRANCE®
Intervention type:
Other
Intervention name:
sasanlimab
Description:
an immunoglobulin G4 (IgG4) monoclonal antibody that blocks PD-1; a solution for
injection for subcutaneous administration
Arm group label:
Expansion Triplet combination
Arm group label:
Lead-in Triplet combination
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.
Detailed description:
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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University of California San Diego
Address:
City:
La Jolla
Zip:
92093
Country:
United States
Facility:
Name:
Northwestern University - Feinberg School of Medicine
Address:
City:
Chicago
Zip:
60611
Country:
United States
Facility:
Name:
Dana-Farber Cancer Institute
Address:
City:
Boston
Zip:
02215
Country:
United States
Facility:
Name:
University of Michigan-Rogel Cancer Center
Address:
City:
Ann Arbor
Zip:
48109
Country:
United States
Facility:
Name:
Nebraska Cancer Specialists
Address:
City:
Omaha
Zip:
68130
Country:
United States
Facility:
Name:
Memorial Sloan Kettering Cancer Center
Address:
City:
New York
Zip:
10065-6094
Country:
United States
Facility:
Name:
UT Southwestern Medical Center
Address:
City:
Dallas
Zip:
75390-9324
Country:
United States
Facility:
Name:
University of Virginia Health System
Address:
City:
Charlottesville
Zip:
22908
Country:
United States
Start date:
July 28, 2023
Completion date:
June 2026
Lead sponsor:
Agency:
NiKang Therapeutics, Inc.
Agency class:
Industry
Collaborator:
Agency:
Pfizer
Agency class:
Industry
Source:
NiKang Therapeutics, Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05935748
