Ph2 Study NKT2152 With Palbociclib & Sasanlimab in Subjects With Advanced Clear Cell Renal Cell Carcinoma (ccRcc)
NCT ID: NCT05935748
Last Updated: 2025-11-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
PHASE2
18 participants
INTERVENTIONAL
2023-07-28
2025-09-04
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Lead-in Doublet 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).
NKT2152
Oral HIF2a inhibitor
palbociclib
a cyclin-dependent kinases (CDK) 4 and 6 inhibitor
Lead-in Triplet combination
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
NKT2152
Oral HIF2a inhibitor
palbociclib
a cyclin-dependent kinases (CDK) 4 and 6 inhibitor
sasanlimab
an immunoglobulin G4 (IgG4) monoclonal antibody that blocks PD-1; a solution for injection for subcutaneous administration
Expansion Doublet combination
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.
NKT2152
Oral HIF2a inhibitor
palbociclib
a cyclin-dependent kinases (CDK) 4 and 6 inhibitor
Expansion Triplet combination
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.
NKT2152
Oral HIF2a inhibitor
palbociclib
a cyclin-dependent kinases (CDK) 4 and 6 inhibitor
sasanlimab
an immunoglobulin G4 (IgG4) monoclonal antibody that blocks PD-1; a solution for injection for subcutaneous administration
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
NKT2152
Oral HIF2a inhibitor
palbociclib
a cyclin-dependent kinases (CDK) 4 and 6 inhibitor
sasanlimab
an immunoglobulin G4 (IgG4) monoclonal antibody that blocks PD-1; a solution for injection for subcutaneous administration
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Pfizer
INDUSTRY
NiKang Therapeutics, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of California San Diego
La Jolla, California, United States
Northwestern University - Feinberg School of Medicine
Chicago, Illinois, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
University of Michigan-Rogel Cancer Center
Ann Arbor, Michigan, United States
Nebraska Cancer Specialists
Omaha, Nebraska, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
UT Southwestern Medical Center
Dallas, Texas, United States
University of Virginia Health System
Charlottesville, Virginia, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
NKT2152-202
Identifier Type: -
Identifier Source: org_study_id