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NKT2152 + Palbociclib + Sasanlimab for Kidney Cancer
Phase 2
Waitlist Available
Research Sponsored by NiKang Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a new drug combination for patients with advanced kidney cancer who have already tried other treatments. The goal is to see if these drugs can work better together to stop cancer growth and help the immune system fight the disease.
Who is the study for?
This trial is for adults with advanced kidney cancer (ccRCC) who've already tried at least one anti-VEGF/VEGFR therapy and one immune checkpoint inhibitor. Participants must be able to take oral meds, have a certain level of physical function (KPS score ≥70%), and measurable disease by RECIST 1.1 standards. Excluded are those with recent major heart issues, surgeries, HIV, active hepatitis B or C, recent radiation treatment, abnormal ECG readings, need for oxygen therapy due to hypoxia, brain metastases complications or history of autoimmune diseases.
What is being tested?
The study tests the safety and effectiveness of NKT2152 combined with palbociclib ('Doublet') and then adds sasanlimab ('Triplet') in patients with advanced kidney cancer post previous treatments. The Lead-in phase determines safe dosage levels while the Expansion phase evaluates these dosages further to find an optimal dose for future use.
What are the potential side effects?
Potential side effects may include reactions related to immune system activation such as inflammation in various organs; possible effects from cell growth inhibition like fatigue or blood count changes; gastrointestinal disturbances; liver enzyme alterations; skin rash; respiratory issues including potential lung tissue problems.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Number of Participants with Dose Limiting Toxicity (DLT) events during the DLT monitoring period (first 28 days of dosing) in the Lead-in Phase
Objective Response Rate (ORR) determined by the Investigator
Secondary study objectives
Area under the plasma concentration time curve (AUC0-t) of NKT2152, and accumulation ratio (RAC)
Area under the plasma concentration time curve (AUC0-t) of palbociclib, and accumulation ratio (RAC)
Clinical Benefit Rate (CBR)
+13 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
4Treatment groups
Experimental Treatment
Group I: Lead-in Triplet combinationExperimental Treatment3 Interventions
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
Group II: Lead-in Doublet combinationExperimental Treatment2 Interventions
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).
Group III: Expansion Triplet combinationExperimental Treatment3 Interventions
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.
Group IV: Expansion Doublet combinationExperimental Treatment2 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
palbociclib
2020
Completed Phase 2
~1230
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for urological diseases, particularly advanced cancers, often involve a combination of targeted therapies and immunotherapies. Palbociclib, a CDK4/6 inhibitor, works by blocking proteins essential for cell division, thereby slowing down the proliferation of cancer cells.
Sasanlimab, an anti-PD-1 monoclonal antibody, enhances the immune system's ability to recognize and destroy cancer cells by inhibiting the PD-1 pathway, which tumors use to evade immune detection. Novel agents like NKT2152 are being explored for their unique mechanisms, potentially offering new avenues for treatment.
These therapies are significant for patients as they provide targeted approaches to manage and potentially overcome resistance in urological cancers, leading to better disease control and improved survival rates.
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Who is running the clinical trial?
NiKang Therapeutics, Inc.Lead Sponsor
4 Previous Clinical Trials
826 Total Patients Enrolled
PfizerIndustry Sponsor
4,669 Previous Clinical Trials
17,861,752 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a history of lung scarring or fibrosis.I haven't had major surgery in the last 3 months.I have HIV.I have had hepatitis B or currently have hepatitis C.I can take pills by mouth.I am mostly able to care for myself and carry out daily activities.I haven't had a major heart event or significant heart disease in the last 6 months.I haven't had radiation for bone metastasis in the last 2 weeks or any other radiation in the last 4 weeks.I need or have needed extra oxygen due to a lung condition.I have been treated with NKT2152, HIF2α inhibitors, CDK 4/6 inhibitors, palbociclib, or sasanlimab.I have or recently had an autoimmune disease.My cancer has spread to my brain or its coverings.My kidney cancer has spread or returned after treatment with anti-VEGF and ICI therapies.
Research Study Groups:
This trial has the following groups:- Group 1: Lead-in Doublet combination
- Group 2: Lead-in Triplet combination
- Group 3: Expansion Doublet combination
- Group 4: Expansion Triplet combination
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.