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NKT2152 + Palbociclib + Sasanlimab for Kidney Cancer
Phase 2
Recruiting
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
Study Summary
This trial studies the safety and effectiveness of two drug combinations to treat advanced or metastatic kidney cancer.
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.Check my eligibility
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.See study design
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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 outcome measures
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 moreTrial 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
Find a Location
Who is running the clinical trial?
NiKang Therapeutics, Inc.Lead Sponsor
2 Previous Clinical Trials
218 Total Patients Enrolled
PfizerIndustry Sponsor
4,570 Previous Clinical Trials
10,915,834 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What deleterious effects may be caused by Expansion Triplet combination?
"In light of the Phase 2 status, our team at Power gave Expansion Triplet combination a safety rating of two due to limited clinical data demonstrating its efficacy."
Answered by AI
How many volunteers have participated in this experiment?
"Affirmative. Clinicaltrials.gov's data signifies that the trial, which was posted on July 28th 2023 has opened recruitment for 172 people at one centre. This information was recently updated as of August 10th 2023."
Answered by AI
Are new participants still being accepted for this research endeavor?
"Affirmative. Clinicaltrials.gov data highlights that the trial, which was first declared on July 28th 2023, is actively seeking applicants. The research project requires 172 patients at a single medical site."
Answered by AI
What outcomes is this research endeavor trying to realize?
"This 28-day clinical trial is primarily assessing the efficacy of NKT2152 based on its Objective Response Rate (ORR) determined by an Investigator. Secondary outcomes include Area Under Curve (AUC0-t), Accumulation Ratio (RAC), Observed Trough Concentration of the drug, and Maximum Plasma Concentration of Palbociclib."
Answered by AI
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