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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 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

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 more

Awards & 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.
Novel Redirected T-Cell Immunotherapies for Advanced Prostate Cancer.CHALLENGES IN MANIPULATING IMMUNE SYSTEM TO TREAT PROSTATE CANCER.Results of a multicenter, phase 2 study of nivolumab and ipilimumab for patients with advanced rare genitourinary malignancies.

Find a Location

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

NKT2152 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05935748 — Phase 2
Kidney Disease Research Study Groups: Lead-in Doublet combination, Lead-in Triplet combination, Expansion Doublet combination, Expansion Triplet combination
Kidney Disease Clinical Trial 2023: NKT2152 Highlights & Side Effects. Trial Name: NCT05935748 — Phase 2
NKT2152 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05935748 — Phase 2
~39 spots leftby Jun 2025