What side effects are associated with this type of intervention?

Treatments for urological diseases, particularly those involving CDK4/6 inhibitors like Palbociclib, anti-PD-1 monoclonal antibodies such as Sasanlimab, and novel therapeutic agents like NKT2152, are associated with several side effects. CDK4/6 inhibitors commonly cause neutropenia, fatigue, nausea, and infections. Anti-PD-1 monoclonal antibodies can lead to immune-related adverse events including colitis, hepatitis, endocrinopathies, and pneumonitis. Novel therapeutic agents may present unique side effects, but often include gastrointestinal disturbances, fatigue, and hematologic abnormalities.

What prior FDA approvals exist?

The FDA has approved several treatments for urological diseases that are similar to the combination being studied in the NKT2152 trial. Palbociclib, a CDK4/6 inhibitor, is primarily approved for breast cancer but is being explored in other cancers. Anti-PD-1 monoclonal antibodies like Pembrolizumab and Nivolumab have been approved for various cancers, including metastatic renal cell carcinoma and metastatic castration-resistant prostate cancer. These approvals highlight the potential of combining CDK4/6 inhibitors with immune checkpoint inhibitors in treating urological malignancies.

What other types of research exist?

Promising alternatives for urological diseases include: 1) Pembrolizumab plus Axitinib, which has shown efficacy in advanced renal cell carcinoma (KEYNOTE-426). 2) Nivolumab plus Ipilimumab, which has demonstrated benefits in metastatic renal cell carcinoma (CheckMate 214). 3) Atezolizumab plus Bevacizumab, which has been effective in previously untreated metastatic renal cell carcinoma (IMmotion151). These combinations have shown favorable outcomes in clinical trials and could be considered as novel alternatives in 2024.

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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

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

Do I qualify?Apply below to find out

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.