NKT2152 + Palbociclib + Sasanlimab for Kidney Cancer

Recruiting at 7 trial locations

Overseen By Joanna Dojillo, M.Sc.

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: NiKang Therapeutics, Inc.

Must not be taking: HIF2α inhibitors, CDK 4/6 inhibitors

Disqualifiers: CNS metastases, Cardiovascular disease, HIV, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

172 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you have previously been treated with NKT2152, palbociclib, or sasanlimab, you cannot participate in this trial.

What data supports the effectiveness of the drug combination NKT2152, Palbociclib, and Sasanlimab for kidney cancer?

While there is no direct data on the combination of NKT2152, Palbociclib, and Sasanlimab, similar combinations of drugs that target the immune system and cancer cell growth, like axitinib plus pembrolizumab, have shown improved outcomes in kidney cancer, suggesting potential effectiveness. ^{1 2 3 4 5}

What makes the drug combination of NKT2152, Palbociclib, and Sasanlimab unique for kidney cancer?

This drug combination is unique because it includes NKT2152, which is a novel agent potentially targeting new pathways in kidney cancer, combined with Palbociclib, a cell cycle inhibitor, and Sasanlimab, an immune checkpoint inhibitor, offering a multi-faceted approach that differs from the standard treatments focusing mainly on angiogenesis and existing immune checkpoints. ^{4 6 7 8 9}

Eligibility Criteria

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.

Inclusion Criteria

Measurable disease per the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1)

I can take pills by mouth.

I am mostly able to care for myself and carry out daily activities.

Exclusion Criteria

I have a history of lung scarring or fibrosis.

I haven't had major surgery in the last 3 months.

I have HIV.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Lead-in

Dose escalation phase to evaluate safety, efficacy, and pharmacokinetics (PK) and determine recommended dose for expansion (RDE) of NKT2152 in combination with palbociclib and sasanlimab

4 weeks

Expansion

Evaluate safety, efficacy, and PK at the selected RDE and identify the RP2D for NKT2152 in combination with palbociclib and sasanlimab

1 year

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 year

Treatment Details

Interventions

• NKT2152
• Palbociclib
• Sasanlimab

Trial Overview 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.

Participant Groups

Group I: Lead-in Triplet combination Experimental Treatment 3 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 combination Experimental Treatment 2 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 combination Experimental Treatment 3 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 combination Experimental Treatment 2 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.

Who Is Running the Clinical Trial?

NiKang Therapeutics, Inc.

Lead Sponsor

Trials

5

Recruited

1,000+

Pfizer

Industry Sponsor

Trials

4,712

Recruited

50,980,000+

Known For

Vaccine Innovations

Top Products

Viagra, Zoloft, Lipitor, Prevnar 13

Albert Bourla

Pfizer

Chief Executive Officer since 2019

PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki

Patrizia Cavazzoni

Pfizer

Chief Medical Officer

MD from McGill University

Findings from Research

Combination therapies using immune checkpoint inhibitors, such as axitinib plus pembrolizumab, have shown improved outcomes compared to traditional sequential monotherapy in patients with metastatic renal cell carcinoma.

Phase III trials indicate that these combination regimens significantly enhance both progression-free survival and overall survival, addressing the issue of drug resistance seen with single-agent treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pembrolizumab plus axitinib combination and the paradigm change in the treatment of advanced renal cell carcinoma. Spisarová, M., Melichar, B., Vitásková, D., et al.[2021]

Recent clinical trials have led to significant advancements in the treatment of metastatic renal cell carcinoma, particularly with the introduction of targeted therapies like bevacizumab, sunitinib, and newer agents such as axitinib and tivozanib.

Understanding the mechanisms of disease and drug resistance has opened up new targets for treatment, suggesting that the therapeutic landscape for kidney cancer is evolving rapidly with the potential for more effective interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Targeted therapies in metastatic renal cell carcinoma: overview of the past year. Gross-Goupil, M., Massard, C., Ravaud, A.[2021]

Recent advancements in the treatment of metastatic kidney cancer include the approval of several drugs targeting the vascular endothelial growth factor pathway, such as sorafenib and sunitinib, which have shown efficacy particularly in patients with good- or intermediate-risk profiles and clear cell histology.

The development of effective treatment plans should consider not only drug therapies but also individual patient factors, surgical options, and emerging investigational therapies, emphasizing the importance of personalized treatment strategies based on data from pivotal trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Targeted therapy of kidney cancer: keeping the art around the algorithms. Fishman, MN.[2017]

Nivolumab, when combined with ipilimumab, significantly improves overall survival rates in previously untreated advanced renal cell carcinoma (RCC), achieving an 18-month survival rate of 75% compared to 60% with sunitinib alone.

The combination therapy also results in a higher objective response rate of 42% versus 27% for sunitinib, indicating that immune checkpoint inhibitors are becoming a promising first-line treatment option for metastatic RCC.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Frontline immunotherapy treatment with nivolumab and ipilimumab in metastatic renal cell cancer: a new standard of care. Nizam, A., Aragon-Ching, JB.[2020]

References

1. England pubmed.ncbi.nlm.nih.gov

Pembrolizumab plus axitinib combination and the paradigm change in the treatment of advanced renal cell carcinoma. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Targeted therapies in metastatic renal cell carcinoma: overview of the past year. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Targeted therapy of kidney cancer: keeping the art around the algorithms. [2017]

4. Australia pubmed.ncbi.nlm.nih.gov

Current Options for Second-Line Systemic Therapy in Metastatic Renal Cell Carcinoma. [2022]

5. England pubmed.ncbi.nlm.nih.gov

New approaches to first-line treatment of advanced renal cell carcinoma. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

A Multicenter Phase II Trial of Axitinib in Patients With Recurrent or Metastatic Non-clear-cell Renal Cell Carcinoma Who Had Failed Prior Treatment With Temsirolimus. [2019]

7. Australia pubmed.ncbi.nlm.nih.gov

Emerging Therapies for Advanced Clear Cell Renal Cell Carcinoma. [2020]

8. United States pubmed.ncbi.nlm.nih.gov

Novel Therapeutic Approaches and the Evolution of Drug Development in Advanced Kidney Cancer. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Frontline immunotherapy treatment with nivolumab and ipilimumab in metastatic renal cell cancer: a new standard of care. [2020]