Kidney Cancer Clinical Trial

Ph2 Study NKT2152 With Palbociclib & Sasanlimab in Subjects With Advanced Clear Cell Renal Cell Carcinoma (ccRcc)

Summary

The goal of the Lead-in phase of the study is to evaluate the safety, efficacy, pharmacokinetics (PK) and determine recommended dose for expansion (RDE) of NKT2152 in combination with palbociclib (Doublet) and with palbociclib and sasanlimab (Triplet) in subjects with advanced or metastatic clear cell renal cell carcinoma (ccRCC) who received prior therapy. The goal of the Expansion phase of the study is to evaluate the safety, efficacy, PK at the selected RDE and identify the RP2D for NKT2152 in combination with palbociclib (Doublet) and with palbociclib and sasanlimab (Triplet) in subjects with advanced or metastatic clear cell renal cell carcinoma (ccRCC) who received prior therapy.

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Full Description

This is a Phase 2 open-label, multicenter, global study of NKT2152. This study is designed as two phases: a Lead-in phase and an Expansion phase. Patients must be 18 years or older, with advanced or metastatic clear cell renal cell carcinoma (ccRCC). Eligible patients must have progressed or relapsed after at least 1 prior anti-vascular endothelial growth factor (VEGF)/VEGF receptor (VEGFR) systemic therapy and 1 immune checkpoint inhibitor (ICI) for advanced or metastatic ccRCC alone or in combination.

The Lead-in phase is designed as a dose escalation phase to evaluate the safety, efficacy, pharmacokinetics (PK) and determine recommended dose for expansion (RDE) of NKT2152 in combination with palbociclib and sasanlimab in advanced or metastatic ccRCC patients who received prior therapy.

The subsequent Expansion phase will evaluate the safety, efficacy, PK at the selected RDE and identify the RP2D for NKT2152 in combination with palbociclib and sasanlimab in advanced or metastatic ccRCC patients who received prior therapy.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Must have locally advanced or metastatic ccRCC and have progressed or relapsed after at least 1 prior anti-VEGF/VEGFR systemic therapy and 1 ICI.
Measurable disease per the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1)
KPS score of at least 70%
Able to swallow oral medications.

Exclusion Criteria:

Active CNS metastases and/or carcinomatous meningitis
Has had any major cardiovascular event within 6 months or clinically significant cardiovascular disease
Major surgery (eg, GI surgery, removal or biopsy of brain metastasis) within 3 months before administration of study drug.
Has known HIV
History of hepatitis B or known active hepatitis C infection
Has received prior treatment with NKT2152, other HIF2α inhibitors, other CDK 4/6 inhibitors, palbociclib, or sasanlimab
Radiation therapy for bone metastasis within 2 weeks, or any other external radiation therapy within 4 weeks before administration of the first dose of study treatment
Corrected QT interval calculated by Fridericia formula (QTcF) > 480 ms within 28 days prior to first dose
Hypoxia or requires intermittent or chronic supplemental oxygen or any chronic lung condition which has required supplemental oxygen in the past
Has a history of interstitial lung disease
Has any active or recent history of a known or suspected autoimmune disease

Study is for people with:

Kidney Cancer

Phase:

Phase 2

Estimated Enrollment:

172

Study ID:

NCT05935748

Recruitment Status:

Recruiting

Sponsor:

NiKang Therapeutics, Inc.

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There are 8 Locations for this study

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University of California San Diego
La Jolla California, 92093, United States More Info
Katie O'Neil
Contact
858-246-1093
Rana McKay, MD
Principal Investigator
Northwestern University - Feinberg School of Medicine
Chicago Illinois, 60611, United States More Info
Rachel Springdorf
Contact
312-926-2984
[email protected]
Ashley Matza-Wambaja
Contact
3126959198
[email protected]
David VanderWelle, MD
Principal Investigator
Dana-Farber Cancer Institute
Boston Massachusetts, 02215, United States More Info
Elena Stratis
Contact
617-632-2461
[email protected]
Meredith Flynn
Contact
617-632-5701
[email protected]
Toni Choueiri, MD
Principal Investigator
University of Michigan-Rogel Cancer Center
Ann Arbor Michigan, 48109, United States More Info
Cherie Donze
Contact
734-647-8902
[email protected]
Ulka Vaishmpayan, MD
Principal Investigator
Nebraska Cancer Specialists
Omaha Nebraska, 68130, United States More Info
Tiffiny Bradley
Contact
402-905-9761
[email protected]
Hanna Kurz
Contact
402-905-9761
[email protected]
Ralphe Hauke, MD
Principal Investigator
Memorial Sloan Kettering Cancer Center
New York New York, 10065, United States More Info
Jodi-Ann Powell
Contact
646-422-4631
[email protected]
Martin Voss, MD
Principal Investigator
UT Southwestern Medical Center
Dallas Texas, 75390, United States More Info
Amy Rowell
Contact
214-645-9688
[email protected]
Andrea Flaten
Contact
214-648-8174
[email protected]
Hans Hammers
Principal Investigator
University of Virginia Health System
Charlottesville Virginia, 22908, United States More Info
Sydney Sanders
Contact
434-924-9333
[email protected]
Alexandra Cash
Contact
434-243-4305
[email protected]
Robert Dreicer, MD
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Kidney Cancer

Phase:

Phase 2

Estimated Enrollment:

172

Study ID:

NCT05935748

Recruitment Status:

Recruiting

Sponsor:


NiKang Therapeutics, Inc.

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