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ccRCCPhase 2NCT05935748

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

A Phase 2 study testing NKT2152, palbociclib and sasanlimab in people with ccRCC and Clear Cell Renal Cell Carcinoma, run by NiKang Therapeutics, Inc. at 8 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
NKT2152, palbociclib and sasanlimab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
18 participants
Where
8 sitesUnited States
Study dates
28 Jul 2023to 4 Sep 2025
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 11Show fewer
  • 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

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

United States8 sites

  • University of Michigan-Rogel Cancer Center

    Ann Arbor, Michigan, 48109

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215

  • University of Virginia Health System

    Charlottesville, Virginia, 22908

  • Northwestern University - Feinberg School of Medicine

    Chicago, Illinois, 60611

  • UT Southwestern Medical Center

    Dallas, Texas, 75390-9324

  • University of California San Diego

    La Jolla, California, 92093

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065-6094

  • Nebraska Cancer Specialists

    Omaha, Nebraska, 68130

Other trials in United States

About this study

Official title: A Phase 2 Trial to Evaluate the Safety and Efficacy of NKT2152 in Combination With Palbociclib (Doublet) and With Palbociclib and Sasanlimab (Triplet) in Subjects With Advanced or Metastatic Clear Cell Renal Cell Carcinoma

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.

Read the detailed 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.

Being tested
NKT2152, palbociclib, sasanlimab
Keywords
HIF2a, Hypoxia-inducible factor 2alpha, CDK4 inhibitor, CDK6 inhibitor, PD-1, immune checkpoint inhibitors
Medical subject headings
Carcinoma, Renal Cell, Kidney Neoplasms, Carcinoma, Neoplasms, Neoplasms, Glandular and Epithelial, Adenocarcinoma, Urologic Neoplasms, Urogenital Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NKT2152Drug

    Oral HIF2a inhibitor

  • palbociclibDrug

    Also called IBRANCE®

    a cyclin-dependent kinases (CDK) 4 and 6 inhibitor

  • sasanlimabOther

    an immunoglobulin G4 (IgG4) monoclonal antibody that blocks PD-1; a solution for injection for subcutaneous administration

Study groups in NCT05935748
Study groupRoleWhat they receive
Lead-in Doublet combinationExperimentalLead-in Doublet assesses safety of oral dosing NKT2152 at increasing dosage levels in combination with palbociclib to determine a recommended dose for expansion (RDE).
Receives: Drug: NKT2152; Drug: palbociclib
Lead-in Triplet combinationExperimentalLead-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
Receives: Drug: NKT2152; Drug: palbociclib; Other: sasanlimab
Expansion Doublet combinationExperimentalSubjects 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.
Receives: Drug: NKT2152; Drug: palbociclib
Expansion Triplet combinationExperimentalSubjects 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.
Receives: Drug: NKT2152; Drug: palbociclib; Other: sasanlimab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants with Dose Limiting Toxicity (DLT) events during the DLT monitoring period (first 28 days of dosing) in the Lead-in Phase

    DLTs graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5 .0.

    Measured: 28 days

  2. Objective Response Rate (ORR) determined by the Investigator

    ORR defined as the percentage of participants with a confirmed complete response (CR) or partial response (PR) based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.

    Measured: 1 years

Secondary outcomes (16)

  1. Progression-free survival (PFS)

    PFS defined as the time from the date the participant started study drug to the date the participant experiences an event of disease progression or death.

    Measured: 2 years

  2. Duration of Response (DOR)

    Duration of overall response is defined as the time from the date of first documented CR or PR, assessed by investigator and based on RECIST v. 1.1, to the documented date of progressive disease (PD) or death, whichever occurred first.

    Measured: 1 years

  3. Time to Response (TTR)

    TTR is defined as the time from first dose to the first documented CR or PR which is subsequently confirmed.

    Measured: 1 years

  4. Overall Survival (OS)

    OS defined as the time from the date the participant started study drug to death for any reason.

    Measured: 2 years

  5. Clinical Benefit Rate (CBR)

    CBR defined as the percentage of participants with a confirmed complete response (CR) or partial response (PR) or a stable disease (SD) of 8 weeks or longer based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.

    Measured: 1 years

  6. Number of Participants with Adverse Events

    An adverse event (AE) is defined as any untoward medical occurrence in a patient and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related.

    Measured: 2 years

  7. Maximum observed plasma concentration (Cmax) of NKT2152

    Maximum observed plasma concentration (Cmax) of NKT2152

    Measured: 1 years

  8. Time to maximum observed plasma concentration of NKT2152 (Tmax)

    Time to maximum observed plasma concentration of NKT2152 (Tmax)

    Measured: 1 years

  9. Observed trough concentration of NKT2152 (Ctrough)

    Observed trough concentration of NKT2152 (Ctrough)

    Measured: 1 years

  10. 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 NKT2152, and accumulation ratio (RAC)

    Measured: 1 years

  11. Maximum observed plasma concentration (Cmax) of palbociclib

    Maximum observed plasma concentration (Cmax) of palbociclib

    Measured: 1 years

  12. Time to maximum observed plasma concentration of palbociclib (Tmax)

    Time to maximum observed plasma concentration of palbociclib (Tmax)

    Measured: 1 years

  13. Observed trough concentration of palbociclib (Ctrough)

    Observed trough concentration of palbociclib (Ctrough)

    Measured: 1 years

  14. Area under the plasma concentration time curve (AUC0-t) of palbociclib, and accumulation ratio (RAC)

    Area under the plasma concentration time curve (AUC0-t) of palbociclib, and accumulation ratio (RAC)

    Measured: 1 years

  15. Observed trough concentration of sasanlimab (Ctrough)

    Observed trough concentration of sasanlimab (Ctrough)

    Measured: 1 years

  16. Maximum observed plasma concentration (Cmax) of sasanlimab

    Maximum observed plasma concentration (Cmax) of sasanlimab

    Measured: 1 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jul 2023
  2. Study start28 Jul 2023
  3. Primary completion30 Jun 2025
  4. Study completion4 Sep 2025

Why it stopped: This study was terminated as a result of Sponsor portfolio reprioritization.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Lead-in/Dose Escalation (doublet \& triplet combination) and Dose Expansion (doublet \& triplet combination)
Masking
None (open label)
Enrolment
18 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05935748
Sponsor's protocol ID
NKT2152-202
Status last verified
Nov 2025
First submitted
29 Jun 2023
Last updated
12 Nov 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: IPD are not planned to be shared at this time

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing NKT2152, palbociclib and sasanlimab in people with ccRCC and Clear Cell Renal Cell Carcinoma, run by NiKang Therapeutics, Inc. at 8 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 12 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: This study was terminated as a result of Sponsor portfolio reprioritization.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants with Dose Limiting Toxicity (DLT) events during the DLT monitoring period (first 28 days of dosing) in the Lead-in Phase (time frame: 28 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05935748.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2025.

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