Not provided
Not provided
Not provided
Not provided
Not provided
This study was terminated as a result of Sponsor portfolio reprioritization.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Pfizer | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lead-in Doublet combination | Experimental | 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). |
|
| Lead-in Triplet combination | Experimental | 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 |
|
| Expansion Doublet combination | Experimental | 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. |
|
| Expansion Triplet combination | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NKT2152 | Drug | Oral HIF2a inhibitor |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 28 days |
| 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. | 1 years |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 2 years |
| Duration of Response (DOR) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California San Diego | La Jolla | California | 92093 | United States | ||
| Northwestern University - Feinberg School of Medicine |
IPD are not planned to be shared at this time
Not provided
Not provided
Not provided
Not provided
Not provided
Lead-in/Dose Escalation (doublet & triplet combination) and Dose Expansion (doublet & triplet combination)
Not provided
Not provided
Randomization during Expansion phase
Not provided
| palbociclib | Drug | a cyclin-dependent kinases (CDK) 4 and 6 inhibitor |
|
|
| sasanlimab | Other | an immunoglobulin G4 (IgG4) monoclonal antibody that blocks PD-1; a solution for injection for subcutaneous administration |
|
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.
| 1 years |
| Time to Response (TTR) | TTR is defined as the time from first dose to the first documented CR or PR which is subsequently confirmed. | 1 years |
| Overall Survival (OS) | OS defined as the time from the date the participant started study drug to death for any reason. | 2 years |
| 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. | 1 years |
| 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. | 2 years |
| Maximum observed plasma concentration (Cmax) of NKT2152 | Maximum observed plasma concentration (Cmax) of NKT2152 | 1 years |
| Time to maximum observed plasma concentration of NKT2152 (Tmax) | Time to maximum observed plasma concentration of NKT2152 (Tmax) | 1 years |
| Observed trough concentration of NKT2152 (Ctrough) | Observed trough concentration of NKT2152 (Ctrough) | 1 years |
| 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) | 1 years |
| Maximum observed plasma concentration (Cmax) of palbociclib | Maximum observed plasma concentration (Cmax) of palbociclib | 1 years |
| Time to maximum observed plasma concentration of palbociclib (Tmax) | Time to maximum observed plasma concentration of palbociclib (Tmax) | 1 years |
| Observed trough concentration of palbociclib (Ctrough) | Observed trough concentration of palbociclib (Ctrough) | 1 years |
| 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) | 1 years |
| Observed trough concentration of sasanlimab (Ctrough) | Observed trough concentration of sasanlimab (Ctrough) | 1 years |
| Maximum observed plasma concentration (Cmax) of sasanlimab | Maximum observed plasma concentration (Cmax) of sasanlimab | 1 years |
| Chicago |
| Illinois |
| 60611 |
| United States |
| Dana-Farber Cancer Institute | Boston | Massachusetts | 02215 | United States |
| University of Michigan-Rogel Cancer Center | Ann Arbor | Michigan | 48109 | United States |
| Nebraska Cancer Specialists | Omaha | Nebraska | 68130 | United States |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065-6094 | United States |
| UT Southwestern Medical Center | Dallas | Texas | 75390-9324 | United States |
| University of Virginia Health System | Charlottesville | Virginia | 22908 | United States |
Not provided
| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 8, 2026 | Jul 2, 2026 | 10 | ||
| Jul 2, 2026 |
| ID | Term |
|---|---|
| D002292 | Carcinoma, Renal Cell |
| D007680 | Kidney Neoplasms |
| D002277 | Carcinoma |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D000230 | Adenocarcinoma |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C500026 | palbociclib |
Not provided
Not provided
Not provided