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

NCT05935748 | Terminated Phase 2 DMC FDA Drug

• 1 other identifier: NKT2152-202
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 8

Brief 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.

Conditions

ccRCC; Clear Cell Renal Cell Carcinoma; Kidney Cancer; Kidney Neoplasms; Renal Cancer; Renal Neoplasms; Recurrent Renal Cell Carcinoma; Metastatic Renal Cell Carcinoma; Refractory Renal Cell Carcinoma; Advanced Renal Cell Carcinoma; Carcinoma; Neoplasms; Carcinoma, Renal Cell; Neoplasms, Glandular and Epithelial; Neoplasm by Histology; Adenocarcinoma; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Kidney Diseases; Urologic Diseases

Keywords

HIF2a; Hypoxia-inducible factor 2alpha; CDK4 inhibitor; CDK6 inhibitor; PD-1; immune checkpoint inhibitors

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (16)

• Progression-free survival (PFS)

  2 years

• Duration of Response (DOR)

  1 years

• Time to Response (TTR)

  1 years

• Overall Survival (OS)

  2 years

• Clinical Benefit Rate (CBR)

  1 years

Study Arms (4)

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).

Drug: NKT2152; Drug: palbociclib

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

Drug: NKT2152; Drug: palbociclib; Other: 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.

Drug: NKT2152; Drug: palbociclib

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.

Drug: NKT2152; Drug: palbociclib; Other: sasanlimab

Interventions

NKT2152 DRUG

Oral HIF2a inhibitor

Expansion Doublet combination; Expansion Triplet combination; Lead-in Doublet combination; Lead-in Triplet combination

palbociclib DRUG

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

Also known as: IBRANCE®

Expansion Doublet combination; Expansion Triplet combination; Lead-in Doublet combination; Lead-in Triplet combination

sasanlimab OTHER

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

Expansion Triplet combination; Lead-in Triplet combination

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• NiKang Therapeutics, Inc.: lead
• Pfizer: collaborator

Study Sites (8)

University of California San Diego

La Jolla, California, 92093, United States

Location

Northwestern University - Feinberg School of Medicine

Chicago, Illinois, 60611, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

University of Michigan-Rogel Cancer Center

Ann Arbor, Michigan, 48109, United States

Location

Nebraska Cancer Specialists

Omaha, Nebraska, 68130, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065-6094, United States

Location

UT Southwestern Medical Center

Dallas, Texas, 75390-9324, United States

Location

University of Virginia Health System

Charlottesville, Virginia, 22908, United States

Location

MeSH Terms

Conditions

Carcinoma, Renal Cell; Kidney Neoplasms; Carcinoma; Neoplasms; Neoplasms, Glandular and Epithelial; Adenocarcinoma; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Kidney Diseases; Urologic Diseases

Interventions

palbociclib

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Randomization during Expansion phase
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Lead-in/Dose Escalation (doublet \& triplet combination) and Dose Expansion (doublet \& triplet combination)

Study Record Dates

• First Submitted: June 29, 2023
• First Posted: July 7, 2023
• Study Start: July 28, 2023
• Primary Completion: June 30, 2025
• Study Completion: September 4, 2025
• Last Updated: November 12, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (8)