A Study With NKT5097 for Adults With Advanced/Metastatic Solid Tumors

May 15, 2026 updated by: NiKang Therapeutics, Inc.

A Phase 1, First-in-Human, Open-Label Study to Evaluate the Safety, Tolerability, PK, and Preliminary Anti-tumor Activity of the Novel Oral Selective CDK2/CDK4 Dual Degrader NKT5097 in Adults With Advanced/Metastatic Solid Tumors

The goal of this open-label dose escalation and expansion study is to evaluate the safety and tolerability of NKT5097 in adults with advanced/metastatic tumors (emphasis on breast cancer and solid tumors with CCNE1 amplification). Main questions to answer include:

  • What is the recommended dose for expansion and/or Phase 2, for both monotherapy and in combination with ET
  • What medical issues/symptoms do participants experience when taking NKT5097 as monotherapy as well as in combination with ET

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This First-in-Human, Open-Label Study to Evaluate the Safety, Tolerability, PK, and Preliminary Anti-tumor Activity of NKT5097, a novel dual protein degrader of CDK2 and CDK4, is split into 3 Parts:

Part 1: Monotherapy Dose Escalation in selected advanced/metastatic non-CNS primary solid tumors will be enrolled based on a projected total of 5 dose levels

Part 2: Food Effect Analysis: Subjects with solid tumors (as noted in Part 1) will be enrolled (by backfilling selected dose cohorts) to evaluate the effect of dosing with food on NKT5097.

Part 3: Monotherapy Tumor-specific Expansion: Subjects may be enrolled (by backfilling selected dose cohorts) into each selected tumor-specific cohort. One or more of these cohorts may be opened at the discretion of the Sponsor in consultation with the DEC

Part 4: Combination Dose Escalation with ET in selected HR+/HER2- breast cancer will be enrolled based on a projected 2 dose levels

Part 5: Combination Dose Expansion with ET in HR+/HER2- breast cancer in one or more various cohorts

In addition to the above, the study will explore pharmacokinetics, various pharmacodynamic biomarkers, gene mutations, and tumor responses such as PFS and DOR.

Study Type

Interventional

Enrollment (Estimated)

361

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • La Jolla, California, United States, 92037
        • Recruiting
        • UC San Diego Moores Cancer Center
        • Principal Investigator:
          • Rebecca Shatsky, MD
        • Contact:
    • Colorado
      • Denver, Colorado, United States, 80218
        • Recruiting
        • Sarah Cannon Research Institute at HealthONE
        • Principal Investigator:
          • Gerald Falchook, MD
        • Contact:
    • Connecticut
      • New Haven, Connecticut, United States, 06520
        • Recruiting
        • Yale Cancer Center
        • Principal Investigator:
          • Adriana Kahn, MD
        • Contact:
    • Florida
      • Sarasota, Florida, United States, 34232
        • Recruiting
        • SCRI Florida Cancer Specialists - Sarasota
        • Principal Investigator:
          • Judy Wang, MD
        • Contact:
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Recruiting
        • Dana-Farber Cancer Institute
        • Principal Investigator:
          • Antonio Giordano, MD
        • Contact:
          • Dana Faber Institutional clinical.gov contact
          • Phone Number: 877-338-7425
    • Michigan
      • Grand Rapids, Michigan, United States, 49546
        • Recruiting
        • South Texas Accelerated Research Therapeutics (START) Midwest
        • Principal Investigator:
          • Manish Sharma
        • Contact:
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Recruiting
        • Washington University
        • Contact:
        • Principal Investigator:
          • Faisal Fa'ak, MD
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Recruiting
        • Cleveland Clinic
        • Principal Investigator:
          • Azka Ali, MD
        • Contact:
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15232
        • Recruiting
        • UPMC Hillman Cancer Center
        • Contact:
        • Principal Investigator:
          • Marija Balic, MD, PhD, MBA
    • Texas
      • Dallas, Texas, United States, 75390
        • Recruiting
        • University of Texas Southwestern Medical Center
        • Principal Investigator:
          • Nisha Unni, MD
        • Contact:
      • Houston, Texas, United States, 77030
        • Recruiting
        • MD Anderson Cancer Center
        • Principal Investigator:
          • Timothy Yap, MD
        • Contact:
      • San Antonio, Texas, United States, 78229
        • Recruiting
        • South Texas Accelerated Research Therapeutics (START) San Antonio
        • Principal Investigator:
          • Amita Patnaik
        • Contact:
    • Utah
      • West Valley City, Utah, United States, 84119
        • Recruiting
        • South Texas Accelerated Research Therapeutics (START) Mountain Region
        • Principal Investigator:
          • William McKean
        • Contact:
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Recruiting
        • NEXT Virginia
        • Contact:
        • Principal Investigator:
          • Alexander Spira

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Able to provide written informed consent
  • Advanced unresectable or metastatic solid tumor (Part 1, 2 & 3 only)
  • Advanced unresectable or metastatic HR+/HER2- breast cancer (Part 4 & 5 only)
  • Refractory to or unable to tolerate existing therapies (Part 1, 2 & 4 only)
  • Measurable or evaluable disease (Part 1, 2, & 4 only).
  • Measurable disease (Part 3 & 5 only)
  • Eighteen years of age or older
  • ECOG status of 0 or 1
  • Adequate organ function
  • Patients with female reproductive organs must be surgically sterile, post- menopausal or willing to use effective contraception per protocol
  • Patients who are capable of insemination must be willing to use highly effective contraception and to refrain from sperm donation during treatment and for 28 days after the last dose
  • Able to swallow oral meds
  • Willing to provide tumor tissue

Exclusion Criteria:

  • Advanced solid tumor that is a candidate for curative treatment
  • History of another malignancy except for the following: adequately treated local basal cell or squamous carcinoma of the skin, in situ cervical cancer, adequately treated papillary noninvasive bladder cancer, other adequately treated Stage I or Stage II cancers currently in complete remission
  • Not recovered from the effects of prior anticancer therapy
  • Clinically significant cardiovascular event, including myocardial infarction, arterial thromboembolism, or cerebrovascular thromboembolism, within 6 months
  • Known active CNS metastases and/or carcinomatous meningitis
  • Active interstitial lung disease requiring treatment
  • History of uveitis, retinopathy, or other clinically significant retinal disease
  • Major surgery within 30 days of administration of first dose
  • Active uncontrolled infectious disease
  • Significant liver disease (Child Pugh class B or C)
  • Should not have received any prior selective investigational inhibitors or degraders (Part 5 only)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Part 1 Dose Escalation
Escalation of orally administered NKT5097
Drug: NKT5097 CDK2/CDK4 dual degrader
NKT5097 will be distributed in tablet form and dosed daily or twice a day
Experimental: Part 2 Food Effect
Orally administered NKT5097 with and without meal
Drug: NKT5097 CDK2/CDK4 dual degrader
NKT5097 will be distributed in tablet form and dosed daily or twice a day
Experimental: Part 3 Expansion
Expansion of dose levels based upon safety and PK following Part 1 escalation.
Drug: NKT5097 CDK2/CDK4 dual degrader
NKT5097 will be distributed in tablet form and dosed daily or twice a day
Experimental: Part 4 Combination Dose Escalation
Escalation of orally administered NKT5097 in combination with Endocrine Therapy (ET)
Drug: NKT5097 CDK2/CDK4 dual degrader
NKT5097 will be distributed in tablet form and dosed daily or twice a day
Drug: Fulvestrant
Fulvestrant will be administered as an injection and dosed on C1D1, C1D15 and Day 1 of every cycle thereafter.
Drug: Letrozole
Letrozole will be administered orally once daily.
Experimental: Part 5 Combination Expansion
Expansion of dose levels based upon safety and PK following Part 4 escalation
Drug: NKT5097 CDK2/CDK4 dual degrader
NKT5097 will be distributed in tablet form and dosed daily or twice a day
Drug: Fulvestrant
Fulvestrant will be administered as an injection and dosed on C1D1, C1D15 and Day 1 of every cycle thereafter.
Drug: Letrozole
Letrozole will be administered orally once daily.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of dose-limiting toxicities as Assessed by CTCAE
Time Frame: From enrollment through end of safety monitoring period of 28 days from first dose
From enrollment through end of safety monitoring period of 28 days from first dose

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence of adverse events (AEs) as defined by CTCAE Version 5
Time Frame: From enrollment through end of treatment up to 2 years
From enrollment through end of treatment up to 2 years
Maximum concentration Cmax after a single dose and multiple doses
Time Frame: Day 1 and Day 15 of Cycle 1 (Cycle 1 is 28 days)
Day 1 and Day 15 of Cycle 1 (Cycle 1 is 28 days)
Area under the concentration-time curve (AUC last) after a single dose and multiple doses from first dose through the last timepoint with quantifiable concentration (Tlast)
Time Frame: Day 1 and Day 15 of Cycle 1 ((Cycle 1 is 28 days)
Day 1 and Day 15 of Cycle 1 ((Cycle 1 is 28 days)
Maximum concentration (Cmax) when dosed with and without food
Time Frame: Day 1 and Day 2 of Cycle 1 (Cycle 1 is 28 days)
Day 1 and Day 2 of Cycle 1 (Cycle 1 is 28 days)
Area under the concentration-time curve (AUC last) when dosed with and without food from dosing through the last timepoint with quantifiable concentration (Tlast)
Time Frame: Day 1 through Day 3 of Cycle 1 (Cycle 1 is 28 days)
Day 1 through Day 3 of Cycle 1 (Cycle 1 is 28 days)
Time to maximum plasma concentration (Tmax) after a single dose and multiple doses
Time Frame: Day 1 through Day 3 and Day 15 of Cycle 1 (Cycle 1 is 28 days)
Day 1 through Day 3 and Day 15 of Cycle 1 (Cycle 1 is 28 days)
Investigator-assessed ORR by RECIST v1.1
Time Frame: From enrollment (Day 1) through end of treatment (up to 3 years) with an average of 4 months
From enrollment (Day 1) through end of treatment (up to 3 years) with an average of 4 months
Investigator-assessed PFS by RECIST v1.1
Time Frame: From enrollment (Day 1) through end of treatment (up to 3 years) with an average of 4 months
From enrollment (Day 1) through end of treatment (up to 3 years) with an average of 4 months
Duration of Response (DOR)
Time Frame: From enrollment (Day 1) through end of treatment (up to 3 years) with an average of 4 months
From enrollment (Day 1) through end of treatment (up to 3 years) with an average of 4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NiKang Therapeutics, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 25, 2025

Primary Completion (Estimated)

July 31, 2027

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

May 28, 2025

First Submitted That Met QC Criteria

June 18, 2025

First Posted (Actual)

June 19, 2025

Study Record Updates

Last Update Posted (Actual)

May 19, 2026

Last Update Submitted That Met QC Criteria

May 15, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NKT5097-101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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