Recruiting

Phase 1

NKT5097A Study With NKT5097 for Adults With Advanced/Metastatic Solid Tumors

Sponsor:

NiKang Therapeutics, Inc.

Code:

NCT07029399

Conditions

HR+ Breast Cancer

Triple Negative Breast Cancer (TNBC)

CCNE1 Amplified Advanced Solid Tumors

HR+ HER2- Breast Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

NKT5097 CDK2/CDK4 dual degrader

Fulvestrant

Letrozole

Study Details

Brief summary:

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

Conditions

HR+ Breast Cancer

Triple Negative Breast Cancer (TNBC)

CCNE1 Amplified Advanced Solid Tumors

HR+ HER2- Breast Cancer

Study ID

NCT07029399

Start date

Mar 25, 2025

Status verified date

Aug, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Jul 31, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

361 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Part 1 Dose Escalation

Escalation of orally administered NKT5097

experimental: Part 2 Food Effect

Orally administered NKT5097 with and without meal

experimental: Part 3 Expansion

Expansion of dose levels based upon safety and PK following Part 1 escalation.

experimental: Part 4 Combination Dose Escalation

Escalation of orally administered NKT5097 in combination with Endocrine Therapy (ET)

experimental: Part 5 Combination Expansion

Expansion of dose levels based upon safety and PK following Part 4 escalation

Interventions

NKT5097 CDK2/CDK4 dual degrader

NKT5097 will be distributed in tablet form and dosed daily or twice a day

Fulvestrant

Fulvestrant will be administered as an injection and dosed on C1D1, C1D15 and Day 1 of every cycle thereafter.

Letrozole

Letrozole will be administered orally once daily.

Primary outcome measure

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 ]

Central Contacts and Locations

Central contacts

Sponsor Contact

302-596-8654 clinicaltrials@nikangtx.com

Locations

City of Hope

Recruiting

Duarte, California, United States, 91010

Contacts

Jenny Sanchez

949-671-4920 jesanchez@coh.org

Principal Investigator:

Hope Rugo, MD

UC San Diego Moores Cancer Center

Recruiting

La Jolla, California, United States, 92037

Contacts

Cristal Martinez

858-822-5223 cmm015@health.ucsd.edu

Principal Investigator:

Rebecca Shatsky, MD

Sarah Cannon Research Institute at HealthONE

Recruiting

Denver, Colorado, United States, 80218

Contacts

SCRI Contact Email

720-754-2610 CANN.DDUDenverGeneral@SarahCannon.com

Principal Investigator:

Gerald Falchook, MD

Yale Cancer Center

Recruiting

New Haven, Connecticut, United States, 06520

Contacts

Priscilla Steve

203-785-4069 Priscilla.Steve@yale.edu

Principal Investigator:

Adriana Kahn, MD

SCRI Florida Cancer Specialists - Sarasota

Recruiting

Sarasota, Florida, United States, 34232

Contacts

Carly Taylor

941-377-9993 ctaylor@flcancer.com

Principal Investigator:

Judy Wang, MD

University of Iowa

Recruiting

Iowa City, Iowa, United States, 52242

Contacts

Clinical Trial Inquiry Line

319-353-8155 kerri-fitch@uiowa.edu

Principal Investigator:

Mark Burkard, MD

Dana-Farber Cancer Institute

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Dana Faber Institutional clinical.gov contact

877-338-7425

Principal Investigator:

Antonio Giordano, MD

South Texas Accelerated Research Therapeutics (START) Midwest

Recruiting

Grand Rapids, Michigan, United States, 49546

Contacts

Ashley Spagnuolo

616.954.5552 ashley.spagnuolo@startresearch.com

Principal Investigator:

Manish Sharma

Washington University

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Katlyn Kraft

314-747-5440 Katlyn.Kraft@wustl.edu

Principal Investigator:

Faisal Fa'ak, MD

Comprehensive Cancer Centers of Nevada

Recruiting

Las Vegas, Nevada, United States, 89169

Contacts

Ann Lovelace

702-609-9460 Ann.lovelace@usoncology.com

Principal Investigator:

Fadi Braiteh, MD

Cleveland Clinic

Recruiting

Cleveland, Ohio, United States, 44195

Contacts

Cancer Answer

216-444-7923 TaussigResearch@ccf.org

Principal Investigator:

Azka Ali, MD

UPMC Hillman Cancer Center

Recruiting

Pittsburgh, Pennsylvania, United States, 15232

Contacts

Julie Urban

412-623-7396 IDDCReferrals@upmc.edu

Principal Investigator:

Marija Balic, MD, PhD, MBA

University of Texas Southwestern Medical Center

Recruiting

Dallas, Texas, United States, 75390

Contacts

Jennifer Knight

214-645-7097 Jennifer.Knight@UTSouthwestern.edu

Principal Investigator:

Nisha Unni, MD

MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Ileana Gutierrez

832-829-2161 ilgutierrez@mdanderson.org

Principal Investigator:

Timothy Yap, MD

South Texas Accelerated Research Therapeutics (START) San Antonio

Recruiting

San Antonio, Texas, United States, 78229

Contacts

Isabel Jimenez

210-593-5265 isabel.jimenez@startresearch.com

Principal Investigator:

Amita Patnaik

South Texas Accelerated Research Therapeutics (START) Mountain Region

Recruiting

West Valley City, Utah, United States, 84119

Contacts

HOPE Team

801-907-4750 hopeteam@startresearch.com

Principal Investigator:

William McKean

NEXT Virginia

Recruiting

Fairfax, Virginia, United States, 22031

Contacts

Blake Patterson

703-783-4505 bpatterson@nextoncology.com

Principal Investigator:

Alexander Spira

West Virginia University

Recruiting

Morgantown, West Virginia, United States, 26506

Contacts

Emily Hawkins

304-293-7375 emily.hawkins@hsc.wvu.edu

Principal Investigator:

Bei Jiang, MD, PhD

More Information

Sponsor

NiKang Therapeutics, Inc.

Last update posted

Aug 28, 2026

Last verified

Aug, 2026

Keywords

CCNE1
cyclin E1
triple negative breast cancer
TNBC
estrogen receptor positive
HER2-
breast cancer
post CDK4/6i
HER2 expression
Fulvestrant
Letrozole
endocrine therapy
refractory
endocrine resistant
endocrine sensitivity
metastatic

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by NiKang Therapeutics, Inc. on 2026-08-28.