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

Recruiting now · Phase 1

Conditions studied: HR+ Breast Cancer, Triple Negative Breast Cancer (TNBC), CCNE1 Amplified Advanced Solid Tumors, HR+ HER2- Breast Cancer

In brief

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

Key facts

Study ID

NCT07029399

Run by

NiKang Therapeutics, Inc.

People needed

361

Starts

2025-03-25

Expected to finish

2027-12-31

Last updated by the study team

2026-06-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• City of Hope — Duarte, California, United States (enrolling)
• UC San Diego Moores Cancer Center — La Jolla, California, United States (enrolling)
• Sarah Cannon Research Institute at HealthONE — Denver, Colorado, United States (enrolling)
• Yale Cancer Center — New Haven, Connecticut, United States (enrolling)
• SCRI Florida Cancer Specialists - Sarasota — Sarasota, Florida, United States (enrolling)
• University of Iowa — Iowa City, Iowa, United States (enrolling)
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States (enrolling)
• South Texas Accelerated Research Therapeutics (START) Midwest — Grand Rapids, Michigan, United States (enrolling)
• Washington University — St Louis, Missouri, United States (enrolling)
• Comprehensive Cancer Centers of Nevada — Las Vegas, Nevada, United States (enrolling)
• Cleveland Clinic — Cleveland, Ohio, United States (enrolling)
• UPMC Hillman Cancer Center — Pittsburgh, Pennsylvania, United States (enrolling)
• University of Texas Southwestern Medical Center — Dallas, Texas, United States (enrolling)
• MD Anderson Cancer Center — Houston, Texas, United States (enrolling)
• South Texas Accelerated Research Therapeutics (START) San Antonio — San Antonio, Texas, United States (enrolling)
• South Texas Accelerated Research Therapeutics (START) Mountain Region — West Valley City, Utah, United States (enrolling)
• NEXT Virginia — Fairfax, Virginia, United States (enrolling)
• West Virginia University — Morgantown, West Virginia, United States (enrolling)

Full record on ClinicalTrials.gov

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