Actively Recruiting
A Phase 1, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Anti-Tumor Activity of the Oral CDK2/CDK4 Dual Degrader NKT5097 in Adults With Advanced or Metastatic Solid Tumors
Led by NiKang Therapeutics, Inc. · Updated on 2026-05-19
361
Participants Needed
14
Research Sites
21 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating NKT5097, a new oral drug that targets CDK2 and CDK4 proteins, in adults with advanced or metastatic solid tumors, including breast cancer and tumors with CCNE1 amplification. This open-label Phase 1 study aims to find the best dose for further testing and to understand the safety and side effects of NKT5097 alone and combined with endocrine therapy (ET). The study is divided into several parts: initial dose escalation of NKT5097 alone in selected solid tumors; evaluation of the effect of food on the drug; expansion of dose levels based on safety and pharmacokinetics; dose escalation of NKT5097 combined with ET in HR+/HER2- breast cancer; and expansion cohorts for combination therapy. NKT5097 will be taken orally once or twice daily, while ET drugs like fulvestrant (injection) and letrozole (oral) are given in specific schedules. Participants will undergo regular safety monitoring for dose-limiting toxicities and adverse events, pharmacokinetic testing at specified days, and tumor assessments to measure response and progression. The study includes collection of tumor tissue and biomarker analyses. Treatment and monitoring may last up to several years, with detailed follow-up to evaluate how the drug behaves in the body and its effects on tumors.
CONDITIONS
Brief Title
A Study With NKT5097 for Adults With Advanced/Metastatic Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to provide written informed consent
- Have advanced unresectable or metastatic solid tumor (Parts 1, 2, and 3) or HR+/HER2- breast cancer (Parts 4 and 5)
- Refractory to or unable to tolerate existing therapies (Parts 1, 2, and 4)
- Have measurable or evaluable disease (Parts 1, 2, and 4); measurable disease (Parts 3 and 5)
- Be 18 years of age or older
- ECOG performance status of 0 or 1
- Have adequate organ function
- Patients with female reproductive organs must be surgically sterile, post-menopausal, or willing to use effective contraception per protocol
- Patients capable of insemination must be willing to use highly effective contraception and refrain from sperm donation during treatment and for 28 days after last dose
- Able to swallow oral medications
- Willing to provide tumor tissue
You will not qualify if you...
- Have advanced solid tumor that is a candidate for curative treatment
- History of another malignancy except certain treated cancers in complete remission
- Not recovered from effects of prior anticancer therapy
- Clinically significant cardiovascular event within 6 months
- Known active CNS metastases or carcinomatous meningitis
- Active interstitial lung disease requiring treatment
- History of uveitis, retinopathy, or other significant retinal disease
- Major surgery within 30 days before first dose
- Active uncontrolled infectious disease
- Significant liver disease (Child Pugh class B or C)
- Prior selective investigational inhibitors or degraders (Part 5 only)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 3 years
Participants receive daily or twice daily oral doses of NKT5097, with some receiving combination therapy including Fulvestrant injections and daily oral Letrozole. Treatment duration varies based on dose escalation and cohort assignment.
Visits on Day 1, Day 15, and every cycle thereafter with more frequent visits during initial dose escalation
Duration - 28 days after last dose
Participants are monitored for safety and treatment outcomes after ending active treatment.
Approximately 1 to 2 follow-up visits
Trial Site Locations
Total: 14 locations
1
UC San Diego Moores Cancer Center
La Jolla, California, United States, 92037
Actively Recruiting
2
Sarah Cannon Research Institute at HealthONE
Denver, Colorado, United States, 80218
Actively Recruiting
3
Yale Cancer Center
New Haven, Connecticut, United States, 06520
Actively Recruiting
4
SCRI Florida Cancer Specialists - Sarasota
Sarasota, Florida, United States, 34232
Actively Recruiting
5
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Actively Recruiting
6
South Texas Accelerated Research Therapeutics (START) Midwest
Grand Rapids, Michigan, United States, 49546
Actively Recruiting
7
Washington University
St Louis, Missouri, United States, 63110
Actively Recruiting
8
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Actively Recruiting
9
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, United States, 15232
Actively Recruiting
10
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
Actively Recruiting
11
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
12
South Texas Accelerated Research Therapeutics (START) San Antonio
San Antonio, Texas, United States, 78229
Actively Recruiting
13
South Texas Accelerated Research Therapeutics (START) Mountain Region
West Valley City, Utah, United States, 84119
Actively Recruiting
14
NEXT Virginia
Fairfax, Virginia, United States, 22031
Actively Recruiting
Research Team
S
Sponsor Contact
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
5
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here