A Study With NKT5097 for Adults With Advanced/Metastatic Solid Tumors
Condition(s) studied
Investigational drug(s) / intervention(s)
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.
Study 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
Eligibility
Primary outcome measure(s)
- Incidence of dose-limiting toxicities as Assessed by CTCAE — From enrollment through end of safety monitoring period of 28 days from first dose
Trial sites (18)
| Facility | City | Region | Status |
|---|---|---|---|
| City of Hope | Duarte | California | Recruiting |
| UC San Diego Moores Cancer Center | La Jolla | California | Recruiting |
| Sarah Cannon Research Institute at HealthONE | Denver | Colorado | Recruiting |
| Yale Cancer Center | New Haven | Connecticut | Recruiting |
| SCRI Florida Cancer Specialists - Sarasota | Sarasota | Florida | Recruiting |
| University of Iowa | Iowa City | Iowa | Recruiting |
| Dana-Farber Cancer Institute | Boston | Massachusetts | Recruiting |
| South Texas Accelerated Research Therapeutics (START) Midwest | Grand Rapids | Michigan | Recruiting |
| Washington University | St Louis | Missouri | Recruiting |
| Comprehensive Cancer Centers of Nevada | Las Vegas | Nevada | Recruiting |
| Cleveland Clinic | Cleveland | Ohio | Recruiting |
| UPMC Hillman Cancer Center | Pittsburgh | Pennsylvania | Recruiting |
| University of Texas Southwestern Medical Center | Dallas | Texas | Recruiting |
| MD Anderson Cancer Center | Houston | Texas | Recruiting |
| South Texas Accelerated Research Therapeutics (START) San Antonio | San Antonio | Texas | Recruiting |
| South Texas Accelerated Research Therapeutics (START) Mountain Region | West Valley City | Utah | Recruiting |
| NEXT Virginia | Fairfax | Virginia | Recruiting |
| West Virginia University | Morgantown | West Virginia | Recruiting |
More NiKang Therapeutics, Inc. trials in the USA
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07029399 on ClinicalTrials.gov ↗ ← All trials in the USA