A Study With NKT5097 for Adults With Advanced/Metastatic Solid Tumors
Public ClinicalTrials.gov record NCT07029399. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 identification
- NCT ID
- NCT07029399
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 361 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Mar 24, 2025
- Primary completion
- Jul 30, 2027
- Completion
- Dec 30, 2027
- Last update posted
- Aug 27, 2026
2025 – 2027
United States locations
- U.S. sites
- 18
- U.S. states
- 15
- U.S. cities
- 18
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| City of Hope | Duarte | California | 91010 | Recruiting |
| UC San Diego Moores Cancer Center | La Jolla | California | 92037 | Recruiting |
| Sarah Cannon Research Institute at HealthONE | Denver | Colorado | 80218 | Recruiting |
| Yale Cancer Center | New Haven | Connecticut | 06520 | Recruiting |
| SCRI Florida Cancer Specialists - Sarasota | Sarasota | Florida | 34232 | Recruiting |
| University of Iowa | Iowa City | Iowa | 52242 | Recruiting |
| Dana-Farber Cancer Institute | Boston | Massachusetts | 02115 | Recruiting |
| South Texas Accelerated Research Therapeutics (START) Midwest | Grand Rapids | Michigan | 49546 | Recruiting |
| Washington University | St Louis | Missouri | 63110 | Recruiting |
| Comprehensive Cancer Centers of Nevada | Las Vegas | Nevada | 89169 | Recruiting |
| Cleveland Clinic | Cleveland | Ohio | 44195 | Recruiting |
| UPMC Hillman Cancer Center | Pittsburgh | Pennsylvania | 15232 | Recruiting |
| University of Texas Southwestern Medical Center | Dallas | Texas | 75390 | Recruiting |
| MD Anderson Cancer Center | Houston | Texas | 77030 | Recruiting |
| South Texas Accelerated Research Therapeutics (START) San Antonio | San Antonio | Texas | 78229 | Recruiting |
| South Texas Accelerated Research Therapeutics (START) Mountain Region | West Valley City | Utah | 84119 | Recruiting |
| NEXT Virginia | Fairfax | Virginia | 22031 | Recruiting |
| West Virginia University | Morgantown | West Virginia | 26506 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07029399, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 27, 2026 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT07029399 live on ClinicalTrials.gov.