OncoMatch/Clinical Trials/NCT07029399
A Study With NKT5097 for Adults With Advanced/Metastatic Solid Tumors
Is NCT07029399 recruiting? Yes, currently enrolling (Sep 2026). This Phase 1 trial studies multiple treatments including NKT5097 CDK2/CDK4 dual degrader and Fulvestrant for hr+ breast cancer.
Treatment: NKT5097 CDK2/CDK4 dual degrader · Fulvestrant · Letrozole — 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
Check if I qualifyExtracted eligibility criteria
Treatments studied
Endocrine / hormonal
Other
Cancer type
Breast Carcinoma
Triple-Negative Breast Cancer
Tumor Agnostic
Performance status
ECOG 0–1(Restricted strenuous activity)
Lab requirements
Liver function
Adequate organ function; Significant liver disease (Child Pugh class B or C) [excluded]
Cardiac function
Clinically significant cardiovascular event, including myocardial infarction, arterial thromboembolism, or cerebrovascular thromboembolism, within 6 months [excluded]
Adequate organ function; Significant liver disease (Child Pugh class B or C) [excluded]; Clinically significant cardiovascular event, including myocardial infarction, arterial thromboembolism, or cerebrovascular thromboembolism, within 6 months [excluded]
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- City of Hope · Duarte, California
- UC San Diego Moores Cancer Center · La Jolla, California
- Sarah Cannon Research Institute at HealthONE · Denver, Colorado
- Yale Cancer Center · New Haven, Connecticut
- SCRI Florida Cancer Specialists - Sarasota · Sarasota, Florida
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT07029399 currently recruiting?
Yes, this trial is currently recruiting patients.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify