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A Study With NKT5097 for Adults With Advanced/Metastatic Solid Tumors
NCT07029399 · View on ClinicalTrials.gov ↗
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 * What medical issues/symptoms do participants experience when taking NKT5097
Conditions Studied
Interventions
- DRUG NKT5097 CDK2/CDK4 dual degrader
Study Locations (14)
Texas
- University of Texas Southwestern Medical Center — Dallas
- MD Anderson Cancer Center — Houston
- South Texas Accelerated Research Therapeutics (START) San Antonio — San Antonio
California
- UC San Diego Moores Cancer Center — La Jolla
Colorado
- Sarah Cannon Research Institute at HealthONE — Denver
Connecticut
- Yale Cancer Center — New Haven
Florida
- SCRI Florida Cancer Specialists - Sarasota — Sarasota
Massachusetts
- Dana-Farber Cancer Institute — Boston
Michigan
- South Texas Accelerated Research Therapeutics (START) Midwest — Grand Rapids
Missouri
- Washington University — St Louis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 205 participants |
| Start Date | 2025-03-25 |
| Est. Completion | 2027-12-31 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07029399
The ClinicalTrials.gov registry entry for NCT07029399 describes a study currently listed as recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 205 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is NiKang Therapeutics, which has 33 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 7 conditions, with Ovarian Cancer appearing as the primary indexed condition, and to 1 intervention — of which NKT5097 CDK2/CDK4 dual degrader is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT07029399 reports 14 study locations spanning 12 distinct geographic areas — top geographies include Texas, California, Colorado. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT07029399 about?
NCT07029399 is a clinical study titled "A Study With NKT5097 for Adults With Advanced/Metastatic Solid Tumors". 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...
What is the current status of trial NCT07029399?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 205 participants. The study started on 2025-03-25. Estimated completion is 2027-12-31.
What conditions does trial NCT07029399 study?
This clinical trial studies the following conditions: Ovarian Cancer, Endometrial Cancer, Triple Negative Breast Cancer (TNBC), Uterine Carcinosarcoma, HR+ Breast Cancer. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT07029399?
The interventions under investigation include: NKT5097 CDK2/CDK4 dual degrader (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT07029399?
This trial is sponsored by NiKang Therapeutics, which has 33 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT07029399 being conducted?
This trial has 14 study locations across California, Colorado, Connecticut, Florida, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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