A Study With NKT3447 for Adults With Advanced/Metastatic Solid Tumors
Public ClinicalTrials.gov record NCT06264921. 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 Orally Available CDK2 Inhibitor NKT3447 in Adults With Advanced/Metastatic Solid Tumors
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The goal of the Dose Escalation phase of the study is to evaluate the safety, tolerability, and pharmacokinetics (PK) to determine the maximum tolerated dose (MTD) and/or preliminary recommended dose for expansion (RDE) of NKT3447 in adults with advanced or metastatic solid tumors. The goal of the Expansion phase of the study is to evaluate the safety, tolerability, pharmacokinetics (PK), and the preliminary antitumor activity of NKT3447 in adult subjects with cyclin E1 (CCNE1) amplified ovarian cancer at the RDEs selected in Dose Escalation and to determine the preliminary recommended phase 2 dose (RP2D).
Study identification
- NCT ID
- NCT06264921
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 23 participants
Conditions and interventions
Conditions
- Solid Tumor
- Solid Tumor, Adult
- Advanced Solid Tumor
- Metastatic Tumor
- Ovarian Cancer
- Ovarian Neoplasms
- Ovarian Carcinoma
- Metastatic Ovarian Carcinoma
- Endometrial Cancer
- Endometrial Neoplasms
- Endometrial Diseases
- Metastatic Endometrial Cancer
- Metastatic Endometrial Carcinoma
- Advanced Endometrial Carcinoma
- Advanced Ovarian Carcinoma
- Gastric Cancer
- Advanced Gastric Carcinoma
- Metastatic Gastric Cancer
- Metastatic Gastric Carcinoma
- Small-cell Lung Cancer
- Small Cell Lung Carcinoma
- Triple Negative Breast Cancer
- Triple Negative Breast Neoplasms
- Platinum-resistant Ovarian Cancer
- Platinum-refractory Ovarian Carcinoma
- CCNE1 Amplification
- Hormone Receptor Negative Breast Carcinoma
- Human Epidermal Growth Factor 2 Negative Carcinoma of Breast
- Progesterone-receptor-positive Breast Cancer
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
- Feb 22, 2024
- Primary completion
- Apr 6, 2025
- Completion
- Apr 15, 2025
- Last update posted
- Sep 24, 2025
2024 – 2025
United States locations
- U.S. sites
- 8
- U.S. states
- 8
- U.S. cities
- 8
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of California San Francisco (UCSF) - Helen Diller Family Comprehensive Cancer Center | San Francisco | California | 94158 | — |
| Sarah Cannon Research Institute at HealthONE | Denver | Colorado | 80218 | — |
| AdventHealth Cancer Institute | Celebration | Florida | 34747 | — |
| Augusta University Georgia Cancer Center | Augusta | Georgia | 30909 | — |
| Norton Cancer Institute - Broadway | Louisville | Kentucky | 40202 | — |
| The Gabrail Pharmacology Phase 1 Research Center | Canton | Ohio | 44718 | — |
| Texas Oncology-Austin Midtown NEXT Oncology | Austin | Texas | 78758 | — |
| START Mountain Region | West Valley City | Utah | 84119 | — |
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 NCT06264921, 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 Sep 24, 2025 · Synced Sep 6, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06264921 live on ClinicalTrials.gov.