A Study With NKT3964 for Adults With Advanced/Metastatic Solid Tumors
Public ClinicalTrials.gov record NCT06586957. 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 CDK2 Degrader NKT3964 in Adults With Advanced/Metastatic Solid Tumors
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The goal of the Monotherapy Dose Escalation phase (Part 1) of the study is to evaluate the safety, tolerability, pharmacokinetics (PK) and preliminary anti-tumor activity to determine the preliminary recommended dose for expansion (RDE) of NKT3964 in adults with advanced or metastatic solid tumors. The goal of the Monotherapy Expansion phase of the study (Part 2) is to evaluate the preliminary anti-tumor activity of NKT3964 at the RDE based on objective response rate (ORR) and determine the preliminary recommended Phase 2 dose (RP2D). The goal of the Combination Dose Escalation phase (Part 3) of the study is to identify the RDE of NKT3964 in combination with chemotherapy in adult subjects with advanced/metastatic endometrial cancer. The goal of the Combination Expansion phase of the study (Part 4) is to evaluate the preliminary anti-tumor activity of NKT3964 in combination with chemotherapy at the RDE based on ORR.
Study identification
- NCT ID
- NCT06586957
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 238 participants
Conditions and interventions
Conditions
- Solid Tumor
- Advanced Solid Tumor
- Solid Tumor, Adult
- Metastatic Tumor
- Ovarian Cancer
- Ovarian Neoplasms
- Ovarian Carcinoma
- Metastatic Ovarian Carcinoma
- Endometrial Neoplasms
- Endometrial Diseases
- Metastatic Endometrial Cancer
- Triple Negative Breast 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 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
- 19 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
- Sep 19, 2024 (Actual)
- Primary completion
- Jan 2029 (Estimated)
- Completion
- May 2029 (Estimated)
- Last update posted
- Oct 16, 2026
2024 – 2029
United States locations
- U.S. sites
- 19
- U.S. states
- 13
- U.S. cities
- 19
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Arkansas Medical School | Little Rock | Arkansas | 72205 | Recruiting |
| University of California - Los Angeles | Los Angeles | California | 90095 | Recruiting |
| UCSF | San Francisco | California | 94158 | Withdrawn |
| SCRI at HealthOne | Denver | Colorado | 80218 | Recruiting |
| Florida Cancer Specialists & Research Institute | Lake Mary | Florida | 32746 | Terminated |
| AdventHealth Cancer Institute | Orlando | Florida | 32804 | Recruiting |
| Emory Winship Cancer Institute | Atlanta | Georgia | 30322 | Recruiting |
| Augusta University | Augusta | Georgia | 30912 | Recruiting |
| University of Kansas | Fairway | Kansas | 66205 | Withdrawn |
| Dana Farber Cancer Institute | Boston | Massachusetts | 02215 | Recruiting |
| John Theurer Cancer Center at Hackensack UMC | Hackensack | New Jersey | 07601 | Recruiting |
| Sidney Kimmell Cancer Center - Jefferson Health | Philadelphia | Pennsylvania | 19107 | Recruiting |
| UPMC | Pittsburgh | Pennsylvania | 15213 | Withdrawn |
| Sarah Cannon Research Institute (SCRI) | Nashville | Tennessee | 37203 | Recruiting |
| NEXT Oncology | Austin | Texas | 78758 | Recruiting |
| UT Southwestern | Dallas | Texas | 75235 | Recruiting |
| Intermountain Health | Salt Lake City | Utah | 84145 | Recruiting |
| University of Virginia | Charlottesville | Virginia | 22903 | Recruiting |
| NEXT Virginia | Fairfax | Virginia | 22031 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 1 non-U.S. site.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06586957, 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 Oct 16, 2026 · Synced Oct 19, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT06586957 live on ClinicalTrials.gov.