A Study With NKT3447 for Adults With Advanced/Metastatic Solid Tumors
Reason given: This study was terminated as a result of Sponsor portfolio reprioritization.
Key facts
- Where
- Augusta, Austin, Canton, Celebration, Denver, Louisville, San Francisco, and West Valley City, United StatesSee the 8 sites
- Phase
- Phase 1
Where in United States
- Augusta University, Georgia Cancer CenterAugusta, United StatesNo longer taking part
- Texas Oncology-Austin Midtown NEXT OncologyAustin, United StatesNo longer taking part
- The Gabrail Pharmacology Phase 1 Research CenterCanton, United StatesNo longer taking part
- AdventHealth Cancer InstituteCelebration, United StatesNo longer taking part
- Sarah Cannon Research Institute at HealthONEDenver, United StatesNo longer taking part
- Norton Cancer Institute - BroadwayLouisville, United StatesNo longer taking part
- University of California San Francisco (UCSF) - Helen Diller Family Comprehensive Cancer CenterSan Francisco, United StatesNo longer taking part
- START Mountain RegionWest Valley City, United StatesNo longer taking part
Trial details
- Who runs it
- NiKang Therapeutics, Inc.
- Trial code
- NCT06264921
- Record updated
- 25 September 2025
- Original description
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).Read full original descriptionShow less
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
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).
Inclusion: Must have confirmed unresectable advanced/metastatic solid tumors (as outlined below) with disease progression on prior standard treatment, intolerance to or ineligibility for standard treatment, or no available standard treatment likely to improve the disease outcome in the judgment of the Investigator; Measurable disease per the RECIST v1.1; An Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1; Able to swallow oral medications; Dose Escalation(Part 1):; Ovarian cancer; Endometrial cancer; Gastric cancer or gastroesophageal junction cancer; Small cell lung cancer (SCLC); Triple-negative breast cancer (human epidermal growth factor receptor 2 [HER2], estrogen receptor [ER], progesterone receptor negative); ER/progesterone-receptor positive, HER2 negative breast cancer (must have progressed following treatment with a CDK4/6 inhibitor, and not suitable for endocrine therapy); Other solid tumors with CCNE1 amplification as determined by NGS by local liquid or tissue biopsy; Dose Expansion (Part 2):; Platinum resistant or refractory ovarian cancer (defined as recurrence ≤6 months after completing platinum-based regimen) with progression on at least 1 platinum containing therapy with CCNE1 amplification as determined by NGS by local liquid or tissue biopsy; Measurable disease per the RECIST v1.1; An Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1; Able to swallow oral medications.
Exclusion: Locally advanced solid tumor that is a candidate for curative treatment through radical surgery and/or radiotherapy, or chemotherapy; Failed to recover from effects of prior anticancer treatment therapy to baseline or Grade ≤ 1 severity (per CTCAE); Prior CDK2 inhibitor; Major surgery within 2 months or minor surgery within 10 days before the first dose of NKT3447; History of another malignancy with exceptions; Clinically active interstitial lung disease; History of uveitis, retinopathy or other clinically significant retinal disease; Has known human immunodeficiency virus (HIV), active hepatitis B or C infection; Visceral crisis with life-threatening complications, lymphangitic spread, CNS metastasis and/or carcinomatous meningitis.