nctId: NCT06264921 id: NKT3447-101 briefTitle: A Study With NKT3447 for Adults With Advanced/Metastatic Solid Tumors overallStatus: RECRUITING date: 2024-02-23 date: 2025-03 date: 2025-05 date: 2024-02-20 date: 2024-04-12 name: NiKang Therapeutics, Inc. class: INDUSTRY briefSummary: 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). conditions: Solid Tumor conditions: Solid Tumor, Adult conditions: Advanced Solid Tumor conditions: Metastatic Tumor conditions: Ovarian Cancer conditions: Ovarian Neoplasms conditions: Ovarian Carcinoma conditions: Metastatic Ovarian Carcinoma conditions: Endometrial Cancer conditions: Endometrial Neoplasms conditions: Endometrial Diseases conditions: Metastatic Endometrial Cancer conditions: Metastatic Endometrial Carcinoma conditions: Advanced Endometrial Carcinoma conditions: Advanced Ovarian Carcinoma conditions: Gastric Cancer conditions: Advanced Gastric Carcinoma conditions: Metastatic Gastric Cancer conditions: Metastatic Gastric Carcinoma conditions: Small-cell Lung Cancer conditions: Small Cell Lung Carcinoma conditions: Triple Negative Breast Cancer conditions: Triple Negative Breast Neoplasms conditions: Platinum-resistant Ovarian Cancer conditions: Platinum-refractory Ovarian Carcinoma conditions: CCNE1 Amplification conditions: Hormone Receptor Negative Breast Carcinoma conditions: Human Epidermal Growth Factor 2 Negative Carcinoma of Breast conditions: Progesterone-receptor-positive Breast Cancer studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL interventionModelDescription: Dose Escalation and Dose Expansion primaryPurpose: TREATMENT masking: NONE maskingDescription: Randomized for the Expansion Phase count: 90 type: ESTIMATED name: NKT3447 measure: Number of Participants with Dose Limiting Toxicity (DLT) events measure: Objective Response Rate (ORR) measure: Progression-free survival (PFS) measure: Duration of Response (DOR) measure: Disease control rate measure: Overall Survival (OS) measure: Time to Response (TTR) measure: Number of Participants with Adverse Events measure: Maximum observed plasma concentration (Cmax) of NKT3447 measure: Time to maximum observed plasma concentration of NKT3447 (Tmax) measure: Observed trough concentration of NKT3447 (Ctrough) measure: Area under the plasma concentration-time curve (AUC0-t) of NKT3447 measure: Apparent clearance (CL/F) measure: Apparent volume of distribution (V/F) measure: Half-life (t1/2) measure: Accumulation ratio (AR) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Sarah Cannon Research Institute at HealthONE status: RECRUITING city: Denver state: Colorado zip: 80218 country: United States name: Kelly Mozzetta role: CONTACT name: Gerald Falchook, MD, MS role: PRINCIPAL_INVESTIGATOR lat: 39.73915 lon: -104.9847 facility: AdventHealth Cancer Institute status: RECRUITING city: Celebration state: Florida zip: 34747 country: United States name: Heather Osorio role: CONTACT email: Heather.Osorio@AdventHealth.com name: Karolina Kilowski, DO role: PRINCIPAL_INVESTIGATOR lat: 28.32529 lon: -81.53313 facility: The Gabrail Pharmacology Phase 1 Research Center status: RECRUITING city: Canton state: Ohio zip: 44718 country: United States name: Carrie Smith role: CONTACT email: csmith@gabrailcancercenter.com name: Nashat Y Gabrail, MD role: PRINCIPAL_INVESTIGATOR lat: 40.79895 lon: -81.37845 facility: Texas Oncology-Austin Midtown NEXT Oncology status: RECRUITING city: Austin state: Texas zip: 78758 country: United States name: Erica Torres role: CONTACT phone: 210-610-5205 email: etorres@nextoncology.com name: Andrae Vandross, MD role: PRINCIPAL_INVESTIGATOR lat: 30.26715 lon: -97.74306 facility: START Mountain Region status: RECRUITING city: West Valley City state: Utah zip: 84119 country: United States name: Marie Asay role: CONTACT phone: 801-907-4770 email: marie.asay@startthecure.com name: Justin A Call, MD role: PRINCIPAL_INVESTIGATOR lat: 40.69161 lon: -112.00105 hasResults: False