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