[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659520":3},{"organization":4,"outcomesModule":7,"designInfo":59,"detailedDescription":67,"studyPopulation":64,"armGroups":68,"interventions":84,"overallOfficials":64,"centralContacts":64,"locations":103,"responsibleParty":124,"collaborators":64,"id":126,"slug":127,"hasResults":128,"nctId":129,"briefTitle":130,"officialTitle":131,"acronym":64,"eligibilityCriteria":132,"healthyVolunteers":128,"sex":133,"minAge":134,"maxAge":64,"enrollmentInfo":135,"targetDuration":64,"studyType":138,"phases":139,"briefSummary":142,"conditions":143,"keywords":145,"overallStatus":148,"whyStopped":64,"lastUpdateSubmitDate":149,"lastUpdatePostDateStruct":150,"startDateStruct":153,"completionDateStruct":155,"leadSponsor":157,"locationsCount":158},{"fullName":5,"class":6},"Nob Hill Therapeutics, Inc.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":31,"otherOutcomes":54},[9,13,17,21,24,27],{"measure":10,"description":11,"timeFrame":12},"Incidence and Severity of Adverse Events (AEs)","Treatment emergent adverse events, serious adverse events, and clinically significant laboratory or vital sign abnormalities assessed using CTCAE v6.0 (Part I).","From first dose through 30 days after the last dose.",{"measure":14,"description":15,"timeFrame":16},"Incidence of dose-limiting toxicities (DLT)-Part I","Number of participants experiencing DLTs during the DLT evaluation period, defined per protocol.","28-day DLT evaluation period (Cycle 1)",{"measure":18,"description":19,"timeFrame":20},"Overall Response Rate (ORR)-Parts 2 and 3.","Proportion of participants achieving complete or partial response per RECIST v1.1.","From first dose until first documented disease progression, date of death or patient withdrawal from the study for any reason, assessed up to six months.",{"measure":22,"description":23,"timeFrame":20},"Progression Free Survival (PFS)-Parts 2 and 3.","Time from first dose to disease progression or death.",{"measure":25,"description":26,"timeFrame":20},"Overall Survival (OS)-Parts 2 and 3.","Time from first dose to death.",{"measure":28,"description":29,"timeFrame":30},"Duration of Response (DOR)-Parts 2 and 3.","Time from first observation of response to progression or death.","From first documented response to date of first documented disease progression, date of death or patient withdrawal from the study for any reason, assessed up to six months.",[32,36,39,43,46,50],{"measure":33,"description":34,"timeFrame":35},"Pharmacokinetic Parameters of NHT102-Parts 1, 2, and 3.","To determine the PK parameter for the peak plasma concentration (Cmax).","At the end of Cycle 1. (Each cycle is 28 days)",{"measure":37,"description":38,"timeFrame":12},"Incidence and Severity of Adverse Events (AEs)-Parts 2 and 3.","TEAEs, SAEs, and clinically significant abnormalities assessed using CTCAE v6.0.",{"measure":40,"description":41,"timeFrame":42},"Percent Change in DNA Methylation-Parts 2 and 3.","Percent change in global DNA methylation in tumor and\u002For bronchial epithelium compared with pre treatment.","Baseline to post-treatment (estimated to be minimum of 7 months)",{"measure":44,"description":45,"timeFrame":35},"PK parameters of NHT102. Parts 1, 2, and 3.","Area under the curve (AUC) plasma concentration versus time curve.",{"measure":47,"description":48,"timeFrame":49},"PK Parameters of NHT102. Parts 1, 2, and 3.","Time to maximum plasma concentration (Tmax)","At the end of cycle 1. (Each cycle is 28 days)",{"measure":51,"description":52,"timeFrame":53},"PK parameters of NHT102. Parts 1, 2 and 3.","Estimated time to reduce the plasma concentration by exactly one half (T1\u002F2)","At the end of Cycle 1. (Each Cycle is 28 days)",[55],{"measure":56,"description":57,"timeFrame":58},"Percent Change in DNA Methylation - Part I.","Percent change in global DNA methylation in tumor and\u002For bronchial epithelium compared with pre-treatment.","Baseline (Day 1) to post-treatment. (Estimated minimum of 7 months)",{"allocation":60,"interventionModel":61,"interventionModelDescription":62,"primaryPurpose":63,"observationalModel":64,"timePerspective":64,"maskingInfo":65},"RANDOMIZED","SEQUENTIAL","Part I-Dose Escalation Part 2-Dose Optimization. Part 3-Dose Expansion.","TREATMENT",null,{"masking":66,"maskingDescription":64,"whoMasked":64},"NONE","This is an open label, multi-center Phase 1\u002F2 study of NHT102, 5-Azacytidine Mircronised, Dry Powder Formulation Delivered by a Novel Inhalation Delivery System (device constituent product \\[DCP\\]). The study will enroll patients with advanced NSCLC limited to the lung and thoracic region. The study consists of three sequential parts:\n\nPart 1 (Dose Escalation): Approximately five dose levels of NHT102 will be evaluated using a standard 3+3 design to determine dose limiting toxicities (DLTs) and the maximum tolerated dose (MTD). Patients receive NHT102 once daily on Days 1-5 and Days 15-19 of each 28 day cycle. A Safety Review Committee (SRC) will review safety data after each cohort completes the DLT evaluation period.\n\nPart 2 (Dose Optimization): At least two dose levels selected from Part 1 will be evaluated using Simon's two stage design. Each dose level will enroll up to 25 evaluable patients to assess anti-tumor activity, safety, pharmacokinetics (PK), pharmacodynamics, and exploratory biomarkers.\n\nPart 3 (Dose Expansion): The recommended Phase 2 dose (RP2D) selected from Part 2 will be further evaluated to characterize safety, pharmacokinetics, pharmacodynamics, and anti-tumor activity.\n\nPatients will continue treatment until disease progression, unacceptable toxicity, withdrawal of consent, investigator decision, or study termination. Follow up includes safety assessment at 30 days after end of treatment and 6 month survival follow up.",[69,76,80],{"label":70,"type":71,"description":72,"interventionNames":73},"Dose Escalation","EXPERIMENTAL","Participants receive NHT102 via inhalation once daily on Days 1-5 and Days 15-19 of each 28 day cycle. Up to five dose levels (7 mg to 42 mg target lung dose \\[TLD\\] per treatment day) are evaluated using a standard 3+3 design to determine dose limiting toxicities (DLTs) and the maximum tolerated dose (MTD). Additional intermediate dose level cohorts may be added at the recommendation of the Safety Review Committee (SRC).\n\nInterventions:\n\nNHT102 (5-AZA dry powder for inhalation) DryNeb Device",[74,75],"Drug: NHT102","Device: DryNeb",{"label":77,"type":71,"description":78,"interventionNames":79},"Dose Optimization","Participants are randomized 1:1 to one of two dose levels selected from Part 1. Each dose level is evaluated using Simon Two Stage design to assess anti-tumor activity, safety, pharmacokinetics, pharmacodynamics, and exploratory biomarkers. Up to approximately 25 evaluable patients may be enrolled per dose level.",[74,75],{"label":81,"type":71,"description":82,"interventionNames":83},"Dose Expansion","Participants receive NHT102 at the recommended Phase 2 dose (RP2D) determined from Part 2. This part further evaluates safety, pharmacokinetics, pharmacodynamics, and anti-tumor activity.",[74,75],[85,95],{"type":86,"name":87,"description":88,"armGroupLabels":89,"otherNames":90},"DRUG","NHT102","NHT102 is an investigational drug product, 5-Azacytidine dry powder for oral inhalation. NHT102 is administered once daily via inhalation using a novel investigational inhalation delivery system.\n\nDosing occurs on Days 1-5 and Days 15-19 of each 28-day cycle. Multiple dose levels (7 mg to 42 mg target lung dose per treatment day) are evaluated in Part 1, selected dose levels in Part 2, and the recommended Phase 2 dose (RP2D) in Part 3.",[70,81,77],[91,92,93,94],"5-AZA","5-Azacytidine dry powder","NHT102-5-AZA","Azacitidine",{"type":96,"name":97,"description":98,"armGroupLabels":99,"otherNames":100},"DEVICE","DryNeb","The DryNeb is a novel investigational inhalation delivery system that delivers micronized dry powder to the lungs.",[70,81,77],[101,102],"Clinical Benchtop DryNeb","Novel Inhalation Delivery System",[104],{"facility":105,"status":64,"city":106,"state":107,"zip":108,"country":109,"countryCode":110,"cosmosGeoPoint":111,"geoPoint":116,"contacts":117},"Gabrail Cancer Center Research","Canton","Ohio","44718","United States","US",{"type":112,"coordinates":113},"Point",[114,115],-81.37845,40.79895,{"lat":115,"lon":114},[118,121],{"name":119,"role":120,"phone":64,"phoneExt":64,"email":64},"Carrie Smith, RN","CONTACT",{"name":122,"role":123,"phone":64,"phoneExt":64,"email":64},"Nashat Gabrail, MD","PRINCIPAL_INVESTIGATOR",{"type":125,"investigatorFullName":64,"investigatorTitle":64,"investigatorAffiliation":64,"oldNameTitle":64,"oldOrganization":64},"SPONSOR","100659520","phase-1-study-using-a-drug-device-combination-product-to-determine-safety-tolerability-and-antitumor-activity-for-patients-with-advanced-non-small-cell-lung-cancer-100659520",false,"NCT07864584","Study Using a Drug-device Combination Product to Determine Safety, Tolerability and Antitumor Activity for Patients With Advanced, Non-small Cell Lung Cancer","A Phase 1\u002F2 Open-label, Multi-Center Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Antitumor Activity of NHT102 (5-Azacytidine Dry Powder Formulation Delivered by a Novel Inhalation Delivery System) in Patients With Advanced Non-Small Cell Lung Cancer","Inclusion Criteria:\n\n* Age ≥18 years\n* Able to provide informed consent\n* Able to perform acceptable and reproducible spirometry per ATS criteria\n* Able to perform inhalation maneuver\n* Histologically or cytologically confirmed NSCLC (squamous, adenocarcinoma, or large cell undifferentiated)\n* Stage I-III NSCLC per AJCC 9th edition with recurrent or persistent thoracic confined disease\n* Prior therapy with curative intent completed\n* Actionable genomic alterations must have been treated or offered appropriate targeted therapy\n* Not eligible for additional curative therapy\n* At least one measurable lung lesion per RECIST v1.1 (measurable extra-pulmonary thoracic lesions do not qualify unless a measurable lung lesion is also present)\n* ECOG performance status ≤2\n* Life expectancy ≥12 weeks\n* Adequate hematologic, renal, hepatic, and cardiovascular function\n* Washout from prior therapy ≥30 days or ≥5 half lives\n* Adequate pulmonary reserve: FEV1 ≥50% predicted, FEV1\u002FFVC ≥45%, and DLCO ≥50% predicted\n* No growth factor support, transfusions, or albumin within 14 days prior to first dose\n* Resolution of adverse effects of prior therapy to Grade ≤1 (except fatigue, alopecia, and peripheral neuropathy)\n* Contraception requirements for WOCBP and fertile men\n* Agreement to refrain from smoking or inhaled substances during treatment\n\nExclusion Criteria:\n\n* Systemic metastases beyond the lung, thoracic lymph nodes, or mediastinum region\n* Anticancer therapy within 30 days or 5 half-lives, or current immunomodulator requirement\n* Hypersensitivity to study drug or device components\n* Concurrent anticancer therapy or immunomodulators\n* Systemic or inhaled corticosteroids (exceptions apply)\n* Active smokers within past 6 months\n* Severe airway disease (criteria defined)\n* Radiation therapy within 6 months\n* Contraindication to study procedures\n* Other malignancies except specified low risk types\n* Major surgery within 4 weeks\n* Clinically significant cardiovascular disease\n* Uncontrolled medical conditions\n* Active infection requiring IV therapy\n* Live vaccine within 2 weeks of Cycle 1 Day 1\n* Bleeding disorder unrelated to cancer\n* Pregnancy or breastfeeding","ALL","18 Years",{"count":136,"type":137},100,"ESTIMATED","INTERVENTIONAL",[140,141],"PHASE1","PHASE2","There are 3 parts to this clinical trial. The goal of this clinical trial (NHT102-001) is to learn how safe NHT102 is, what dose works best, and whether it can help treat advanced non-small cell lung cancer (NSCLC) that has come back or remained after earlier treatment and is still confined to the lung \u002F chest region by providing targeted inhaled treatment directly to the lungs. NHT102 is a dry powder that participants breathe in through a mouthpiece using an investigational inhalation device. Doses are given at the study site by trained staff, not at home. NHT102 is taken on days 1-5 and days 15-19 of a 28-day cycle.\n\nThe main questions this clinical trial aims to answer are:\n\nPart 1 (Dose Escalation): To look at up to five different increasing dose levels of NHT102 to see if they are safe and well-tolerated and if the body absorbs the medicine from the lungs. To see if up to two dose levels studied are not only safe, but also make the cancer slow its growth or lessen its spread. And to see the highest dose that is tolerated by participants.\n\nPart 2 (Dose Optimization): To further study at up to two dose levels from Part 1 and randomly assign participants in equal numbers to one of them to learn more about NHT102's safety, how well the drug is absorbed from the lungs and how well each dose level works against the NSCLC after at least 4 months. Then identify which of the two doses is chosen for further study.\n\nPart 3 (Dose Expansion): Take the dose chosen in from Part 2 and study it in more patients to continue look at the drug safety, how much of it is absorbed into the body from the lungs and if it works to stop or reduce the spread of NSCLC.\n\nParticipants will:\n\n* Take NHT102 at the study site daily on days 1-5 days and days 15-19 during a 28-day cycle for as long as it is helping them and they can tolerate it. Treatment stops if the cancer worsens, if side effects become too difficult to manage, or if the participant or their doctor decides to stop.\n* Tell doctors and staff about all medications they are taking, any issues with their study medication and all side effects they may be having whether they are taking the medication that day or not.\n* Return for a safety visit about 30 days after their last dose, then receive phone calls about 3 months and 6 months later to check on their health.",[144],"NSCLC (Advanced Non-small Cell Lung Cancer)",[146,147],"Lung Cancer","Non-small cell","NOT_YET_RECRUITING","2026-10-02",{"date":151,"type":152},"2026-10-08","ACTUAL",{"date":154,"type":137},"2027-01-11",{"date":156,"type":137},"2030-07-12",{"name":5,"class":6},1]