[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Oscotec Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":73},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,42],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":4},"100644969","phase-1-bioequivalence-study-of-ski-o-703-in-healthy-adults-under-fed-conditions-100644969",false,"NCT07675226","Bioequivalence Study of SKI-O-703 in Healthy Adults Under Fed Conditions","An Open-label, Randomized, Fed, Single-dose, Oral Administration, 2-treatment, 2-period, Crossover Design, Phase 1 Clinical Trial to Evaluate the Bioequivalence of SKI-O-703 in Healthy Adult Participants","Inclusion Criteria:\n\n1. Korean or Caucasian adults aged 19 years and older at screening. Caucasian: An individual whose parents and grandparents are of European, North American, or Middle Eastern origin; who was born in Europe, North America, or West Asia; and who has resided outside these regions for less than 10 years\n2. Body mass index (weight \\[kg\\] \u002F height2 \\[m\\]2) between 18 and 30 kg\u002Fm2, and body weight not less than 50 kg.\n3. Healthy on the basis of physical examination, medical history, vital signs, and 12-lead ECG performed at screening.\n4. Healthy on the basis of clinical laboratory tests performed at screening. If the results of the serum chemistry panel including liver enzymes, other specific tests, hematology, blood coagulation test, urinalysis or urine drug test are outside the normal reference ranges, the participant may be included only if the investigator judges the abnormalities or deviations from normal to be not clinically significant. This determination must be recorded in the participant's source documents.\n5. Must sign voluntarily an informed consent form indicating they understand the purpose of, procedures required for, and comply to the prohibitions and restrictions specified in the study and is willing to participate in the study.\n\nExclusion Criteria:\n\n1. Any significant surgical\u002Fmedical procedure or trauma within 4 weeks before the planned first dose of the study drug or history of gastrointestinal surgery that may affect drug absorption (excluding appendectomy and hernia repair)\n2. Any current active infections, including localized infections, or any recent history (within 1 week prior to study drug administration) of active infections (including severe acute respiratory syndrome coronavirus 2 \\[SARS-CoV-2\\], cough or fever, or a history of recurrent or chronic infections).\n3. Unable to swallow multiple capsules by mouth.\n4. Received an experimental drug within 1 month or within a period less than 10 times the drug's half-life, whichever is longer, before the first dose of the study drug is scheduled. Prior experience of participating in another clinical trial within 6 months before the planned first dose of the study drug.\n5. Individuals who have dietary habits that may influence the absorption, distribution, metabolism, or excretion of the investigational product or who consume foods known to affect drug metabolism.\n6. Before the start of the study (first day of administration) those who have donated whole blood or blood components within 8 weeks or within 2 weeks, respectively, or received a blood transfusion within 1 month, or cannot refrain from donating blood from the time of written consent until the end of the trial.\n7. History of human immunodeficiency virus (HIV) antibody positive, or tests positive for HIV at screening.\n8. Individual unable to abstain from alcohol-, caffeine-, or xanthine-containing products within 72 hours before the first dose of study drug and during the study or who tested positive for drug abuse, alcohol at screening or check-in (Day -1).\n\n10\\) Smoker or has used nicotine or nicotine-containing products (eg, snuff, nicotine patch, nicotine chewing gum, mock cigarrets, or inhalers) within 30 days before the first dose of study drug or who tested positive for cotinine(indicating active current smoking) at screening or check-in (Day -1) 11) Individuals with hypersensitive to investigational product or components of investigational product 12) A women who are pregnant or suspected of being pregnant or breastfeeding. 13) Participants who do not consent to use medically acceptable methods of contraception\\* to eliminate the possibility of pregnancy from the date of the first dose until 1 month after the last dose of the study drug.\n\n\\*Combined use of an intrauterine device (IUD), intrauterine hormone-releasing system (IUS), vasectomized partner, tubal ligation, and barrier methods (male condom, female condom, cervical cap, diaphragm, sponge, etc.), or a combination of at least two barrier methods with spermicide.\n\n14\\) Individuals with hereditary problems of galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption.",true,"ALL","19 Years",{"count":20,"type":21},48,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","This is an open-label, randomized, crossover Phase 1 study to evaluate the bioequivalence, pharmacokinetics, and safety of two oral SKI-O-703 drugs (test and reference) in healthy adults under fed conditions. Approximately 48 Korean and Caucasian participants will receive a single oral dose of the test drug and a single oral dose of the reference drug in a randomized sequence, separated by a washout period, with pharmacokinetic sampling and safety assessments performed throughout the study.",[27,28,29],"Bioequivalence Study in Healthy Subjects","Immune Thrombocytopenia (ITP)","Rheumatoid Arthritis (RA)","NOT_YET_RECRUITING","2026-06-23",{"date":33,"type":34},"2026-06-30","ACTUAL",{"date":36,"type":21},"2026-07-10",{"date":38,"type":21},"2026-12-31",{"name":40,"class":41},"Oscotec Inc.","INDUSTRY",{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":17,"minAge":49,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":22,"phases":52,"briefSummary":53,"conditions":54,"keywords":61,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":72},"100620529","phase-1-study-to-assess-the-effect-of-oct-598-in-patients-with-advanced-solid-tumors-100620529","NCT07358806","Study to Assess the Effect of OCT-598 in Patients With Advanced Solid Tumors","A Phase 1 Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of OCT-598 as a Single Agent and in Combination With Standard-of-Care Treatment in Patients With Advanced Solid Tumors","Inclusion Criteria:\n\n* Female or male, ≥18 years of age (or ≥19 years according to according to the local regulatory guidance), at the time of screening\n* Signed informed consent prior to any study-related procedures that are not considered standard of care\n* Life expectancy \\>12 weeks in the opinion of the investigator\n* Adequate organ and marrow function, defined as follows:\n\n  * Absolute neutrophil count ≥1.5 × 109\u002FL\n  * Platelets ≥100,000\u002FμL\n  * Hemoglobin ≥9.0 g\u002FdL\n  * Total bilirubin \\\u003C1.5 × ULN\n  * ALT or AST ≤2.5 × ULN\n  * Creatinine clearance calculated using the Cockcroft-Gault formula ≥60 mL\u002Fmin (In equivocal cases, a 24-hour urine collection test can be used to estimate the creatinine clearance more accurately)\n* LVEF \\>50% or within institutional values\n* At least 1 measurable lesion based on RECIST version 1.1\n* Cohort-specific disease requirements:\n\n  1. Part A: patients with advanced solid tumors and no effective standard therapy option or for whom standard-of-care treatment is not available or not appropriate as per the investigator's discretion\n  2. Part B: patients with advanced solid tumors who are candidates for receiving docetaxel as a single agent for their cancer treatment, including but not limited to: advanced human epidermal growth factor receptor 2-negative breast cancer, recurrent\u002Fmetastatic head and neck cancer, non-small cell lung cancer, prostate cancer, or gastric\u002Fgastroesophageal cancer\n* Docetaxel-appropriate (Part B): patients who have not received prior docetaxel in the advanced setting are eligible\n\nExclusion Criteria:\n\n* Treatment with any IP or other anticancer therapy (including chemotherapy, antibody-drug conjugates, targeted agents, and immunotherapy) within 28 days or 5 half-lives, whichever is longer, of the first dose of study drug.\n* Prior clinically significant treatment-related toxicities not resolved to Grade ≤1 or baseline (per CTCAE version 5.0) except for alopecia. Participants with stable Grade 2 peripheral neuropathy or endocrinopathies with stable endocrine replacement therapy are eligible. Patients with irreversible toxicity that is not reasonably expected to be exacerbated by study treatment (eg, vitiligo or hearing loss) may be eligible after discussion with the Sponsor.\n* Prior treatment with an EP2 and\u002For EP4 antagonist.\n* Major surgery or wide-field radiation within 28 days or limited field palliative radiation within 7 days prior to the first dose of the study drug.\n* Known active central nervous system metastasis. Patients with asymptomatic previously treated brain metastasis are eligible if they are clinically stable for at least 4 weeks prior to enrollment and do not require treatment with corticosteroids.\n* Treatment with systemic corticosteroids at a dose of \\>10 mg of prednisone or equivalent at the time of enrollment, or any other immunosuppressive medication 7 days before the first dose of the study drug. Premedication with corticosteroids prior to chemotherapy administration in the combination phase is allowed, as per the site standard of care. Systemic treatment with NSAIDs, COX2 inhibitors, or synthetic prostaglandins within 5 half-lives prior to the first dose of study drug (acetylsalicylic acid ≤160 mg\u002Fday, or 325 mg ≤3 times\u002Fweek is permitted).\n* Patients who are pregnant, breastfeeding, or planning to become pregnant during the study .\n* Concomitant active malignancy or previous malignancy within 2 years of the time of enrollment. Patients with adequately resected basal or squamous cell carcinoma of the skin, carcinoma in situ or the cervix or breast, stage 1 prostate cancer, or other malignancy deemed to be cured by prior therapy in the judgment of the investigator may enroll regardless of the time of diagnosis.\n* History of bleeding disorders, including gastrointestinal bleeding. Subjects with prior gastrointestinal bleeding due to the primary tumor, that is currently controlled, are allowed to participate.\n* Mean resting corrected QT (QTc) interval using Fridericia's formula (QTcF) \\>470 ms, regardless of gender, or history of additional risk factors for torsades de pointes (eg, heart failure, hypokalemia, family history of long QT syndrome). Patients with left bundle block or atrial fibrillation are eligible if QTc cannot be accurately calculated provided that there is no prior history of prolonged QTc.\n* For patients in Part B only: AST and\u002For ALT \\>1.5 × ULN concomitant with alkaline phosphatase \\>2.5 × ULN.","18 Years",{"count":51,"type":21},51,[24],"This is a Phase 1 study intended to determine the MTD of OCT-598 following multiple-dose therapy and to establish the RP2D for OCT-598 as a single agent, by assessing its safety and tolerability as monotherapy and in combination with standard-of-care treatments in patients with advanced solid tumors.",[55,56,57,58,59,60],"Solid Tumor","Breast Cancer","Head and Neck Cancer","Non-Small Cell Lung Cancer","Prostate Cancer","Gastric\u002FGastroesophageal Junction Cancer",[62],"EP2\u002FEP4 antagonist","RECRUITING","2026-01-13",{"date":66,"type":34},"2026-01-22",{"date":68,"type":34},"2025-12-18",{"date":70,"type":21},"2027-12",{"name":40,"class":41},3,""]