[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Taivex Therapeutics Corporation\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":60},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,41],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100451261","phase-1-safety-and-tolerability-study-for-t-1301-capsules-to-treat-advanced-solid-tumors-100451261",false,"NCT05156203","Safety and Tolerability Study for T-1301 Capsules to Treat Advanced Solid Tumors","A Phase I Study of Safety, Tolerability and Pharmacokinetics of T-1301 Capsules in Subjects With Advanced Solid Tumors","Inclusion Criteria:\n\n1. Having signed and dated informed consent form indicating that the subject has been informed of all pertinent aspects of the study.\n2. Subjects with histologically and cytologically confirmed advanced solid tumors (including lymphoma) that are refractory to standard treatments, or for whom no standard treatment is available, or who are not amenable or unwilling to receive standard treatments.\n3. Solid tumors that are measurable or evaluable per Response Evaluation Criteria in Solid Tumors (RECIST v1.1). Target lesions that have been previously irradiated will not be considered measurable (lesion) unless increase in size is observed following completion of radiation therapy.\n4. Have a life expectancy of ≥ 3 months in the Investigator's opinion.\n5. Females or males ≥ 20 years old.\n6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n7. Recovered from prior treatment-related toxicity to at least grade 1 with the exception of alopecia.\n8. Adequate organ function as defined by the following criteria:\n\n   1. Serum alanine transaminase (ALT) ≤ 3 x upper limit of normal (ULN)\n   2. Total serum bilirubin ≤ 1.5 x ULN\n   3. Absolute neutrophil count (ANC) ≥ 1500\u002FµL\n   4. Platelets ≥ 100,000\u002FµL\n   5. Hemoglobin ≥ 9.0 g\u002FdL\n   6. Creatinine clearance (CrCl) ≥ 50 mL\u002Fmin CrCl = \\[(140 - age (year)) x weight (kg)\\] \u002F (serum creatinine x 72) (x 0.85 for females)\n9. Willingness and ability to comply with the study scheduled visits, treatment plans, laboratory tests and other procedures.\n\nExclusion Criteria:\n\n1. Major surgery within 4 weeks prior to the first dose of study drug.\n2. Subjects receiving any of the following anti-cancer therapy:\n\n   1. Anti-cancer definitive radiation therapy (4,000-6,000 cGy) within 4 weeks prior to the first dose of study drug.\n   2. Palliative radiation (≤ 10 fractions with total dose \\\u003C 3,000 cGy) within 2 weeks prior to the first dose of study drug.\n   3. Any systemic cytotoxic chemotherapy within 4 weeks prior to the first dose of study drug.\n   4. Any targeted therapy within 2 weeks or 5 half-lives, whichever is longer, prior to the first dose of study drug.\n   5. Any immunotherapy within 4 weeks prior to the first dose of study drug.\n3. Any interventional treatments in another clinical trial following Exclusion Criteria 2c, 2d and 2e.\n4. Subjects received blood transfusion or biological response modifiers (e.g., G-CSF) within 2 weeks prior to the first dose of study drug.\n5. Subject who received autologous bone marrow transplant or stem cells rescue within 6 months prior to the first dose of study drug.\n6. Subjects received strong inhibitors and\u002For inducers of CYP3A4 within 14 days prior to the first dose of study drug. A list of CYP3A4 modulators is provided in Appendix 3.\n7. Documented or suspected brain metastases, spinal cord compression, carcinomatous meningitis, or leptomeningeal disease.\n8. Any of the following within 6 months of the first dose of study drug: myocardial infarction, severe\u002Funstable angina, coronary\u002Fperipheral artery bypass graft, congestive heart failure, or cerebrovascular accident including transient ischemic attack.\n9. Ongoing cardiac dysrhythmias of ≥ NCI CTCAE version 5.0 grade 2, or atrial fibrillation of any grade. Corrected QT interval by Fridericia (QTcF) ≥ 470 msec.\n10. Hypertension that cannot be controlled by medications (\\> 160\u002F100 mm-Hg despite optimal medical therapy).\n11. AIDS-defining opportunistic infections within the past 12 months.\n12. Positive test for hepatitis B (HBsAg) or hepatitis C (anti-hepatitis C virus (anti-HCV) antibody), unless the HCV RNA level is below the limit of detection (for subjects with positive anti-HCV Ab).\n13. Men and women of childbearing potential who are unwilling to use highly effective contraceptive methods during the study period.\n\n    Highly effective contraceptive methods include implants, injectables, combined oral contraceptives, intra-uterine devices (IUDs), sexual abstinence, surgical sterilization or a partner who is sterile.\n14. If females, patient is pregnant or breast feeding.\n15. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that would impart, in the judgement of the investigator and\u002For sponsor, excess risk associated with study participation or study drug administration.","ALL","20 Years",{"count":19,"type":20},30,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","T-1301 is a novel small-molecule inhibitor of multiple kinases being developed as an oral drug for the treatment of advanced solid tumors. The nonclinical study results demonstrate the nonclinical efficacy and safety of T-1301 and support the design of this Phase 1, first-in-human (FIH) clinical trial in subjects with advanced cancer.\n\nThis study is an open-label, multi-center, Phase I dose-escalation study to evaluate the safety, tolerability, and pharmacokinetics of T-1301 capsules in subjects with advanced solid tumors (including lymphoma), and to identify the maximum tolerated dose (MTD) and the recommended phase 2 dose (RP2D). Approximately 30 patients will be enrolled for the dose-escalation phase. Actual number of patients will be determined by the number of dose cohorts until the MTD is reached.\n\nT-1301 will be administered orally QD or BID in a 28-day cycle (21 days on treatment followed by 7 days off treatment) in sequential cohorts. Subjects can continue with the treatment until one of the discontinuation criteria is met or until the planned stop of the study (12 months after the last subject receives the first dose of study drug), whichever comes first.\n\nThe planned dose levels are: 10, 20, 40, 60, 80, 100, 120, 140 and 160 mg\u002Fday. The dosing schedule will be once daily (QD) at the first dose level (10 mg\u002Fday) and be changed to twice daily (BID) starting with the second dose level. Other dose levels or dosing frequency may be explored based on safety and related drug exposure data following the decision of Safety Review Committee.\n\nThe dose escalation will follow accelerated titration and the Bayesian optimal interval (BOIN) design. During the initial accelerated titration phase, one (1) subject is enrolled per dose level. In the subsequent phase when the BOIN design is used, subjects will be enrolled in cohorts of size 3-6.",[26,27],"Advanced Solid Tumor","Lymphoma","RECRUITING","2026-09-30",{"date":31,"type":32},"2026-10-05","ACTUAL",{"date":34,"type":32},"2021-12-19",{"date":36,"type":20},"2027-12",{"name":38,"class":39},"Taivex Therapeutics Corporation","INDUSTRY",3,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":48,"targetDuration":4,"studyType":21,"phases":50,"briefSummary":51,"conditions":52,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":53,"startDateStruct":55,"completionDateStruct":57,"leadSponsor":59,"locationsCount":5},"100429020","phase-1-safety-and-tolerability-study-for-t-1201-injection-100-mg-kit-in-patients-with-advanced-solid-tumors-100429020","NCT04866641","Safety and Tolerability Study for T-1201 Injection 100 mg Kit in Patients With Advanced Solid Tumors","A Phase I, Open-label, Dose-finding Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of T-1201 Injection 100 mg Kit in Patients With Advanced Solid Tumors","Inclusion Criteria:\n\nSubjects must meet all of the following criteria to be eligible for enrollment in the study:\n\n1. Signed and dated informed consent form.\n2. Histologically and cytologically confirmed advanced malignancies that are refractory to standard therapy or have no accepted standard therapy.\n3. Solid tumors that are measurable or evaluable as per Response Evaluation Criteria in Solid Tumors (RECIST v1.1). Target lesions that have been previously irradiated will not be considered measurable (lesion).\n4. Female or male, 20 years of age or older.\n5. ECOG performance status 0 or 1.\n6. QTcF ≤ 470 ms at screening.\n\nExclusion Criteria:\n\nSubjects presenting with any of the following will not be included in the study:\n\n1. Clinically significant comorbidity such as unstable angina, congestive heart failure (NYHA Grade III or IV), uncontrolled hypertension (\\>160\u002F100 mmHg despite optimal medical treatment), chronic obstructive pulmonary disease (COPD) with frequent exacerbations, refractory asthma, inflammatory bowel disease or intestinal obstruction.\n2. Acute myocardial infarction or cerebrovascular accident (CVA) within 6 months prior the first dose of study drug.\n3. Central nervous system (CNS) metastasis or seizure disorder due to underlying malignancy except those who have been treated and have stable CNS metastases or are asymptomatic.\n4. AIDS-defining opportunistic infections within the past 12 months.\n5. HBV infection (positive HBsAg) except for carrier of inactive HBV as defined by negative HBeAg with normal ALT and HBV DNA \\\u003C 2,000 IU\u002FmL or HCV infection (positive anti-HCV antibody) except for those with undetectable HCV RNA.\n6. Inadequate bone marrow reserve, hepatic or renal function as defined by any of the following laboratory values:\n\n   1. absolute neutrophil count (ANC) \\\u003C 1500\u002FµL\n   2. platelet count \\\u003C 100 x 10\\^9 \u002FµL\n   3. hemoglobin \\\u003C 9 g\u002FdL\n   4. total bilirubin \\> 1.5 x the upper limit of normal (ULN)\n   5. aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \\> 3 x ULN if no hepatic metastases are present; \\> 5 x ULN if hepatic metastases are present\n   6. Estimated (Cockroft-Gault formula) creatinine clearance (CrCl) \\\u003C 60 mL\u002Fmin CrCl = \\[(140 - age (year)) x weight (kg)\\] \u002F (serum creatinine x 72) (x 0.85 for females)\n7. Toxicities resulting from prior therapy or surgical procedures not yet resolved to ≤ NCI CTCAE v5.0 Grade 1 with the exception of alopecia, skin hyperpigmentation or hypopigmentation.\n8. Major surgical procedures (as defined by Investigator) within 4 weeks prior to the first dose of study drug or any ongoing post-operative complications.\n9. Receiving any (investigational or approved) anti-cancer therapy (including chemotherapy or targeted therapy) within 28 days or 5 half-lives (whichever is longer) prior to the first dose of study drug.\n10. A history of apparent allergic reactions to irinotecan, Tween 80 (dosed with prior treatment with prophylactic drug), and\u002For ethanol.\n11. If female, is pregnant or breastfeeding.\n12. If men or women with childbearing potential, unwilling to use effective contraceptive methods during the study and for at least 3 months (men) or 1 month (women) after the last dose of study drug. Effective contraceptive methods include implants, injectables, combined oral contraceptives, intra-uterine devices (IUDs), sexual abstinence, surgical sterilization or a partner who is sterile.\n13. Receiving live attenuated vaccine within 28 days prior to the first dose of study drug.\n14. Life expectancy \\\u003C 3 months\n15. Other prior or ongoing condition(s) that, in Investigator's opinion, could affect the safety of the subject, compromise the subject's ability to comply with the study requirements or impair the assessment of study results.",{"count":49,"type":20},40,[23],"The goal of this clinical trial is to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of T-1201 injection in subjects with advanced solid tumors refractory to standard therapy, or for whom no standard therapy is available. The main questions it aims to answer are:\n\n* The Maximum tolerated dose (MTD) of T-1201 on different dosing schedules.\n* The Recommended Phase 2 dose (RP2D) of T-1201 on different dosing schedules.\n\nResearchers will evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of T-1201.\n\nParticipants will:\n\nReceived T-1201 either once every 4 (Part A)\u002F2 (Part B)\u002F3 (Part C) weeks, depend on they participate in which parts of study.\n\nVisit the clinic once every 2\u002F3 weeks for checkups and tests",[26],{"date":54,"type":32},"2026-10-02",{"date":56,"type":32},"2021-06-24",{"date":58,"type":20},"2027-12-31",{"name":38,"class":39},""]