[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"J-Pharma Co., Ltd.\",\"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,[8,46],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100613368","phase-3-a-study-to-select-a-dose-regimen-part-a-and-to-investigate-overall-survival-part-b-with-nanvuranlat-compared-with-physicians-best-choice-in-participants-aged-18-years-or-older-with-biliary-tract-cancer-100613368",false,"NCT07265674","A Study to Select a Dose Regimen (Part A) and to Investigate Overall Survival (Part B) With Nanvuranlat Compared With Physician's Best Choice in Participants Aged 18 Years or Older With Biliary Tract Cancer","A Phase 3, Multicenter, Randomized, Open-label, Study Evaluating the Efficacy and Safety of Nanvuranlat in Patients With Previously Treated Advanced Biliary Tract Cancer","Beacon-BTC","Inclusion Criteria:\n\n\\- Individuals are eligible to be included in the study only if all of the following criteria apply:\n\n1. At least 18 years of age inclusive at the time of signing the informed consent.\n2. Provides informed written consent according to local laws or regulations.\n3. Able and willing to comply with scheduled visits, treatment plans, procedures, and laboratory tests, including peripheral blood and urine sampling during the study.\n4. Willing to participate in LAT1 testing and NAT2 and transporter genotyping. Note: For LAT1 testing, if the participant does not have archival tissue and a fresh biopsy is not in the best interest of the participant, they will still be eligible for the trial.\n5. Cancer must be metastatic, locally advanced and unresectable, or not amenable to treatment with local therapies that could offer a reasonable likelihood of clinical benefit.\n6. Histologic or cytologic diagnosis of BTC.\n7. Has BTC that is classified as either an IHC, EHC, or GBC based on surgical, clinical, or laparoscopic findings and\u002For radiological imaging (eg, CT, MRI).\n8. Has received 1 prior appropriate platinum (cisplatin, carboplatin, or oxaliplatin)-based therapy for advanced disease (locally advanced or metastatic) with or without a mAb targeting PD-1 or PD-L1.\n\n   1. Disease progression during or within 6 months of neoadjuvant or adjuvant treatment with a platinum-containing regimen will count as having received 1 prior regimen.\n   2. If a patient has a mutation\u002Ffusion of IDH1, FGFR2 or NTRK, or an amplified, mutated, or overexpressed form of HER2, or a recognized aberration in a validated \"driver\" of BTC, and was treated with an appropriate targeted agent, or the patient's tumor was determined to be MSI-H and an appropriate PD-1\u002FPD-L1 mAb was administered, the targeted therapy or immunotherapy will NOT count as a separate line of treatment.\n9. ECOG PS of 0 or 1.\n10. Expected life expectancy of at least 90 days after the first day of treatment as per the site Investigator.\n11. At least 1 measurable lesion by RECIST v1.1 based on imaging (eg, CT, MRI) performed within 28 days prior to initiation of study intervention. Those who have received prior local therapy, including but not limited to embolization, chemoembolization, radiation therapy, and\u002For other appropriate ablative procedures to a measurable lesion that is within the treatment and shown ≥ 20% growth in size since posttreatment assessment.\n12. Resolution to ≤ Grade 1 by the NCI CTCAE v 5.0 (or higher) of all clinically significant toxic effects of prior chemotherapy or other treatments, except for alopecia and peripheral neuropathy (these must have resolved to ≤ Grade 2). If medical therapy is required for the treatment of a laboratory abnormality, the dose and laboratory value(s) should be stable.\n13. Adequate hematologic function:\n\n    1. ANC ≥ 1.5 × 109\u002FL. Myeloid growth factors must not have been administered within 7 days before the participant's first dose of study intervention.\n    2. Hemoglobin ≥ 8.5 g\u002FdL and no RBC transfusions during the 14 days before the participant's first dose of study intervention.\n    3. Platelet count ≥ 100 × 109\u002FL and no platelet transfusions during the 14 days before the participant's first dose of study intervention.\n14. Adequate baseline organ function, as demonstrated by the following:\n\n    1. eGFR ≥ 50 mL\u002Fmin as estimated by CKD-EPI 2021.\n    2. Bilirubin ≤ 2 × ULN (local institution).\n    3. AST and ALT ≤ 5 × ULN (local institution).\n15. Adequate coagulation function as defined by INR ≤ 1.5 OR a PT ≤ 1.5 × ULN AND an aPTT ≤ 1.5 × ULN if not receiving anticoagulation therapy. Note: Participants may receive subtherapeutic doses of warfarin while on study to maintain patency of venous devices but not with therapeutic doses of warfarin. Participants may be treated with low-molecular weight heparin.\n16. Women of childbearing potential must be willing to use a highly effective method of contraception throughout the study and study follow up or for at least 9 months after the last dose of study intervention. Note: A woman is of nonchildbearing potential if she meets 1 of the following criteria: a) postmenopausal with at least 12 months of spontaneous amenorrhea; b) has had a bilateral oophorectomy; or c) has had a hysterectomy. Highly effective methods of contraception include:\n\n    * Abstinence from sexual activity.\n    * Hormonal contraception (eg, injection, implant, pill, patch, or vaginal ring as available in each country) associated with inhibition of ovulation (both estrogen and progestogen and progestogen only) in use for at least 30 days before administration of study intervention.\n    * Intrauterine device in use for at least 30 days before administration of study intervention.\n    * Intrauterine hormone-releasing system in use for at least 30 days before administration of study intervention.\n    * Bilateral tubal occlusion\u002Fligation at least 6 months before administration of study intervention.\n    * Partner who has been vasectomized at least 6 months before administration of study intervention.\n17. Males and their female partners must use a highly effective method of birth control if female partner(s) is of childbearing potential, and males must not donate sperm during the study and for 9 months after the last dose of study intervention.\n\nExclusion Criteria:\n\n* Individuals will be excluded from study participation if they meet any of the following criteria:\n\n  1. Received systemic therapy or an investigational agent before washing out, as follows:\n\n     1. \\\u003C 2 weeks prior to Cycle 1 Day 1 for systemic non-immune-based therapy\n     2. \\\u003C 3 weeks prior to Cycle 1 Day 1 for immune-based therapy\n     3. ≤ 5 half-lives or 3 weeks (whichever is longer) prior to Cycle 1 Day 1 for an investigational agent\n  2. Received radiotherapy to metastatic sites within 2 weeks of Cycle 1 Day 1. Patients must have recovered from all radiation-related toxicities and not require corticosteroids. A 1 week washout is permitted for palliative radiation with a limited port ≤ 2 weeks of radiotherapy to non-CNS disease.\n  3. Underwent hepatic radiation, chemoembolization, or radiofrequency ablation \\\u003C 4 weeks prior to Cycle 1 Day 1.\n  4. Underwent major surgery \\\u003C 3 weeks before Screening and has not recovered adequately from the procedure and\u002For any complications from the surgery prior to starting study intervention.\n  5. Known active CNS metastases and\u002For carcinomatous meningitis. Those with previously treated brain metastases may participate provided they are radiologically stable (ie, without evidence of PD for at least 4 weeks by repeat imaging), clinically stable, and without requirement of corticosteroid treatment for at least 14 days prior to first dose of study intervention. For those with a history of CNS involvement, repeat imaging should be performed during study screening. However, CNS imaging is not required prior to study entry unless there is clinical suspicion of CNS involvement.\n  6. Clinically significant cardiovascular disease (eg, uncontrolled or any New York Heart Association Class 3 or 4 heart failure, uncontrolled angina, history of myocardial infarction, unstable angina, or stroke within 6 months prior to study entry, uncontrolled hypertension or clinically significant arrhythmias not controlled by medication).\n  7. Resting QTcF \\> 470 msec at screening.\n  8. An additional active malignancy that is progressing or has required active treatment within the past 3 years. Cases involving a past cancer history with substantial potential for recurrence must be discussed with the Medical Monitor before study entry. Patients with the following concomitant neoplastic diagnoses are eligible: non-melanoma skin cancer, carcinoma in situ (including transitional cell carcinoma, cervical intraepithelial neoplasia, breast cancer, and melanoma in situ), organ-confined prostate cancer with no evidence of PD.\n  9. Require strong inhibitors of P-gp, BCRP, OATP1B1, OATP1B3, OATP1A2, and OAT3 transporters unless they can be transferred to other medications within ≥ 5 half-lives of treatment.\n  10. Require sensitive substrates of OATP1B1 and OATP1B3 unless they can be transferred to other medications within ≥ 5 half-lives of treatment.\n  11. Known positive status for HIV, has not been treated with established appropriate antiretroviral therapy for at least 4 weeks, and has a hydrophobic interaction chromatography viral load \\\u003C 400 copies\u002FmL and a CD4+ T-cell (CD4+) counts ≥ 350 cells\u002FµL prior to enrollment. No HIV testing is required unless mandated by local health authority.\n  12. Active or chronic HBV and active (not cured) HCV. Participants who are HBV carriers without active disease (HBV DNA titer \\\u003C 1000 copies\u002FmL or 200 IU\u002FmL) or cured HCV (negative HCV RNA test) with confirmed viral clearance that are not receiving ongoing treatment and without residual chronic liver disease may be enrolled.\n  13. An uncontrolled intercurrent illness including, but not limited to medical illness; uncontrolled infection requiring therapy; psychiatric illness; alcohol or drug dependence; social situations or a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating Investigator or Medical Monitor.\n  14. Requires therapeutic doses of warfarin (ie, requires monitoring). A washout period of 7 days before administration of a participant's first dose of study intervention is required for those in whom therapeutic doses of warfarin are discontinued. Note: Warfarin at a low daily dose to maintain patency for indwelling venous catheters is allowed. Low-molecular weight heparin and direct-acting oral anticoagulants, according to the inclusion requirements pertaining to coagulation test results, are allowed.\n  15. Clinically significant edema or intracavitary fluid collections (eg, ascites, pleural effusion, pericardial effusions) resulting in moderate symptoms and\u002For requiring frequent drainage.\n  16. Previously developed shock, anaphylaxis, or renal disorder due to SBECD.\n  17. WOCBP who is pregnant, lactating, or discontinued lactation \\\u003C 12 weeks prior to Screening, or who plans to become pregnant or initiate lactation during the study.\n  18. Known reaction or contraindication to any component of study intervention (ie, oxaliplatin, leucovorin \\[including levoleucovorin\\], and 5-FU \\[FOLFOX\\] and irinotecan, leucovorin, and 5-FU \\[FOLFIRI\\]).\n  19. Known DPD deficiency. Screening for DPD deficiency is not mandated but should be considered in subjects who have had severe toxicity due to fluoropyrimidine-based therapy in the past.","ALL","18 Years",{"count":20,"type":21},480,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","This study is designed to 1) select a dose regimen for continued development and 2) evaluate nanvuranlat versus Physicians Best Choice (PBC) (FOLFOX, FOLFIRI, or Best Supportive Care (BSC)) in participants aged 18 years and over with BTC. Participants enrolling in Part A the trial will be randomly assigned to receive 1 of 3 nanvuranlat dose regimens or PBC. In Part B, participants will be randomly assigned to receive nanvuranlat or PBC. Participants will receive treatment every 2 weeks for as long as they do not experience safety issues, or their cancer gets worse, and the study doctor feels they should stop treatment. Health measurements including physical examinations, vital signs, ECGs, and safety laboratory tests will be performed to monitor safety, and tumor imaging will be performed to monitor cancer response to treatment. Other exploratory makers will be measured to better understand how nanvuranlat works.",[27,28],"Advanced Biliary Tract Cancer","Biliary Tract Cancer (BTC)",[30,31,32],"Intrahepatic cholangiocarcinoma (IHC)","Extrahepatic cholangiocarcinoma (EHC)","Gallbladder carcinoma (GBC)","RECRUITING","2026-06-29",{"date":36,"type":37},"2026-07-01","ACTUAL",{"date":39,"type":37},"2026-05-11",{"date":41,"type":21},"2027-10",{"name":43,"class":44},"J-Pharma Co., Ltd.","INDUSTRY",18,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":53,"sex":17,"minAge":18,"maxAge":54,"enrollmentInfo":55,"targetDuration":4,"studyType":22,"phases":57,"briefSummary":59,"conditions":60,"keywords":62,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":72},"100634051","phase-1-a-study-of-jph034-in-healthy-adult-participants-100634051","NCT07534657","A Study of JPH034 in Healthy Adult Participants","A Phase 1, Randomized, Double-blind, Placebo-controlled Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single-ascending Doses of JPH034 in Healthy Adult Male and Female Participants","Inclusion Criteria:\n\n1. Age 18 to 50 years, inclusive, at the time of Screening.\n2. Body mass index (BMI) ≥ 18.5 and ≤ 34 kg\u002Fm2 at Screening and Check-in. Sex and Contraceptive\u002FBarrier Requirements\n3. Females who are not pregnant or breastfeeding, agree to refrain from donating eggs during the study intervention period and for at least 30 days after the last dose of study intervention, and who meet one of the following conditions:\n\n   1. Postmenopausal (no menses for 12 months, without an alternative medical cause; Section 10.2.1), or\n   2. Permanent infertility (documented hysterectomy, bilateral salpingectomy, or bilateral oophorectomy), or\n   3. Agree to abstain from heterosexual intercourse or to use a highly effective method of contraception (listed in Section 10.2.2) during the study intervention period and for at least 30 days after the last dose of study intervention.\n4. Females with a negative serum pregnancy test at Screening and a negative urine pregnancy test at Check-in (within 24 hours before the first dose of study intervention).\n5. Males who agree to the following conditions during the study intervention period and for at least 30 days after the last dose of study intervention:\n\n   1. Refrain from donating sperm and\n   2. Use one of the following forms of contraception:\n\n      * Abstinence from heterosexual intercourse or\n      * Condom if partner is a woman of CBP (defined in Section 10.2.1), plus highly effective method of contraception (listed in Section 10.2.2) if partner is a woman of CBP who is not currently pregnant.\n6. Willing and able to provide voluntary, written informed consent to participate in the study.\n7. Able to communicate well with the Investigator and\u002For study site personnel and to comply with the requirements of the entire study.\n8. Negative drug\u002Falcohol testing at Screening and Check-in.\n9. Vital signs (after semi-recumbent for at least 5 minutes) that are within the following ranges at Screening and Check-in. If not within the stated ranges, they must be without clinical significance as determined by the Investigator.\n\n   1. Systolic BP, 90 to 140 mmHg, inclusive\n   2. Diastolic BP, 50 to 90 mmHg, inclusive\n   3. Heart rate (HR), \\> 45 to ≤ 100 bpm\n10. Normal renal function, defined as eGFR \\> 90 mL\u002Fmin at Screening; an Investigator can determine based on clinical judgment whether a lower rate can be accepted based on the muscle composition of the participants.\n\nExclusion Criteria:\n\n1. History or presence of cardiovascular, respiratory, hepatic, renal, GI, endocrinological, hematological, neurological, or psychiatric disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention; or interfering with the interpretation of data.\n2. History of any active infection within 14 days of dosing with study intervention, if deemed clinically significant by the Investigator and Sponsor.\n3. Any acute illness within 30 days prior to dosing with study intervention.\n4. Clinically significant (as determined by the Investigator) abnormal laboratory test results, including, but not limited to, lipase, amylase, alkaline phosphatase, WBC count, or platelets, at Screening and Check-in. Note: Alkaline phosphatase, WBC count, and platelets must be within normal limits at Screening and Check-in.\n5. Concurrent conditions that could interfere with safety and\u002For tolerability measurements, as determined by the Investigator or designee.\n6. Existence of any surgical or medical condition that, in the judgment of the Investigator, might interfere with the absorption, distribution, metabolism, or excretion of JPH034.\n7. History (within 2 years prior to the first dose of study intervention) of moderate or severe use disorder for any substance other than caffeine (based on DSM-5 criteria).\n8. History of a major psychiatric disorder, ongoing suicidal ideations, or endorsement of suicidal ideation or behavior based on the C-SSRS at Screening.\n9. Reduced sense of taste, as assessed by taste strips at Screening.\n10. QTcF \\> 450 msec for males or \\> 470 msec for females observed at Screening or Check-in.\n11. History or presence of any type of arrhythmia or irregular heartbeat.\n12. Long QT syndrome or a history of cardiac disease.\n13. Potassium or magnesium outside the normal range at Screening or Check-in (potassium normal range = 3.6-5.2 mEq\u002FL; magnesium normal range = 1.9-2.7 mg\u002FdL).\n14. Use of any drug known to prolong the QT interval within 4 weeks prior to study.\n15. ALT or AST \\> 1.5 × ULN at Screening or Check-in.\n16. Total bilirubin \\> 1.5 × ULN at Screening or Check-in. For participants with known Gilbert's syndrome these criteria only apply if total bilirubin \\> 1.5 × ULN as long as direct bilirubin is ≤ 1.5 × ULN.\n17. Current or chronic history of liver disease. This includes but is not limited to hepatitis virus infections, drug- or alcohol-related liver disease, steatotic liver disease, autoimmune hepatitis, hemochromatosis, Wilson's disease, α-1 antitrypsin deficiency, primary biliary cholangitis, primary sclerosing cholangitis, or any other liver disease considered clinically significant by the Investigator.\n18. Use of prescription or non-prescription medications within 14 days or 5 half-lives, whichever is longer, before the first dose of study intervention.\n19. Exposure to any investigational agent within 5 half-lives or 30 days, whichever is longer, prior to Screening.\n20. Diagnosis of or positive Screening result for HCVAb, or HIV-1 or HIV-2.\n21. Diagnosis of or positive Screening result for current or previous natural hepatitis B infection. Results indicative of vaccine-induced immunity (negative HBsAg and HBcAb plus positive HBsAb) will not be exclusionary.\n22. Positive COVID-19 test.\n23. Positive or indeterminate IGRA (QuantiFERON®-TB Gold Plus \\[QFT-Plus\\]) TB test.\n24. Known history of allergy to JPH034 or other related drugs or their components.\n25. Any food allergy, intolerance, restriction, or special diet that, in the opinion of the Investigator or designee, could contraindicate the participant's participation in the study.\n26. Unable to ingest an entire high-fat\u002Fhigh-calorie meal.\n27. Blood donation (excluding plasma donation) of approximately 500 mL within 56 days prior to Screening.\n28. Plasma donation within 7 days of Screening.\n29. Unable or unwilling to cooperate with site staff for any reason.\n30. Study site employees, immediate family members of a study site employee, or anyone whose participation in the study would create a conflict of interest for a study site employee.",true,"50 Years",{"count":56,"type":21},40,[58],"PHASE1","This study is designed to evaluate the safety, tolerability, and PK of JPH034 and identify side effects that occur in healthy participants between the ages of 18 and 50 years. Participants enrolling in the trial will be randomly assigned to receive JPH034 or placebo. Participants in the in single-ascending dose (SAD) cohorts will receive treatment once, and one group of participants will receive treatment a second time to study the effects of food. Health measurements including physical examinations, vital signs, ECGs, and safety laboratory tests will be performed to monitor safety. Blood tests will be performed to measure how much JPH034 and its major metabolite (M1) gets into the bloodstream and how long it stays in the body.",[61],"Health Adult Subjects",[63],"Single Ascending Dose","2026-04-14",{"date":66,"type":37},"2026-04-16",{"date":68,"type":21},"2026-03-22",{"date":70,"type":21},"2026-10-10",{"name":43,"class":44},1,""]