[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"InSilico Medicine Hong Kong Limited\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":213},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,7,0,[8,45,74,101,129,155,186],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100613360","phase-2-study-evaluating-ism5411-administered-orally-to-subjects-with-active-ulcerative-colitis-bethesda-100613360",false,"NCT07265570","Study Evaluating ISM5411 Administered Orally to Subjects With Active Ulcerative Colitis (BETHESDA)","A Phase IIa, Multicenter, Randomized, Double-blind, Placebo-controlled, Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Clinical Efficacy of ISM5411 in Adult Patients With Active Ulcerative Colitis","Inclusion Criteria:\n\n1. Subject who fully understand the content, process and possible adverse events of the study and capable of giving written informed consent form (ICF).\n2. Female subjects must be nonpregnancy and nonlactating. Subjects (male or female) are willing to take medically approved effective contraceptive measures from the screening period to 3 months after the last administration and have no sperm or egg donation plan during the study period and within 3 months after the last dose.\n3. Male or female between 18 and 75 years of age (inclusive), at the time of signing the ICF.\n4. Subject has a diagnosis of ulcerative colitis for at least 3 months prior to colonoscopy during the screening period, and meets the criteria defined in the current protocol.\n5. If the subjects have concomitant medication defined in the current protocol, they must meet the relevant criteria to be enrolled.\n6. If the subjects have discontinued medication defined in the current protocol, they must meet the relevant criteria to be enrolled.\n\nExclusion Criteria:\n\n1. Subjects have suspected or diagnosed Crohn's disease (CD), undefined colitis, ischemic colitis, fulminant colitis, toxic megacolon, radiation colitis, gastrointestinal perforation (other than appendicitis or penetrating injury), diverticular disease associated with colitis, enterophthisis, abdominal abscess or fistula, etc.\n2. Subjects with previously diagnosed but uneradicated or current gastrointestinal dysplasia.\n3. Subjects have received surgery for UC or any other type of major intestinal surgery (i.e., surgical procedure requiring general anesthesia) or are likely to require related surgery during the study.\n4. Subjects have evidence of a pathogenic intestinal infection, or have a Clostridium Difficile infection or other intestinal infection within 30 days prior to the screening endoscopy or have tested positive for Clostridium Difficile toxins or other intestinal pathogens at the screening period.\n5. Subjects have chronic recurring infection and\u002For active viral infection that, based on the investigator's clinical assessment, make them an unsuitable candidate for the study.\n6. Subjects who are unable to take oral medications and\u002For have an impact on absorption of medication due to severe malnutrition or disease and surgery, etc., or who are currently receiving or plan to receive total parenteral nutrition (TPN) during the study period.\n7. Subjects who have received the relevant treatments defined in the protocol.\n8. Subjects with recurrent or disseminated (even if single episode) herpes zoster, or cytomegalovirus infection.\n9. Subjects who have the risks of tuberculosis defined in the protocol.\n10. Subjects have any of the infection defined in the protocol.\n11. Subjects who are known to be allergic to the investigational product or any components of it or who have allergic constitution (allergy to multiple drugs or foods).\n12. Subjects have unstable or uncontrolled and clinically significant allergic (except for untreated, asymptomatic, seasonal allergies), hematological, endocrine\u002Fmetabolic, coagulation, immunologic, pulmonary, cardiovascular, hepatic (expect hepatic steatohepatitis), digestion system (expect UC), genitourinary, psychiatric, oncologic or neurological disease or other medical disorder that would make them ineligible for the study.\n13. Subjects have concomitant illness that in the opinion of the investigator, are likely to require systemic glucocorticosteroid therapy during the study (e.g., moderate to severe asthma).\n14. Subjects have received major organ surgery (except needle biopsy, tracheotomy, gastrotomy, etc.) or significant trauma within 28 days prior to randomization or is likely to require related surgery during the study.\n15. Subjects have history of any malignancy within 5 years of screening, except for successfully treated nonmelanoma skin cancer (NMSC), skin basal cell carcinoma, or localized carcinoma in situ of the cervix.\n16. Any abnormal results defined in the protocol were identified during the screening period.\n17. Subjects with poorly controlled hypertension (systolic blood pressure ≥160 mmHg and\u002For diastolic blood pressure ≥100 mmHg) despite medication at screening.\n18. Subjects have a clinically significant abnormal ECG at screening, including QTcF \\> 450 msec for males and \\> 470 msec for females.\n19. Subjects have difficulty in venous blood collection or history of acupuncture syncope reaction or blood phobia.\n20. Subjects have contraindications to colonoscopy, including but not limited to gastrointestinal fistulas, early post abdominal surgery, severe coagulopathy, large abdominal aneurysms, or any condition that the investigator determines significantly increases the risk of colonoscopy complications.\n21. Subjects have a history of alcohol or drug abuse within 3 months of screening, according to the judgement of the investigator. Alcohol abuse refers to consuming alcohol at least twice per day or more than 14 units of alcohol per week.\n22. Subjects have participated in other clinical trials of other drugs or medical devices within 30 days prior to screening period and have already received the investigational product, or are currently participating in another clinical trial of a drug or medical device.\n23. Subjects are deemed by the investigator to be inappropriate for the study; or have any condition which would confound or interfere with the evaluation of the safety, tolerability, or PK of the investigational drug; or are unable or unwilling to comply with the study protocol.","ALL","18 Years","75 Years",{"count":20,"type":21},80,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","This is a multicenter, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics and clinical efficacy of ISM5411 in adult patients with active ulcerative colitis.",[27],"Ulcerative Colitis",[29,30,31],"Prolyl hydroxylase (PHD) inhibitor","Ulcerative colitis（UC）","Inflammatory bowel disease (IBD)","RECRUITING","2026-06-30",{"date":35,"type":36},"2026-07-01","ACTUAL",{"date":38,"type":36},"2025-12-10",{"date":40,"type":21},"2027-08-30",{"name":42,"class":43},"InSilico Medicine Hong Kong Limited","INDUSTRY",28,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":52,"sex":16,"minAge":17,"maxAge":53,"enrollmentInfo":54,"targetDuration":4,"studyType":22,"phases":56,"briefSummary":58,"conditions":59,"keywords":62,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":73},"100641469","phase-1-a-phase-1-evaluate-the-safety-tolerability-pharmacokinetics-and-pharmacodynamics-of-ism8969-100641469","NCT07581431","A Phase 1, Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ISM8969","A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Ascending Oral Doses of ISM8969 in Healthy Adult and Elderly Participants and Obese Adult Participants at Risk of Cardiovascular Disease","Inclusion Criteria:\n\nParticipants must meet all the following criteria to be included in the study:\n\nInclusion criteria 1\\~4 are only for the healthy participants in the SAD and MAD study:\n\n1. Male or female participants, including adult participants (≥18 and \\\u003C65 years of age) for the SAD cohorts 1-6 and MAD cohorts 1-3, and elderly participants (≥65 and ≤80 years of age) for MAD cohort 4.\n2. Body mass index (BMI) \\>18.5 and \\\u003C30.0 kg\u002Fm2 and body weight ≥50.0 kg for males and ≥45.0 kg for females.\n3. Non-smokers (no use of tobacco or nicotine products within 1 month prior to screening).\n4. Healthy as defined the current protocol.\n\n   Inclusion criteria 5\\~9 are only for the obese participants at risk of cardiovascular disease in MAD study):\n5. Male or female, ≥18 and ≤65 years of age.\n6. 30.0 kg\u002Fm2 ≤ BMI \\\u003C 42.0 kg\u002Fm2.\n7. No change in body weight or self-reported change of less than 5.0% within 3 months before screening.\n8. Presence of 1 or more risk factors for cardiovascular disease such as hypertension, hyperlipidemia. If present, must be controlled with stable medication dose\u002Ftherapy (defined as a stable medication dose\u002Ftherapy for 3 months or longer).\n9. hsCRP ≥3 mg\u002FL.\n\nExclusion Criteria:\n\nParticipants for whom any of the following applies will be excluded from the study:\n\n1. Columbia suicide severity rating scale (C-SSRS) score above Type 1 ideation.\n2. Positive serology test results for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, human immunodeficiency virus (HIV) antigen and antibody, treponema pallidum antibody or QuantiFERON®-TB test at screening.\n3. Positive pregnancy test or lactating female participant.\n4. History of any central nervous system (CNS) disorder or history of seizure of any cause.\n5. Clinically significant 12-lead ECG, physical examination, vital signs or laboratory abnormalities at screening, including but not limited to defined in the protocol.\n6. History of significant cardiovascular or cerebrovascular disease within 6 months before screening, including but not limited to defined in the protocol.\n7. History of an active or untreated malignancy or are in remission from a clinically significant malignancy (other than basal- or squamous-cell skin cancer, or in situ carcinomas of the cervix) for less than 5 years; or there is a potential malignancy during screening.\n8. Participation in a clinical research study involving the administration of an investigational or marketed drug or device within 30 days (or 5 half-lives, whichever is longer) prior to the first dosing, administration of a biological product in the context of a clinical research study within 90 days (or 5 half-lives, whichever is longer) prior to the first dosing, or concomitant participation in an investigational study involving no drug or device administration.\n9. Presence of contraindication to lumbar puncture or lumbar catheter as judged by Investigator.",true,"80 Years",{"count":55,"type":21},100,[57],"PHASE1","This is a single center, phase 1, randomized, double-blind, placebo-controlled sequential study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple ascending oral doses of ISM8969 in healthy adults and elderly participants and obese adult participants at risk of cardiovascular disease.",[60,61],"Healthy Subjects (HS)","Obese Adult Participants at Risk of Cardiovascular Disease",[63,64],"NLRP3 Inhibitor","ISM8969","2026-06-17",{"date":67,"type":36},"2026-06-22",{"date":69,"type":36},"2026-06-15",{"date":71,"type":21},"2027-03-31",{"name":42,"class":43},1,{"id":75,"slug":76,"hasResults":11,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":4,"eligibilityCriteria":80,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":81,"targetDuration":4,"studyType":22,"phases":83,"briefSummary":84,"conditions":85,"keywords":87,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":100},"100547937","phase-1-study-of-ism3412-in-participants-with-locally-advancedmetastatic-solid-tumors-100547937","NCT06414460","Study of ISM3412 in Participants With Locally Advanced\u002FMetastatic Solid Tumors","A Phase 1\u002F2, Open-Label, Multicenter, First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics\u002FPharmacodynamics, and Preliminary Efficacy of ISM3412 in Participants With Locally Advanced\u002FMetastatic Solid Tumors","Inclusion Criteria:\n\n1. Male or female participants with age ≥18 years at the time of signing the informed consent.\n2. Histologically confirmed unresectable locally advanced or metastatic solid tumors with confirmed homozygous MTAP deletion, who have disease progression after standard therapy, intolerable to standard therapy, or for whom no standard therapy exists.\n3. Have measurable or evaluable lesions in Part 1 and at least one measurable target lesion in Part 2 as defined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria.\n4. ECOG PS (Eastern Cooperative Oncology Group Performance Status) ≤1.\n5. Life expectancy of ≥12 weeks as judged by the investigator.\n6. Adequate organ function as determined by medical assessment.\n7. Capable of providing signed ICF and complying with the requirements and restrictions listed in the ICF and in this study protocol.\n\nExclusion Criteria:\n\n1. Prior treated with other MAT2A inhibitors and\u002For PRMT inhibitors.\n2. Participation in other therapeutic clinical studies within 28 days or 5 half-lives (whichever is shorter) prior to first dose of study treatment.\n3. Anti-tumor therapy (chemotherapy, immunotherapy, hormonal therapy, targeted therapy, biologic therapy, or other anti-tumor therapy, except for hormones for hypothyroidism or estrogen replacement therapy, anti-estrogen analogues, agonists required to suppress serum testosterone levels) within 28 days or 5 half-lives, whichever is shorter prior to first dose of study treatment.\n4. Toxicities of prior therapy have not resolved to Grade ≤1 or to baseline (as evaluated by NCI CTCAE version 5.0)\n5. History of another primary tumor that has been diagnosed or required therapy within the past 3 years.\n6. Previous history of, or presence of Gilbert's syndrome.\n7. Previous history of myelodysplastic syndrome.\n8. Prior solid organ or hematopoietic stem cell transplant.\n9. Known active central nervous system (CNS) primary tumor or untreated CNS metastases.\n10. Have serious cardiovascular or cerebrovascular disease as per protocol.\n11. Presence of uncontrolled systemic infection as per protocol.\n12. Unwillingness or unable to comply with the requirements of oral drug administration, or presence of a gastro-intestinal condition.\n\nOther protocol inclusion and exclusion criteria may apply.",{"count":82,"type":21},114,[57,24],"The study has consists of two parts, a dose escalation part (Part 1) and a dose selection optimization part (Part 2). The primary objectives of this study are to evaluate the safety and tolerability of ISM3412 in participants with locally advanced\u002Fmetastatic solid tumors, and to determine the RP2D of ISM3412.",[86],"Locally Advanced\u002FMetastatic Solid Tumors",[88,89,90,91],"Methionine adenosyltransferase 2A (MAT2A)","homozygous MTAP deletion","MAT2A inhibitor","ISM3412","2026-06-16",{"date":94,"type":36},"2026-06-18",{"date":96,"type":36},"2025-04-25",{"date":98,"type":21},"2029-03-31",{"name":42,"class":43},10,{"id":102,"slug":103,"hasResults":11,"nctId":104,"briefTitle":105,"officialTitle":106,"acronym":4,"eligibilityCriteria":107,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":108,"targetDuration":4,"studyType":22,"phases":109,"briefSummary":110,"conditions":111,"keywords":115,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":100},"100559588","phase-1-study-of-ism6331-in-participants-with-advancedmetastatic-malignant-mesothelioma-or-other-solid-tumors-100559588","NCT06566079","Study of ISM6331 in Participants With Advanced\u002FMetastatic Malignant Mesothelioma or Other Solid Tumors","A Phase 1, Open-Label, Multicenter, FIH Study to Evaluate the Safety, Tolerability, Pharmacokinetics\u002FPharmacodynamics, and Preliminary Efficacy of ISM6331 in Participants With Advanced\u002FMetastatic Malignant Mesothelioma or Other Solid Tumors","Inclusion Criteria:\n\n1. Male or female participants with age ≥18 years at the time of signing the informed consent.\n2. Histologically confirmed unresectable advanced or metastatic malignant mesothelioma or other solid tumors, who have failed standard therapy or for whom no effective standard therapy exists, participants for part 1 is regardless of the presence or absence of the genetic alterations of the Hippo pathway, but for part 2 participants with solid tumors other than mesothelioma, genetic testing documentation must demonstrate Hippo signaling pathway dysregulation.\n3. Participants with malignant mesothelioma must have prior exposure to at least immune checkpoint therapy and platinum-based chemotherapy.\n4. Presence of at least one evaluable lesion in Part 1 or one measurable target lesion in Part 2 according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) for participants with non-pleural mesothelioma or other solid tumors and modified RECIST (mRECIST) v1.1 for participants with malignant pleural mesothelioma.\n5. Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤1.\n6. Life expectancy of ≥12 weeks as judged by the investigator.\n7. Adequate organ function as determined by medical assessment (within 7 days prior to the first dose of study treatment).\n8. Capable of providing signed informed consent form (ICF) and complying with the requirements and restrictions listed in the ICF and in this study protocol.\n\nExclusion Criteria:\n\n1. Participants who have previously received a TEAD inhibitor.\n2. Participation in other therapeutic clinical studies within 28 days or 5 half-lives (whichever is shorter) prior to first dose of study treatment.\n3. Anti-tumor therapy within 28 days or 5 half-lives (whichever is shorter) prior to first dose of study treatment.\n4. Known active central nervous system (CNS) primary tumor or untreated CNS metastases.\n5. As judged by the investigator, any evidence of severe or uncontrolled systemic diseases.\n6. Unwillingness or unable to comply with the requirements of oral drug administration, or presence of a gastro-intestinal condition\n7. Have prior or ongoing clinically significant illness, medical condition, surgical history, physical finding, laboratory abnormality or any other conditions that, in the investigator's opinion, would not be in the best interest of the participant; or that could alter the absorption, distribution, metabolism, or excretion of the study treatment; or impair the assessment of study result.\n8. Currently receiving any of Strong inhibitors or inducers of P-gp, or Sensitive substrates of P-gp, CYP1A2, CYP2B6, and CYP3A4 that cannot be discontinued 14 days or 5 half-lives for inhibitors or substrates (whichever is shorter) prior to the first dose of study treatment.\n\nOther protocol inclusion and exclusion criteria may apply.",{"count":55,"type":21},[57],"This is a Phase 1, open-label, multicenter, FIH study to evaluate the safety, tolerability, recommended Phase 2 dose (RP2D), PK\u002FPD, and preliminary anti-tumor activity of ISM6331 in participants with advanced or metastatic malignant mesothelioma or other solid tumors. The study consists of two parts, a dose escalation part (Part 1) and a dose selection optimization part (Part 2).",[112,113,114],"Malignant Mesothelioma","Metastatic Malignant Solid Tumor","Advanced Solid Tumor",[116,117,118,119,120],"Transcriptional enhanced associate domain (TEAD)","TEAD inhibitor","ISM6331","Hippo pathway","YAP\u002FTAZ-TEAD","2026-02-12",{"date":123,"type":36},"2026-02-17",{"date":125,"type":36},"2024-12-27",{"date":127,"type":21},"2028-02-28",{"name":42,"class":43},{"id":130,"slug":131,"hasResults":11,"nctId":132,"briefTitle":133,"officialTitle":134,"acronym":4,"eligibilityCriteria":135,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":136,"targetDuration":4,"studyType":22,"phases":138,"briefSummary":139,"conditions":140,"keywords":143,"overallStatus":148,"whyStopped":4,"lastUpdateSubmitDate":149,"lastUpdatePostDateStruct":150,"startDateStruct":151,"completionDateStruct":152,"leadSponsor":154,"locationsCount":4},"100571729","phase-1-study-of-ism5939-in-patients-with-advanced-andor-metastatic-solid-tumors-100571729","NCT06724042","Study of ISM5939 in Patients With Advanced and\u002For Metastatic Solid Tumors","First-in-human Phase 1a\u002Fb, Open-Label, Multicenter, Dose Escalation, Optimization and Expansion Study of ISM5939 in Patients With Advanced and\u002For Metastatic Solid Tumors","Inclusion Criteria:\n\n1. Patients aged ≥18 years.\n2. Patients with histologically or cytologically confirmed diagnosis of advanced\u002Fmetastatic solid tumor that is either locally advanced and not amenable to curative therapy or stage 4 disease.\n3. Patients must have tumor relapse\u002Frecurrence and be refractory to available SOC treatment, be intolerant to or ineligible for available SOC treatment, or have no SOC treatment available.\n4. Patients enrolled in Part 3 (combination cohorts) must be acceptable and eligible for treatment with cisplatin, docetaxel, or pembrolizumab.\n5. Measurable disease per RECIST version 1.1 or PCWG3 criteria for patients with metastatic castration-resistant prostate cancer.\n6. Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 1.\n7. Patients must have recovered to Grade 1 or baseline levels from toxicity or AEs related to prior treatment for their cancer, excluding: Grade ≤2 neuropathy; alopecia of any grade, or skin pigmentation; Grade ≤2 hypothyroidism stable on hormone replacement therapy, Grade ≤2 anorexia or fatigue.\n8. Patients must have an understanding, ability, and willingness to fully comply with study procedures and restrictions.\n9. Patient must be capable of oral administration of ISM5939 and not have any clinically significant gastrointestinal abnormalities that may alter absorption.\n10. Adequate bone marrow and organ function.\n11. If receiving corticosteroids, patient must be maintained on a stable or decreasing dose for at least 7 days prior to Day 1.\n12. Life expectancy ≥3 months in the opinion of the investigator.\n\nExclusion Criteria:\n\n1. Patient has had prior systemic anti-cancer therapy within 3 weeks or at least 5 half-lives (whichever is shorter, but no less than 2 weeks) prior to Day 1.\n2. Prior radiation therapy at the target lesion, unless there is evidence of disease progression and the prior radiation therapy is to have been completed at least 7 days before study drug.\n3. Treatment with any investigational agent administered within 30 days or 5 half-lives, whichever is shorter, before the first dose of ISM5939.\n4. Prior therapy with an ENPP1 inhibitor.\n5. Currently receiving any of the CYP3A4\u002F5 inhibitors\u002Finducers, or CYP2C9 inhibitors, or inhibitors\u002Finducers of MDR1, or medications known to prolong the QT interval that cannot be discontinued 14 days or 5 half-lives prior to Day 1.\n6. Major surgery within 21 days prior to Day 1.\n7. Patients with active (uncontrolled, metastatic) second malignancies or requiring therapy, or who have undergone potentially curative therapy with no evidence of the disease recurrence for at least 3 years prior to the first dose of study treatment.\n8. Patients with a primary CNS tumor.\n9. Patient has uncontrolled hypertension, or heart disease and\u002For cardiac repolarization abnormality, or uncontrolled systemic infection.\n10. Other medical illness that, in the opinion of the investigator, may impact the safety of the patient or the objectives of the study.\n\nOther protocol inclusion and exclusion criteria may apply.",{"count":137,"type":21},159,[57],"This is a first-in-human Phase 1a\u002Fb, open-label, multicenter, dose escalation, optimization and expansion study of ISM5939 to evaluate the safety, tolerability, PK, PD, and preliminary antitumor activity of ISM5939 in patients with advanced or metastatic solid tumors.\n\nThe study will be conducted in 3 parts sequentially: Part 1 dose escalation ISM5939 monotherapy, Part 2 dose optimization to determine RP2D of ISM5939 monotherapy, and Part 3 dose expansion in 3 cohorts after initial safety run-in of ISM5939 combination therapy.",[114,141,142],"Metastatic Solid Tumor","Advanced and\u002For Metastatic Solid Tumors",[144,145,146,147],"ISM5939","Ectonucleotide pyrophosphatase\u002Fphosphodiesterase 1 (ENPP1)","ENPP1 inhibitor","Solid Tumor","NOT_YET_RECRUITING","2025-12-03",{"date":38,"type":36},{"date":33,"type":21},{"date":153,"type":21},"2030-06-30",{"name":42,"class":43},{"id":156,"slug":157,"hasResults":11,"nctId":158,"briefTitle":159,"officialTitle":160,"acronym":4,"eligibilityCriteria":161,"healthyVolunteers":11,"sex":16,"minAge":162,"maxAge":4,"enrollmentInfo":163,"targetDuration":4,"studyType":22,"phases":165,"briefSummary":166,"conditions":167,"keywords":169,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":177,"lastUpdatePostDateStruct":178,"startDateStruct":180,"completionDateStruct":182,"leadSponsor":184,"locationsCount":185},"100514245","phase-2-study-evaluating-ins018055-administered-orally-to-subjects-with-idiopathic-pulmonary-fibrosis-100514245","NCT05975983","Study Evaluating INS018_055 Administered Orally to Subjects With Idiopathic Pulmonary Fibrosis","A Phase IIa, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of INS018_055 Administered Orally to Subjects With Idiopathic Pulmonary Fibrosis (IPF)","Inclusion Criteria:\n\n1. Male or female patients aged ≥40 years based on the date of the written informed consent form\n2. Diagnosis of IPF as defined by American Thoracic Society\u002FEuropean Respiratory Society\u002FJapanese Respiratory Society\u002FLatin American Thoracic Association guidelines\n3. In a stable condition and suitable for study participation based on the results of medical history, physical examination, vital signs, 12-lead ECG, and laboratory evaluation\n4. Meeting all of the following criteria during the screening period:\n\n   1. FVC ≥40% predicted normal\n   2. DLCO corrected for Hgb ≥25% and \\\u003C80% predicted normal\n   3. Forced Expiratory Volume in the first second\u002FFVC (FEV1\u002FFVC) ratio \\>0.7 based on pre-bronchodilator value\n\nExclusion Criteria:\n\n1. Acute IPF exacerbation within 4 months prior to Visit 1 and\u002For Day 1, as determined by the investigator\n2. Patients who are unwilling to refrain from smoking within 3 months prior to screening and until the end of the study\n3. Female patients who are pregnant or nursing\n4. Abnormal ECG findings","40 Years",{"count":164,"type":21},40,[24],"The purpose of this revised Phase IIa study is to demonstrate safety of INS018\\_055 over 12 weeks in adults with Idiopathic Pulmonary Fibrosis (IPF).",[168],"Idiopathic Pulmonary Fibrosis (IPF)",[170,171,172,173,174,175,176],"Pulmonary Fibrosis","Idiopathic Pulmonary Fibrosis","Fibrosis","Pathologic Processes","Lung Diseases, Interstitial","Lung Diseases","Respiratory Tract Diseases","2025-11-10",{"date":179,"type":36},"2025-11-12",{"date":181,"type":36},"2024-02-08",{"date":183,"type":21},"2026-02-28",{"name":42,"class":43},12,{"id":187,"slug":188,"hasResults":11,"nctId":189,"briefTitle":190,"officialTitle":191,"acronym":4,"eligibilityCriteria":192,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":193,"targetDuration":4,"studyType":22,"phases":195,"briefSummary":196,"conditions":197,"keywords":200,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":204,"lastUpdatePostDateStruct":205,"startDateStruct":207,"completionDateStruct":209,"leadSponsor":211,"locationsCount":212},"100550318","phase-1-study-evaluating-ism8207-in-participants-with-advanced-solid-tumors-and-relapsedrefractory-b-cell-lymphoma-100550318","NCT06445517","Study Evaluating ISM8207 in Participants With Advanced Solid Tumors and Relapsed\u002FRefractory B-Cell Lymphoma","A Phase 1, Open-label, Multicenter, First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of ISM8207 Monotherapy in Patients With Advanced Solid Tumors or Relapsed\u002FRefractory B-Lymphoid Malignancies","Inclusion Criteria:\n\n1. Male or female participants with age ≥18 years at the time of signing the informed consent.\n2. Advanced solid tumors: Histologically confirmed advanced or metastatic solid tumors who have disease progression after standard therapy, intolerable to standard therapy, or for whom no standard therapy exists.\n\n   B-cell lymphoma: Histologically confirmed B-cell lymphoma who had received at least one prior line of standard therapy and were relapsed after or refractory to the standard therapy.\n3. Have measurable or evaluable lesions in Part 1 and at least one measurable target lesion in Part 2 as defined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria or Lugano 2014.\n4. ECOG PS (Eastern Cooperative Oncology Group Performance Status)≤1.\n5. Life expectancy of ≥12 weeks as judged by the investigator.\n6. Adequate organ function as determined by medical assessment.\n7. Capable of providing signed ICF and complying with the requirements and restrictions listed in the ICF and in this study protocol.\n8. Female subjects of childbearing potential and male subjects must agree to use an effective method of contraception during the treatment period and for 90 days after the last dose of ISM8207.\n\nExclusion Criteria:\n\n1. Prior treated with other QPCTL, CD47 or SIRPα inhibitors.\n2. Burkitt lymphoma\u002Fleukemia, plasma cell myeloma, plasmablastic lymphoma.\n3. Participation in other therapeutic clinical studies within 28 days or 5 half- lives (whichever is shorter) prior to first dose of study treatment.\n4. Anti-tumor therapy (chemotherapy, immunotherapy, targeted therapy, biologic therapy, or other anti-tumor therapy) within 28 days or 5 half-lives, whichever is shorter prior to first dose of study treatment.\n5. Previous allogeneic stem cell transplantation or autologous stem cell. transplantation within 3 months prior to first receiving study treatment.\n6. Unresolved toxicity of Grade \\>1 attributed to any prior therapies (excluding alopecia).\n7. Received antitumor steroid therapy within 7 days prior to the first study treatment administration.\n8. A serious illness or medical condition(s)",{"count":194,"type":21},60,[57],"The goal of this clinical trial is to study ISM8207 in participants with advanced solid tumors and relapsed\u002Frefractory B-cell lymphoma. The primary objective is to evaluate the safety and tolerability of ISM8207 orally administered in participants with advanced solid tumors and relapsed\u002Frefractory B-cell lymphoma",[198,199],"Advanced Solid Tumors","Relapsed\u002FRefractory B-cell Lymphoma",[201,202,203],"Advanced solid tumors","Relapsed\u002Frefractory B-cell lymphoma","Lymphoma, B-cell","2024-06-05",{"date":206,"type":36},"2024-06-07",{"date":208,"type":36},"2024-04-25",{"date":210,"type":21},"2027-02-28",{"name":42,"class":43},2,""]