[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Jiangsu Simcere Pharmaceutical Co., Ltd.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":358},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,15,0,[8,40,64,86,108,137,159,184,204,228,248,269,293,317,336],{"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":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":39},"100641744","phase-1-a-study-of-sim0689-in-adult-participants-with-locally-advanced-or-metastatic-solid-tumors-100641744",false,"NCT07660432","A Study of SIM0689 in Adult Participants With Locally Advanced or Metastatic Solid Tumors","Phase I First-in-Human, Open-label, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of SIM0689 in Adult Participants With Locally Advanced or Metastatic Solid Tumors","Inclusion Criteria:\n\n* In dose-escalation cohorts (Part 1), histologically or cytologically documented advanced or metastatic solid tumor that is refractory\u002Frelapsed to standard therapies, or for which no effective standard therapy is available, or the subject refuses standard therapy.\n* In the dose-expansion cohorts (Part 2), histologically or cytologically confirmed selected advanced solid tumors.\n* Subjects must have at least one measurable lesion according to RECIST Version1.1.\n* Eastern Cooperative Oncology Group (ECOG) Performance Score of 0 or 1.\n* Adequate organ function.\n* Available archived tumor tissue sample to allow for correlative biomarker studies. If unavailable or unsuitable, the subject must consent and undergo fresh tumor biopsy.\n* Life expectancy ≥12 weeks.\n* Patients of childbearing potential (male and female) must agree to use reliable methods of contraception until at least 180 days after the last dose.\n\nExclusion Criteria:\n\n* Symptomatic brain metastases.\n* Serious non-healing wounds, ulcers or fractures.\n* Toxicity from previous treatment has to restore to ≤ grade 1.\n* Major surgery (excluding biopsy) or significant trauma within 4 weeks prior to enrollment.\n* Use of aspirin (\\> 325 mg\u002Fday) within 6 months prior to the first dose.\n* Active hepatitis B or hepatitis C.\n* Known human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS).\n* Known hereditary or acquired predisposition to bleeding and thrombosis.\n* History of gastrointestinal perforation, gastrointestinal bleeding, fistula, or any life-threatening bleeding event within 6 months prior to enrollment.\n* Prior permanent discontinuation of PD-(L)1 and\u002For VEGF monoclonal antibody because of immune\u002Fanti-angiogenesis toxicities, or history of Grade ≥3 immune\u002Fanti-angiogenesis-related AEs\n* Known or suspected active autoimmune disease.\n* Patients with proteinuria at screening (Urine protein \\>2+ at screening, or 2+ urine protein accompanied by 24-h urine protein ≥1 g\u002F24 h).\n* History of myocardial infarction or stroke within 6 months prior to enrollment.\n* Subjects with clinically significant cardiovascular disease within 6 months prior to the first dose.\n* Pregnant and lactating women.\n* Known allergies to any excipient in the study drug.","ALL","18 Years",{"count":19,"type":20},472,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","This study will evaluate the safety, of SIM0689 and how the body processes it, how it affects the body, and its early signs of activity against tumors when given alone to Adult Participants with Locally Advanced or Metastatic Solid Tumors. The study has a dose escalation part to find the highest dose that can be given safely, or recommended dose (RD) for SIM0689 when given alone, and a dose expansion part in subjects with specific tumor types treated with SIM0689 as a single agent at RD.",[26],"Neoplasms, Malignant","NOT_YET_RECRUITING","2026-06-16",{"date":30,"type":31},"2026-06-22","ACTUAL",{"date":33,"type":20},"2027-07",{"date":35,"type":20},"2029-06",{"name":37,"class":38},"Jiangsu Simcere Pharmaceutical Co., Ltd.","INDUSTRY",6,{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":46,"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":54,"whyStopped":4,"lastUpdateSubmitDate":55,"lastUpdatePostDateStruct":56,"startDateStruct":58,"completionDateStruct":60,"leadSponsor":62,"locationsCount":63},"100639446","phase-1-sim0613-in-participants-with-advanced-solid-tumors-100639446","NCT07618260","SIM0613 in Participants With Advanced Solid Tumors","A Phase I First-in-human, Open-label, Multicenter Study to Investigate the Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of SIM0613 in Participants With Advanced Solid Tumors","SIM0613-101","Inclusion Criteria:\n\n1. Written informed consent (ICF) is obtained prior to any of the specified procedures required for the study\n2. ≥18 years of age\n3. Histologically or cytologically confirmed locally advanced\u002Fmetastatic solid tumors\n4. Have at least one measurable disease per RECIST Version 1.1 criteria\n5. Have experienced disease progression on\u002Fafter at least one accessible standard therapy, or are intolerant to standard therapy, or are not suitable for standard therapy, or for whom clinical trial of the investigational drug serves as standard treatment\n6. Life expectancy of ≥12 weeks\n7. Have adequate organ function\n8. Women of childbearing potential (WOCBP) must have a negative serum pregnancy test within 3 days prior to the start of study treatment.\n9. For Part 1, archival or fresh tumor tissue sample (preferably 12 with a minimum number of 10 sections) should be collected if available at Biomarker-screening or screening visit. For Part 2, it is mandatory to collect archival tumor tissue sample (preferably 12 with a minimum number of 10 sections) performed within 6 months prior to consent or fresh tumor tissue sample at Biomarker-screening or screening visit\n\nExclusion Criteria：\n\n1. Any other malignancy within 2 years prior to the first dose of the study treatment except for localized cancers that are considered to have been cured and in the opinion of the Investigator present a low risk for recurrence (e.g., basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix or breast)\n2. Participants with symptomatic central nervous system (CNS) metastases, or CNS metastases requiring CNS-directed local therapy (such as radiotherapy or surgery), or CNS metastases requiring corticosteroids therapy within 2 weeks of first dose of study treatment.\n3. History of bowel obstruction within 3 months prior to the first dose of study treatment.\n4. Known psychiatric disorder or drug abuse that would interfere the study requirements\n5. Uncontrollable pleural effusion, pericardial effusion, or ascites requiring drainage or medical intervention within 4 weeks before the first dose of study treatment\n6. Any active infection requires systemic treatment via intravenous infusion within 2 weeks prior to the first dose of study treatment\n7. Has not recovered (i.e., to Grade 1 or to baseline) from previous anticancer therapy-induced AEs.\n8. Participant is currently participating or has participated in a study of an investigational agent or using an investigational device within 4 weeks of first dose of SIM0613.\n9. Major surgery within 2 weeks of receiving the first dose of study treatment (minor procedures such as mediastinoscopy, insertion of a central venous access device, insertion of a feeding tube, needle biopsy and percutaneous nephrostomy are not considered major surgery)\n10. Prior exposure to topoisomerase I (TOP-I) inhibitor inhibitor-based antibody-drug conjugate (ADC) therapies or LRRC15-targeted therapies.\n11. Use of any live vaccine therapy within 4 weeks prior to the first dose of study treatment\n12. Known human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS)\n13. Active hepatitis B (HBsAg or HBcAb positive）\n14. History of allogeneic organ transplantation or graft-versus-host disease\n15. Known hypersensitivity to study drug or any of the excipients\n16. Participant is pregnant or breastfeeding\n17. Other conditions that researchers consider inappropriate for inclusion.",{"count":49,"type":20},294,[23],"This is a multicenter, open-label, first-in-human (FIH) study to evaluate the safety, tolerability, efficacy and pharmacokinetic\u002Fpharmacodynamic characteristics of SIM0613 in participants with locally advanced\u002F metastatic solid tumors. The study starts with a dose escalation part (Part 1) followed by a dose expansion part (Part 2).",[53],"Advanced Solid Cancer","RECRUITING","2026-05-26",{"date":57,"type":31},"2026-06-01",{"date":59,"type":31},"2026-05-15",{"date":61,"type":20},"2028-12",{"name":37,"class":38},1,{"id":65,"slug":66,"hasResults":11,"nctId":67,"briefTitle":68,"officialTitle":68,"acronym":4,"eligibilityCriteria":69,"healthyVolunteers":70,"sex":16,"minAge":17,"maxAge":71,"enrollmentInfo":72,"targetDuration":4,"studyType":21,"phases":74,"briefSummary":75,"conditions":76,"keywords":4,"overallStatus":54,"whyStopped":4,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":63},"100619495","phase-1-a-phase-i-randomized-double-blind-placebo-controlled-study-to-evaluate-the-safety-tolerability-and-pharmacokinetics-of-single-ascending-doses-of-sim0811-injection-in-healthy-chinese-adult-participants-100619495","NCT07345364","A Phase I, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Ascending Doses of SIM0811 Injection in Healthy Chinese Adult Participants","Inclusion Criteria:\n\n1. Healthy Chinese male or female adults aged 18 to 45 years (inclusive), not pregnant and not breastfeeding.\n2. Male participants weight ≥50 kg, female participants weight ≥45 kg, all ≤90 kg. Body Mass Index (BMI) between 19 and 26 kg\u002Fm² (inclusive). BMI = weight (kg) \u002F height² (m²).\n3. Female participants must avoid the menstrual period during the trial. participants of childbearing potential must commit to no plan for pregnancy, sperm\u002Fegg donation within 2 weeks before screening and for 6 months after the last dose, and voluntarily adopt highly effective contraception (including partner).\n4. Able to complete the study according to protocol requirements and commit to abstaining from smoking and alcohol during the trial.\n5. Prior to the trial, have fully understood the nature, significance, potential benefits, possible inconveniences, and potential risks of the trial, voluntarily participate, can communicate well with the investigator, comply with all study requirements, and voluntarily sign the Ethics Committee-approved Informed Consent Form.\n\nExclusion Criteria:\n\nParticipants meeting any of the following criteria will be excluded:\n\n1. History of drug allergy, or specific allergies (asthma, urticaria, eczema, etc.), or allergic constitution (e.g., allergy to two or more drugs, foods, pollen), or known allergy or significant intolerance to the investigational product or any of its components.\n2. Presence of clinically significant history of cardiovascular, respiratory, endocrine, urinary, digestive, hematological, neurological, skin, malignant tumor, infectious diseases, psychiatric disorders (e.g., seizures), metabolic abnormalities\u002Fdysfunction, etc.\n3. Screening physical examination, vital signs, laboratory tests, or other examination results judged by the clinician as abnormal with clinical significance (confirmed upon repeat assessment); OR presence of the following abnormal laboratory indicators: Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), total bilirubin, direct bilirubin, creatinine above the upper limit of normal (ULN); platelet count below the lower limit of normal (LLN); hyperkalemia, hypokalemia, hypercalcemia, or hypocalcemia judged by the investigator as abnormal and clinically significant; PT prolongation \\> ULN + 3s, TT prolongation \\> ULN + 3s, APTT prolongation \\> ULN + 10s, INR \\> 1.2, FIB \\\u003C 1.5 g\u002FL or \\> 4.0 g\u002FL, D-Dimer above ULN.\n4. Screening ECG findings judged as abnormal with clinical significance. Resting heart rate not within the range of 50 to 100 beats per minute (exclusive of boundaries). QTcF interval \\> 470 ms (QTcF = QT\u002F(RR)\\^0.33) or PR interval outside the range of 120 to 220 ms.\n5. Risk factors for Torsades de Pointes, or family history (first-degree relatives - biological parents, siblings, or children) of short QT syndrome, long QT syndrome, unexplained sudden death at a young age (≤40 years), drowning, or sudden infant death syndrome.\n6. Positive screening results for Hepatitis B surface antigen (HBsAg), Hepatitis C virus (HCV) antibody, Treponema pallidum specific antibody, or Human Immunodeficiency Virus (HIV) antibody.\n7. Average daily alcohol consumption exceeding 2 units in the 2 years prior to screening, or weekly alcohol consumption \\>14 units (1 unit alcohol ≈ 360 ml beer or 45 ml 40% spirits or 150 ml wine); consumption of any alcohol-containing product within 24 hours prior to investigational product administration; or inability to stop alcohol consumption during the trial; or positive alcohol breath test.\n8. Average daily cigarette consumption \\>5 in the 2 years prior to screening, or inability to stop using any tobacco products during the trial.\n9. Positive screening result for drug abuse, or history of drug abuse or use of narcotics within the past five years.\n10. Use of any prescription drugs, over-the-counter (OTC) drugs, Chinese herbal medicines, or health products within 2 weeks prior to screening and during screening, or within 5 half-lives of such drugs.\n11. Any surgery or trauma within 1 year prior to investigational product administration that may affect trial safety or drug disposition, and judged by the investigator to be of current clinical significance; OR planned surgery during the trial or within 7 days after trial completion.\n12. Difficulty with venous blood sampling, history of hematophobia or trypanophobia, or intolerance to indwelling venous catheter for blood sampling; OR history of phlebitis.\n13. Blood donation or blood loss \\>200 ml within 3 months prior to screening, or receipt of blood transfusion or blood products within 4 weeks; OR plan to donate blood during the trial or within 3 months after trial completion.\n14. History of blood abnormalities or related diseases, bleeding tendency, bleeding disorders (hemophilia, intracranial hemorrhage, gastrointestinal bleeding, urinary tract bleeding, hemoptysis, vitreous hemorrhage, etc.); OR arterial puncture at a site difficult to compress for hemostasis within 1 week prior; history of aneurysm.\n15. Pregnancy, lactation, positive pregnancy test, sexual intercourse without protocol-required contraception within 2 weeks prior to screening, or planned pregnancy.\n16. Vaccination within 1 month prior to screening, or planned vaccination during the trial \u002F within 2 weeks after the last investigational product dose.\n17. Participation in another drug or medical device clinical trial within 3 months prior to screening, or planned participation in another clinical trial during this study.\n18. Special dietary requirements and unable to accept unified diet and schedule arrangements.\n19. Other conditions judged by the clinical research physician as unsuitable for participation, or other reasons the participant may be unable to complete the study.",true,"45 Years",{"count":73,"type":20},72,[23],"This study plans to set up 5 dose groups across 7 cohorts, including intravenous bolus plus infusion administration as well as intravenous bolus alone. The study plans to enroll 8 participants per cohort (investigational drug: placebo = 6:2), including both males and females, totaling 56 healthy participants. The study begins with dose-escalation enrollment starting from Cohort 1. Each cohort receives a single dose, sequentially completing Cohorts 2, 3, 4, 5, 6, and 7. After each cohort's dosing is completed, a 7-day observation period is conducted for safety evaluation. If the termination criteria are not met, the study may proceed to the next dose level following assessment by the Safety Review Committee. By collecting adverse events, as well as abnormal indicators from vital signs, electrocardiograms, and laboratory tests, and collecting blood samples at planned time points to measure SIM0811 plasma concentration and thrombotic molecular markers, the study aims to evaluate the tolerability and safety of SIM0811 injection in Chinese healthy adult participants, characterize its pharmacokinetic profile after single-dose administration, and explore the change curves of thrombotic molecular markers (plasmin-α2 antiplasmin complex PIC, fibrin degradation products FDP)",[77],"Health, Subjective","2026-05-18",{"date":80,"type":31},"2026-05-20",{"date":82,"type":31},"2026-01-12",{"date":84,"type":20},"2026-08-31",{"name":37,"class":38},{"id":87,"slug":88,"hasResults":11,"nctId":89,"briefTitle":90,"officialTitle":91,"acronym":4,"eligibilityCriteria":92,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":93,"targetDuration":4,"studyType":21,"phases":95,"briefSummary":96,"conditions":97,"keywords":4,"overallStatus":54,"whyStopped":4,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":107},"100544911","phase-1-study-of-sim0500-alone-in-participants-with-relapsed-or-refractory-multiple-myeloma-100544911","NCT06375044","Study of SIM0500 Alone in Participants With Relapsed or Refractory Multiple Myeloma","A Phase I First-in-human, Open-label Trial to Investigate the Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of SIM0500, A Humanized GPRC5D-BCMA-CD3 Tri-specific Antibody, in Participants With Relapsed or Refractory Multiple Myeloma","Inclusion Criteria:\n\n1. Voluntary participation and signature of informed consent form.\n2. ≥18 years of age.\n3. Have documented diagnosis of relapsed or refractory multiple myeloma according to Criteria for Response to Multiple Myeloma Treatment(IMWG)diagnostic criteria who have failed all established standard of care.\n4. Life expectancy ≥12 weeks.\n5. Eastern Cooperative Oncology Group (ECOG) score of 0 or 1.\n6. Adequate hematologic, hepatic, and renal function.\n\nExclusion Criteria:\n\n1. Toxicities from previous anticancer therapies should have resolved to baseline levels or to Grade 1 or less except for alopecia or peripheral neuropathy.\n2. Active hepatitis B (HBsAg positive and HBV DNA ≥ 1×104 copies\u002FmL or ≥ 2,000 international unit \\[IU\\]\u002FmL) or hepatitis C (HCV antibody positive and HCV RNA ≥ ULN) infection; participant with HBsAg positive or detective HBV-DNA at screening should receive antiviral treatment as per local practice during the trial.\n3. Known human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS).\n4. Participant is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial.\n5. Active known or suspected autoimmune disease. Participants with vitiligo, residual hypothyroidism only requiring hormone replacement, psoriasis not requiring systemic treatment or conditions not expected to recur in the absence of an external trigger, type 1 diabetes mellitus (blood glucose can be controlled by insulin therapy) can be included.\n6. Current or previous other malignancy within 3 years of study entry, except basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix or breast.\n7. Known active central nervous system (CNS) involvement or exhibits clinical signs of meningeal involvement of multiple myeloma.\n8. Participants with known active infection within 14 days prior to the first SIM0500.",{"count":94,"type":20},130,[23],"This is an open-label, multicenter phase 1 clinical trial to evaluate the safety and tolerability, efficacy, and pharmacokinetics of SIM0500 in adult participants with Relapsed or Refractory Multiple Myeloma(RRMM). The trial is consisted of two parts, Part 1 (dose escalation) and Part 2 (dose optimization). In both parts, SIM0500 will be administered until disease progression, intolerable toxicity, withdraw of consent or end of trial.",[98],"Relapsed or Refractory Multiple Myeloma","2026-03-04",{"date":101,"type":31},"2026-03-06",{"date":103,"type":31},"2024-05-24",{"date":105,"type":20},"2028-12-30",{"name":37,"class":38},11,{"id":109,"slug":110,"hasResults":11,"nctId":111,"briefTitle":112,"officialTitle":113,"acronym":114,"eligibilityCriteria":115,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":116,"targetDuration":4,"studyType":21,"phases":118,"briefSummary":119,"conditions":120,"keywords":126,"overallStatus":54,"whyStopped":4,"lastUpdateSubmitDate":128,"lastUpdatePostDateStruct":129,"startDateStruct":131,"completionDateStruct":133,"leadSponsor":135,"locationsCount":136},"100619714","phase-1-first-in-human-study-of-sim0610-in-solid-tumors-100619714","NCT07348211","First in Human Study of SIM0610 in Solid Tumors","An Open-Label, Multicenter, First-in-Human Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of SIM0610 in Adult Subjects With Locally Advanced\u002FMetastatic Solid Tumors","SIM0610-101","Inclusion Criteria:\n\n* Voluntarily participate and sign the informed consent form\n* At least 18 years old, male or female\n* Subjects with locally advanced\u002Fmetastatic solid tumors confirmed by histology and\u002For cytology;\n* Subjects in Part 1 should have at least one tumor lesion evaluable by RECIST v1.1 criteria, and subjects in Part 2 should have at least one measurable tumor lesion by RECIST v1.1 (lesions that have received radiotherapy or other local treatments cannot be used as target lesions unless there is clear progression of the lesion)\n* Subjects with locally advanced\u002Fmetastatic solid tumors who have failed standard treatment: Part 1: Subjects with solid tumors who have experienced disease progression during\u002Fafter at least one previous standard systemic anti-tumor regimen and are not suitable for standard treatment. Part 2: Non-small cell lung cancer, liver cancer, head and neck squamous cell carcinoma, colorectal cancer that have experienced disease progression during\u002Fafter at least one previous standard systemic anti-tumor regimen and are not suitable for standard treatment\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n* Expected survival period ≥ 12 weeks\n* Adequate organ and bone marrow function\n* Archived formalin-fixed, paraffin-embedded (FFPE) tumor tissue or fresh biopsy tissue within 5 years must be provided before the first administration\n\nExclusion Criteria:\n\n* A history of active second primary malignancy within the past 2 years, except for localized tumors that are considered cured and have a low risk of recurrence as assessed by the investigator.\n* Symptomatic central nervous system (CNS) metastases occurring within 2 weeks prior to the first dose of study treatment; or requirement for local therapy (e.g., radiotherapy or surgery) for CNS metastases; or requirement for corticosteroid therapy for CNS metastases.\n* A history of non-infectious interstitial lung disease (ILD)\u002Fpulmonary inflammation requiring corticosteroid treatment; current ILD\u002Fpulmonary inflammation; or suspected ILD\u002Fpulmonary inflammation that cannot be ruled out by screening imaging.\n* Uncontrolled pleural effusion, pericardial effusion, or ascites, or occurrence of such effusions requiring drainage or medical intervention within 4 weeks prior to the first dose of study treatment.\n* Failure to recover from adverse events (AEs) induced by prior anti-tumor therapy (i.e., recovery to Grade 1 or baseline level).\n* Current participation in a study involving investigational drugs or medical devices, or participation in such a study within 4 weeks prior to the first dose of study treatment.\n* Receipt of the following therapies prior to the first dose of study treatment:\n\n  1. Cytotoxic therapy within 3 weeks; or anti-tumor targeted small-molecule drugs (e.g., tyrosine kinase inhibitors) within 2 weeks.\n  2. Anti-tumor antibody-based immune checkpoint inhibitors, antibody-drug conjugates (ADCs), or other anti-tumor biologics within the shorter of 5 half-lives or 4 weeks.\n  3. Traditional Chinese medicines (TCMs)\u002Fherbal preparations with anti-tumor indications within 2 weeks.\n  4. Radiotherapy within 4 weeks.\n* Received antibody-drug conjugate (ADC) with topoisomerase I inhibitor (TOP1i) or other ADC targeting EGFR\u002FcMET.\n* Received any live vaccine within 4 weeks prior to the first dose of study treatment.\n* Received the following medications ≤ 14 days prior to the first dose of study treatment:\n\n  1. Strong or moderate CYP3A4 induction\u002Finhibitor;\n  2. Drugs known to be at risk for torsade de pointes (TdP);\n  3. Drugs associated with QTcF interval prolongation (TdP risk equivocal).\n* Known human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS).\n* A history of clinically significant cardiovascular diseases within 6 months prior to the first dose of study treatment, including but not limited to myocardial infarction, severe\u002Funstable angina pectoris, primary cardiomyopathy, cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction) or congestive heart failure (New York Heart Association \\[NYHA\\] Functional Classification \\> Class II); symptomatic coronary artery disease requiring pharmacotherapy.\n* A history of allogeneic organ transplantation or graft-versus-host disease (GVHD).\n* A history of hypersensitivity to the active ingredients, inactive excipients of SIM0610, or drugs with similar chemical structures or classifications to SIM0610.\n* Pregnant or lactating women. For women of childbearing potential (WOCBP), they are also excluded unless:\n\n  1. The result of serum pregnancy test within 72 hours prior to the first dose of study treatment is negative;\n  2. They use highly effective contraceptive methods from the time of signing the informed consent form (ICF) until 180 days after the last dose of study treatment.\n* Male subjects with female partners of childbearing potential are excluded unless they use highly effective contraceptive methods from the time of signing the ICF until 180 days after the last dose of study treatment.\n* Any other conditions that may increase subject-related risks or interfere with the interpretation of study results, and that, in the investigator's judgment, render the subject unsuitable for study enrollment.",{"count":117,"type":20},260,[23],"This is a multicenter, open-label, first-in-human (FIH) study to evaluate the safety, tolerability, pharmacokinetic\u002Fpharmacodynamic profile, and preliminary antitumor activity of SIM0610 in subjects with locally advanced\u002Fmetastatic solid tumors. Accelerated titration (ATD) and Bayesian optimal interval design (BOIN) will be used to guide dose escalation in part1, the preliminary anti-tumor effect of SIM0610 will to be further evaluated in part 2.",[121,122,123,124,125],"Advanced Solid Tumours","Non-Small Cell Lung Cancer","Colorectal Cancer","Head and Neck Squamous Cell Carcinoma","Hepatocellular Carcinoma",[127],"Locally Advanced\u002FMetastatic Solid Tumors","2026-01-21",{"date":130,"type":31},"2026-01-23",{"date":132,"type":31},"2026-01-19",{"date":134,"type":20},"2029-07",{"name":37,"class":38},7,{"id":138,"slug":139,"hasResults":11,"nctId":140,"briefTitle":141,"officialTitle":141,"acronym":142,"eligibilityCriteria":143,"healthyVolunteers":70,"sex":16,"minAge":17,"maxAge":144,"enrollmentInfo":145,"targetDuration":4,"studyType":21,"phases":147,"briefSummary":148,"conditions":149,"keywords":4,"overallStatus":54,"whyStopped":4,"lastUpdateSubmitDate":151,"lastUpdatePostDateStruct":152,"startDateStruct":154,"completionDateStruct":156,"leadSponsor":158,"locationsCount":63},"100620437","phase-1-an-open-label-drug-interaction-clinical-study-to-evaluate-itraconazole-rifampin-midazolam-and-sim0270-in-chinese-healthy-adult-participants-100620437","NCT07357610","An Open-Label Drug Interaction Clinical Study to Evaluate Itraconazole, Rifampin, Midazolam and SIM0270 in Chinese Healthy Adult Participants","SIM0270-104","Inclusion Criteria:\n\n* The participant fully understand the test content, process and possible adverse reactions, voluntarily sign informed consent, have good communication with the researchers, and can complete all the test procedures in accordance with the protocol.\n* Cohorts 1 and 2: healthy male and female participants aged ≥ 18 and ≤ 55 years; Cohort 3: healthy male participants aged ≥ 18 and ≤ 55 years.\n* Male participants weigh ≥ 50 kg; Female participants weigh ≥ 45 kg; Body mass index ≥ 19 kg\u002Fm2 and ≤ 26 kg\u002Fm2.\n* Cohorts 1 and 2: all female participants of childbearing potential and male participants with partners of women of childbearing potential agree to take recognized effective contraceptive measures during the study period and within 6 months after the last dose of the investigational product, starting from signing the informed consent; Cohort 3: male participants with partners of women of childbearing potential agree to take recognized effective contraceptive measures during the study period and within 6 months after the last dose of the investigational product, starting from signing the informed consent.\n\nExclusion Criteria:\n\nPast\u002FOngoing Medical History\n\n* Neurological\u002Fpsychiatric, respiratory, cardiovascular, gastrointestinal, urinary, hematological and lymphatic, endocrine, skeletal-muscular disorders, especially hepatic and renal insufficiency, or any other disease and condition that may affect the results of the study or the safety of the participants.\n* History of dysphagia or any gastrointestinal disorder affecting drug absorption.\n* Presence of risk factors for Torsade de Pointes (e.g., history of heart failure, hypokalemia, family history of QT prolongation syndrome), or other clinically significant abnormalities judged by the study doctor (including but not limited to: complete left bundle branch block; right bundle branch block; first-, second-, or third-degree heart block; sick sinus syndrome or previous history of myocardial infarction).\n* History of active or latent tuberculosis.\n* History of malignancy. Except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin cancer, or stage I uterine cancer (disease-free interval of at least 5 years).\n* Any acute or chronic condition that, in the opinion of the investigator, would limit the ability of participants to complete and\u002For participate in this clinical study.\n\nSurgical history • Those who have undergone major surgery within 6 months prior to screening or are scheduled to undergo surgery during the study and are judged by the investigator to be inappropriate for enrollment.\n\nHistory of allergy\n\n• Allergic to the study drug or any component of the study drug, with a history of specific allergies (asthma, urticaria, eczema, etc.) or allergic constitution (e.g., those allergic to two or more drugs, food such as milk and pollen).\n\nMedication history\n\n* Use of hormone replacement therapy or selective estrogen mediators within 1 year prior to screening.\n* Use or planned use of any drug\u002Fproduct within 4 weeks prior to screening that would alter the process of drug absorption, metabolism, or elimination.\n* Use of any prescription drugs\u002Fproducts within 2 weeks prior to screening or over-the-counter medications (including vitamins, minerals, phytotherapies, herbal and botanical preparations) within 1 week prior to screening.\n\nScreening or Baseline Examinations\n\n* Laboratory tests, physical examination, vital signs, 12-lead electrocardiogram, chest anterolateral film, abdominal B-ultrasound results were abnormal and clinically significant as judged by the investigator.\n* Screening (mean) or baseline ECG heart rate \\\u003C 60 beats\u002Fmin or \\> 100 beats\u002Fmin, QTcF interval \\> 450 ms.\n* Women of childbearing potential who have a positive pregnancy test or are pregnant or lactating (see Appendix 1 for definitions of women of non-childbearing potential).\n* Positive tests for hepatitis B surface antigen, hepatitis C antibody, human immunodeficiency virus (HIV) antibody, treponema pallidum antibody.\n* History of drug abuse or positive drug abuse screening.\n* Regular drinkers, i.e., on average, more than 2 units of alcohol per day (1 unit = 360 mL beer or 45 mL spirits with 40% alcohol or 150 mL wine) within 3 months prior to screening or during the screening period to the first dose; Or alcohol breath test positive.\n* Those who smoke more than 5 cigarettes per day within 3 months prior to screening or who cannot quit during the trial.\n* Participation in any drug clinical trial as a participant and taking study drug or medical device intervention within 3 months prior to screening.\n* Consumption of grapefruit or grapefruit-related citrus (e.g., grapefruit) fruit or juice within 1 week prior to screening, or use of alcoholic or caffeinated food or beverages within 72 h prior to screening.\n* Those who have special requirements for diet and cannot comply with the diet provided and corresponding regulations.\n* Those who have difficulty in venous blood collection, or have a history of fainting blood and needle sickness, or who cannot tolerate venous indwelling needle blood collection.\n* Those who have donated blood or lost more than 200 mL of blood within 3 months prior to screening, or have received blood transfusions or blood products within 2 months.\n* Participants have other conditions that are not suitable for participation in the study, or participants may not be able to complete the study for other reasons","55 Years",{"count":146,"type":20},60,[23],"This study is an open-label, fixed-sequence, two-period Phase 1 clinical trial in healthy adult Chinese participants with a total of 3 cohorts, 16-20 healthy adult Chinese participants are planned to be enrolled in each cohort.",[150],"Healthy Adult Participants","2026-01-20",{"date":153,"type":31},"2026-01-22",{"date":155,"type":20},"2026-01-05",{"date":157,"type":20},"2026-10-30",{"name":37,"class":38},{"id":160,"slug":161,"hasResults":11,"nctId":162,"briefTitle":163,"officialTitle":164,"acronym":4,"eligibilityCriteria":165,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":166,"targetDuration":4,"studyType":21,"phases":168,"briefSummary":170,"conditions":171,"keywords":173,"overallStatus":54,"whyStopped":4,"lastUpdateSubmitDate":177,"lastUpdatePostDateStruct":178,"startDateStruct":179,"completionDateStruct":181,"leadSponsor":183,"locationsCount":39},"100620698","phase-3-a-phase-ibiii-study-of-suvemcitug-plus-ftdtpi-in-participants-with-refractory-metastatic-colorectal-cancer-100620698","NCT07361003","A Phase Ib\u002FIII Study of Suvemcitug Plus FTD\u002FTPI in Participants With Refractory Metastatic Colorectal Cancer","A Phase Ib\u002FIII Study of Suvemcitug Plus Trifluridine\u002FTipiracil Tablets (FTD\u002FTPI) Versus Placebo Plus Trifluridine\u002FTipiracil Tablets in Participants With Refractory Metastatic Colorectal Cancer","Inclusion Criteria:\n\n* 1\\. Confirmed by histological and\u002For cytological examination as unresectable metastatic colon or rectal adenocarcinoma;\n* 2\\. At least one measurable tumor lesion (RECIST v1.1);\n* 3\\. Previously received fluorouracil, oxaliplatin, and irinotecan based chemotherapy; had previously undergone or was unsuitable for anti-VEGF therapy. (For participants with RAS wild-type, had previously undergone or was unsuitable for anti-EGFR therapy.);\n* 4\\. Refractory metastatic colorectal cancer having progressed on or are intolerant to the last systemic treatment;\n* 5\\. Good organ and bone marrow function (no administration of hematopoietic growth factors, blood transfusion, or platelets within 14 days before screening hematology test);\n* 6\\. RAS mutation status confirmed by testing tumor tissue and \u002For blood sample.\n\nExclusion Criteria:\n\n* 1\\. Having a second active primary malignancy within the past 5 years;\n* 2\\. Symptomatic central nervous system (CNS) metastases or CNS metastases requiring local CNS-directed therapy (e.g., radiotherapy or surgery) or corticosteroid treatment within 2 weeks prior to the first administration of the study treatment;\n* 3\\. Any active infection requiring systemic treatment within 2 weeks prior to the initiation of the study treatment;\n* 4\\. Pleural effusion, pericardial effusion, or ascites that is uncontrolled or has required drainage or medical intervention within 4 weeks prior to the first administration of the study treatment;\n* 5\\. Received systemic immuno suppressive therapy within 4 weeks prior to randomization (excluding prophylactic use or chronic low-dose steroids \\[≤20 mg\u002Fday prednisone equivalent dose\\]);\n* 6\\. Currently taking or has recently taken (within 10 days prior to the first dose) aspirin (\\>325 mg\u002Fday);\n* 7\\. Active or chronic hepatitis B (HBsAg or HBcAb positive and HBV DNA≥2000 IU\u002FmL or ≥10000 copies\u002FmL) or hepatitis C infection (HCV antibody positive and HCV RNA≥ULN);\n* 8\\. Clinically significant cardiovascular disease within 6 months prior to the first administration of the study treatment;symptomatic coronary artery disease requiring medication; arrhythmia requiring medication (excluding asymptomatic atrial fibrillation with controlled ventricular rate); QTcF interval \\>470 ms at rest state; or uncontrolled hypertension or pulmonary hypertension;\n* 9\\. Known hereditary or acquired bleeding and thrombotic tendencies (e.g., hemophilia, coagulation disorders, thrombocytopenia, hypersplenism, etc.); clinically significant bleeding events, arterial or deep venous thrombotic events, or superficial venous thrombosis and intermuscular venous thrombosis requiring intervention within 6 months prior to enrollment;\n* 10\\. Participants with proteinuria (urine protein \\>2+ found during screening examinations; or urine protein 2+ with 24-hour urine protein quantification ≥1g\u002F24h);\n* 11\\. Participants with a history of intestinal obstruction (including incomplete intestinal obstruction) within 1 month prior to enrollment; participants with a history of abdominal fistula, gastrointestinal perforation, or abdominal abscess.",{"count":167,"type":20},464,[169],"PHASE3","The primary goal of Phase Ib Study is to evaluate the safety of Suvemcitug in combination with trifluridine\u002Ftipiracil tablets in colorectal cancer participants.\n\nThe primary goal of Phase III Study is to evaluate the efficacy of Suvemcitug in combination with trifluridine\u002Ftipiracil tablets in colorectal cancer participants. Researchers will compare Suvemcitug + trifluridine\u002Ftipiracil tablets with placebo (a look-alike substance that contains no drug)+ trifluridine\u002Ftipiracil tablets to see if Suvemcitug + trifluridine\u002Ftipiracil tablets works better in treating refractory metastatic colorectal cancer.",[172],"Refractory Metastatic Colorectal Cancer",[174,175,176],"refractory metastatic colorectal cancer","Suvemcitug","trifluridine\u002Ftipiracil","2026-01-14",{"date":153,"type":31},{"date":180,"type":31},"2025-11-12",{"date":182,"type":20},"2028-07",{"name":37,"class":38},{"id":185,"slug":186,"hasResults":11,"nctId":187,"briefTitle":188,"officialTitle":189,"acronym":190,"eligibilityCriteria":191,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":192,"targetDuration":4,"studyType":21,"phases":194,"briefSummary":195,"conditions":196,"keywords":4,"overallStatus":54,"whyStopped":4,"lastUpdateSubmitDate":197,"lastUpdatePostDateStruct":198,"startDateStruct":200,"completionDateStruct":202,"leadSponsor":203,"locationsCount":39},"100613387","phase-1-a-phase-i-study-of-sim0609-in-adult-participants-with-locally-advancedmetastatic-solid-tumors-100613387","NCT07265921","A Phase I Study of SIM0609 in Adult Participants With Locally Advanced\u002FMetastatic Solid Tumors","A Phase I First-in-Human, Multicenter Study to Investigate the Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of SIM0609 in Adult Participants With Locally Advanced\u002FMetastatic Solid Tumors","Solid Tumors","Inclusion Criteria:\n\n1. Voluntary participation and signature of informed consent form;\n2. At least 18 years old, male or female;\n3. Participants with histologically and\u002For cytologically confirmed locally advanced\u002Fmetastatic solid tumors;\n4. Participants should have at least one evaluable or measurable tumor lesion;\n5. Participants have failed the standard of therapy in the locally advanced\u002Fmetastatic setting;\n6. Eastern Cooperative Oncology Group (ECOG) performance score of 0 or 1;\n7. Expected survival ≥12 weeks;\n8. Adequate organ and bone marrow function;\n9. Availability of archival formalin-fixed, paraffin-embedded (FFPE) tumor tissue, or fresh biopsies within 28 days before first administration, is mandatory\n\nExclusion Criteria:\n\n1. Active second primary malignancies within the previous 2 years except for localized cancers that are considered to have been cured and in the opinion of the Investigator present a low risk for recurrence;\n2. Symptomatic central nervous system (CNS) metastases or CNS metastases requiring CNS-directed local therapy or corticosteroid treatment that occurred within 2 weeks prior to the first administration of the investigational treatment;\n3. Has a history of (non-infectious) interstitial lung disease (ILD)\u002Fpneumonitis that required steroids, current ILD\u002Fpneumonitis, or where suspected ILD\u002Fpneumonitis cannot be ruled out by imaging screening;\n4. Presence of any serious or unstable concomitant systemic disorder incompatible with the clinical study ;\n5. Any active infections requiring systemic therapy within 2 weeks prior to the initiation of the study treatment;\n6. Uncontrollable pleural effusion, pericardial effusion, or ascites requiring drainage or medical intervention within 4 weeks before the first dose of study treatment;\n7. Not recovered from previous anticancer therapy-induced AEs(Adverse Events);\n8. Currently participating or has participated in a study of an investigational agent or using an investigational device within 4 weeks of first dose of study treatment;\n9. Received prior therapies within the following time frames prior to the first dose of study treatment:\n\n   1. Previous cytotoxic therapy, anticancer targeted small molecules within 2 weeks.\n   2. Anti-cancer antibody, immune checkpoint inhibitor or ADC within 5 half-lives or 4 weeks (whichever is shorter).\n   3. Chinese medicines\u002Fherbal preparations with anticancer indication taken within 2 weeks.\n   4. Radiation therapy within 4 weeks.\n10. Prior exposure to topoisomerase I inhibitor (TOP1i)-based antibody drug conjugate (ADC) therapies or CDH17-targeted ADC therapies.\n11. Use of any live vaccine therapy within 4 weeks prior to the first dose of study treatment.\n12. Administration of below medications ≤14 days prior to the first dose of study treatment.\n\n    1. Strong or moderate CYP3A4 inducers\u002Finhibitors;\n    2. Drugs with known risk of Torsades de Pointes(TdP);\n    3. Drugs that may prolong the QT interval;\n13. Major surgery within 2 weeks of receiving the first dose of study treatment;\n14. Known human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome ;\n15. Active or chronic hepatitis B or hepatitis C infection;\n16. Participants with clinically significant cardiovascular diseases;\n17. History of allogeneic organ transplantation or graft-versus-host disease;\n18. History of hypersensitivity to active or inactive excipients of SIM0609 or drugs with a similar chemical structure or class to SIM0609;\n19. Pregnant or nursing (lactating) women;\n20. Male participants with female partners of reproductive potential, unless they are using highly effective contraceptive methods from signing of informed consent to 180 days after the last dose of study treatment;\n21. Presence of any other condition that may increase the risk associate with study participant or may interfere with the interpretation of study results, and, in the opinion of the Investigator, would make the participant inappropriate for entry into the study.",{"count":193,"type":20},232,[23],"This is an open-label,multicenter phase I study to evaluate the safety,Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of SIM0609 in Adult Participants with Locally Advanced\u002FMetastatic Solid Tumors",[53],"2025-12-04",{"date":199,"type":31},"2025-12-05",{"date":201,"type":31},"2025-11-07",{"date":35,"type":20},{"name":37,"class":38},{"id":205,"slug":206,"hasResults":11,"nctId":207,"briefTitle":208,"officialTitle":209,"acronym":4,"eligibilityCriteria":210,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":211,"enrollmentInfo":212,"targetDuration":4,"studyType":21,"phases":214,"briefSummary":216,"conditions":217,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":219,"lastUpdatePostDateStruct":220,"startDateStruct":222,"completionDateStruct":224,"leadSponsor":226,"locationsCount":227},"100606413","phase-2-a-phase-2-study-to-evaluate-the-efficacy-safety-of-sim0278-in-subjects-with-moderate-to-severe-atopic-dermatitis-100606413","NCT07175233","A Phase 2 Study to Evaluate the Efficacy, Safety of SIM0278 in Subjects With Moderate to Severe Atopic Dermatitis","A Randomized, Double-blind, Placebo-Controlled Phase 2 Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of SIM0278 in Subjects With Moderate to Severe Atopic Dermatitis","Inclusion Criteria:\n\n1. Atopic dermatitis was diagnosed at screening (according to the American Academy of Dermatology consensus criteria for atopic dermatitis, 2014);\n2. Use of a stable dose of emollients at least twice daily at sites of AD involvement starting at least 7 days prior to baseline;Alternatively, if the subject is using a prescribed emollients or moisturizers containing ceramide, urea, filaggrin degradation products, or hyaluronic acid prior to the Screening Visit, they may continue in the study but require a stable dose at least twice daily at the AD affected site starting at least 7 days prior to baseline;\n3. Female and male subjects are willing to use protocol-required contraception from the Screening Visit until at least 90 days after the last dose and do not plan to become pregnant or donate sperm\u002Feggs during this period.\n\nExclusion Criteria:\n\n1. The subject was in an acute exacerbation of AD at baseline (e.g., the subject had a tendency to rapidly develop erythroderma or erythroderma in a short period of time, whichever was judged by the investigator);\n2. Previous drug therapy with IL-2 or IL-2 analogues (including clinical studies);\n3. Use of other immunomodulatory biologics within 3 months prior to baseline or within 5 drug half-lives, whichever is longer, including, but not limited to, anti-IL-23 (e.g., guselkumab), anti-IL-12\u002F23 (e.g., ustekinumab), anti-IL-17 (e.g., secukinumab), or anti-IgE (e.g., omalizumab);\n4. Use of cell depleting agents (e.g. rituximab) within 6 months prior to baseline;\n5. Use of topical drugs for the treatment of AD or that may affect the assessment of the condition of AD within 2 weeks prior to baseline, including but not limited to TCS, TCI, phosphodiesterase-4 (PDE-4) inhibitors, Janus kinase (JAK) inhibitors, aromatic hydrocarbon receptor agonists, or Chinese herbal or herbal treatments, etc.;\n6. ≥ 2 bleaching baths per week within 2 weeks prior to baseline;\n7. Systemic treatment (except glucocorticoid inhalers and nasal sprays) with glucocorticoids or other immunosuppressive\u002Fimmunomodulatory drugs (e.g., cyclosporine, mycophenolate mofetil, azathioprine, methotrexate, or oral JAK inhibitors) within 8 weeks prior to baseline;\n8. Use of systemic Chinese herbal medicine within 4 weeks prior to baseline ;\n9. Phototherapy (narrow-band ultraviolet B (NBUVB), ultraviolet B (UVB), ultraviolet A (UVA), psoralen + ultraviolet A (PUVA)) tanning beds or any other phototherapy within 4 weeks prior to baseline;\n10. Use of any investigational drug\u002Ftherapy within 3 months or 5 drug half-lives (whichever is longer) prior to baseline;","75 Years",{"count":213,"type":20},184,[215],"PHASE2","This is a randomized, double-blind, placebo-controlled multicenter clinical study to evaluate the efficacy, safety, and pharmacokinetics of SIM0278 in adult patients (18-75 years) with moderate to severe AD suitable for systemic therapy.\n\nApproximately 184 subjects with moderate to severe AD are planned to be randomized in a 1: 1: 1: 1 ratio to SIM0278 low dose, SIM0278 medium dose, SIM0278 high dose, or placebo. Subjects were stratified at randomization by baseline disease severity (moderate \\[IGA = 3\\] VS severe \\[IGA = 4\\]).\n\nThe study consisted of 4 phases: screening, double-blind induction, open-label maintenance, and safety follow-up.",[218],"Atopic Dermatitis (AD)","2025-09-18",{"date":221,"type":31},"2025-09-23",{"date":223,"type":20},"2025-10-27",{"date":225,"type":20},"2027-08-20",{"name":37,"class":38},2,{"id":229,"slug":230,"hasResults":11,"nctId":231,"briefTitle":232,"officialTitle":233,"acronym":4,"eligibilityCriteria":234,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":235,"targetDuration":4,"studyType":21,"phases":237,"briefSummary":238,"conditions":239,"keywords":4,"overallStatus":54,"whyStopped":4,"lastUpdateSubmitDate":219,"lastUpdatePostDateStruct":241,"startDateStruct":243,"completionDateStruct":245,"leadSponsor":247,"locationsCount":146},"100568415","phase-3-a-study-of-sim0270-combined-with-everolimus-vs-treatment-of-physicians-choice-in-patients-with-erher2--advanced-breast-cancer-simrise-100568415","NCT06680921","A Study of SIM0270 Combined With Everolimus vs. Treatment of Physician's Choice in Patients With ER+\u002FHER2- Advanced Breast Cancer (SIMRISE)","A Randomized, Open-label, Phase III Study of SIM0270 Combined With Everolimus Versus Treatment of Physician's Choice in Patients With CDK4\u002F6 Inhibitors Previously Treated , ER+\u002FHER2- Locally Advanced or Metastatic Breast Cancer","Inclusion criteria:\n\n1. Subjects with histologically or cytologically confirmed ER+\u002FHER2- locally advanced or metastatic breast cancer\n2. Subjects must have at least one RECIST 1.1 measurable disease and \u002For at least 1 lytic or mixed (lytic + sclerotic) bone lesion\n3. For women who are post menopausal must meet criteria as defined in the protocol.For women who are premenopausal or perimenopausal and for men: treatment with approved LHRH agonist therapy for screening period and the duration of study treatment\n4. Have disease that has demonstrated progression on or after prior treatment:\n\n   1. subjects had received 1 to 2 endocrine therapies in the locally advanced or metastatic setting with disease recurrence\u002Fdisease progression while being treated with adjuvant endocrine therapy for ≥ 24 months and\u002For endocrine therapy in the locally advanced or metastatic setting, and derived a clinical benefit from therapy\n   2. subjects had received ≤ 1 chemotherapy in the locally advanced or metastatic setting.\n5. Eastern Cooperative Oncology Group Performance Status 0-1\n6. Adequate organ function\n\nexclusion criteria:\n\n1. Prior treatment with a oral selective estrogen receptor degrader (SERD) or other investigational-ER-directed therapy, or any PI3K-AKI-mTOR inhibitors\n2. Treatment with any investigational therapy within 28 days prior to study treatment.Treatment with moderate\u002Fstrong CYP3A inhibitors or P-gP inhibitor within 14 days prior to first dose or moderate\u002Fstrong CYP3A inducer within 28 days prior to first dose\n3. Advanced, symptomatic, visceral spread that is at risk of life-threatening complications in the short term\n4. Active or symptomatic CNS metastases, carcinomatous meningitis, or leptomeningeal disease\n5. Active cardiac disease or history of cardiac dysfunction, as defined in the protocol\n6. Pregnant or breastfeeding",{"count":236,"type":20},460,[169],"This Phase III, randomized, open label, multicenter study will evaluate the efficacy and safety of SIM0270 combined with everolimus compared to physician's choice of treatment in subjects with ER+\u002FHER2- locally advanced or metastatic breast cancer who have had previous treatment with CDK4\u002F6 inhibitor.",[240],"Locally Advanced or Metastatic Breast Cancer",{"date":242,"type":31},"2025-09-22",{"date":244,"type":31},"2024-11-14",{"date":246,"type":20},"2028-08-31",{"name":37,"class":38},{"id":249,"slug":250,"hasResults":11,"nctId":251,"briefTitle":252,"officialTitle":253,"acronym":4,"eligibilityCriteria":254,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":255,"targetDuration":4,"studyType":21,"phases":257,"briefSummary":258,"conditions":259,"keywords":4,"overallStatus":54,"whyStopped":4,"lastUpdateSubmitDate":261,"lastUpdatePostDateStruct":262,"startDateStruct":264,"completionDateStruct":266,"leadSponsor":267,"locationsCount":268},"100596821","phase-1-a-phase-i-study-of-sim0686-in-participants-with-locally-advancedmetastatic-solid-tumors-100596821","NCT07050459","A Phase I Study of SIM0686 in Participants With Locally Advanced\u002FMetastatic Solid Tumors","A Phase I First-in-Human, Open-label, Multicenter Study to Investigate the Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of SIM0686 in Adult Participants With Locally Advanced\u002FMetastatic Solid Tumors","Inclusion Criteria:\n\n* Voluntary participation and signature of informed consent form;\n* At least 18 years old, male, or female;\n* Participants with histologically and\u002For cytologically confirmed locally advanced\u002Fmetastatic solid tumors;\n* Participants should have at least one evaluable or measurable tumor lesion (RECIST v1.1);\n* Participants have failed the standard of therapy in the locally advanced\u002Fmetastatic setting\n* Eastern Cooperative Oncology Group (ECOG) performance score of 0 or 1;\n* Expected survival ≥12 weeks;\n* Adequate organ and bone marrow function;\n* Availability of archival formalin-fixed, paraffin-embedded (FFPE) tumor tissue, or fresh biopsies within 6 months before first administration for evaluation of FGFR2b expression levels\n\nExclusion Criteria:\n\n* Active second primary malignancies within the previous 2 years except for localized cancers that are considered to have been cured and in the opinion of the Investigator present a low risk for recurrence.\n* Participant has symptomatic central nervous system (CNS) metastases, or CNS metastases requiring CNS-directed local therapy (such as radiotherapy or surgery) or corticosteroids therapy within 2 weeks of first dose of study treatment.\n* Active or chronic corneal disorder, history of corneal transplantation, keratitis, keratoconjunctivitis, keratopathy, keratoconus, corneal abrasion, inflammation or ulceration, other active ocular conditions and any clinically significant corneal disease that prevents adequate monitoring of drug-induced keratopathy.\n* Has a history of (non-infectious) interstitial lung disease (ILD)\u002Fpneumonitis that required steroids, current ILD\u002Fpneumonitis, or where suspected ILD\u002Fpneumonitis cannot be ruled out by imaging screening.\n* Participant has not recovered (i.e., to Grade 1 or to baseline) from previous anticancer therapy-induced AEs.\n* Has received prior therapies within the following time frames prior to the first dose of study treatment:\n\n  1. Previous cytotoxic therapy, anticancer targeted small molecules (e.g., tyrosine kinase inhibitors) within 2 weeks.\n  2. Anti-cancer antibody, immune checkpoint inhibitor or ADC within 5 half-lives or 4 weeks (whichever is shorter).\n  3. Chinese medicines\u002Fherbal preparations with anticancer indication taken within 2 weeks.\n  4. Radiation therapy within 4 weeks.\n* Prior exposure to topoisomerase I inhibitor (TOP1i)-based antibody-drug conjugate (ADC) therapies or FGFR2b-targeted ADC therapies.\n* Known human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS).\n* Active or chronic hepatitis B or hepatitis C infection;",{"count":256,"type":20},220,[23],"This is an open-label, multicenter phase 1 study to evaluate the safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of SIM0686 in Adult Participants with Locally Advanced\u002FMetastatic Solid Tumors",[260],"Locally Advanced Solid Tumors","2025-07-02",{"date":263,"type":31},"2025-07-03",{"date":265,"type":31},"2025-05-20",{"date":61,"type":20},{"name":37,"class":38},10,{"id":270,"slug":271,"hasResults":11,"nctId":272,"briefTitle":273,"officialTitle":274,"acronym":275,"eligibilityCriteria":276,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":277,"targetDuration":4,"studyType":21,"phases":279,"briefSummary":280,"conditions":281,"keywords":283,"overallStatus":54,"whyStopped":4,"lastUpdateSubmitDate":285,"lastUpdatePostDateStruct":286,"startDateStruct":288,"completionDateStruct":290,"leadSponsor":292,"locationsCount":63},"100593557","phase-1-a-phase-i-study-of-sim0388-in-participants-with-malignant-ascites-100593557","NCT07007988","A Phase I Study of SIM0388 in Participants With Malignant Ascites.","An Open-Label, Multicenter Phase I Study to Evaluate the Safety, Efficacy, and Pharmacokinetic Characteristics of Intraperitoneal Perfusion With Docetaxel Polymeric Micelles for Injection in Patients With Malignant Ascites","SIM0388-101","Inclusion Criteria:\n\n* Voluntary participation and signature of informed consent form;.\n* ≥ 18 years of age, male or female.\n* Participants with histologically and\u002For cytologically confirmed advanced\u002Fmetastatic solid tumors;.\n* Failure of at least one line of standard systemic anti-tumor therapy, unsuitability for standard systemic therapy, or absence of standard systemic therapy options.\n* Moderate or greater ascites confirmed by ultrasonography\n* ECOG performance status of 0, 1or 2.\n* Life expectancy ≥ 3 months.\n* Adequate hematologic and organ function.\n* Women of childbearing potential (WOCBP) must have a negative serum pregnancy test. WOCBP and male subjects agree to use adequate contraception.\n\nExclusion Criteria:\n\n* Participant is currently participating or has participated in a study of an investigational agent or using an investigational device within 4 weeks of first dose of study treatment\n* Prior history of intraperitoneal paclitaxel-based therapy.\n* Use of strong CYP3A4 inhibitors or inducers within 7 days before the first dose or anticipated use during the study.\n* Failure to recover from adverse events caused by prior interventions to ≤Grade 1\n* Complete intestinal obstruction within 30 days prior to the first dose.\n* Myocardial infarction within 6 months, current unstable angina, primary cardiomyopathy, cerebrovascular events, congestive heart failure, symptomatic coronary artery disease requiring medication, arrhythmia requiring medication, QTcF interval \\>470 ms, or uncontrolled hypertension.\n* Uncontrolled primary brain tumors or CNS metastases.\n* Active infection.\n* Known history of HIV infection.\n* Active hepatitis B or hepatitis C infection.\n* Hypersensitivity to any active or inactive ingredient of SIM0388.\n* Pregnant or lactating women.\n* Any condition (medical history, disease, treatment, or lab abnormality) that may interfere with study results, impede full participation, or deemed by the investigator to contradict the subject's best interests.",{"count":278,"type":20},50,[23],"Malignant Ascites is a common complication of malignant tumor. The objective of this study is to evaluate the safety, efficacy, and pharmacokinetic characteristics of intraperitoneal perfusion with Docetaxel Polymeric Micelles (SIM0388) for injection in patients with malignant ascites",[282],"Malignant Ascites",[282,284],"Solid tumor","2025-06-03",{"date":287,"type":31},"2025-06-06",{"date":289,"type":31},"2025-04-24",{"date":291,"type":20},"2027-12",{"name":37,"class":38},{"id":294,"slug":295,"hasResults":11,"nctId":296,"briefTitle":297,"officialTitle":298,"acronym":4,"eligibilityCriteria":299,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":300,"targetDuration":4,"studyType":21,"phases":302,"briefSummary":303,"conditions":304,"keywords":306,"overallStatus":54,"whyStopped":4,"lastUpdateSubmitDate":308,"lastUpdatePostDateStruct":309,"startDateStruct":311,"completionDateStruct":313,"leadSponsor":315,"locationsCount":316},"100530410","phase-1-a-study-to-investigate-the-safety-tolerability-pharmacokinetics-and-preliminary-efficacy-of-sim0237-alone-or-in-combination-with-bcg-in-nmibc-100530410","NCT06186414","A Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of SIM0237 Alone or in Combination with BCG in NMIBC","An Open-Label, Multicenter Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of SIM0237 Alone or in Combination with BCG in Non-Muscle-Invasive Bladder Cancer","Inclusion Criteria:\n\n* Written informed consent.\n* ≥ 18 years of age, male or female.\n* • Histologically confirmed presence of BCG-unresponsive CIS (with or without Ta or T1 disease) or histologically confirmed presence of BCG-unresponsive high-grade Ta or T1 disease. Histologic confirmation of urothelial carcinoma (mixed histology tumors allowed if urothelial histology is predominant histology).\n* Dose escalation phase: BCG-unresponsive high-risk NMIBC.\n* Dose expansion phase: a) Cohorts 1 and 3: BCG-unresponsive CIS (with or without Ta or T1 disease); b) Cohort 2 and 4: BCG-unresponsive high-risk Ta or T1 disease.\n* Absence of resectable disease after transurethral resection (TURBT) procedures \\[residual carcinoma in situ (CIS) acceptable\\]. patients with T1 tumors must undergo repeat resection and pathological test if initial pathological test sample did not include muscularis propria, to ensure the inclusive of muscularis propria and the absence of invasive tumor.\n* Not suitable for or unwilling to undergo radical cystectomy.\n* ECOG performance status of 0, 1or 2.\n* Life expectancy ≥ 2 years.\n* Adequate hematologic and organ function.\n* Women of childbearing potential (WOCBP) must have a negative serum pregnancy test. WOCBP and male subjects agree to use adequate contraception.\n* Tumor tissue (archival or fresh) for biomarker analysis.\n\nExclusion Criteria:\n\n* • Subjects received TURBT or other surgical treatment for bladder lesions or pelvic radiotherapy or interventional therapy within 2 weeks prior to the first dose.\n* Previous treatment with: a) IL-15 or IL-2; b) immune checkpoint inhibitors (such as anti-PD-1 or PD-L1 antibodies), ADCs, chemotherapies, oncolytic viruses, BCG or other anti-tumor treatments, unless there is clear evidence of disease persistence\u002Frecurrence\u002Fprogression after the above treatments and beyond 4 weeks prior to the first dose; c) Chinese herbal medicine treatment beyond 2 weeks prior to the first dose is allowed; d) A single immediate instillation of chemotherapy within 4 weeks prior to the first dose is allowed; e) intravesical instillation of mucosal protective agents (e.g., sodium hyaluronate) are allowed.\n* Subject is participating in an investigational drug or investigational device study.\n* Subjects have not recovered from AEs caused by previous anti-tumor treatment.\n* History\u002Fevidence of prior muscle-invasive, locally advanced, metastatic bladder cancer or upper urinary tract (kidney, renal pelvis, ureter) and prostatic urethral tumors; or evidence of Ta\u002FT1\u002FCIS urothelial transitional cell carcinoma outside the bladder (urethra, ureter, renal pelvis) during the screening period.\n* Patients with other malignancies within 5 years before the first dose.\n* Any active infection or urinary tract infection requiring systemic treatment by intravenous infusion within 2 weeks before the first dose.\n* Subjects with clinically significant cardiovascular disease within 6 months before the first dose of study treatment.\n* Known human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS).\n* Active or chronic hepatitis B or hepatitis C infection.\n* Known or suspected active autoimmune diseases.\n* Concurrent use of any other anticancer therapy or chronic use of systemic corticosteroids at immunosuppressive doses (more than 10 mg\u002Fday prednisone or equivalent).\n* History of pneumonitis or interstitial lung disease or severe obstructive pulmonary disease that requires oral or intravenous steroids to help recover.\n* Known to be allergic or intolerant to study drugs, monoclonal antibodies, excipients; or allergic or intolerant to BCG (only for subjects receiving combined BCG therapy)\n* Subjects discontinued prior BCG treatment due to AEs such as toxemia, systemic infection, or urinary incontinence (only for subjects receiving combined BCG therapy).\n* History of allogeneic organ transplantation or graft-versus-host disease.\n* Any live vaccines within 4 weeks before the first dose.\n* Known mental illness or substance abuse that would interfere with trial complies.\n* Subject is pregnant or lactating, or is expected to become pregnant or parent a child during the planned study period.\n* Other conditions that investigators consider inappropriate for inclusion.",{"count":301,"type":20},152,[23],"This is an open-label, multicenter phase 1 study to evaluate the safety, efficacy, and pharmacokinetics (PK) characteristics of SIM0237 alone or in combination with bacillus Calmette-Guerin (BCG) in participants with Non-Muscle-Invasive Bladder Cancer (NMIBC)",[305],"Non-Muscle-Invasive Bladder Cancer (NMIBC)",[307],"NMIBC","2025-01-13",{"date":310,"type":31},"2025-01-15",{"date":312,"type":31},"2024-01-23",{"date":314,"type":20},"2030-12",{"name":37,"class":38},14,{"id":318,"slug":319,"hasResults":11,"nctId":320,"briefTitle":321,"officialTitle":322,"acronym":4,"eligibilityCriteria":323,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":324,"targetDuration":4,"studyType":21,"phases":325,"briefSummary":326,"conditions":327,"keywords":4,"overallStatus":54,"whyStopped":4,"lastUpdateSubmitDate":329,"lastUpdatePostDateStruct":330,"startDateStruct":332,"completionDateStruct":334,"leadSponsor":335,"locationsCount":227},"100568862","phase-1-study-of-sim0508-alone-and-in-combination-in-patients-with-advanced-solid-tumors-100568862","NCT06686745","Study of SIM0508 Alone and in Combination in Patients With Advanced Solid Tumors","A Phase I, First-in-Human, Multicenter Study to Investigate the Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of SIM0508 Monotherapy and Combination Therapy in Adult Participants With Locally Advanced\u002FMetastatic Solid Tumors","Inclusion Criteria:\n\n1. Voluntary participation and signature of informed consent form.\n2. Participants with histologically confirmed ovarian cancer, prostate cancer,breast cancer , or pancreatic cancer.\n3. ECOG score of 0 or 1.\n4. Expected survival ≥ 12 weeks.\n\nExclusion Criteria:\n\n1. Active hepatitis B (HBsAg or HBcAb positive and HBV DNA≥1×104 copies\u002FmL or≥2000 international unit \\[IU\\]\u002FmL) or hepatitis C (HCV antibody positive and HCV RNA≥ULN) infection; participant with HBsAg positive or detective HBV-DNA at screening should receive antiviral treatment as per local practice during the study.\n2. Known human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS).\n3. Participants unable to swallow study drug and participants with gastrointestinal disorders likely to interfere with absorption of the study drug.\n4. Toxicities from previous anticancer therapies have not resolved (e.g to ≤ Grade 1).\n5. Pregnant or nursing (lactating) women; other women of childbearing potential, unless the blood pregnancy test within 7 days of first dose of study drug is negative, and participants agree to use highly effective contraceptive methods from signing of informed consent to 180 days after the last dose of SIM0508 or olaparib, whichever comes later.\n6. Male partinipants with female partners of reproductive potential, unless they agree to use highly effective contraceptive methods from signing of informed consent to 180 days after the last dose of SIM0508 and 90 days after the last dose of olaparib, whichever comes later.",{"count":94,"type":20},[23],"This is a multicenter, open-label, first-in-human study to evaluate the safety,efficacy, and PK\u002FPD characteristics of SIM0508 as a single agent and in combination with olaparib in participants with locally advanced\u002Fmetastatic solid tumors.",[328],"Advanced Solid Tumors","2025-01-06",{"date":331,"type":31},"2025-01-07",{"date":333,"type":31},"2024-12-06",{"date":105,"type":20},{"name":37,"class":38},{"id":337,"slug":338,"hasResults":11,"nctId":339,"briefTitle":340,"officialTitle":341,"acronym":4,"eligibilityCriteria":342,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":211,"enrollmentInfo":343,"targetDuration":4,"studyType":21,"phases":345,"briefSummary":346,"conditions":347,"keywords":4,"overallStatus":54,"whyStopped":4,"lastUpdateSubmitDate":350,"lastUpdatePostDateStruct":351,"startDateStruct":353,"completionDateStruct":355,"leadSponsor":357,"locationsCount":63},"100479828","phase-1-a-study-to-investigate-the-safety-and-tolerability-of-scr-6920-capsule-in-patients-with-advanced-malignant-tumors-100479828","NCT05528055","A Study to Investigate the Safety and Tolerability of SCR-6920 Capsule in Patients With Advanced Malignant Tumors","A Phase I Study to Investigate the Safety, Tolerability, Preliminary Efficacy and Pharmacokinetics(PK) of SCR-6920 Capsule in Patients With Advanced Malignant Tumors","Inclusion Criteria:\n\n* Histologically or cytologically confirmed locally advanced or metastatic solid tumors or histopathologically confirmed NHL\n* Relapsed\u002Frefractory solid tumor or relapsed\u002Frefractory NHL who have progressed during or after standard therapy or for which treatment is not tolerated, not suitable, not available.\n* At least one evaluable or measurable lesion (as defined in the protocol).\n* ECOG Performance Status 0 or 1.\n* Life expectancy ≥12 weeks.\n* Adequate organ function (as defined in the protocol).\n* Reproductive criteria (as defined in the protocol).\n\nExclusion Criteria:\n\n* Any clinically significant gastrointestinal (GI) abnormalities that may alter absorption.\n* Major surgery, systemic anti-cancer therapy or investigational drug(s) within 4 weeks prior to study entry. Radiation therapy within 2 weeks prior to study entry.\n* Adverse reactions from previous anti-tumor therapy have not yet recovered to ≤ grade 1(excluding hair loss, peripheral neurotoxicity caused by chemotherapy have recovered to ≤ grade 2 ).\n* Autologous hematopoietic stem cell transplantation was performed within 9 months prior to the first dose.\n* History of a second malignancy within 2 years (as defined in the protocol).\n* Active uncontrolled or symptomatic lung disease (as defined in the protocol).\n* Intracranial hypertension or active uncontrolled or symptomatic CNS metastases.\n* Known or suspected hypersensitivity to study medications.\n* Known active uncontrolled or symptomatic CNS metastases.\n* The investigator determined that the patient should not participate in the study.\n* Known mental illness or substance abuse that may disrupt therapy.\n* Clinically significant cardiac abnormalities (as defined in the protocol).\n* Gestating or Lactating women.\n* Pleural effusion, pericardial effusion or ascites that need diuretics or draining within 2 weeks prior to first dose.\n* The patient is currently using a drug known to be a strong inhibitor or inducer of CYP3A4.",{"count":344,"type":20},122,[23],"A Phase 1, open label, multi center, dose escalation and expansion study will assess the safety, tolerability, PK, and preliminary efficacy of SCR-6920 capsule in participants with advanced malignant tumors. The purpose of the study is to identify the maximum tolerated dose (MTD) and\u002For the recommended Phase 2 dose (RP2D), and to confirm the tolerability and preliminary efficacy of SCR-6920 in participants with advanced solid tumors and relapsed\u002Frefractory non-Hodgkin lymphoma(NHL).",[348,349],"Solid Tumor","Non Hodgkin Lymphoma","2022-09-02",{"date":352,"type":31},"2022-09-06",{"date":354,"type":31},"2022-05-18",{"date":356,"type":20},"2027-10",{"name":37,"class":38},""]