[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Wuhan Humanwell Innovative Drug Research and Development Center Limited Company\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":84},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,40,64],{"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},"100624722","phase-1-hws116-monotherapy-in-patients-with-advanced-solid-tumors-100624722",false,"NCT07413328","HWS116 Monotherapy in Patients With Advanced Solid Tumors","A Phase I, Single-Arm, Open-Label, Dose-Escalation and Expansion Study of HWS116 Injection in Advanced Solid Tumors","Inclusion Criteria:\n\n* Aged ≥18 years at the time of signing the Informed Consent Form (ICF);\n* Patients with recurrent or metastatic solid tumors confirmed by histology or cytology, who have progressed or developed intolerance after System Organ Class (SOC), or have no SOC available, or are not suitable for SOC, including but not limited to colorectal cancer, gastric cancer, esophageal cancer, pancreatic cancer, and cholangiocarcinoma;\n* According to the Response Evaluation Criteria In Solid Tumors (RECIST) 1.1, there is at least one evaluable lesion or one measurable target lesion；\n* Life expectancy ≥ 12 weeks;\n* Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score is 0 or 1；\n* Participant must have adequate main organ function.\n* Participants who are capable of having children must agree to use two medically approved effective contraceptive methods during the study and for 6 months after the last dose. Women of childbearing age must have a negative serum pregnancy test within 7 days before dosing；\n* Have a full understanding of this study, voluntarily sign the informed consent form, and be able to follow the study's operating procedures and requirements for follow - up examinations.\n\nExclusion Criteria:\n\n* Known allergy to the investigational product, drugs of the same class, or any excipients;\n* Have previously received any Fibroblast Growth Factor- Fibroblast Growth Factor Receptor (FGF-FGFR) pathway inhibitor;\n* For previous anti-tumor therapies (including investigational products\u002Ftreatments): those who have received chemotherapy, small molecule targeted therapy, endocrine therapy, herbal medicine therapy\u002Fphysiotherapy within 14 days prior to the first dose or within at least 5 half-lives of the corresponding drug, whichever is longer; or those who have undergone surgery (excluding diagnostic procedures such as needle biopsy), radiotherapy (palliative radiation for non-target lesions is within 14 days prior to the first dose), biotherapy, immunotherapy, or other anti-tumor therapies within 28 days prior to the first dose or within at least 5 half-lives of the corresponding drug, whichever is longer;\n* Have undergone major surgery within 28 days prior to the first dose;\n* Have Grade ≥ 2 toxicity caused by previous anti-tumor treatment prior to the first dose, except for those deemed by investigators to pose no safety risk, such as alopecia, pigmentation, or specific laboratory abnormalities;\n* Have corneal defects, or other known corneal abnormalities that may increase the risk of corneal ulcer . undergone corneal surgery within 6 months prior to the first dose;\n* Have severe cardiovascular or cerebrovascular diseases；\n* Have a history of clinically significant corrected QT Interval (QTc) prolongation, or QTc interval \\> 480 msec at screening;\n* Metastases to central nervous system with clinical symptoms or active progression;\n* Have tested positive for hepatitis B surface antigen (HBsAg) (except for patients with hepatocellular carcinoma) with hepatitis B virus deoxyribonucleic acid (HBV DNA) \\> 1000 IU\u002FmL, or positive for hepatitis C virus (HCV) antibody with HCV ribonucleic acid (RNA) positive, or positive for human immunodeficiency virus (HIV) antibody, or have active syphilis;\n* Have autoimmune diseases, immunodeficiencies, a history of organ transplantation, or are planning to undergo organ transplantation;\n* Presence of any severe, uncontrolled clinical issues (e.g., uncontrolled malignant pleural effusion, ascites, pericardial effusion, or unstable psychiatric conditions) deemed unsuitable for study participation by the investigator；\n* Have acute inflammation or clinically significant active infections;\n* Have a history of alcohol abuse or drug abuse;\n* Pregnant or lactating women or women who are preparing for pregnancy or lactation during the study period;\n* Any other condition that, at the discretion of investigators, renders the participant unsuitable for enrollment.","ALL","18 Years",{"count":19,"type":20},56,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","This is a Phase I open-label study that will evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of HWS116 monotherapy in patients with advanced solid tumors.",[26],"Advanced Solid Tumors","RECRUITING","2026-04-22",{"date":30,"type":31},"2026-04-28","ACTUAL",{"date":33,"type":31},"2026-04-07",{"date":35,"type":20},"2028-02-28",{"name":37,"class":38},"Wuhan Humanwell Innovative Drug Research and Development Center Limited Company","INDUSTRY",1,{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":47,"sex":16,"minAge":17,"maxAge":48,"enrollmentInfo":49,"targetDuration":4,"studyType":21,"phases":51,"briefSummary":52,"conditions":53,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":39},"100621656","phase-1-a-phase-i-study-of-hw201877-in-healthy-subjects-100621656","NCT07373457","A Phase I Study of HW201877 in Healthy Subjects","A Single-Center, Randomized, Double-blind, Placebo-controlled, Single and Multiple Dosing, Dose-escalation, Phase 1 Clinical Trial to Evaluate the Safety, Tolerability, PK\u002FPD, Food Effect of HW201877 in Healthy Volunteers.","Key Inclusion Criteria:\n\n* Before enrollment in the study, each subject shall sign the informed consent form and be fully apprised of the study content, implementation procedures and potential adverse reactions.\n* Subjects are willing to voluntarily use effectivecontraceptives from screening to at least 6 months after the last dose administration.\n* 18 years to 55 years (inclusive), male and female.\n* Male subjects weight ≥50 kg and female subjects weight ≥45 kg. Bodymass index (BMI) : 18-28 kg\u002Fm2 (inclusive) .\n\nKey Exclusion Criteria:\n\n* Smoking more than 5 cigarettes per day within 3 months prior to screening.\n* Allergic diathesis (with a history of allergies to multiple drugs and foods).\n* A history of drug abuse and\u002For alcoholism (consuming 14 units of alcohol per week; 1 unit = 285 mL of beer, 25 mL of distilled spirits, or 100 mL of wine).\n* Have taken any medications that alter hepatic enzyme activity within 28 days prior to screening.\n* Have consumed special diets (including pitaya, mango, lime, grapefruit, carambola, orange, grapefruit or grapefruit-containing products, etc.) or engaged in strenuous exercise within 2 weeks prior to screening, or having other factors that may affect the absorption, distribution, metabolism and excretion of the study drug.\n* Have taken any investigational drugs or participated in any other clinical drug trials within 3 months prior to the first administration of the study drug.\n* Clinically significant abnormalities in clinical laboratory tests, or a history of clinically significant findings of the following diseases within 12 months prior to screening (including but not limited to gastrointestinal, renal, hepatic, neurological, hematological, endocrine, oncological, pulmonary, immunological, psychiatric, or cardio-cerebrovascular diseases).\n* Unable to tolerate venipuncture, or with a history of needle phobia or hematophobia.\n* Not suitable for this study as judged by the investigator.",true,"55 Years",{"count":50,"type":20},104,[23],"This is a Phase I, randomized, double-blind, placebo-controlled study to assess the safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD), and food effect (FE) of HW201877 in healthy subjects following (1) a single ascending dose (Part 1), which includes a single-dose, two-period crossover FE cohort; (2) a multiple ascending dose (Part 2).",[54,55],"Healthy Participants","IBD (Inflammatory Bowel Disease)","2026-01-19",{"date":58,"type":31},"2026-01-28",{"date":60,"type":31},"2025-06-26",{"date":62,"type":20},"2026-03",{"name":37,"class":38},{"id":65,"slug":66,"hasResults":11,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":4,"eligibilityCriteria":70,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":71,"targetDuration":4,"studyType":21,"phases":73,"briefSummary":74,"conditions":75,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":39},"100583884","phase-1-hw071021-monotherapy-in-patients-with-advanced-solid-tumors-100583884","NCT06882135","HW071021 Monotherapy in Patients With Advanced Solid Tumors","A Phase I Open-Label, Dose-Escalation and Dose-Expansion Trial Evaluating Safety, Pharmacokinetics, and Efficacy of HW071021 in Patients With Advanced Solid Tumors","Inclusion Criteria:\n\n1. Age of 18 years or older, applicable to both males and females.\n2. Patients with histologically and\u002For cytologically confirmed recurrent and\u002For metastatic advanced solid tumors, mainly covering non - small cell lung cancer, colorectal cancer, pancreatic cancer, cholangiocarcinoma, and other cancer types that investigators believe may bring benefits. The selection of cancer types in the dose - expansion phase will be decided based on the data from the dose - escalation phase.\n3. No standard treatment is accessible, standard treatment has failed, or the patient is not suitable for standard treatment.\n4. The expected survival time is ≥ 12 weeks.\n5. Participant must have adequate main organ function.\n6. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score is 0 or 1.\n7. According to the Response Evaluation Criteria In Solid Tumors (RECIST) 1.1, there is at least one measurable target lesion.\n8. Participants who are capable of having children must agree to use two medically approved effective contraceptive methods during the study and for 6 months after the last dose. Women of childbearing age must have a negative serum pregnancy test within 7 days before dosing.\n9. Have a full understanding of this study, voluntarily sign the informed consent form, and be able to follow the study's operating procedures and requirements for follow - up examinations.\n\nExclusion Criteria:\n\n1. Known allergy to the investigational drug, drugs with the same mechanism of action or excipients.\n2. Prior treatment with drugs targeting the same molecular target.\n3. Use of other investigational drugs within 28 days before the first dose or at least 5 half - lives of the respective drug (whichever is shorter).\n4. Receipt of surgery, chemotherapy, radiotherapy, targeted therapy, endocrine therapy, biological therapy, immunotherapy, anti - tumor herbal medicine, or other anti - cancer treatments within 28 days before the first dose or at least 5 half - lives of the respective drug (whichever is shorter).\n5. Use of any drugs likely to interfere with trial safety within 2 weeks before dosing or at least 5 half - lives of the respective drug (whichever is shorter), and planned use during the study, including strong inhibitors\u002Finducers of hepatic metabolic enzymes and P - gp, or substrates of hepatic metabolic enzymes with narrow therapeutic indices.\n6. Undergoing major surgery within 28 days before the first dose.\n7. Presence of ≥ Grade 2 toxicity from prior anti - cancer treatment (per Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0), except for toxicities deemed non - safety - critical by the investigator (e.g., alopecia, pigmentation, specific laboratory abnormalities).\n8. Severe cardiovascular or cerebrovascular diseases.\n9. History of clinically significant QTc interval prolongation, or QTc interval \\> 470 ms in females and \\> 450 ms in males at screening.\n10. Uncontrolled\u002Fclinically symptomatic central nervous system metastases.\n11. Positive for hepatitis B surface antigen (HBsAg) (except for hepatocellular carcinoma patients) with HBV DNA \\> 1000 IU\u002FmL; positive for hepatitis C virus (HCV) antibody with HCV RNA positive; positive for human immunodeficiency virus (HIV) antibody; or active syphilis (positive for both TPPA and RPR).\n12. Diagnosis of autoimmune disease, immunodeficiency disorder, history of organ transplantation, or planned organ transplantation.\n13. Inability to swallow oral formulations and\u002For gastrointestinal disorders that may interfere with drug absorption.\n14. Presence of any severe, uncontrolled clinical issues (e.g., uncontrolled malignant pleural effusion, ascites, pericardial effusion, or unstable psychiatric conditions) deemed unsuitable for study participation by the investigator.\n15. Any significant clinical or laboratory abnormalities affecting safety assessment, as determined by the investigator.\n16. Severe pulmonary diseases at screening, including pulmonary embolism, interstitial lung disease, active pulmonary infection, or other active infections deemed unsuitable for study entry by the investigator.\n17. History of alcohol abuse or substance dependence.\n18. Pregnant or lactating females, or females planning to become pregnant or breastfeed during the study.\n19. Other conditions deemed unsuitable for enrollment by the investigator.",{"count":72,"type":20},76,[23],"This is a Phase I open-label study that will evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of HW071021 monotherapy in patients with advanced solid tumors.",[26],"2025-12-19",{"date":78,"type":31},"2025-12-29",{"date":80,"type":31},"2025-05-28",{"date":82,"type":20},"2027-02-28",{"name":37,"class":38},""]