[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"HC Biopharma Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":195},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,8,0,[8,40,60,82,103,124,151,171],{"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":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":34,"leadSponsor":36,"locationsCount":39},"100629674","phase-1-a-phase-ib-clinical-study-on-the-safety-and-efficacy-of-hc010-combinations-in-advanced-solid-tumors-100629674",false,"NCT07477743","A Phase Ib Clinical Study on the Safety and Efficacy of HC010 Combinations in Advanced Solid Tumors","Phase Ib Study to Evaluate the Tolerability, Safety, Pharmacokinetics and Preliminary Efficacy of HC010 Combinations in Patients With Advanced Solid Tumors and Determine the Recommended Dose for Subsequent Studies.","Inclusion Criteria:\n\n* 1\\. Fully understand this trial and voluntarily sign the informed consent form. 2. For locally recurrent or metastatic unresectable advanced solid tumors that are diagnosed by histological or cytopathological pathology and cannot be radically treated with radiotherapy, the range-finding stage does not limit specific tumor types and previous treatment conditions.\n\n  3\\. At least one measurable lesion according to RECIST v1.1 (patients with only brain lesion as target lesion are not accepted).\n\n  4\\. Eastern Cancer Assistance Group (ECOG) in the United States had a performance score of 0 or 1 and did not worsen within 2 weeks prior to the first dose.\n\n  5\\. The expected survival time is more than 3 months. 6. Have adequate organ and bone marrow functions. 7.For subjects with reproductive capacity, take effective medical contraceptive measures during the study treatment and within 6 months after the last administration.\n\nExclusion Criteria:\n\n* 1.Imaging shows that the tumor invades great vessels or is not clearly demarcated from blood vessels.\n\n  2\\. Combination of brain metastasis, meningeal metastasis and spinal cord compression.\n\n  3\\. Prior concurrent anti-programmed death receptor 1 (PD-1)\u002Fprogrammed death ligand (PD-L1), anti-cytotoxic T lymphocyte antigen 4 (CTLA-4), and anti-vascular endothelial growth factor (VEGF) target drugs.\n\n  4\\. Anti-tumor therapy such as radiotherapy, biological therapy, endocrine therapy, targeted therapy and immunotherapy within 4 weeks prior to the first dose of study drug.\n\n  5\\. Concomitant diseases or conditions that may significantly affect the autoimmune status, such as known or suspected active autoimmune system disease, congenital or acquired immunodeficiency, hematopoietic stem cell transplantation or organ transplantation (except keratoplasty), use of live vaccine or attenuated live vaccine within 4 weeks, and use of systemic corticosteroids and immunomodulatory drugs within 2 weeks.\n\n  6\\. Concurrent with severe, uncontrolled and unrecovered acute and chronic diseases, such as acute coronary syndrome, uncontrolled hypertension, serious or poorly controlled diabetes, interstitial pneumonia requiring hormone therapy, severe bleeding tendency or coagulation disorders within the first 6 months.\n\n  7\\. Subjects with other malignant tumors within 5 years before the first dose of study drug.\n\n  8\\. Subjects who have undergone major organ surgery (excluding aspiration biopsy) within 4 weeks prior to the first dose of study drug, or have experienced significant trauma, or require elective surgery during the trial.\n\n  9\\. Adverse reactions from previous anti-tumor treatment have not recovered to NCI-CTCAE Grade 5.0 or below.\n\n  10\\. Subjects with known hypersensitivity to other monoclonal antibodies and allergies to any preparation component of the investigational drug to be used.\n\n  11\\. Subjects with known or suspected immune-related toxicity requiring permanent discontinuation after receiving any previous immunocheckpoint inhibitor therapy.\n\n  12\\. Patients who have received prior anti-angiogenic therapy and experienced Grade ≥3 toxicity associated with anti-angiogenic therapy.\n\n  13\\. The investigator believes that the subject is not suitable to participate in this clinical study for other reasons.","ALL","18 Years","75 Years",{"count":20,"type":21},331,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","Phase Ib study to evaluate the tolerability, safety, pharmacokinetics and preliminary efficacy of HC010 in combination with chemotherapy regimens in patients with advanced gastrointestinal cancer and determine the recommended dose for subsequent studies.",[27],"Advanced Solid Tumor Cancer","RECRUITING","2026-03-12",{"date":31,"type":32},"2026-03-17","ACTUAL",{"date":31,"type":21},{"date":35,"type":21},"2028-03-31",{"name":37,"class":38},"HC Biopharma Inc.","INDUSTRY",1,{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":47,"targetDuration":4,"studyType":22,"phases":49,"briefSummary":50,"conditions":51,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":52,"lastUpdatePostDateStruct":53,"startDateStruct":55,"completionDateStruct":57,"leadSponsor":59,"locationsCount":39},"100622300","phase-1-a-phase-ib-clinical-study-on-the-safety-and-efficacy-of-hc010-combined-with-chemotherapy-in-lung-cancer-100622300","NCT07381829","A Phase Ib Clinical Study on the Safety and Efficacy of HC010 Combined With Chemotherapy in Lung Cancer","Safety, Tolerability, Pharmacokinetics, Immunogenicity and Preliminary Efficacy Study of the Combination Therapy With HC010 for Injection in Patients With Advanced Solid Tumors:A Multicenter, Open-Label, Dose Range-Finding and Multiple Cohort Dose Expansion Phase Ib Clinical Trial-Lung Cancer Population","Inclusion Criteria:\n\n* 1\\. Fully understand this trial and voluntarily sign the informed consent form.\n* 2\\. For locally recurrent or metastatic non-resectable advanced solid tumors that are diagnosed by histological or cytopathological pathology and cannot be radically treated with radiotherapy, the range-finding stage does not limit specific tumor types and previous treatment conditions, while the dose-expansion stage is limited to NSCLC without standard of care, NSCLC with EGFR-sensitive mutations and progressing after adequate EGFR-TKI therapy. First-line population with driver gene negative non-small cell lung cancer and first-line population with extensive small cell lung cancer.\n* 3\\. At least one measurable lesion according to RECIST v1.1 (patients with only brain lesion as target lesion are not accepted).\n* 4\\. Eastern Cancer Assistance Group (ECOG) in the United States had a performance score of 0 or 1 and did not worsen within 2 weeks prior to the first dose.\n* 5\\. The expected survival time is more than 3 months.\n* 6\\. Adequate organ and bone marrow function.\n* 7\\. Females of childbearing potential must have a negative blood pregnancy test within 7 days prior to the first dose of the investigational drug and be non-lactating; Eligible patients of childbearing potential (male and female) must agree to use a reliable method of contraception (hormonal or barrier method or abstinence) with their partner for at least 6 months from signing informed consent until after the last dose of study drug. Women of non-childbearing potential may not undergo pregnancy test and contraception (postmenopausal for at least 1 year or surgically sterilized).\n\nExclusion Criteria:\n\n* 1\\. Imaging shows that the tumor invades great vessels or is not clearly demarcated from blood vessels.\n* 2\\. Combination of brain metastasis, meningeal metastasis and spinal cord compression.\n* 3\\. Prior concurrent anti-programmed death receptor 1 (PD-1)\u002Fprogrammed death ligand (PD-L1), anti-cytotoxic T lymphocyte antigen 4 (CTLA-4), and anti-vascular endothelial growth factor (VEGF) target drugs.\n* 4\\. Anti-tumor therapy such as radiotherapy, biological therapy, endocrine therapy, targeted therapy and immunotherapy within 4 weeks prior to the first dose of study drug.\n* 5\\. Concomitant diseases or conditions that may significantly affect the autoimmune status, such as known or suspected active autoimmune system disease, congenital or acquired immunodeficiency, hematopoietic stem cell transplantation or organ transplantation (except keratoplasty), use of live vaccine or attenuated live vaccine within 4 weeks, and use of systemic corticosteroids and immunomodulatory drugs within 2 weeks.\n* 6\\. Concurrent with severe, uncontrolled and unrecovered acute and chronic diseases, such as acute coronary syndrome, uncontrolled hypertension, serious or poorly controlled diabetes, interstitial pneumonia requiring hormone therapy, severe bleeding tendency or coagulation disorders within the first 6 months.\n* 7\\. Subjects with other malignant tumors within 5 years before the first dose of study drug.\n* 8\\. Subjects who have undergone major organ surgery (excluding aspiration biopsy) within 4 weeks prior to the first dose of study drug, or have experienced significant trauma, or require elective surgery during the trial.\n* 9\\. Adverse reactions from previous anti-tumor treatment have not recovered to NCI-CTCAE Grade 5.0 or below.\n* 10\\. Subjects with known hypersensitivity to other monoclonal antibodies and allergies to any preparation component of the investigational drug to be used.\n* 11\\. Subjects with known or suspected immune-related toxicity requiring permanent discontinuation after receiving any previous immunocheckpoint inhibitor therapy.\n* 12\\. Patients who have received prior anti-angiogenic therapy and experienced Grade ≥3 toxicity associated with anti-angiogenic therapy.\n* 13\\. The investigator believes that the subject is not suitable to participate in this clinical study for other reasons.",{"count":48,"type":21},328,[24],"Phase Ib study to evaluate the tolerability, safety, pharmacokinetics and preliminary efficacy of HC010 in combination with chemotherapy regimens in patients with advanced lung cancer and determine the recommended dose for subsequent studies.",[27],"2026-01-26",{"date":54,"type":32},"2026-02-02",{"date":56,"type":32},"2025-10-27",{"date":58,"type":21},"2026-12-30",{"name":37,"class":38},{"id":61,"slug":62,"hasResults":11,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":4,"eligibilityCriteria":66,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":67,"targetDuration":4,"studyType":22,"phases":69,"briefSummary":70,"conditions":71,"keywords":4,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":52,"lastUpdatePostDateStruct":75,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":39},"100616513","phase-1-the-safety-tolerability-pharmacokinetics-immunogenicity-and-preliminary-efficacy-of-hc022-injection-in-subjects-with-slecle-100616513","NCT07306585","The Safety, Tolerability, Pharmacokinetics, Immunogenicity and Preliminary Efficacy of HC022 Injection in Subjects With SLE\u002FCLE","A Multicenter, Randomized, Double-blind, Placebo-controlled Phase Ib Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity Characteristics and Preliminary Efficacy of Multiple Ascending Doses of HC022 Injection in Subjects With Systemic Lupus Erythematosus and\u002For Cutaneous Lupus Erythematosus","Inclusion Criteria:\n\n* 1\\. Subjects who voluntarily participate in the study, are able to sign the informed consent form and comply with the requirements on the informed consent form;\n* 2\\. Age ≥ 18 years, regardless of gender;\n* 3\\. Subjects and their partners have no birth plan during the study treatment period and within 6 months after the last dose, and voluntarily use effective and reliable contraception (Attachment 1). Female subjects must have a negative serum pregnancy test and be non-lactating;\n* 4\\. Patients diagnosed with SLE or CLE by the investigator\n\nExclusion Criteria:\n\n* 1\\. active severe lupus nephritis\n* 2\\. active neuropsychiatric SLE\n* 3 .History or current diagnosis of any other systemic autoimmune disease other than secondary Sjogren's syndrome, including but not limited to rheumatoid arthritis, psoriatic arthritis, dermatomyositis, systemic sclerosis (scleroderma), clinically significant non-SLE related vasculitis;\n* 4\\. Drug-induced lupus;\n* 5\\. HIV medical history or positive test results, treponema pallidum antibody positive, hepatitis B infection (HBsAg or HBcAb positive), hepatitis C infection (HCV antibody positive and quantitative abnormality), cytomegalovirus infection (IgM positive and quantitative abnormality) and Epstein-Barr virus infection (IgM positive and quantitative abnormality);\n* 6.History of tuberculosis infection, or evidence of active or latent mycobacterium tuberculosis infection at the time of signing informed consent;\n* 7\\. The following laboratory abnormalities were present, including but not limited to: a) Subjects with abnormal liver function: e.g., aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \\> 2 times the upper limit of normal (ULN), or total bilirubin \\> 1.5 × ULN (except for those due to Gilbert syndrome); or b) Subjects with abnormal hematology: Hemoglobin \\\u003C 90 g\u002FL, or platelet count \\\u003C 75 x 109\u002FL, or absolute neutrophil count \\\u003C 1.5 x 109\u002FL;\n* 8\\. Subjects with a history of chronic, recurrent (3 or more infections of the same type within 1 year) or severe infections (e.g. pneumonia and sepsis) within half a year before informed consent as determined by the investigator, including viral infection, or requiring systemic anti-infective treatment within 12 weeks before informed consent;\n* 9.History of severe herpes infection (e.g., herpetic encephalitis, ocular herpes or diffuse herpes) or signs of herpes or varicella-zoster virus infection within 12 weeks prior to knowledge (especially chickenpox and herpes zoster);\n* 10\\. History or current history of malignant disease, including solid tumors and hematologic malignancies (except for basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and cervical cancer in situ that have been completely removed and considered cured \\> 2 years at the time of informed consent).\n* 11\\. New York Heart Association Functional Class III or IV congestive heart failure\n* 12\\. Subjects with informed consent or abnormal and clinically significant ECG results before administration\n* 13.Patients with suicidal behavior or thoughts within 1 year before informed consent;\n* 14.Subjects with a history of drug abuse within 12 months before informed consent, or positive baseline urine drug test results;\n* 15\\. Use the prohibited drugs stipulated in the plan\n* 16\\. Antimalarials were started within 12 weeks prior to randomization, and subjects must have been on a stable dose from screening through the end of study (only for CLE patients) if they were receiving antimalarial treatment at screening;\n* 17\\. Treatment with oral systemic corticosteroids at doses greater than 15 mg\u002Fday prednisone (or its equivalent) prior to randomization (only for patients with CLE);\n* 18\\. Patients who have previously received drugs that inhibit BDCA2 targets;\n* 19\\. Subjects who have participated in other clinical trials within 4 weeks before informed consent, or within 5 half-lives of the investigational drug, whichever is longer;\n* 20\\. Presence of a past or present condition other than SLE and\u002For CLE that, in the opinion of the Investigator, may interfere with the assessment of skin inflammation and disease activity;\n* 21\\. Subjects who are allergic to the investigational drug (including excipients) or suffer from serious allergic diseases or have an allergic constitution (such as allergy to two or more drugs, food or pollen), which may impair the safety of subjects in the judgment of the investigator;\n* 22\\. Tattoos, scars or other physical examination findings in the area of planned injection sites that interfere with local injection site evaluation;\n* 23\\. Live vaccine or live attenuated vaccine within 4 weeks before informed consent, or planned during the study and within 24 weeks after the last dose of study drug;\n* 24\\. Subjects with a blood donation volume ≥ 500 mL within 4 weeks before informed consent or planned during the study, or have a history of blood transfusion within 4 weeks before informed consent;\n* 25\\. Subjects with an average daily alcohol intake of more than 2 units (1 unit of alcohol ≈ 360 mL of beer containing 5% alcohol or 45 mL of spirits containing 40% alcohol or 150 mL of wine containing 12% alcohol) within 3 months before informed consent, or subjects with positive baseline alcohol breath test;\n* 26\\. Other reasons that the investigator considers unsuitable for participation in this study.",{"count":68,"type":21},32,[24],"The primary objective of this phase Ib study is to evaluate the safety and tolerability of multiple-ascending, subcutaneous (SC) doses of HC022 in SLE\u002FCLE subjects. Secondary objectives of study are as follows: To estimate the PK parameters of multiple-ascending SC doses of HC022 in SLE\u002FCLE subjects；To evaluate the immunogenicity of HC022 administered to SLE\u002FCLE subjects.",[72,73],"Systemic Lupus Erythematosus (SLE)","Cutaneous Lupus Erythematosus (CLE)","NOT_YET_RECRUITING",{"date":76,"type":32},"2026-01-28",{"date":78,"type":21},"2025-12-30",{"date":80,"type":21},"2027-09-24",{"name":37,"class":38},{"id":83,"slug":84,"hasResults":11,"nctId":85,"briefTitle":86,"officialTitle":87,"acronym":4,"eligibilityCriteria":88,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":89,"targetDuration":4,"studyType":22,"phases":91,"briefSummary":93,"conditions":94,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":99,"completionDateStruct":100,"leadSponsor":102,"locationsCount":39},"100605977","phase-2-hc010-in-first-line-pd-l1-positive-advanced-nsclc-patients-100605977","NCT07169552","HC010 in First-line PD-L1 Positive Advanced NSCLC Patients","A Multicenter, Single-arm, Open-label Phase II Clinical Study to Evaluate the Efficacy and Safety of HC010 for Injection in the First-line Treatment of Advanced Non-small Cell Lung Cancer Positive for Programmed Death Ligand-1 (PD-L1)","Inclusion Criteria:\n\n* 1\\. Voluntarily participate in the study, communicate well with investigators, understand and voluntarily complete the study process according to this protocol, and sign the informed consent form (ICF).\n* 2\\. Male or female, aged ≥ 18 years at the time of signing the informed consent form.\n* 3\\. Histologically or cytologically confirmed locally advanced or metastatic (stage IIIb\\~IV) NSCLC (United States Cancer Confederation \\[AJCC\\] 8th edition), positive PD-L1 expression confirmed by IHC with central laboratory or local test results.\n* 4\\. Not previously receiving systemic therapy for locally advanced or metastatic NSCLC; not allowed if the last dose of prior treatment is \\\u003C6 months from disease recurrence in subjects who received prior adjuvant or neoadjuvant therapy.\n* 5\\. No EGFR mutation\u002FROS1 rearrangement\u002FALK rearrangement. If other targeted mutations such as BRAF V600E mutation\u002FNTRK1\u002F2\u002F3 gene fusion\u002FMET14 exon skipping mutation\u002FRET rearrangement positive are known, they will not be included in this study if the corresponding targeted therapy drugs have been approved.\n* 6\\. Expected survival ≥ 3 months.\n* 7.There should be at least one measurable lesion according to RECIST v1.1; radiotherapy-experienced lesions may not be selected as target lesions, unless the radiotherapy lesion is the only measurable lesion and clearly progresses based on imaging judgment.\n* 8\\. Eastern Cooperative Oncology Group (ECOG) performance status scored 0 or 1 in the United States and did not worsen within one week prior to first dose.\n* 9\\. Subjects (both female and male) agreed to use effective contraception from signing the ICF until 180 days after last dose of investigational product. Female patients of childbearing potential must have a negative blood or urine pregnancy test within 7 days prior to the first dose; females who are not pregnant or lactating from signing informed consent until 6 months after the last use of investigational drug (including those who agree to stop breastfeeding during this period).\n\nExclusion Criteria:\n\n* 1\\. Subjects who have received Chinese patent medicine or immunomodulatory drugs (including but not limited to thymopeptide, interferon and interleukin) with anti-tumor indications within 2 weeks before the first dose;\n* 2\\. Pulmonary radiation therapy \\>30 Gy within 6 months prior to the first dose;\n* 3\\. Complete palliative radiotherapy within 7 days before the first dose;\n* 4\\. Any other form of anti-tumor therapy is expected to be required during the study;\n* 5\\. Pericardial effusion (a stable small amount of pericardium can be included actively), or uncontrolled or symptomatic pleural and ascites effusions requiring puncture drainage;\n* 6\\. Presence of brain stem, meningeal metastases\u002Fmeningitis carcinoma, spinal cord metastasis or compression;\n* 7\\. Known brain metastases. Previously treated subjects with brain metastasis may participate in the study if they are clinically stable for at least 4 weeks prior to first dose, have no evidence of new or expanded brain metastases, and discontinue steroids 7 days prior to first dose. According to this definition, the stability of brain metastasis should be established prior to the first dose of study drug. Subjects with known untreated asymptomatic brain metastases stable for at least 4 weeks (i.e., no neurological symptoms, no corticosteroid treatment required, no or only slight peripheral edema, no lesion \\>1.5 cm, or stable brain lesion as determined by imaging) can participate in the study;\n* 8\\. Patients who have taken systemic corticosteroids (\\> 10 mg prednisone or equivalent daily) or other immunosuppressive drugs (such as cyclophosphamide, azathioprine, methotrexate, thalidomide, TNF-α inhibitors, etc.) within 2 weeks prior to the first dose;\n* 9\\. Systemic infection or other serious infection requiring intravenous antibiotics for \\>7 days within 2 weeks prior to the first dose, or fever of unexplained origin \\>38.5 °C during screening and before enrollment (except for fever due to tumor in the investigator's judgment).\n* 10\\. Concurrent with other malignant tumors within 5 years before the first dose, except for patients with adequately treated cervical carcinoma in situ, basal cell, squamous epithelial cell skin cancer, papillary thyroid carcinoma, local prostate cancer after radical resection and ductal carcinoma in situ after radical resection;\n* 11\\. Subjects with diseases that may jeopardize their safety or compliance with the study protocol, and other conditions unsuitable for participation in this study as judged by the investigator.",{"count":90,"type":21},50,[92],"PHASE2","Phase 2 clinical study to evaluate the efficacy, safety, pharmacokinetics and immunogenicity profile of HC010 for injection in patients with positive PD-L1 (TPS ≥1%)",[95],"NSCLC","2025-12-09",{"date":98,"type":32},"2025-12-17",{"date":96,"type":21},{"date":101,"type":21},"2027-09-30",{"name":37,"class":38},{"id":104,"slug":105,"hasResults":11,"nctId":106,"briefTitle":107,"officialTitle":108,"acronym":4,"eligibilityCriteria":109,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":110,"targetDuration":4,"studyType":22,"phases":112,"briefSummary":113,"conditions":114,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":116,"lastUpdatePostDateStruct":117,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":39},"100590161","phase-1-study-of-hc006-in-combination-with-a-pd-1-inhibitor-in-patients-with-advanced-solid-tumors-100590161","NCT06963814","Study of HC006 in Combination With a PD-1 Inhibitor in Patients With Advanced Solid Tumors","A Safety, Tolerability, Pharmacokinetics, Immunogenicity and Preliminary Efficacy Study of HC006 in Combination With a PD-1 Inhibitor in Patients With Advanced Solid Tumors:A Multicenter, Open-Label, Dose-Escalation and Multiple Cohort Dose Expansion Phase 1b Clinical Trial","Inclusion Criteria:\n\n1. Fully understand this trial and voluntarily sign the informed consent form;\n2. Advanced solid tumors diagnosed by histology or cytopathology;\n3. Be able to provide archived (within 2 years after the first treatment with study drug) or fresh tumor tissue samples for relevant biological sample analysis required by the protocol;\n4. At least one measurable lesion according to RECIST Version 1.1 (patients with only brain lesion as target lesion are not accepted);\n5. Eastern United States Oncology Assistance Group (ECOG) performance status score of 0 or 1;\n6. The expected survival time is more than 3 months;\n7. Adequate organ and bone marrow function\n8. Females of childbearing potential must have a negative blood pregnancy test within 7 days prior to the first dose of investigational product and be non-lactating; Eligible patients of childbearing potential (male and female) must agree to use a reliable method of contraception (hormonal or barrier method or abstinence) with their partner for at least 6 months from signing informed consent until after the last dose of study drug. Women of non-childbearing potential may not undergo pregnancy test and contraception (postmenopausal for at least 1 year or surgically sterilized).\n\nExclusion Criteria:\n\n1. Patients with imaging findings showing tumor invasion of great vessels or unclear demarcation from blood vessels;\n2. Patients with combined brain metastasis, meningeal metastasis, spinal cord compression or leptomeningeal disease;\n3. Previous treatment with monoclonal antibodies, bispecific antibodies, small molecule compounds and cells targeting CCR8 at any time;\n4. Conditions may significantly affect the autoimmune status;\n5. Patients with serious, uncontrolled and unrecoverable acute and chronic diseases:\n6. Subjects with other malignant tumors within 5 years prior to the first dose of the investigational drug ;\n7. Subjects who have undergone major organ surgery (excluding aspiration biopsy) within 4 weeks prior to the first dose of study drug, or have experienced significant trauma, or require elective surgery during the trial;",{"count":111,"type":21},252,[24],"This is an open-label, multicenter Phase 1b clinical study to evaluate the safety, tolerability, pharmacokinetics, immunogenicity and preliminary efficacy of HC006 in combination with a PD-1 inhibitor in patients with advanced solid tumors. The trial is divided into two stages: dose-escalation and dose expansion. First, the dose-escalation study is completed to determine the recommended dose for subsequent extension studies, and then the dose expansion study is conducted in the proposed tumors with potential treatment benefits.",[115],"Advanced Cancer","2025-07-14",{"date":118,"type":32},"2025-07-17",{"date":120,"type":32},"2025-07-04",{"date":122,"type":21},"2027-05-30",{"name":37,"class":38},{"id":125,"slug":126,"hasResults":11,"nctId":127,"briefTitle":128,"officialTitle":129,"acronym":4,"eligibilityCriteria":130,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":131,"targetDuration":4,"studyType":22,"phases":133,"briefSummary":134,"conditions":135,"keywords":137,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":143,"lastUpdatePostDateStruct":144,"startDateStruct":146,"completionDateStruct":148,"leadSponsor":150,"locationsCount":39},"100539752","phase-1-a-phase-i-study-to-evaluate-the-safety-pharmacokinetics-and-antitumor-activity-of-hc010-in-patients-with-advanced-solid-tumors-100539752","NCT06307925","A Phase I Study to Evaluate the Safety, Pharmacokinetics and Antitumor Activity of HC010 in Patients With Advanced Solid Tumors","A Phase I Open-label, Multi-center, Dose Escalation and Expansion Study to Evaluate the Safety, Pharmacokinetics and Antitumor Activity of HC010 in Patients With Advanced Solid Tumors","Inclusion Criteria:\n\n1. Voluntary participation in this clinical trial, understanding and following the research protocol, and voluntarily signing the Informed Consent Form (ICF).\n2. Age ≥18 and ≤75, male or female.\n3. Participants with histologically or cytologically confirmed diagnosis of advanced solid tumors who have failed standard therapy or for whom no standard therapy is available.\n4. Participants must have at least one measurable lesion according to RECIST Version1.1\n5. Eastern Cooperative Oncology Group (ECOG) Performance Score of 0 or 1\n6. Hepatocellular carcinoma patients with Child-Pugh score ≤ 7\n7. Expected survival time is at least 3 months\n8. Adequate organ function: neutrophil count≥1.5×109\u002FL,platelet count ≥100×109\u002FL,hemoglobin≥90g\u002FL,alanine aminotransferase and aspartate aminotransferase ≤2.5×upper limit of normal (ULN); patients with hepatocellular carcinoma or concomitant hepatic metastases ≤5.0×ULN, total bilirubin ≤1.5×ULN, renal function and cardiopulmonary function are basically normal.\n9. Subjects should provide, whenever possible, freshly obtained or archived tumor tissue sample prior to study treatment that can be used for biomarker analysis\n10. Participants of childbearing potential (males and females) must agree to effective contraception for at least 90 days from the time of signing the informed consent form to the time of the last dose; females of childbearing potential must have a negative blood pregnancy test within 7 days prior to the first dose of the HC010\n\nExclusion Criteria:\n\n1. Receipt of any interventional clinical trial treatment or other systemic chemotherapy, radiotherapy, etc. within 28 days or 5 half-lives (whichever is shorter) prior to the first dose of the HC010; Receipt of herbal or proprietary Chinese medicine with an anti-tumor indication within 2 weeks prior to the first dose of HC010;\n2. Underwent surgery, experienced severe trauma, etc,within 4 weeks prior to the first administration of HC010 ;\n3. Receipt of systemic glucocorticoids (prednisone \\>10 mg\u002Fday or equivalent doses of similar drugs) or other immunosuppressive agents within 2 weeks prior to the first dose of HC010;\n4. Receipt of immunomodulatory drugs within 2 weeks prior to the first dose of HC010;\n5. Receipt of live attenuated vaccination within 4 weeks prior to the first dose of HC010;\n6. Patients who have received biomolecule therapy for anti-programmed death receptor 1 (PD-1)\u002Fprogrammed death ligand (PD-L1), anti-cytotoxic T-lymphocyte antigen 4 (CTLA-4), and anti-vascular endothelial growth factor (VEGF) targets in prior antitumor therapy;\n7. Unresolved toxicities from prior anticancer therapy, defined as having not resolved to NCI CTCAE v5.0 Grade≤1;\n8. History of immune-related adverse event (irAE) leading to permanent discontinuation from prior immunotherapy ,or grade ≥3 toxicity related to anti-angiogenic therapy from prior anti-angiogenic therapy；\n9. Previous allogeneic hematopoietic stem cell transplantation or organ transplantation；\n10. Patients with known active brain metastases, or the presence of meningeal metastases, spinal cord compression, or molluscum contagiosum disease；\n11. Combination of other malignancies within 5 years prior to the first dose; excludes radically treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, papillary thyroid carcinoma and\u002For radically resected carcinoma in situ;\n12. Patients with active autoimmune disease, or a history of autoimmune disease；\n13. Infections: 1) active hepatitis B and C; Note: HBsAg and\u002For hepatitis B core antibody (HBcAb) positive individuals with HBV DNA ≥500 IU\u002Fml (≥2000 IU\u002Fml in patients with hepatocellular carcinoma) tested within 28 days prior to the initiation of treatment are eligible for inclusion.2) known history of human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS); 3) known active syphilis; 4) active tuberculosis; 5) active infection within two weeks prior to first dose of HC010;\n14. Unstable systemic disease, including but not limited to, severe cardiovascular disease; pleural effusion, pericardial effusion or peritoneal effusion requiring repeated drainage;\n15. Severe bleeding tendencies or coagulation disorders;\n16. History of non-infectious pneumonia\u002Finterstitial lung disease requiring systemic glucocorticoid therapy;\n17. Females who are pregnant or breastfeeding;\n18. Inappropriate for this study in the opinion of the investigator;\n19. History of systemic hypersensitivity or anaphylaxis to any component of HC010.",{"count":132,"type":21},122,[24],"This clinical trial is a multicenter, open, single-arm, non-randomized, dose-escalation and dose-expansion, phase I clinical study in patients with advanced recurrent or metastatic solid tumors.The goal of this study is to evaluate the safety and tolerability of HC010 monotherapy in patients with advanced solid tumors.",[136],"Advanced Solid Tumor",[138,139,140,141,142],"advanced solid tumor","Non-small cell lung cancer","Hepatocellular carcinoma","colorectal cancer","cervical cancer","2025-05-08",{"date":145,"type":32},"2025-05-13",{"date":147,"type":32},"2024-03-27",{"date":149,"type":21},"2025-12-31",{"name":37,"class":38},{"id":152,"slug":153,"hasResults":11,"nctId":154,"briefTitle":155,"officialTitle":156,"acronym":4,"eligibilityCriteria":157,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":158,"targetDuration":4,"studyType":22,"phases":160,"briefSummary":161,"conditions":162,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":163,"lastUpdatePostDateStruct":164,"startDateStruct":166,"completionDateStruct":168,"leadSponsor":170,"locationsCount":39},"100539494","phase-1-a-study-of-hc006-in-subjects-with-advanced-solid-tumors-100539494","NCT06304571","A Study of HC006 in Subjects With Advanced Solid Tumors","A Phase I, Open-label, Dose-Escalation and Dose-expansion Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity and Efficacy of HC006 in Advanced Solid Tumor Subjects","Inclusion Criteria:\n\n* Subjects must have histologically confirmed and documented diagnosis of locally advanced unresectable or metastatic advanced solid tumor that is refractory to standard treatment, or intolerant to standard treatment, or for which no standard treatment exists.\n* At least one measurable disease for expansion cohorts per Response Evaluation Criteria in Solid Tumours (RECIST) v1.1(dose escalation only requires at least one assessable lesion)\n* Agree to provide archived or fresh tumor tissue samples of primary or metastatic lesions for expansion cohorts.\n* Life expectancy ≥12 weeks\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1\n* Have adequate organ function as described in the protocol.\n* Agree to adopt effective contraceptive measures.\n\nExclusion Criteria:\n\n* Prior exposure to CCR8 inhibitor or hypersensitivity to any ingredient of the study drug.\n* Treatment with any systemic anti-cancer treatment within 4 weeks before first dose of study drug.\n* Use of any live attenuated vaccines within 28 days.\n* With primary central nervous system (CNS) tumors or unstable CNS metastases.\n* Have active or history of autoimmune disease or immunodeficiency disease.\n* With active, uncontrolled bacterial, viral, or fungal infections requiring systemic therapy.\n* With any mental or cognitive impairment that may limit their understanding, implementation.\n* Major surgery within 4 weeks of study drug administration.\n* Have uncontrolled or severe illness, including but not limited to severe cardiovascular disease, interstitial lung disease or non-infectious pneumonia, or uncontrollable clinical third luminal effusion.\n* Any adverse event from prior anti-tumor therapy has not yet recovered to ≤ grade 1 of CTCAE v5.0.\n* History of other malignancy within the last 5 years, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma.\n* Women who are pregnant or breastfeeding.\n* Other protocol defined exclusion criteria may apply.",{"count":159,"type":21},76,[24],"The purpose of this study is to characterize the safety, tolerability, pharmacokinetics (PK), Immunogenicity and preliminary antitumor activity of HC006 in subjects with advanced solid tumor malignancies. This study is a first-in-human (FIH) study of HC006 in subjects with advanced solid tumors.",[136],"2025-04-30",{"date":165,"type":32},"2025-05-06",{"date":167,"type":32},"2024-02-27",{"date":169,"type":21},"2026-07-16",{"name":37,"class":38},{"id":172,"slug":173,"hasResults":11,"nctId":174,"briefTitle":175,"officialTitle":176,"acronym":4,"eligibilityCriteria":177,"healthyVolunteers":178,"sex":16,"minAge":17,"maxAge":179,"enrollmentInfo":180,"targetDuration":4,"studyType":22,"phases":182,"briefSummary":183,"conditions":184,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":186,"lastUpdatePostDateStruct":187,"startDateStruct":189,"completionDateStruct":191,"leadSponsor":193,"locationsCount":194},"100566632","phase-1-safety-tolerability-and-pharmacokinetics-of-single-doses-of-hc022-in-healthy-subjects-100566632","NCT06657703","Safety, Tolerability, and Pharmacokinetics of Single Doses of HC022 in Healthy Subjects.","A Phase Ia Single Center, Randomized, Double-blind, Placebo-controlled Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Single Doses of HC022 in Healthy Subjects","Inclusion Criteria:\n\n1. Ability to understand the purpose and risks of the study and provide signed and dated informed consent and comply with study requirements;\n2. Aged 18 to 55 years old, inclusive, male or female;\n3. 3.A body weigh ≥ 50 kg for male , and a body weigh ≥ 45 kg for female, and must have a body mass index between 19 and 28 kilogram per square meter (kg\u002Fm2)；\n4. Be in good health as based on medical history, physical examination, vital signs, laboratory tests, chest radiographs, abdominal ultrasound and 12-lead ECG；\n5. All women of childbearing potential and all men must practice highly effective contraception during the study and for 6 months (for female) or 3 months (for male) after their dose of study treatment；\n\nExclusion Criteria:\n\n1. Have participated in other clinical trials within 3 months, or within the 5 half lives of the investigational drug prior to screening, whichever is longer;\n2. History of or positive test results at screening for the following: for human immunodeficiency virus (HIV), hepatitis C virus antibody (HCV Ab), hepatitis B virus (defined as positive for HBsAg or HBcAb or HBeAg)；\n3. History of or current diagnosis of active tuberculosis (TB), or untreated latent TB infection (LTBI) at screening；\n4. History of severe herpes infection or zoster viral infection；\n5. Serious infection, serious injuries, or major surgical procedures within 6 months prior to Screening；\n6. History of alcohol or substance abuse, a positive urine drug or alcohol test at Day -1；\n7. History of severe allergic or anaphylactic reactions or history of allergic reactions likely to be exacerbated by any component of the study drug；\n8. Any disease or conditons that are not suitable for participation in this study as determined by the Investigator；",true,"55 Years",{"count":181,"type":21},38,[24],"The primary objective of this phase Ia study is to evaluate the safety and tolerability of single-ascending, subcutaneous (SC) doses of HC022 in healthy subjects. Secondary objectives of study are as follows: To estimate the PK parameters of single-ascending SC doses of HC022 in healthy subjects；To evaluate the immunogenicity of HC022 administered to healthy subjects.",[185],"Systemic Lupus Erythematosus","2025-04-16",{"date":188,"type":32},"2025-04-17",{"date":190,"type":32},"2024-11-25",{"date":192,"type":21},"2026-01-08",{"name":37,"class":38},3,""]