[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Zhejiang Haichang Biotech Co., Ltd.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":85},{"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":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":4},"100634526","phase-1-phase-2-study-of-wgi-0301-plus-lenvatinib-in-patients-with-advanced-hcc-100634526",false,"NCT07540832","Phase 2 Study of WGI-0301 Plus Lenvatinib in Patients With Advanced HCC","An Open-Label Phase 2 Study of WGI-0301 Plus Lenvatinib in Patients With Advanced Hepatocellular Carcinoma as Second Line Therapy","Inclusion Criteria:\n\n* 1\\. ≥18 years of age on the day of signing informed consent, male or female. 2. Voluntarily agree to provide signed informed consent and are willing and able to comply with all aspects of the protocol.\n\n  3\\. Histologically or cytologically confirmed diagnosis of HCC, or clinical diagnosis of HCC as per AASLD criteria.\n\n  4\\. BCLC Stage C or BCLC Stage B with bilobar involvement and infiltrative nature that is only suitable for systemic anti-tumor therapy, and not suitable for any curative surgeries, liver transplantation, or local therapy (BCLC Classification see Appendix 6, Section 14.6).\n\n  5\\. Stage 1 only: At least first-line standard treatment failure (disease progression confirmed by imaging) or intolerance with no restriction on the number of prior lines of systemic treatment.\n\n  6\\. Stage 2 only: Patients must have objective radiographic disease progression or intolerance after only one prior line of systemic immunotherapy treatment with an anti-PD-1\u002F PD-L1 mAb administered either as monotherapy or in combination with other checkpoint inhibitors or other therapies (Prior locoregional therapy such as surgery, radiofrequency ablation or trans-arterial chemoembolization are also allowed but not counted as systemic therapy, provided that progression has been documented after these therapies, and ≥4 weeks have elapsed since the last therapy).\n\n  7\\. Eligible for treatment with Lenvatinib, as determined by investigators according to the Package Insert and clinical judgment.\n\n  8\\. ECOG PS of 0 or 1 within 7 days prior to the first dose of study intervention (ECOG PS see Appendix 3 in Section 14.3).\n\n  9\\. Patients must have at least one measurable lesion according to RECIST 1.1 as determined by the investigator, and that has not been the target of local or regional therapy including trans-arterial chemoembolization, intra-arterial chemotherapy, ethanol, or radiofrequency ablation; a new area of tumor progression within or adjacent to a previously treated lesion, if clearly measurable by a radiologist, is acceptable.\n\n  10\\. Life expectancy in the judgement of the Investigator \\> 12 weeks. 11. Recovery to ≤ Grade 1 (CTCAE V6.0) from toxicities related to any prior treatments unless the adverse events are clinically non-significant and\u002F or stable on supportive therapy, such as alopecia, Grade 2 peripheral neuropathy, and hypothyroidism stabilized on hormone replacement therapy.\n\n  12\\. Collection of an archived tissue sample will be requested (where available) or agree to undergo tumor tissue biopsy for biomarker testing; however, a subject will not be precluded from participating in the study if tissue sample is not available for collection or is otherwise insufficient for analysis.\n\n  13\\. Patients must have adequate organ function as defined below:\n  * Child-Pugh Liver Function Class A or Class B (score ≤ 7) (see Appendix 6 in Section 14.6)\n  * AST and ALT ≤ 3.0 × ULN, and total bilirubin ≤ 2 × ULN\n  * Serum albumin ≥ 2.8 g\u002F dL\n  * CrCL ≥ 50 ml\u002F min (Cockcroft-Gault formula: CrCL (mL\u002F min) = \\[140-age(year)\\] × body weight (Kg)\u002F \\[72 × Scr (mg\u002F dl)\\]{ × 0.85 for female subjects})\n  * Urine protein \\\u003C 2+ by dipstick analysis; if urine protein is ≥ 2+, a 24-hour urine protein quantification must be performed. Patients with 24-hour urine protein ≥ 1 g will be excluded.\n  * International normalized ratio (INR) ≤ 2.0 (except for warfarin therapy)\n  * Hemoglobin ≥ 8.5 g\u002F dL, absolute neutrophil count \\> 1000\u002F mm3, platelet count ≥ 60 000\u002F mm3 (no blood transfusion, blood products, cell growth factors, albumin or any other corrective therapeutic drugs within 14 days) 14. Participants with HBV or HCV infection will be allowed if they meet the following criteria:\n  * HBV-HCC: Resolved HBV infection (as evidenced by detectable HBV surface antibody, detectable HBV core antibody, undetectable HBV DNA, and undetectable HBV surface antigen) or chronic HBV infection (as evidenced by detectable HBV surface antigen or HBV DNA). Subjects with chronic HBV infection must have HBV DNA \\\u003C 500 IU\u002F mL and should be managed according to treatment guidelines. Those on antiviral therapy at screening should have been treated for \\>2 weeks before the first dose.\n  * HCV-HCC: Resolved HCV infection (as evidenced by undetectable HCV RNA), or stable HCV infection (such as normal LFTs or being asymptomatic). Patients with positive HCV RNA requiring direct antiviral agent treatment, or those with HBV and HCV co-infection are excluded.\n\n    15\\. WOCBP must have a negative serum pregnancy within 3 days prior to receiving the first dose of study medication and must use accepted highly effective methods of contraception from the time of signing the informed consent through 6 months after the last dose of study drug. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, or be surgically sterile, for the duration of study participation, and for 3 months after completion of study drug administration. See Appendix 1 for protocol-approved highly effective methods of contraceptive combinations.\n\nExclusion Criteria:\n\n* 1\\. Pregnant or breastfeeding patients or expecting to conceive or father children within the projected duration of the study.\n\n  2\\. Fibrolamellar carcinoma or mixed hepatocellular cholangiocarcinoma. 3. Complete occlusion of the major portal vein or vena cava due to HCC (The major portal vein is defined as the part of portal vein between the union of the splenic and superior mesenteric veins and the first bifurcation into the left and right vein).\n\n  4\\. Major surgery within 4 weeks prior to the first dose of study intervention, or presence of any serious unhealed wounds, ulcers, or untreated fractures at screening.\n\n  5\\. Previous identified allergy or hypersensitivity to components of WGI-0301 similar drugs or liposomal drugs or related excipients.\n\n  6\\. Previous identified allergy or hypersensitivity to components of Lenvatinib or similar drugs.\n\n  7\\. Stage 2 only: Has received prior Lenvatinib therapy or treatment with any agents targeting the PI3K\u002FAKT pathway.\n\n  8\\. Currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks prior to the first dose of study intervention.\n\n  9\\. Locoregional therapy to the liver within 4 weeks prior to the first dose, including but not limited to TACE, radiotherapy, radiofrequency ablation, microwave (except palliative radiotherapy for bone pain relief completed at least 2 weeks prior to the first dose).\n\n  10\\. Small molecule targeted therapy and traditional Chinese medicine with antitumor indications received within 2 weeks prior to the first dose, or chemotherapy, biological therapy, and other antitumor treatments received within 4 weeks prior to the first dose.\n\n  11\\. Clinically significant abnormalities of glucose metabolism (e.g., Patients with diabetes mellitus type1 or diabetes mellitus type 2 requiring treatment, or those with HbA1c ≥8.0%.\n\n  12\\. Clinically significant cardiovascular disease including:\n  * Uncontrolled chronic hypertension, defined as systolic blood pressure ≥150 mmHg or diastolic blood pressure ≥ 90 mmHg based on the average of ≥ 2 measurements; or a history of hypertensive crisis or hypertensive encephalopathy.\n  * Clinically significant hypotension as assessed by the investigator (e.g., systolic blood pressure \\\u003C 90 mmHg or mean arterial pressure \\\u003C 65 mmHg on two consecutive measurements at the Screening Visit).\n  * NYHA class III or IV Congestive heart failure, myocardial infarction or stroke, unstable angina pectoris, pericardial effusion (excluding trace pericardial effusion identified by echocardiography) or left ventricular ejection fraction \\\u003C 45% within 6 months prior to the first dose.\n  * Primary cardiomyopathy (e.g., dilated cardiomyopathy, hypertrophic cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy, restrictive cardiomyopathy, indeterminate cardiomyopathy).\n  * Bradycardia (known history of cardiovascular disease and either physical examination at rest or electrocardiogram indicating heart rate \\\u003C 50 bpm), or screening ECG indicating QTcF \\> 470 msec, 2 retests were required for the first abnormal QTcF, and 3 mean values were taken. Or there is severe arrhythmia requiring further treatment, including but not limited to ventricular fibrillation, atrial fibrillation, sustained ventricular tachycardia, second-degree or third-degree atrioventricular block, torsades de pointes, etc.\n\n    13\\. Clinically significant gastrointestinal disorders including:\n  * Medical history of difficulty swallowing, malabsorption, or other chronic gastrointestinal disease, or conditions that may hamper compliance and\u002For absorption of the tested products.\n  * Gastrointestinal perforation and\u002F or fistula intra-abdominal abscess or intestinal obstruction within 6 months prior to the first dose.\n  * Clinically significant gastric bleeding within 6 months prior to the first dose (patients may be enrolled if esophageal and gastric varices are present on imaging, but no bleeding event or inpatient medical intervention occurs within 6 months prior to the first dose).\n\n    14\\. Clinically significant bleeding risks including:\n  * Known hereditary or acquired bleeding or thrombotic tendencies (e.g., hereditary hemorrhagic telangiectasia or von Willebrand disease)\n  * Bleeding symptoms such as hemoptysis (\\> half teaspoon bright red blood) and gastrointestinal bleeding within 3 months prior to screening\n  * Thrombolytic agents within 10 days prior to the first dose\n  * Receiving anticoagulant therapy (e.g., anticoagulants, antiplatelets), and subject 's INR and APTT are not within expected therapeutic range of anticoagulant (except sodium heparin for maintenance of central venous catheter patency) 15. History of solid organ transplant. 16. Known HIV or AIDS related illness or is receiving systemic steroid therapy (prednisone \\\u003C10 mg\u002Fday or equivalent doses of other corticosteroids are acceptable) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study intervention.\n\n    17\\. Known active or uncontrolled infection that could interfere with the study (such as requiring intravenous antibiotics, antiviral or antifungal medications).\n\n    18\\. Uncontrolled ascites or pleural effusion requiring repeated drainage (Investigator 's judgment).\n\n    19\\. Past or current history of neoplasm other than HCC, except for curatively treated nonmelanoma skin cancer, in situ carcinoma of the cervix, or other cancer curatively treated and with no evidence of disease for at least 3 years.\n\n    20\\. Known CNS or leptomeningeal metastasis that is either symptomatic or untreated (except for asymptomatic cases not requiring treatment).\n\n    21\\. History of drug abuse or addiction at the present stage. 22. Subject has any other conditions or reason that, in the opinion of the Investigator, interferes with the ability of the subject to participate in the trial, places the subject at undue risk or complicates the interpretation of data","ALL","18 Years",{"count":19,"type":20},80,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE1","PHASE2","This is a Phase II study being done at several hospitals without using a placebo. It will look at how safe and tolerable the drug WGI-0301 is when given together with Lenvatinib, how the body processes and responds to WGI-0301, and whether this combination shows early signs of working in people with advanced liver cancer.",[27],"Advanced Hepatocellular Carcinoma (HCC)","NOT_YET_RECRUITING","2026-04-14",{"date":31,"type":32},"2026-04-20","ACTUAL",{"date":34,"type":20},"2026-09",{"date":36,"type":20},"2028-10",{"name":38,"class":39},"Zhejiang Haichang Biotech Co., Ltd.","INDUSTRY",{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":47,"enrollmentInfo":48,"targetDuration":4,"studyType":21,"phases":50,"briefSummary":51,"conditions":52,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":55,"lastUpdatePostDateStruct":56,"startDateStruct":58,"completionDateStruct":60,"leadSponsor":62,"locationsCount":63},"100630958","phase-2-phase-2-study-of-wgi-0301-plus-nivolumab-in-patients-with-hcc-and-rcc-100630958","NCT07494435","Phase 2 Study of WGI-0301 Plus Nivolumab in Patients With HCC and RCC","An Open-Label Phase 2 Study of WGI-0301 Plus Nivolumab in Patients With Advanced Hepatocellular Carcinoma or Advance Renal Cell Carcinoma","Inclusion Criteria:\n\n* 1\\) Age 18-75 (inclusive) on the day of singing informed consent, male or female.\n\n  2\\) Voluntarily agree to provide signed informed consent and are willing and able to comply with all aspects of the protocol 3) Subjects in each disease cohorts will need to fulfill the following criteria:\n\n  • HCC Cohort:\n  1. Histologically or cytologically confirmed diagnosis of HCC, or clinical diagnosis of HCC as per American Association for the Study of Liver Diseases (AASLD) criteria\n  2. 4\\. Barcelona Clinic Liver Cancer (BCLC) Stage C, or BCLC Stage B that is not suitable for any curative surgeries or locoregional therapy\n  3. Child-Pugh Liver Function Class A or Class B (score ≤ 7)\n  4. Documented first-line standard treatment failure (disease progression or intolerance)；\n\n     * nccRCC Cohort：Histologically or cytologically confirmed diagnosis of nccRCC，that is locally advanced or with distant metastasis, and have not received any prior systemic antitumor therapy. If disease progression occurs within 6 months after the last dose of adjuvant therapy, it is considered a failure of first-line treatment and thus does not meet the criteria.\n     * ccRCC Cohort：Histologically or cytologically confirmed ccRCC, with locally advanced unresectable disease or distant metastasis, and disease progression or intolerance after prior first-line therapy. Patients who have received adjuvant or neoadjuvant therapy may also be screened if they meet the above criteria.\n\n       4\\) Eligible for treatment with Nivolumab as determined by investigators according to the Package Insert and clinical judgment.\n\n       5\\) Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1 within 7 days prior to the first dose of study intervention 6) Life expectancy in the judgement of the Investigator \\> 12 weeks. 7) Patients must have at least one measurable lesion according to RECIST 1.1 as determined by the investigator, and that has not been the target of local or regional therapy such as radiotherapy; a new area of tumor progression within or adjacent to a previously treated lesion, if clearly measurable by a radiologist, is acceptable.\n\n       8\\) Any adverse events (AEs) related to prior anti-tumor therapy must have resolved to ≤ Grade 1 (CTCAE v6.0). However, patients may still be screened if the investigator determines that the toxicity is well-controlled and does not affect the patient's safety or compliance with the study drug, and this has been confirmed with the sponsor.\n\n       9\\) Collection of an archived tissue sample will be requested (where available) or agree to undergo tumor tissue biopsy for biomarker testing; however, a subject will not be precluded from participating in the study if tissue sample is not available for collection or is otherwise insufficient for analysis.\n\n       10\\) Patients must have adequate organ function as defined below:\n     * For patients with no liver metastasis or lesion: AST and ALT ≤2.0× ULN, and total bilirubin ≤1.5×ULN; For patients with liver metastasis or lesion: AST and ALT ≤3.0× ULN, and total bilirubin ≤2×ULN; For patients with Gilbert Syndrome: Total bilirubin ≤3×ULN\n     * Serum albumin≥30g\u002FL\n     * Creatinine Clearance (CrCL) ≥50 mL\u002Fmin (Cockcroft-Gault formula: Ccr=(140-Age)×body weight (Kg)\u002F72×Scr（mg\u002Fdl）{×0.85 for female subject}\n     * International Normalized Ratio (INR) ≤2.0 (except for patients on warfarin therapy)\n     * Hemeglobin≥90g\u002FL, ANC ≥1.5×10\\^9\u002FL, platelet count≥75×10\\^9\u002FL (no blood transfusion, blood products, cell growth factors, albumin or any other corrective therapeutic drugs within 14 days) 11) Participants with hepatitis B virus (HBV) or hepatitis C virus (HCV) infection will be allowed if they meet the following criteria:\n     * HBV-HCC: Resolved HBV infection (as evidenced by detectable HBV surface antibody, detectable HBV core antibody, undetectable HBV DNA, and undetectable HBV surface antigen) or chronic HBV infection (as evidenced by detectable HBV surface antigen or HBV DNA). Subjects with chronic HBV infection must have HBV DNA \\\u003C 500 IU\u002F mL, and should be managed according to treatment guidelines. Those on antiviral therapy at screening should have been treated for \\>2 weeks before the first dose\n     * HCV-HCC: • HCV-HCC: Resolved HCV infection (as evidenced by detectable HCV RNA or antibody), or stable HCV infection (such as normal LFTs or being asymptomatic). Patients with positive HCV RNA requiring direct antiviral agent treatment, or those with HBV and HCV co-infection are excluded 12) Women of child-bearing potential (WOCBP) must have a negative serum pregnancy within 3 days prior to receiving the first dose of study medication and must use accepted highly effective methods of contraception from the time of signing the informed consent through 6 months after the last dose of study drug. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, or be surgically sterile, for the duration of study participation, and for 3 months after completion of study drug administration.\n\n     Exclusion Criteria:\n* 1\\) Pregnant or breastfeeding patients or expecting to conceive or father children within the projected duration of the study 2) For the HCC Cohort, any of the following criteria：\n\n  * Locoregional therapy to liver within 4 weeks prior to the first dose, including but not limited to TACE, radiotherapy, radiofrequency ablation, microwave (except palliative radiotherapy for bone pain relief completed at least 2 weeks prior to the first dose).\n  * Fibrolamellar carcinoma, sarcomatoid hepatocellular carcinoma or mixed hepatocellular cholangiocarcinoma；\n  * 3\\. Complete occlusion of the major portal vein or vena cava due to HCC (The major portal vein is defined as the part of portal vein between the union of the splenic and superior mesenteric veins and the first bifurcation into the left and right vein) 3) Major surgery within 4 weeks prior to the first dose of study intervention. 4) Currently participating in and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks prior to the first dose of study intervention (except for observational clinical trials) 5) Small molecule targeted therapy and traditional Chinese medicine with antitumor indications received within 2 weeks prior to the first dose, or chemotherapy, biological therapy, and other antitumor treatments received within 4 weeks prior to the first dose 6) Received systemic corticosteroid (prednisone \\>10mg\u002Fday or equivalent) or other immunosuppressive agents within 2 weeks prior to the first dose of study intervention. Inhale or local corticosteroid, or pre-medications for infusion-related reactions\u002F hypersensitivity is allowed.\n\n    7\\) Received live vaccines and live attenuated vaccines within 4 weeks prior to the first dose of study treatment, or expected to received live vaccinve or live attenuated vaccine while participating in the study 8) Previous identified allergy or hypersensitivity to components of WGI-0301 similar drugs or liposomal drugs, or Nivolumab or related excipients 9) Prior treatment with agents targeting the PI3K-AKT pathway 10) 13. Clinically significant cardiovascular disease including:\n  * Uncontrolled chronic hypertension defined as systolic \\> 150 mmHg or diastolic \\> 90 mmHg on more than one measurement despite optimal therapy (initiation or adjustment of BP medication prior to study entry is allowed provided that the average of 3 BP readings prior to enrollment is \\\u003C 150\u002F 90 mmHg)\n  * Hypotension as indicated by systolic blood pressure \\\u003C 90 mmHg or mean arterial pressure \\\u003C 65 mmHg on 2 consecutive measurements at the Screening Visit\n  * NYHA class III or IV Congestive heart failure, stroke, transient ischemic attack, pulmonary embolism, myocardial infarction, unstable angina pectoris, or left ventricular ejection fraction \\\u003C 50% within 6 months prior to the first dose.\n  * Primary cardiomyopathy (e.g., dilated cardiomyopathy, hypertrophic cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy, restrictive cardiomyopathy, indeterminate cardiomyopathy)\n  * Bradycardia (known history of cardiovascular disease and either physical examination at rest or electrocardiogram indicating heart rate \\\u003C 50 bpm), or screening ECG indicating QTcF \\> 470 msec, 2 retests are required for the first abnormal QTcF , and the mean value should be taken from the 3 readings. Or there is severe arrhythmia requiring further treatment, including but not limited to ventricular fibrillation, atrial fibrillation, sustained ventricular tachycardia, second-degree or third-degree atrioventricular block, torsades de pointes, etc.\n\n    11\\) Clinically significant bleeding risks including:\n  * Known hereditary or acquired bleeding or thrombotic tendencies (e.g., hereditary hemorrhagic telangiectasia or von Willebrand disease)\n  * History of bleeding symptoms due to esophageal or gastric varices within 6 months prior to the first dose\n  * Received thrombolytic agents within 10 days prior to the first dose, or currently receiving anticoagulant therapy (e.g. anticoagulant, antiplatelet) and subject 's INR and APTT are not within expected therapeutic range of anticoagulant (except sodium heparin for maintenance of central venous catheter patency) 12) Known HIV or AIDS related illness, or history of allogeneic organ transplant or allogeneic hematopoietic stem cell transplant 13) Patients with endocrine disorders that cannot be effectively controlled by hormone replacement therapy 14) Presence of active autoimmune disease requiring systemic treatment within 2 years prior to the first dose, including but not limited to: systemic lupus erythematosus, multiple sclerosis, rheumatoid arthritis, inflammatory bowel disease, etc. However, subjects with hypothyroidism, adrenal insufficiency, or pituitary insufficiency managed with hormone replacement therapy only; skin diseases not requiring systemic treatment (e.g., vitiligo, psoriasis, or alopecia); or conditions not expected to recur in the absence of external triggers are allowed.\n\n    15\\) History of gastrointestinal perforation, gastrointestinal or non-gastrointestinal fistula, or abdominal abscess within 6 months prior to the first dose 16) Skin ulcers or severe, non-healing, or dehisced wounds within 3 months prior to the first dose 17) Known active or uncontrolled infection that may interfere with the study (e.g., active infection requiring intravenous antibiotic therapy or unexplained fever \\>38.5°C) 18) History of interstitial lung disease or prior non-infectious pneumonitis requiring corticosteroid treatment, or imaging findings suggestive of active pneumonia 19) History of other malignancies prior to or at study entry (except for adequately treated carcinoma in situ of the cervix, basal cell and squamous cell skin cancer, or other malignancies that have undergone curative treatment with no evidence of disease for at least 3 years).\n\n    20\\) Pleural effusion, ascites, or pericardial effusion that are clinically symptomatic or requiring repeated drainage (as judged by the investigator) 21) Known symptomatic or untreated brain metastases, leptomeningeal metastases, or other central nervous system metastases (except for asymptomatic cases not requiring treatment).\n\n    22\\) History of drug abuse or addiction 23) Subject has any other conditions or reason that, in the opinion of the Investigator, interferes with the ability of the subject to participate in the trial, places the subject at undue risk or complicates the interpretation of data","75 Years",{"count":49,"type":20},230,[24],"This is a Phase II study being done at several hospitals without using a placebo. It will look at how safe and tolerable the drug WGI-0301 is when given together with nivolumab, how the body processes and responds to WGI-0301, and whether this combination shows early signs of working in people with advanced liver cancer or advanced kidney cancer.",[53,54],"Hepato Cellular Carcinoma (HCC)","Renal Cell Cancer","2026-03-19",{"date":57,"type":32},"2026-03-27",{"date":59,"type":20},"2026-06-01",{"date":61,"type":20},"2028-09-01",{"name":38,"class":39},1,{"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":76,"whyStopped":4,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":84},"100539872","phase-2-phase-2-study-of-wgi-0301-for-advanced-hcc-100539872","NCT06309485","Phase 2 Study of WGI-0301 for Advanced HCC","An Open-Label Phase 1\u002F2 Study of WGI-0301 Plus Sorafenib in Patients With Advanced Hepatocellular Carcinoma as Second Line Therapy","Inclusion Criteria:\n\n1. ≥18 years of age on the day of signing informed consent, male or female.\n2. Voluntarily agree to provide signed informed consent and are willing and able to comply with all aspects of the protocol.\n3. Histologically or cytologically confirmed diagnosis of HCC, or clinical diagnosis of HCC as per 2018 AASLD criteria.\n4. BCLC Stage C or BCLC Stage B with bilobar involvement and infiltrative nature that is only suitable for systemic anti-tumor therapy, and not suitable for any curative surgeries, liver transplantation, or local therapy (BCLC Classification see Appendix 6, Section 14.6).\n5. Stage 1 only: At least first-line standard treatment failure (disease progression confirmed by imaging) with no available standard treatment options, or unsuitability for standard treatment, or intolerance to standard treatment.\n6. Stage 2 only: At least first-line standard treatment failure (disease progression confirmed by imaging) or intolerance.\n7. Stage 3 only: Patients must have objective radiographic disease progression or intolerance (Intolerance is defined as currently discontinued after ≥28 days of treatment due to toxicity) after only one prior line of systemic immunotherapy treatment with an anti-PD-1\u002F PD-L1 mAb administered either as monotherapy or in combination with other checkpoint inhibitors or other therapies (Prior locoregional therapy such as surgery, radiofrequency ablation or trans-arterial chemoembolization are also allowed but not counted as systemic therapy, provided that progression has been documented after these therapies, and ≥4 weeks have elapsed since the last therapy).\n8. Stage 2 and Stage 3: Eligible for treatment with Sorafenib as determined by investigators according to the Package Insert and clinical judgment.\n9. ECOG PS of 0 or 1 within 7 days prior to the first dose of study intervention.\n10. Patients must have at least one measurable lesion according to RECIST 1.1 as determined by the investigator, and that has not been the target of local or regional therapy including trans-arterial chemoembolization, intra-arterial chemotherapy, ethanol, or radiofrequency ablation; a new area of tumor progression within or adjacent to a previously treated lesion, if clearly measurable by a radiologist, is acceptable.\n11. Life expectancy in the judgement of the Investigator \\> 12 weeks.\n12. Recovery to ≤Grade 1 (CTCAE V5.0) from toxicities related to any prior treatments unless the adverse events are clinically non-significant and\u002F or stable on supportive therapy, such as alopecia, Grade 2 peripheral neuropathy, and hypothyroidism stabilized on hormone replacement therapy.\n13. Stage 2 and Stage 3:Collection of an archived tissue sample will be requested (where available) or agree to undergo tumor tissue biopsy for biomarker testing; however, a subject will not be precluded from participating in the study if tissue sample is not available for collection or is otherwise insufficient for analysis.\n14. Patients must have adequate organ function as defined below:\n\n    * Child-Pugh Liver Function Class A or Class B (score ≤ 7) (see Appendix 7 in Section 14.7)\n    * AST and ALT ≤ 3.0 × ULN and total bilirubin ≤ 2 × ULN\n    * Serum albumin ≥ 2.8 g\u002F dL\n    * CrCL ≥ 40 ml\u002F min (Cockcroft-Gault formula: CrCL (mL\u002F min) = \\[140-age(year)\\] × body weight (Kg)\u002F \\[72 × Scr (mg\u002F dl)\\]{ × 0.85 for female subjects})\n    * INR ≤ 2.0 (except for warfarin therapy)\n    * Hemoglobin ≥ 8.5 g\u002F dL, absolute neutrophil count \\> 1000\u002F mm3, platelet count ≥ 60 000\u002F mm3(no blood transfusion, blood products, cell growth factors, albumin or any other corrective therapeutic drugs within 14 days)\n15. Participants with HBV or HCV infection will be allowed if they meet the following criteria:\n\n    * HBV-HCC: Resolved HBV infection (as evidenced by detectable HBV surface antibody, detectable HBV core antibody, undetectable HBV DNA, and undetectable HBV surface antigen) or chronic HBV infection (as evidenced by detectable HBV surface antigen or HBV DNA). Subjects with chronic HBV infection must have HBV DNA \\\u003C 500 IU\u002F mL and must should be managed according to treatment guidelines. Those on antiviral therapy at screening should have been treated for \\>2 weeks before the first dose.\n    * HCV-HCC: Resolved HCV infection (as evidenced by detectable HCV RNA or antibody), or stable HCV infection (such as normal LFTs or being asymptomatic). Patients with positive HCV RNA requiring direct antiviral agent treatment, or those with HBV and HCV co-infection are excluded.\n16. WOCBP must have a negative serum pregnancy within 3 days prior to receiving the first dose of study medication and must use accepted highly effective methods of contraception from the time of signing the informed consent through 6 months after the last dose of study drug. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, or be surgically sterile, for the duration of study participation, and for 3 months after completion of study drug administration. See Appendix 1 for protocol-approved highly effective methods of contraceptive combinations.\n\nExclusion Criteria:\n\n1. Pregnant or breastfeeding patients or expecting to conceive or father children within the projected duration of the study.\n2. Stage 2 and Stage 3: Fibrolamellar carcinoma or mixed hepatocellular cholangiocarcinoma.\n3. Complete occlusion of the major portal vein or vena cava due to HCC (The major portal vein is defined as the part of portal vein between the union of the splenic and superior mesenteric veins and the first bifurcation into the left and right vein).\n4. Major surgery within 4 weeks prior to the first dose of study intervention.\n5. Previous identified allergy or hypersensitivity to components of WGI-0301 similar drugs or liposomal drugs or related excipients.\n6. Stage 2 and Stage 3: Previous identified allergy or hypersensitivity to components of Sorafenib or similar drugs.\n7. Stage 3 only: Received prior Sorafenib therapy or any agents targeting AKT-PI3K pathway.\n8. Currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks prior to the first dose of study intervention (except for observational clinical trials).\n9. Locoregional therapy to liver within 4 weeks prior to the first dose, including but not limited to TACE, radiotherapy, radiofrequency ablation, microwave (except palliative radiotherapy for bone pain relief completed at least 2 weeks prior to the first dose).\n10. Small molecule targeted therapy and traditional Chinese medicine with antitumor indications received within 2 weeks prior to the first dose, or chemotherapy, biological therapy, and other antitumor treatments received within 4 weeks prior to the first dose.\n11. Stage 2 and Stage 3：Patients on concomitant use of strong CYP3A4 inducers (see Appendix 3 in Section 14.3) within 12 days prior to the first dose of study intervention.\n12. Clinically significant abnormalities of glucose metabolism (e.g., Patients with diabetes mellitus type1 or diabetes mellitus type 2 requiring treatment, or those with HbA1c ≥8.0%.\n13. Clinically significant cardiovascular disease including:\n\n    * Uncontrolled chronic hypertension defined as systolic \\> 150 mmHg or diastolic \\> 90 mmHg on more than one measurement despite optimal therapy (initiation or adjustment of BP medication prior to study entry is allowed provided that the average of 3 BP readings prior to enrollment is \\\u003C 150\u002F 90 mmHg).\n    * Hypotension as indicated by systolic blood pressure \\\u003C 90 mmHg or mean arterial pressure \\\u003C 65 mmHg on 2 consecutive measurements at the Screening Visit.\n    * NYHA class III or IV Congestive heart failure, myocardial infarction or stroke, unstable angina pectoris, pericardial effusion (excluding trace pericardial effusion identified by echocardiography), or left ventricular ejection fraction \\\u003C 45% within 6 months prior to the first dose.\n    * Primary cardiomyopathy (e.g., dilated cardiomyopathy, hypertrophic cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy, restrictive cardiomyopathy, indeterminate cardiomyopathy).\n    * Bradycardia (known history of cardiovascular disease and either physical examination at rest or electrocardiogram indicating heart rate \\\u003C 50 bpm), or screening ECG indicating QTcF \\> 470 msec, 2 retests were required for the first abnormal QTcF , and 3 mean values were taken. Or there is severe arrhythmia requiring further treatment, including but not limited to ventricular fibrillation, atrial fibrillation, sustained ventricular tachycardia, second-degree or third-degree atrioventricular block, torsades de pointes, etc.\n14. Stage 2 and Stage 3: Clinically significant gastrointestinal disorders including:\n\n    * Medical history of difficulty swallowing, malabsorption, or other chronic gastrointestinal disease, or conditions that may hamper compliance and\u002F or absorption of the tested products\n    * Gastrointestinal perforation and\u002F or fistula intra-abdominal abscess or intestinal obstruction within 6 months prior to the first dose\n    * Clinically significant gastric bleeding within 6 months prior to the first dose (patients may be enrolled if esophageal and gastric varices are present on imaging, but no bleeding event or inpatient medical intervention occurs within 6 months prior to the first dose)\n15. Clinically significant bleeding risks including:\n\n    * Known hereditary or acquired bleeding or thrombotic tendencies (e.g., hereditary hemorrhagic telangiectasia or von Willebrand disease)\n    * Bleeding symptoms such as hemoptysis (\\> 1\u002F 2 teaspoon bright red blood) and gastrointestinal bleeding within 3 months prior to screening\n    * Thrombolytic agents within 10 days prior to the first dose\n    * Receiving anticoagulant therapy (e.g., anticoagulants, antiplatelets), and subject 's INR and APTT are not within expected therapeutic range of anticoagulant (except sodium heparin for maintenance of central venous catheter patency)\n16. History of solid organ transplant.\n17. Known HIV or AIDS related illness or is receiving systemic steroid therapy (physiological doses of hormones, such as prednisone \\\u003C10 mg\u002Fday or equivalent doses of similar corticosteroids are acceptable) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study intervention.\n18. Known active or uncontrolled infection that could interfere with the study (such as requiring intravenous antibiotics, antiviral or antifungal medications).\n19. Uncontrolled ascites or pleural effusion requiring repeated drainage (Investigator 's judgment).\n20. Past or current history of neoplasm other than HCC, except for curatively treated nonmelanoma skin cancer, in situ carcinoma of the cervix, or other cancer curatively treated and with no evidence of disease for at least 3 years.\n21. Known CNS or brain metastasis that is either symptomatic or untreated (except for asymptomatic cases not requiring treatment).\n22. History of drug abuse or addiction at the present stage.\n23. Subject has any other conditions or reason that, in the opinion of the Investigator, interferes with the ability of the subject to participate in the trial, places the subject at undue risk or complicates the interpretation of data.",{"count":72,"type":20},60,[24],"The purpose of this study is to determine the MTD of WGI-0301 in combination with Sorafenib for advanced Hepatocellular Carcinoma (HCC) and assess its safety and efficacy in adults with advanced unresectable HCC who have previously received PD-1 \u002F PD-L1 immune checkpoint inhibitors.",[27],"RECRUITING","2026-03-16",{"date":55,"type":32},{"date":80,"type":32},"2024-07-31",{"date":82,"type":20},"2027-03",{"name":38,"class":39},4,""]