[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"advanced\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:advanced":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,43],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100622086","phase-2-efficacy-and-safety-of-nb003-in-patients-with-advanced-gastrointestinal-stromal-tumors-gist-100622086",false,"NCT07379047","Efficacy and Safety of NB003 in Patients With Advanced Gastrointestinal Stromal Tumors (GIST)","A Multicenter, Open-label Clinical Study to Evaluate the Efficacy and Safety of NB003 in Patients With Advanced Gastrointestinal Stromal Tumors (GIST)","GISTAR-1","Inclusion Criteria:\n\n1. Participants are \\>=18 years of age (or the legal adult age as per local regulations, whichever is older) at the time of signing the ICF.\n2. Participants, or legally authorized representatives permitted by local regulations, provide written informed consent for participation in the study.\n3. Participants who have histologically confirmed locally advanced, unresectable, or metastatic GIST.\n\n   1. Part 1: Patients who have failed prior treatment with imatinib (including adjuvant therapy) and sunitinib for GIST due to disease progression or intolerance. Participants should also have no prior use of other TKI drugs.\n   2. Part 2: Patients who have failed prior treatment with imatinib (including adjuvant therapy) for GIST due to disease progression or intolerance. Participants should also have no prior use of other TKI drugs.\n4. Participants with confirmed KIT gene mutation based on local or central laboratory molecular pathology reports. Mutation status must be determined using tissue-based PCR or DNA sequencing methods. The report should include results on the presence or absence of KIT exon 9\u002F11\u002F17 mutations for randomization stratification in Part 1 and efficacy-related analyses throughout the study. The molecular pathology report indicating KIT mutation status shall be submitted to the medical monitor for review during the screening period. If a local molecular pathology report is unavailable or provides insufficient information, archived tumor tissue samples or fresh biopsy samples must be provided for central laboratory confirmation of mutation status prior to enrollment.\n5. Participants with at least one measurable lesion according to mRECIST.\n6. Participants with an ECOG PS of 0 to 1.\n7. Tumor sample requirement: Archival tumor samples in the form of formalin-fixed paraffin-embedded (FFPE) tissue sections or FFPE blocks obtained prior to enrollment, or tissue samples from a tumor biopsy (excisional, core needle, or fine-needle aspiration).\n8. Participants with an expected life expectancy of \\>=12 weeks.\n9. Participants shall have adequate organ and bone marrow function. Transfusions and\u002For treatment with erythropoietin and\u002For granulocyte colony stimulating factor\u002Fgranulocyte macrophage colony stimulating factor (G-CSF\u002FGM-CSF) are not permitted within 14 days prior to the screening laboratory blood draw under any circumstances. The criteria are defined as follows:\n\n   * Hemoglobin \\>=9 g\u002FdL (5.59 mmol\u002FL).\n   * Absolute neutrophil count (ANC) \\>=1.5 x 10\\^9\u002FL (1500\u002Fmm\\^3).\n   * Platelet count \\>=100 x 10\\^9\u002FL (100,000\u002Fmm\\^3).\n   * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \\\u003C= 2.5 x upper limit of normal (ULN) (for participants without liver metastases); AST and ALT \\\u003C= 5 x ULN (for participants with liver metastases).\n   * Total bilirubin \\\u003C=1.5 x ULN. Participants with a confirmed diagnosis of Gilbert's syndrome (persistent or recurrent unconjugated hyperbilirubinemia in the absence of hemolysis or hepatic pathology) may be enrolled if total bilirubin \\\u003C=3 x ULN.\n   * Creatinine clearance \\>=60 mL\u002Fmin as calculated by the Cockcroft-Gault formula or 24-hour urine collection.\n   * International normalized ratio (INR) or prothrombin time (PT) and activated partial thromboplastin time (aPTT) \\\u003C=1.5 x ULN; however, if a participant is receiving anticoagulant therapy, PT or aPTT within the therapeutic range of the anticoagulant is acceptable.\n10. Male participants: Male participants must agree to use contraception as detailed in Appendix 9 during the treatment period and for at least 6 months after the last dose of study treatment and refrain from donating sperm during this period.\n11. Female participants: A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:\n\n    i) She is not a woman of childbearing potential (WOCBP) as defined in the Appendix 9; or ii) She is a WOCBP and agrees to follow the contraceptive guidance outlined in the Appendix 9 during the treatment period and for at least 6 months after the last dose of study treatment.\n12. WOCBP must have a negative serum pregnancy test result during screening within 14 days prior to enrollment.\n\nExclusion Criteria:\n\n1. Part 1: Participants who have received prior treatment with NB003 or regorafenib. Part 2: Participants who have received prior treatment with NB003 or sunitinib.\n2. Participants who have received any systemic anti-tumor therapy within 7 days prior to enrollment.\n3. Participants who have undergone major surgery (excluding vascular access placement, tumor biopsy, and feeding tube placement) or major palliative interventions (such as transarterial chemoembolization) within 4 weeks prior to enrollment.\n4. Participants who have received radiation therapy to \\>30% of the bone marrow or extensive radiation therapy within 4 weeks prior to enrollment.\n5. Active infection, including active hepatitis B \\[defined as detectable HBV-DNA by local laboratory. Participants who are HBsAg positive or HBcAb positive at screening should have HBV-DNA tested\\] and active hepatitis C \\[defined as detectable HCV-RNA by local laboratory. Participants who are HCV antibody positive at screening should have HCV-RNA tested\\].\n6. Any of the following cardiac-related criteria:\n\n   * Uncontrolled persistent (\\>4 weeks) hypertension (\\>140\u002F90 mmHg).\n   * New York Heart Association (NYHA) Class (Appendix 11) III and IV heart disease, active ischemia, or other uncontrolled cardiac conditions such as angina.\n   * QTc interval Corrected QT interval using Fridericia's formula (QTcF) \\>=470 ms (based on 3 ECG results) or history of long QT syndrome.\n   * Resting ECG showing any clinically significant abnormalities in rhythm, conduction, or morphology (e.g., complete left bundle branch block, atrioventricular block third degree, atrioventricular block second degree, PR interval \\>250 ms).\n   * Left ventricular ejection fraction (LVEF) \\\u003C50%.\n7. Any unresolved prior treatment toxicity greater than CTCAE Grade 1 at the start of study treatment, with the exception of alopecia, hemoglobin (see Inclusion Criterion #10), Grade 2 hypothyroidism stable on hormone replacement therapy, and Grade 2 pre-existing treatment-related neuropathy.\n8. Participants who have experienced a National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 Grade 3 or higher bleeding event within 4 weeks prior to enrollment.\n9. Participants who have experienced an arterial thrombotic or embolic event (e.g., cerebrovascular accident, including transient ischemic attack) within 6 months prior to enrollment, or a venous thrombotic event (including pulmonary embolism or deep vein thrombosis) within 3 months prior to enrollment.\n10. Participants who have experienced a seizure for any reason within 6 months prior to enrollment.\n11. Participants with known bleeding disorders or risk of intracranial hemorrhage (e.g., unexcised or unrepaired cerebral aneurysm, cerebrovascular malformation), or history of intracranial hemorrhage within 1 year prior to randomization.\n12. Participants with unhealed wounds, active ulceration, gastrointestinal perforation, or fracture within 3 months prior to enrollment.\n13. Participants with brain metastases.\n14. History of pancreatitis with prior tyrosine kinase inhibitors use, or current evidence of mild to moderate pancreatitis.\n15. Refractory nausea and vomiting, chronic gastrointestinal disease, inability to swallow the formulation, or significant bowel resection that may affect adequate absorption of NB003 and regorafenib.\n16. Any other clinically significant comorbidity, such as uncontrolled lung disorder, active infection, uncontrolled pericardial effusion, uncontrolled pleural effusion, or any other condition that, in the investigator's judgment, may affect protocol compliance, interfere with interpretation of study results, or increase participant safety risk.\n17. Participants judged by the investigator to be unwilling or unable (including incompetence) to comply with study procedures, restrictions, and requirements.\n18. Participants currently using (or unable to discontinue at least 2 weeks prior to enrollment) drugs or herbal supplements known to be strong inhibitors or inducers of CYP3A4, and other prohibited concomitant medications (Appendix 3).\n19. History of hypersensitivity to the active or inactive ingredients of NB003, regorafenib, or drugs with similar chemical structure or class to NB003 or regorafenib.\n20. History of other primary neoplasm malignant diagnosed or requiring treatment within 3 years prior to enrollment. The following prior malignancies are not exclusion criteria: completely resected basal cell and squamous cell skin cancers, cured localized prostate cancer, cured superficial or non-muscle invasive bladder cancer, and completely resected carcinoma in situ of any site.","ALL","18 Years",{"count":20,"type":21},255,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE2","PHASE3","NB003-04 is a phase II\u002FIII, multicenter, open-label clinical study designed to evaluate the efficacy, safety, and pharmacokinetic (PK) profile of NB003 in patients with gastrointestinal stromal tumors aged 18 years and above (or the legal adult age of consent per local regulations, whichever is older). Participants who are eligible for this study are those who have experienced disease progression or documented intolerance following treatment with either imatinib and sunitinib or following treatment with imatinib.\n\nThis study consists of two parts. Part 1 (hereinafter referred to as Part 1) compares the efficacy of NB003 versus regorafenib in patients who need a third-line therapy for GIST who have failed sequential therapy with imatinib and sunitinib. Part 2 (hereinafter referred to as Part 2) evaluates the efficacy of NB003 in patients who need a second-line therapy for GIST who have failed treatment with imatinib.",[28,29],"GIST - Gastrointestinal Stromal Tumor","Advanced","RECRUITING","2026-06-08",{"date":33,"type":34},"2026-06-10","ACTUAL",{"date":36,"type":34},"2026-05-11",{"date":38,"type":21},"2028-09-01",{"name":40,"class":41},"Ningbo Newbay Technology Development Co., Ltd","INDUSTRY",32,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":50,"enrollmentInfo":51,"targetDuration":4,"studyType":22,"phases":53,"briefSummary":55,"conditions":56,"keywords":4,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":69},"100620774","phase-1-ibi363-plus-bevacizumab-with-or-without-nab-paclitaxel-for-second-line-treatment-of-advanced-gastric-cancer-100620774","NCT07361991","IBI363 Plus Bevacizumab With or Without Nab-Paclitaxel for Second-Line Treatment of Advanced Gastric Cancer","A Phase Ib\u002FII Study to Evaluate the Safety and Efficacy of IBI363 in Combination With Bevacizumab With or Without Nab-Paclitaxel as Second-Line Therapy in Patients With Advanced Gastric Cancer","Inclusion Criteria\n\n1. Signed informed consent: The patient must voluntarily sign a written informed consent form and be able to comply with the visit schedule and procedures specified in the protocol.\n2. Age: 18 to 75 years (inclusive), male or female.\n3. Diagnosis and prior therapy:\n\n   \\* Histologically confirmed advanced gastric or gastroesophageal junction adenocarcinoma (GC or GEJC).\n   * Disease progression or intolerance after prior first-line systemic antitumor therapy including immunotherapy.\n   * Primary immune resistance: best response during immunotherapy is stable disease (SD) lasting \\\u003C 12 weeks, or progressive disease (PD).\n   * Acquired immune resistance:\n\n1\\. For patients with PD on immunotherapy: best response during treatment is complete response (CR), partial response (PR), or SD lasting ≥ 12 weeks; 2. For patients who discontinued immunotherapy for reasons other than disease progression and subsequently developed PD: best response during treatment is CR, PR, or SD lasting ≥ 12 weeks, and the interval between last immunotherapy dose and PD is ≤ 6 months.\n\n4\\. Baseline hematology (within 7 days before first dose of study drug) must meet all of the following:\n\n* Hemoglobin ≥ 90 g\u002FL;\n* Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹\u002FL;\n* Platelet count ≥ 100 × 10⁹\u002FL;\n* Eosinophils \\\u003C 1.5 × upper limit of normal (ULN).\n\n\\*In this protocol, \"baseline\" is defined as the last available assessment prior to the first dose of study drug. Within 7 days before blood sampling, patients must not receive blood products (including packed red blood cells, apheresis platelets, cryoprecipitate, etc.), erythropoiesis-stimulating agents, or colony-stimulating factor support.\\*\n\n5\\. Baseline serum chemistry (within 7 days before first dose) must meet all of the following:\n\n* Total bilirubin ≤ 1.5 × ULN (patients with total bilirubin \\> 1.5 × ULN are allowed if conjugated bilirubin ≤ ULN);\n* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 × ULN;\n* Serum creatinine ≤ 1.5 × ULN \\*\\*or\\*\\* creatinine clearance (CCr) ≥ 45 mL\u002Fmin, calculated by the Cockcroft-Gault formula using actual body weight;\n* Serum albumin ≥ 32 g\u002FL.\n\n  6\\. Baseline coagulation function (within 7 days before first dose) must meet all of the following:\n* International normalized ratio (INR) ≤ 1.5 × ULN (≤ 3 × ULN if on stable anticoagulation therapy);\n* Partial thromboplastin time (PTT) or activated partial thromboplastin time (APTT) ≤ 1.5 × ULN (≤ 3 × ULN if on stable anticoagulation therapy).\n\n  7\\. Baseline urinalysis (within 7 days before first dose)must meet one of the following:\n* Urine protein (UPRO) \\\u003C 2+ by dipstick, \\*\\*or\\*\\*\n* 24-hour urine protein \\\u003C 1 g.\n\n  8\\. At least one measurable lesion as defined by RECIST v1.1 for solid tumors.\n\n  9\\. ECOG performance status of 0 or 1 (Eastern Cooperative Oncology Group).\n\n  10\\. Estimated life expectancy ≥ 3 months.\n\n  11\\. Contraception: Women of childbearing potential and men whose partners are women of childbearing potential must agree to use effective contraception throughout the treatment period and for 6 months after the last dose of study treatment.\n\nExclusion Criteria\n\n1. Pregnant or breastfeeding women, or women planning to become pregnant before the first dose of study drug, during study treatment, or within 6 months after the last dose.\n2. History of active thrombosis, deep venous thrombosis, or pulmonary embolism within 4 weeks before the first dose of study drug, unless adequately treated and considered clinically stable by the investigator.\n3. Clinically significant cardiovascular or cerebrovascular disease, including but not limited to:\n\n   \\* Ventricular arrhythmias or other uncontrolled arrhythmias requiring medical intervention (e.g., anti-arrhythmic therapy);\n\n   \\* Severe conduction abnormalities (e.g., third-degree atrioventricular block);\n\n   \\* QT interval corrected by Fridericia (QTcF) ≥ 480 ms;\n\n   \\* Uncontrolled arterial hypertension despite optimal medical therapy (systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg);\n\n   \\* History of myocarditis;\n\n   \\* Current congestive heart failure requiring treatment;\n\n   \\* Left ventricular ejection fraction (LVEF) \\\u003C 50%;\n\n   \\* New York Heart Association (NYHA) class III or IV heart failure;\n\n   \\* Acute coronary syndrome (including myocardial infarction or unstable angina), coronary angioplasty, or stent implantation within 6 months prior to the first dose;\n\n   \\* Cerebrovascular accident or transient ischemic attack within 6 months prior to the first dose;\n\n   \\* Known active seizure disorders.\n4. Interstitial lung disease, pulmonary fibrosis, pneumoconiosis, drug-induced pneumonitis, radiation pneumonitis, or other forms of restrictive lung disease that require corticosteroids or other treatment, or a history of severely impaired pulmonary function.\n5. History of atopic constitution, asthma, or atopic dermatitis.\n6. Clinically significant pleural effusion, ascites, or pericardial effusion requiring repeated drainage or associated with significant symptoms.\n7. Active autoimmune disease requiring systemic treatment (e.g., disease-modifying agents, corticosteroids, or immunosuppressive drugs) within 2 years prior to the first dose of study drug. Replacement therapy (e.g., thyroxine, insulin, or physiological replacement doses of corticosteroids for adrenal or pituitary insufficiency) is not considered systemic treatment.\n8. History of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.\n9. Known hypersensitivity or allergy to study drugs or any of their excipients.\n10. History of significant toxicities related to prior immune checkpoint inhibitor therapy that required permanent discontinuation of that treatment.\n11. Unresolved toxicities from prior antitumor therapies \\> Grade 1 (based on NCI CTCAE), with the exception of the following: persistent Grade 2 alopecia, peripheral neuropathy, hypomagnesemia, or other toxicities that are expected to be irreversible but are stable under medical management (e.g., hypothyroidism controlled with replacement therapy, hypertension controlled to \\\u003C160\u002F100 mmHg with antihypertensive medications).\n12. Incomplete recovery from prior surgery, or having undergone any major surgery within 4 weeks before the first dose of study drug.\n13. Active, uncontrolled bleeding or known bleeding diathesis.\n14. Major gastrointestinal diseases or conditions within 6 months prior to the first dose, including:\n\n    \\* History of inflammatory bowel disease;\n\n    \\* ≥ Grade 2 diarrhea occurring within 2 weeks before the first dose;\n\n    \\* Radiation enteritis.\n15. Uncontrolled tumor-related pain or symptomatic hypercalcemia at screening.\n16. Known human immunodeficiency virus (HIV) infection, active hepatitis B virus (HBV) infection, hepatitis C virus (HCV) infection, or active tuberculosis.\n\n    * Patients who are HBsAg-positive and\u002For hepatitis B core antibody (HBcAb)-positive must have HBV DNA testing. Patients with HBV DNA ≤ 2.5 × 10³ copies\u002FmL or ≤ 500 IU\u002FmL or below the lower limit of detection may be enrolled. HBsAg-positive patients should receive antiviral therapy against HBV throughout study treatment to prevent viral reactivation.\n    * Patients who are anti-HBc (+), HBsAg (-), anti-HBs (-), and have undetectable HBV viral load do not require prophylactic antiviral treatment but must be closely monitored for HBV reactivation.\n    * Patients with positive HCV serology but negative HCV RNA or HCV RNA below the lower limit of detection may be enrolled.\n    * Patients who have completed HCV treatment and have undetectable viral load may be enrolled.\n17. Severe or uncontrolled infection, infection requiring systemic intravenous antibiotics, or fever of unknown origin \\> 38°C within 2 weeks prior to the first dose of study drug.\n18. Any other malignancy diagnosed within 5 years before the first dose of study drug, except for adequately treated basal cell carcinoma or squamous cell carcinoma of the skin, carcinoma in situ that has been completely resected, and localized prostate cancer or papillary thyroid carcinoma that has been cured by radical surgery.\n19. \\*\\*Prohibited medications and treatments\\*\\* (patients must not receive any of the following):\n\n1\\) IL-2\u002FIL-15-based cytokine therapies. Use of IL-2\u002FIL-15 as a component of adoptive cell therapy or as immune modulation in immunocompromised patients is allowed.\n\n2\\) Any chemotherapy or small-molecule targeted therapy within 2 weeks or 5 half-lives (whichever is longer) prior to the first dose of study drug, without delayed toxicities, with the exception of:\n\n* Use of nitrosourea agents or mitomycin C within 6 weeks prior to the first dose is prohibited.\n\n  3\\) Any antibody therapy within 4 weeks prior to the first dose of study drug; 4) Participation in any interventional clinical trial involving medical devices or other therapeutic interventions within 2 weeks prior to the first dose; 5) Palliative radiotherapy within 2 weeks prior to the first dose; 6) Live vaccines for prevention of infectious diseases within 4 weeks prior to the first dose; 7) Immunosuppressive or systemic corticosteroid therapy (\\> 10 mg\u002Fday prednisone or equivalent) within 2 weeks prior to the first dose of study drug; 8) Traditional Chinese medicines with definite antitumor effects within 1 week prior to the first dose.\n\n  20\\. History of significant toxicities related to prior paclitaxel therapy that required permanent discontinuation of that treatment, or any contraindications to study drugs that, in the opinion of the investigator, preclude safe administration of the study treatment.\n\n  21\\. Any disease, treatment, laboratory abnormality, or history of drug abuse which, in the opinion of the investigator, may compromise patient safety, interfere with informed consent, affect patient compliance, or interfere with the evaluation of the safety of the study drug.\n\n  22\\. Psychiatric illness, altered mental status, or history of substance abuse that may interfere with the patient's ability to understand the informed consent process and\u002For complete required study assessments.\n\n  23\\. Any other condition that, based on known or foreseeable circumstances, in the investigator's judgment would make the patient unable to comply with the protocol requirements.","75 Years",{"count":52,"type":21},50,[54,24],"PHASE1","This study is for patients with advanced or metastatic gastric cancer whose disease has worsened after first-line systemic therapy. IBI363 is an investigational antibody that may help the immune system recognize and attack cancer cells. This trial will evaluate IBI363 in combination with bevacizumab, with or without nab-paclitaxel, as a second-line treatment.\n\nThe study has two parts. In the phase Ib part, small groups of patients will receive IBI363 plus bevacizumab with or without nab-paclitaxel to evaluate the safety, side effects, and tolerability of the combination and to determine an appropriate dose for further study. In the phase II part, additional patients will receive the selected regimen to assess the preliminary antitumor activity of IBI363 in combination with bevacizumab ± nab-paclitaxel, including tumor response and other clinical outcomes, as well as to further describe the safety profile. Treatment will continue until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons defined in the protocol.",[57,29],"Advan'ce'd","NOT_YET_RECRUITING","2026-01-21",{"date":61,"type":34},"2026-01-23",{"date":63,"type":21},"2026-03",{"date":65,"type":21},"2030-09",{"name":67,"class":68},"The First Affiliated Hospital of Zhengzhou University","OTHER",1]