[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"unresectable\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:unresectable":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,49,84,111,138],{"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":32,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100568241","phase-1-a-study-of-rec-1245-in-participants-with-unresectable-locally-advanced-or-metastatic-cancer-100568241",false,"NCT06678659","A Study of REC-1245 in Participants With Unresectable, Locally Advanced, or Metastatic Cancer","A Phase 1 \u002F 2, Open-Label Study of REC-1245 in Participants With Unresectable, Locally Advanced, or Metastatic Cancer","DAHLIA","Inclusion Criteria:\n\n* Have histologically-confirmed unresectable, locally advanced, or metastatic select solid tumors or select relapsed \u002F refractory lymphoma\n* Have experienced progressive disease, relapsed disease, or be intolerant to at least one established standard systemic anti-cancer treatment for a given tumor type, or have been considered ineligible for standard therapy.\n* Eastern cooperative oncology group (ECOG) performance status ≤1; for adolescent participants, Lansky Performance Status Scale or Karnofsky Performance Status Scale score of ≥70.\n* Measurable disease at baseline per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 \u002F Lugano criteria and documented by computed tomography (CT) and \u002F or magnetic resonance imaging (MRI)\n\nExclusion Criteria:\n\n* Received treatment with another RBM39 degrader\n* Clinically significant gastrointestinal (GI) or GI malabsorption","ALL","12 Years",{"count":20,"type":21},170,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE1","PHASE2","This is a multi-center, open-label study to investigate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary activity of REC-1245 administered orally on a once daily (QD) schedule in participants with unresectable, locally advanced, or metastatic solid tumors.",[28,29,30,31],"Unresectable","Locally Advanced","Metastatic Cancers","Relapsed\u002FRefractory Lymphomas",[33,34,35,30],"RBM39","Cancer","Refractory Lymphomas","RECRUITING","2026-05-06",{"date":39,"type":40},"2026-05-08","ACTUAL",{"date":42,"type":40},"2024-11-21",{"date":44,"type":21},"2028-10-30",{"name":46,"class":47},"Recursion Pharmaceuticals Inc.","INDUSTRY",6,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":17,"minAge":55,"maxAge":4,"enrollmentInfo":56,"targetDuration":4,"studyType":22,"phases":58,"briefSummary":60,"conditions":61,"keywords":65,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":4},"100634142","a-clinical-trial-of-firsekibart-tislelizumab-and-lenvatinib-in-patients-with-unresectable-tp53-mutated-hepatocellular-carcinoma-100634142","NCT07535840","A Clinical Trial of Firsekibart, Tislelizumab, and Lenvatinib in Patients With Unresectable, TP53-Mutated Hepatocellular Carcinoma","Inclusion Criteria:\n\n* Ability to understand and sign written informed consent prior to any study-related procedures.\n\nAge ≥18 years at the time of signing informed consent.\n\nHistologically or cytologically confirmed advanced or unresectable hepatocellular carcinoma (HCC).\n\nDocumented disease progression after prior systemic immunotherapy, including at least one PD-(L)1 inhibitor.\n\nConfirmed TP53 mutation in fresh liver tumor tissue by central laboratory testing.\n\nDetermined by liver tumor MDT to be unsuitable for curative surgery (R0 resection not feasible, insufficient normal liver volume, or other criteria).\n\nBCLC stage B or C.\n\nAt least one measurable lesion per RECIST v1.1 confirmed by BICR.\n\nECOG performance status 0-1.\n\nChild-Pugh class A within 7 days prior to randomization.\n\nAdequate organ and bone marrow function within 7 days prior to enrollment:\n\nANC ≥1.5×10\\^9\u002FL, Platelets ≥75×10\\^9\u002FL, HGB ≥9 g\u002FdL\n\nTBIL ≤2×ULN, ALT\u002FAST ≤5×ULN, Albumin ≥28 g\u002FL, ALP ≤5×ULN\n\nCreatinine ≤1.5×ULN or CCr ≥50 mL\u002Fmin, urine protein \\\u003C2+ (or 24-h urine protein \\\u003C1 g if baseline ≥2+)\n\nINR ≤2.3 or PT prolongation ≤6 sec\n\nExpected survival ≥12 weeks.\n\nWomen of childbearing potential and male participants with partners of childbearing potential must use effective contraception during treatment and for 6 months after last dose.\n\nAbility and willingness to comply with study procedures and visits.\n\nExclusion Criteria:\n\n* Candidates suitable for local curative therapy.\n\nMixed liver tumors containing sarcomatoid or intrahepatic cholangiocarcinoma components.\n\nHematologic malignancies.\n\nHistory of hepatic encephalopathy or prior liver transplantation.\n\nSymptomatic pleural effusion, ascites, or pericardial effusion requiring drainage; asymptomatic small effusions allowed.\n\nActive HBV (HBV DNA \\>2000 IU\u002FmL) or HCV (HCV RNA \\>10\\^3 copies\u002FmL) infection; co-infection HBsAg+\u002FHCV Ab+ excluded.\n\nCNS metastases.\n\nSignificant recent variceal bleeding (within 6 months).\n\nLife-threatening hemorrhagic events within 3 months.\n\nSignificant thromboembolic events within 6 months.\n\nUse of high-dose aspirin (\\>325 mg\u002Fday) or other platelet inhibitors within 2 weeks prior to first dose.\n\nUnresolved grade ≥2 toxicities from prior therapies (excluding hair loss or asymptomatic lab abnormalities).\n\nSymptomatic heart failure NYHA II-IV or LVEF \\\u003C50%.\n\nUncontrolled arrhythmias or congenital long QT syndrome, QTc \\>500 ms.\n\nActive bleeding disorders or on thrombolytic therapy.\n\nRecent history of gastrointestinal perforation, fistula, obstruction, or significant bowel disease.\n\nRadiotherapy within 3-7 weeks prior to first dose with residual toxicity.\n\nHistory of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, drug-induced lung injury, or severe impaired lung function.\n\nActive tuberculosis or treatment for TB within 1 year.\n\nHIV infection or active, untreated syphilis.\n\nActive or uncontrolled severe infection within 4 weeks prior to first dose.\n\nActive autoimmune disease requiring systemic treatment within 2 years. Known primary immunodeficiency.\n\nUse of systemic immunosuppressants within 4 weeks prior to first dose (nasal\u002Finhaled steroids at physiologic dose allowed).\n\nReceipt of live attenuated vaccines within 4 weeks prior to first dose.\n\nMajor surgery within 4 weeks prior to first dose, or unhealed wounds. Minor procedures like IV lines excluded.\n\nUncontrolled metabolic disorders or organ\u002Fsystemic disease posing excess risk.\n\nHistory of other malignancy within 5 years, except curatively treated basal cell carcinoma, squamous cell carcinoma, or in situ carcinoma.\n\nKnown hypersensitivity to study drugs or formulation components.\n\nHistory of aortic dissection or visceral artery aneurysm.\n\nParticipation in another clinical trial within 4 weeks prior to first dose.\n\nPregnant or breastfeeding women.\n\nExtensive metastatic disease (≥5 lesions) or major vascular invasion.\n\nOther acute or chronic diseases, psychiatric conditions, or lab abnormalities deemed by investigator to increase risk or interfere with study.","18 Years",{"count":57,"type":21},25,[59],"NA","This study aims to evaluate the effectiveness and safety of a combination therapy with Fuxinqibai monoclonal antibody, Tislelizumab, and Lenvatinib in patients with advanced, unresectable TP53-mutated hepatocellular carcinoma (HCC) who have previously failed systemic immunotherapy.\n\nEligible patients will receive:\n\nFuxinqibai 200 mg IV every 3 weeks Tislelizumab 200 mg IV every 3 weeks Lenvatinib 8 mg (≤60 kg) or 12 mg (\\>60 kg) orally once daily Treatment will continue until disease progression, unacceptable toxicity, start of a new anticancer therapy, withdrawal of consent, or other protocol-defined reasons. Tumor response will be evaluated by RECIST v1.1 every 6 weeks, and confirmed after 4 weeks if response is observed.\n\nSafety will be monitored through adverse events and laboratory tests, graded according to NCI CTCAE v5.0. After treatment ends, patients will be followed every 6 weeks for tumor assessment and every 12 weeks for survival, until death, loss to follow-up, or withdrawal of consent.\n\nPrimary Objective: To assess the objective response rate (ORR) of the combination therapy.\n\nSecondary Objectives: To evaluate overall efficacy, safety, and explore potential biomarkers predicting treatment response.",[62,63,28,64],"HCC - Hepatocellular Carcinoma","TP53 Gene Mutation","Resistant Cancer",[66,67,68,69,70,71,72],"Firsekibart","Tislelizumab","Lenvatinib","TP53-mutant hepatocellular carcinoma","Unresectable HCC","Advanced liver cancer","Single-arm study","NOT_YET_RECRUITING","2026-04-10",{"date":76,"type":40},"2026-04-17",{"date":78,"type":21},"2026-05",{"date":80,"type":21},"2027-06",{"name":82,"class":83},"Tongji Hospital","OTHER",{"id":85,"slug":86,"hasResults":11,"nctId":87,"briefTitle":88,"officialTitle":89,"acronym":4,"eligibilityCriteria":90,"healthyVolunteers":11,"sex":17,"minAge":55,"maxAge":4,"enrollmentInfo":91,"targetDuration":4,"studyType":22,"phases":93,"briefSummary":94,"conditions":95,"keywords":97,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":110},"100604925","early-feasibility-clinical-investigation-to-assess-yntradose-as-a-neoadjuvant-treatment-for-la-pdac-100604925","NCT07155850","Early Feasibility Clinical Investigation to Assess YntraDose™ as a Neoadjuvant Treatment for LA-PDAC","Early Feasibility Clinical Investigation Using a Novel 90-Yttrium-based Internal Radiotherapy Platform, YntraDose™ in Unresectable Locally Advanced Pancreatic Adenocarcinoma (LA-PDAC) as an add-on Therapy to First-line SOC (Chemotherapy)","Inclusion Criteria (Main):\n\n* Histologically or cytologically proven Pancreatic Adenocarcinoma.\n* Stage of disease defined as unresectable Locally Advanced Pancreatic Cancer.\n* No prior radiotherapy for pancreatic cancer.\n* Target tumour with a minimum diameter of 2.6 cm and a volume of from 9 to 34 ml.\n* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.\n* Patient has acceptable hematological parameters including white and red blood counts, liver and renal function that makes them suitable to receive SoC chemotherapy as per local clinical practice.\n* Life expectancy of ≥6 months at screening.\n\nExclusion Criteria (Main):\n\n* Evidence of distant metastases based on the restaging process after two months of induction chemotherapy identified using CT\u002FMRI\u002F18 FDG PET assessment.\n* Evidence of switch from unresectable status to resectable status of disease after two months of induction chemotherapy.\n* More than one primary lesion, if one of the primary lesions is not a good candidate for debulking with YntraDose™, due to clinical reasons and\u002For decision made by the local MDTB.\n* ECOG is higher than 1.\n* History of malignancy in the last 3 years.\n* Blood clotting disorders (INR \\> 1.5, PLT \\\u003C 50,000\u002Fµl - risk of bleeding during organ puncture).\n* Active systemic or local infection (e.g. peritonitis, abscess).\n* Severe organ failure (e.g. end-stage liver, kidney, heart failure).\n* Cardiological and other diseases that threaten the use of anesthesia.\n* Pancreatitis (acute or exacerbation of chronic inflammation).",{"count":92,"type":21},10,[59],"The goal of this clinical investigation is to learn if a new type of radiotherapy works to treat pancreatic cancer that cannot be removed surgically. It will also learn about the safety of the new treatment when combined with chemotherapy. The treatment involves injecting a radioactive implant (medical device) directly into the pancreatic tumour on one occasion only. The main questions it aims to answer are:\n\n* Is the new treatment safe and tolerable when used in combination with standard of care chemotherapy.\n* Is it feasible to inject the new treatment directly into a patient's pancreatic tumour.\n* What is the impact of this new treatment on a patient's quality of life including a pain evaluation.\n* To assess how the pancreatic tumour responds to the treatment during the 3 month follow up.\n\nParticipants will:\n\n* Participate in the research study for approximately 7 months and will receive standard of care chemotherapy throughout their participation.\n* Participants will initially receive standard of care chemotherapy which will be stopped after 2 months to reassess the tumor by a multidisciplinary tumor board. Chemotherapy will resume and the test device will be administered between chemotherapy treatments. The new treatment involves a single injection of the radioactive implant directly into the pancreatic tumour. Following treatment, the participant's standard of care chemotherapy will resume.\n* Participants will attend follow up visits over 3 months.\n* Participants will visit the clinic on 8 separate occasions and on one occasions, will remain in hospital for 2 nights\u002F3 days to receive treatment with the new radiotherapy device and to monitor for safety.\n* Participants will complete questionnaires to check how the treatment is affecting their daily lives and pain levels.\n* Participants will undergo different types of imaging (scans) such as CT, MRI.\n* Participants will have bloods and urine taken to monitor safety.",[96,29,28],"Pancreatic Ductal Adenocarcinoma (PDAC)",[98,99,100],"LA-PDAC","Yttrium-90","YntraDose™","2026-02-17",{"date":103,"type":40},"2026-02-19",{"date":105,"type":40},"2026-02-03",{"date":107,"type":21},"2027-02",{"name":109,"class":47},"BetaGlue Therapeutics SpA",2,{"id":112,"slug":113,"hasResults":11,"nctId":114,"briefTitle":115,"officialTitle":115,"acronym":116,"eligibilityCriteria":117,"healthyVolunteers":11,"sex":17,"minAge":55,"maxAge":4,"enrollmentInfo":118,"targetDuration":4,"studyType":22,"phases":120,"briefSummary":121,"conditions":122,"keywords":124,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":128,"lastUpdatePostDateStruct":129,"startDateStruct":131,"completionDateStruct":133,"leadSponsor":135,"locationsCount":137},"100523926","phase-2-paccelio---fdg-pet-based-small-volume-accelerated-immuno-chemoradiotherapy-in-locally-advanced-nsclc-100523926","NCT06102057","PACCELIO - FDG-PET Based Small Volume Accelerated Immuno Chemoradiotherapy in Locally Advanced NSCLC","PACCELIO","Inclusion Criteria:\n\n* Written informed consent\n* Patients irrespective of sex and gender, aged 18 years or older at the time of signing the ICF\n* Patients must be willing and able to comply with scheduled visits, treatment schedule, laboratory testing, and other requirements of the study as determined by the investigator\n* Patients with histologically or cytologically documented NSCLC who present with locally advanced, unresectable (Stage III) disease (according to version 8 of the International Association for the Study of Lung Cancer Staging Manual in Thoracic Oncology (IASLC Staging Manual in Thoracic Oncology 2016))\n* Patients fit for simultaneous chemoradiotherapy and consolidation immunotherapy according to interdisciplinary consensus\n* Histologically proven PD-L1-expression of ≥ 1% (tumor proportion score; TPS) in tumor sample as assessed in routine staging using a validated test such as Ventana SP236 assay\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 at enrolment\n* Tumor assessment by FDG-PET CT within 21 days prior to start of chemoradiotherapy.\n* Adequate pulmonary function test results\n\n  * Pre- or post-bronchodilator forced expiratory volume 1 of 1.0 L or \\>40% of predicted AND\n  * Diffusing capacity of the lung for carbon monoxide (DLCO) \\>30% of predicted\n* Adequate bone marrow and organ function at enrolment\n\n  * Hemoglobin ≥9.0 g\u002FdL\n  * Absolute neutrophil count \\>1.5 × 109\u002FL\n  * Platelet count \\>100 × 109\u002FL\n  * Serum bilirubin ≤1.5 × upper limit of normal (ULN)\n  * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 × ULN\n  * Measured creatinine clearance (CrCl) \\>40 mL\u002Fmin or calculated CL \\>40 mL\u002Fmin as determined by Cockcroft-Gault (using actual body weight)\n* Body weight of \\>30 kg at enrolment\n* Evidence of post-menopausal status, or negative urinary or serum pregnancy test for female pre-menopausal patients. Women will be considered post-menopausal if they are amenorrhoic for 12 months or more without an alternative medical cause. The following age-specific requirements apply:\n\n  * Women \\\u003C50 years old would be considered post-menopausal if they have been amenorrhoic for 12 months or more following cessation of exogenous hormonal treatments with luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution\n  * Women ≥50 years old would be considered post-menopausal if they have been amenorrhoic for 12 months or more following cessation of all exogenous hormonal treatments, radiation-induced oophorectomy with last menses \\>1 year ago, chemotherapy-induced menopause with \\>1 year interval since last menses, or surgical sterilization (bilateral oophorectomy or hysterectomy)\n* Women of childbearing potential (WOCBP) and male patients with partners of childbearing potential must agree to always use a highly effective form of contraception according to the Clinical Trials Facilitation and Coordination Group during the treatment phase of this study and for at least 90 days after the last dose durvalumab or 6 months after the last dose of chemotherapy, whichever occurs last\n\nExclusion Criteria:\n\n* Mixed small cell and NSCLC histology\n* Neuroendocrine tumor\n* Distant metastases\n* Malignant pleural effusion or pericardial effusion\n* Acute superior vena cava obstruction\n* Receipt of prior or current cancer treatment for NSCLC, including but not limited to, surgical resection, radiation therapy, investigational agents, chemotherapy, and monoclonal antibodies (mAbs). Exception: Prior surgical resection of limited metachronous NSCLC (i.e., stage I or II) is permitted.\n* Receipt of live attenuated vaccine within 30 days prior to the start of therapy. Note: Patients, if enrolled, should not receive live vaccine during treatment phase and up to 30 days end of treatment\n* Major surgical procedure (as defined by the Investigator) within 28 days prior start of treatment.\n* Prior exposure to immune-mediated therapy, including but not limited to, other anti-CTLA-4, anti-PD-1, anti-PD-L1 (including durvalumab), and anti-PD-L2 antibodies, including therapeutic anticancer vaccines\n* Current use of ongoing long-term immunosuppressive medication. The following are exceptions to this criterion\n\n  * Intranasal, inhaled, topical steroids, or local steroid injections (e.g., intra articular injection)\n  * Systemic corticosteroids at physiologic doses not to exceed 10 mg\u002Fday of prednisone or its equivalent\n  * Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication)\n* History of allogeneic organ transplantation\n* Active or prior documented autoimmune or inflammatory disorders including inflammatory bowel disease \\[e.g., colitis or Crohn's disease\\], diverticulitis \\[with the exception of diverticulosis\\], systemic lupus erythematosus, Sarcoidosis syndrome, Wegener syndrome \\[granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc.\\]). The following are exceptions to this criterion:\n\n  * Patients with vitiligo or alopecia\n  * Patients with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement\n  * Any chronic skin condition that does not require systemic therapy\n  * Patients without active disease in the last 5 years at randomization may be included but only after consultation with the local study physician\n  * Patients with celiac disease controlled by diet alone\n* Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, ILD, serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirement, substantially increase risk of incurring AEs, or compromise the ability of the patient to give written informed consent\n* Patients with oxygen dependence\n* Acute inflammation of mediastinal lymph nodes\u002Fmediastinal lymphadenopathy in the context of active pneumoconiosis, sarcoidosis or tuberculosis\n* History of another primary malignancy, except for\n\n  * Basal cell carcinoma of the skin\n  * Second malignancy diagnosed \\> 2 years prior to NSCLC diagnosis if after curative treatment without persistence or progression at baseline. Patients with a previous history of radiation therapy are eligible provided field overlap is minimal and the risk of toxicity to tissues in the overlapping region(s) is deemed to be acceptable by treating radiation oncologist.\n  * Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease\n  * Adequately treated carcinoma in situ without evidence of disease\n* History of leptomeningeal carcinomatosis\n* Positive diagnostic test for hepatitis B (hepatitis B surface antigen) or hepatitis C (hepatitis C antibody or hepatitis C RNA)\n* Known active infection of tuberculosis or human immunodeficiency virus\n* Known allergy or hypersensitivity to concomitant chemotherapy and durvalumab or any of the excipients\n* Any medical contraindication to treatment with platinum-based doublet chemotherapy as listed in the applying SmPCs\n* Patients who have disease considered for surgical treatment as part of their care plan, such as Pancoast or superior sulcus tumors.\n* Concurrent enrolment in another clinical study, unless it is an observational (noninterventional) clinical study or the follow-up period of an interventional study\n* Participation in another clinical study with an investigational product during the 4 weeks prior to enrolment\n* Pregnancy or breast-feeding",{"count":119,"type":21},110,[25],"Multinational, randomized, controlled, open-label, multicenter phase II trial. Eligible patients will be randomized in a ratio of 1:1 to Experimental Arm (FDG-PET-based small volume accelerated radiotherapy with concurrent standard of care chemotherapy) or Conventional Arm (standard FDG-PET-based radiotherapy with concurrent standard of care chemotherapy). Patients showing complete response, partial response, or stable disease following chemoradiotherapy will receive standard of care consolidation therapy with durvalumab (fixed dose of 1500 mg q4w) for up to 12 months or until progression of disease, unacceptable toxicity, patient´s wish, or investigator´s decision, whichever comes first.\n\nAfter end of durvalumab therapy, patients will undergo safety follow up for 90 (+7) days followed by survival follow up until overall end of study. Overall end of study will be reached 24 months after the last patient has started durvalumab therapy. Patients showing PD following chemoradiotherapy will be treated according to investigator´s decision but will be followed up until overall end of study.",[123,29,28],"Stage III Non-small Cell Lung Cancer",[125,126,127],"chemoradiotherapy","immunotherapy","small volume accelerated chemoradiotherapy","2025-12-09",{"date":130,"type":40},"2025-12-17",{"date":132,"type":40},"2024-07-01",{"date":134,"type":21},"2028-06",{"name":136,"class":83},"TheraOp",11,{"id":139,"slug":140,"hasResults":11,"nctId":141,"briefTitle":142,"officialTitle":143,"acronym":4,"eligibilityCriteria":144,"healthyVolunteers":11,"sex":17,"minAge":55,"maxAge":4,"enrollmentInfo":145,"targetDuration":4,"studyType":22,"phases":147,"briefSummary":148,"conditions":149,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":151,"lastUpdatePostDateStruct":152,"startDateStruct":154,"completionDateStruct":156,"leadSponsor":158,"locationsCount":160},"100548212","phase-1-study-of-ibi3005-in-subjects-with-unresectable-locally-advanced-or-metastatic-solid-tumors-100548212","NCT06418061","Study of IBI3005 in Subjects With Unresectable, Locally Advanced or Metastatic Solid Tumors","A Multicenter, Open-label, Phase Ia\u002FIb Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of IBI3005 in Subjects With Advanced Malignant Solid Tumors","Inclusion Criteria:\n\nSubjects Should have been previously treated with a third-generation EGFR TKI with disease progression. Subjects with positive other driver genes or METex14 mutations are required to undergo targeted therapy and disease progression.\n\nExclusion Criteria:\n\nReceived live vaccines within 4 weeks prior to first administration of the study drug or plan on receiving any live vaccine during the study.Patients are allowed to receive inactivated vaccines.\n\nUncontrolled diseases including:\n\n* Infection requiring systemic antibiotics, antivirals or antifungals within 2 weeks prior to first dose of the study drug（ antiviral medication for hepatitis B and hepatitis C infection that are compliant with the protocol were allowed）;\n* Known human immunodeficiency virus (HIV) infection, or HIV positive (HIV 1\u002F2 Ab positive);\n* Acute or chronic active hepatitis B (HbsAg positive and\u002For HbcAb positive with HBV DNA titer ≥ 104 copies\u002FmL or ≥ 2000 IU\u002FmL or higher than lower limit of detection) or C (HCV Ab positive with HCV RNA titer \\> 103 copies\u002FmL or higher than lower limit of detection);\n* Active COVID-19 infection with obvious symptoms requiring treatment or hospitalization, such as pyrexia, dyspnea, nausea, vomiting, diarrhea, etc.;\n* Active tuberculosis infection, or still on anti-tuberculosis therapy or received anti tuberculosis therapy within 1 year prior to first administration of the study drug;\n* Active syphilis infection or latent syphilis requiring treatment;\n* Symptomatic congestive heart failure Grade II-IV (New York Heart Association \\[NYHA\\]), symptomatic or uncontrolled arrhythmias, QTc interval \\> 480 ms or personal or family history of congenital long\u002Fshort QT syndrome;\n* Hypertension that does not receive standardized therapy or still uncontrollable hypertension (SBP ≥ 160 mmHg or DBP ≥ 100 mmHg); Any history of life-threatening hemorrhage, or hemorrhage requiring (including but not limited to gastrointestinal bleeding, hemoptysis, etc) blood transfusion, endoscopy, or surgery, within 3 months prior to the first administration of study drug;",{"count":146,"type":21},198,[24],"The main purpose of this study is to evaluate the safety and tolerability of IBI3005 and to determine the maximum tolerated dose (MTD) and the recommended Phase 2 Dose (RP2D) of IBI3005.",[28,150],"Locally Advanced or Metastatic Solid Tumors","2025-01-19",{"date":153,"type":40},"2025-01-22",{"date":155,"type":40},"2025-01-08",{"date":157,"type":21},"2027-12-31",{"name":159,"class":47},"Innovent Biologics (Suzhou) Co. Ltd.",1]