[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"locally-advanced--metastatic-solid-tumors\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:locally-advanced--metastatic-solid-tumors":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,52],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":34,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":41,"startDateStruct":44,"completionDateStruct":46,"leadSponsor":48,"locationsCount":51},"100659014","phase-1-si-b036-st-101-in-advancedmetastatic-solid-tumors-100659014",false,"NCT07857616","SI-B036-ST-101 in Advanced\u002FMetastatic Solid Tumors","SI-B036-ST-101: A Multicenter, Open-Label, Phase 1\u002F1b, First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of SI-B036 in Adult Patients With Advanced\u002FMetastatic Solid Tumors That Are Refractory to Standard Therapies","Inclusion Criteria:\n\n* Documented locally advanced or metastatic solid tumor(s) not amenable to curative surgery or radiation and have received at least 1 line of standard therapy, including adjuvant\u002Fneoadjuvant treatment, or whose cancer is considered refractory to the standard of care (SOC) or for which no standard treatment is available.\n* Toxicity of previous antitumor therapy has returned to level ≤1 as defined by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) V6.0.\n* Has no serious cardiac dysfunction and left ventricular ejection fraction ≥50%.\n* Has adequate organ function before enrollment\n\nPART C Additional Inclusion Criteria (Dose Expansion Only)\n\n\\- For immuno-oncology (IO)-exposed non-small cell lung cancer (NSCLC): histologically or cytologically confirmed unresectable locally advanced or metastatic non-small cell lung cancer (NSCLC) in subjects who are previously exposed to immune checkpoint inhibitor (ICI) therapy (IO-exposed) and whose disease is refractory to standard of care (SOC) therapy or for whom no appropriate standard treatment options are available. In addition, subjects must have received at least one prior line of platinum therapy.\n\nFor IO naïve NSCLC: histologically or cytologically confirmed unresectable locally advanced or metastatic NSCLC in subjects who are not previously exposed to ICI therapy. Subjects must also have PD-L1 expression ≥1% (tumor proportion score \\[TPS\\]) as determined by an FDA-approved assay. In addition, subjects must have received at least one prior line of platinum therapy.\n\nFor Melanoma: histologically confirmed unresectable or metastatic melanoma with prior treatment with an immune checkpoint inhibitor regimen and documented disease progression following such therapy.\n\nFor Ovarian Cancer: has histologic documentation of epithelial ovarian, primary peritoneal, or fallopian tube cancer that has progressed or relapsed on or after a previous chemotherapy with or without a poly (ADP-ribose) polymerase (PARP) inhibitor. Prior bevacizumab treatment is allowed.\n\nExclusion Criteria:\n\n* Chemotherapy, biological therapy, immunotherapy, targeted therapy (including small molecule inhibitor of tyrosine kinase), and other antitumor therapy within 4 weeks or 5 half-lives (whichever is shorter) prior to the first administration; radical radiotherapy, major surgery within 4 weeks prior to the first administration; mitomycin and nitrosoureas treatment within 6 weeks prior to the first administration; oral drugs such as Ticio such as capecitabine, or palliative radiotherapy within 2 weeks prior to initial administration.\n* Received systemic immunostimulatory therapy within 4 weeks prior to the first dose or is still within 5 half-lives of the treatment (whichever is longer).\n* Received immunosuppressive drugs within 2 weeks prior to the first dose. The use of topical, inhaled, and locally injected steroids is permitted.\n* Participants with history of severe heart disease within 6 months before enrollment.\n* Participants with prolonged QT interval (QTcF \\>470 msec), complete left bundle branch block, Grade 3 atrioventricular block, or a history of additional risk factors for Torsades de Pointes (TdP) or any current concomitant medication known to prolong the QT\u002FQTc interval or cause TdP.\n* Other malignant tumors were diagnosed within 5 years prior to the first administration.\n* For the dose escalation portion of the study only, participants with a primary diagnosis of lung cancer are excluded.\n* Participants with a thromboembolic event (eg, deep vein thrombosis \\[DVT\\] or pulmonary embolism \\[PE\\]), stroke, or transient ischemic attack (TIA) within 6 months before screening.\n* Participants with active or recent clinically significant bleeding are excluded, or who are at risk of bleeding due to clinically significant platelet abnormalities or coagulopathy, or who require full-dose anticoagulation or high-intensity antiplatelet therapy on high dose nonsteroidal anti-inflammatory drugs (NSAIDs).\n* Active autoimmune diseases and inflammatory diseases. For autoimmune conditions that are active but stable and low-grade on systemic therapy, discussion with the medical monitor is required prior to screening.\n* Participants with advanced\u002Fclinically significant lung diseases, who have a history of noninfectious interstitial lung disease (ILD)\u002Fpneumonitis that required treatment with steroids, have current ILD\u002Fpneumonitis, or where suspected ILD\u002Fpneumonitis cannot be ruled out by imaging at screening, or concurrent pulmonary disease resulting in severe impaired respiratory function.\n* Participants with primary tumors in the central nervous system (CNS), active or untreated CNS metastases or carcinomatous meningitis should be excluded. Participants with previously treated brain metastases may participate provided they are clinically stable for at least 4 weeks and have no evidence of new or enlarging brain metastases and no requirements for corticosteroids 14 days prior to Screening.\n* Participant with active or untreated hemorrhagic CNS lesions.\n* Participants with a history of anaphylaxis or severe hypersensitivity reactions.\n* Previous organ transplantation or allogeneic hematopoietic stem cell transplantation.\n* Subjects with recent surgery, biopsy, or invasive procedures without adequate wound healing prior to study enrollment.\n* Participated in another clinical trial within 4 weeks prior to first dose of study treatment.\n* Participants who are pregnant, breastfeeding, or planning to become pregnant during the study.\n* History of fistula, gastrointestinal perforation, or abdominal abscess within 6 months prior to the first dose.\n* Participant with moderate or major hemoptysis history.\n* Participant has tumors invading large blood vessels\n* Other conditions that the Investigator or sponsor believes are not suitable for participating in this clinical trial.","ALL","18 Years",{"count":19,"type":20},424,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","The objective of the study is to evaluate the safety and tolerability of SI-B036 in participants with solid tumors who have received at least one prior line of therapy for advanced disease.",[26,27,28,29,30,31,32,33],"Locally Advanced \u002FMetastatic Solid Tumors","Locally Advanced \u002F Metastatic Solid Tumors","Metastatic Solid Cancers","Non Small Cell Lung Cancer","Lung Cancer","Melanoma","Ovarian","NSCLC",[35,36,37,38],"PD-L1","VEGFR-2","First in Human","FIH","NOT_YET_RECRUITING","2026-09-30",{"date":42,"type":43},"2026-10-05","ACTUAL",{"date":45,"type":20},"2026-09",{"date":47,"type":20},"2029-10",{"name":49,"class":50},"SystImmune Inc.","INDUSTRY",7,{"id":53,"slug":54,"hasResults":11,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":58,"eligibilityCriteria":59,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":60,"targetDuration":4,"studyType":21,"phases":62,"briefSummary":64,"conditions":65,"keywords":66,"overallStatus":81,"whyStopped":4,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":91},"100618736","phase-1-cr-001-in-adult-participants-with-locally-advanced-or-metastatic-solid-tumors-100618736","NCT07335497","CR-001 in Adult Participants With Locally Advanced or Metastatic Solid Tumors","A Phase 1\u002F2, Multicenter, Open-label, Dose Escalation and Dose Expansion Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Antitumor Activity of CR-001 in Adult Participants With Locally Advanced or Metastatic Solid Tumors","ASCEND","Key Inclusion Criteria\n\n* Life expectancy ≥ 3 months\n* Eastern Cooperative Oncology Group (ECOG) performance status score of 0 - 1\n* Adequate organ function and hematologic reserve based on laboratory parameters\n* Have measurable disease defined by RECIST v1.1\n* For Backfill and Dose Optimization: Willingness to provide recent archival tumor tissue sample or willingness to undergo biopsy\n* Tumor Indication specific inclusion criteria:\n* For dose escalation or backfill: progressing from, intolerant to, or ineligible for (due to unavailability or contraindication) local standard of care therapies and have one of the following locally advanced or metastatic tumor types:\n\n  * Hepatocellular carcinoma\n  * Biliary tract cancer\n  * Endometrial carcinoma\n  * Cervical cancer\n  * Ovarian cancer\n  * Gastric or gastroesophageal cancer\n  * Colorectal cancer\n  * Non-small cell lung cancer\n\nKey Exclusion Criteria\n\n* Has malignancies other than disease under study within the past 3 years\n* Has conditions requiring treatment with clinically significant or increasing doses of systemic steroid therapy\n* Has not adequately recovered from recent major surgery\n* Has ongoing clinically significant toxicity related to prior therapy\n* Has active central nervous system (CNS) metastases\n* Has active autoimmune disease requiring systemic therapy in the past 2 years (replacement therapy is permitted)\n* Has a history of serious Grade ≥ 3 immune-related adverse event (irAE)\n* Has a history of noninfectious pneumonitis\u002Finterstitial lung disease\n* Has an active severe infection\n* Has received a live or attenuated vaccine within 30 days of the first dose\n* Has undergone prior allogeneic stem cell or solid organ transplantation\n* Has protocol-specified events related to gastrointestinal perforation, surgery, wound healing complications, and bleeding\n* Has clinically significant cardiovascular disease NOTE: Other protocol defined Inclusion and Exclusion criteria may apply.",{"count":61,"type":20},290,[23,63],"PHASE2","The purpose of this study is to determine the safety and tolerability of monotherapy CR-001 and identify the maximum tolerated dose (MTD), and\u002For optimal biologic dose and Recommended Phase 2 Dose(s) (RP2D) in participants with locally advanced or metastatic solid tumors.",[27],[67,68,69,70,71,72,73,74,75,76,77,78,79,80],"solid tumors","metastatic","VEGF","PD-1","anti-PD-1","anti VEGF","immuno-oncology","anti-angiogenic therapy","checkpoint inhibitor","metastatic cancer","advanced cancer","First-in-Human","Dose Escalation","Dose Optimization","RECRUITING","2026-09-08",{"date":84,"type":43},"2026-09-10",{"date":86,"type":43},"2026-02-17",{"date":88,"type":20},"2029-02",{"name":90,"class":50},"Crescent Biopharma, Inc.",31]