[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Shanghai EpimAb Biotherapeutics Co., Ltd.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":142},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,43,66,89,112],{"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":27,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100642954","phase-1-a-first-in-human-phase-i-study-to-evaluate-emb-15-in-patients-with-locally-advanced-or-metastatic-solid-tumors-100642954",false,"NCT07607054","A First-in-human Phase I Study to Evaluate EMB-15 in Patients With Locally Advanced or Metastatic Solid Tumors.","A First-in-Human, Phase I, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics, and Preliminary Antitumor Activity of EMB-15 in Patients With Locally Advanced or Metastatic Solid Tumors","Inclusion Criteria:\n\n\\- 1) Able to understand and willing to sign an ICF 2) Males or females with the age ≥ 18 years 3) Life expectancy \\> 3 months. 4) ECOG performance status 0 or 1 5) Patients must have histologically or cytologically confirmed locally advanced or metastatic solid tumors, without standard therapy.\n\n6\\) Patients must provide archived tumor samples collected within 1 year. 7) Adequate hematological and organ function.\n\nExclusion Criteria:\n\n* Patients meeting any of the following criteria will not be enrolled:\n\n  1. Any prior ALPP\u002FALPG targeting therapy\n  2. Has received anticancer therapy, radiotherapy, or investigational drug within \\\u003C 5 half-lives or 4 weeks (whichever is shorter) prior to study treatment;\n  3. Active autoimmune disease or history of autoimmune disease\n  4. Concurrent malignancy \\\u003C 5 years prior to study entry\n  5. active infection\n  6. Severe or uncontrolled cardiovascular disease requiring treatment\n  7. Other severe medical conditions","ALL","18 Years",{"count":19,"type":20},50,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","The primary purpose of this study is to evaluate safety and tolerability profile of EMB-15, identify the recommended Phase 2 dose(s) (RP2Ds) for EMB-15. Pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity, and the anti-tumor activity of EMB-15 will also be assessed.",[26],"Locally Advanced or Metastatic Solid Tumors",[28,29],"Phase 1","EMB-15","RECRUITING","2026-06-11",{"date":33,"type":34},"2026-06-15","ACTUAL",{"date":36,"type":20},"2026-05-26",{"date":38,"type":20},"2029-10-30",{"name":40,"class":41},"Shanghai EpimAb Biotherapeutics Co., Ltd.","INDUSTRY",1,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":50,"enrollmentInfo":51,"targetDuration":4,"studyType":21,"phases":53,"briefSummary":54,"conditions":55,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":4},"100643131","phase-1-emb-01-in-combination-with-chemotherapy-for-unresectable-or-metastatic-colorectal-cancer-100643131","NCT07649655","EMB-01 in Combination With Chemotherapy for Unresectable or Metastatic Colorectal Cancer","A Phase Ib, Open-Label Study of EMB-01 in Combination With Chemotherapy in Patients With Unresectable or Metastatic Colorectal Cancer","Inclusion Criteria:\n\n* 1\\. Male or female patients aged ≥ 18 and \\\u003C 75 years. 2. Histologically or cytologically confirmed unresectable or metastatic left-sided colorectal cancer (primary tumor located from the splenic flexure to the rectum), with measurable disease per RECIST v1.1.\n\n  3\\. ECOG performance status ≤ 1. 4. Agrees to provide archival tumor tissue (formalin-fixed paraffin-embedded, collected within 18 months) or newly obtained biopsy tissue. If no eligible archival tissue is available and the patient's clinical condition is not suitable for biopsy, the patient may be screened after confirmation and agreement between the investigator and sponsor.\n\n  5\\. Adequate organ function within 14 days prior to the first dose of study treatment 6. Prior anti-tumor therapy:\n  1. Patients who received any approved or investigational anti-cancer therapy must have discontinued such therapy at least 4 weeks prior to the first dose of study treatment or 5 half-lives of the agent, whichever is shorter.\n  2. Patients who received local radiotherapy, bone metastasis radiotherapy, or oral fluoropyrimidines must have discontinued such therapy at least 2 weeks prior to the first dose of study treatment. No therapeutic radiopharmaceuticals within 8 weeks prior to the first dose of EMB-01.\n\n     Prior anti-tumor therapy requirements by combination regimen\\*:\n* Arm A (irinotecan) and Arm B (TAS-102): Prior fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, plus prior anti-VEGF therapy (with or without anti-EGFR therapy), with disease progression or intolerance; no prior TAS-102\u002Ffruquintinib\u002Fregorafenib. If prior anti-EGFR therapy was received, the patient must have achieved CR, PR, or SD, with the last anti-EGFR dose administered at least 4 months prior to the first study drug dose.\n* Arm C (mFOLFOX6): No prior oxaliplatin-based chemotherapy and no prior anti-EGFR therapy.\n* Arm D (FOLFIRI): No prior irinotecan-based chemotherapy and no prior anti-EGFR therapy.\n\n  7\\. Female patients of childbearing potential or male patients with partners of childbearing potential must use one or more contraceptive methods from the screening period, continue such methods during study treatment, and until 3 months after the last dose of EMB-01 (for Arm B: 6 months after last TAS-102 dose for both sexes; for Arm C: 9 months after last oxaliplatin dose for females, 6 months for males; for Arm A\u002FD: 6 months after last chemotherapy dose for females, 3 months for males).\n\n  8\\. Able to swallow and retain oral medications, and has adequate venous access.\n\nExclusion Criteria:\n\n* 1\\. Expected survival \\\u003C 3 months. 2. Presence of KRAS\u002FNRAS (exons 2, 3, 4), BRAF V600, HER2 positivity (IHC3+ and\u002For amplification), RET\u002FNTRK fusion, or other molecular alterations that may affect anti-EGFR or cMET therapy efficacy, as detected by central laboratory testing at screening or documented in prior treatment history. (Discussion between investigator and sponsor in writing is recommended if applicable.) 3. Persistent adverse events (AEs) from prior anti-tumor therapy \\> Grade 2 per CTCAE v5.0, except alopecia, Grade 2 fatigue, or Grade 2 peripheral neuropathy.\n\n  4\\. Primary central nervous system (CNS) malignancy or symptomatic CNS\u002Fleptomeningeal metastases. Asymptomatic CNS metastases are allowed if no local radiotherapy is required, or if radiotherapy was completed ≥ 4 weeks prior to first study dose.\n\n  5\\. Prior treatment with anti-EGFR × cMET bispecific antibody or bispecific ADC. 6. Discontinuation of EGFR inhibitors due to skin toxicity. 7. History of life-threatening hypersensitivity, or known allergy to recombinant proteins\u002Fexcipients in EMB-01 or any study treatment contraindication.\n\n  8\\. Systemic corticosteroids (\\> 10 mg prednisone equivalent\u002Fday) or other immunosuppressants required within 14 days prior to first dose, regardless of autoimmune disease. Inhaled\u002Ftopical\u002Focular\u002Fnasal\u002Fjoint steroids are permitted; adrenal replacement steroids are allowed at \\>10 mg\u002Fday if no active autoimmune disease.\n\n  9\\. Severe\u002Funcontrolled cardiac disease requiring treatment 10. Use or planned use of QT-prolonging or rhabdomyolysis-inducing drugs during screening through study end (only Arm C); or known CYP3A4\u002FUGT1A1 strong inhibitors\u002FCYP3A4 inducers\u002Fanticholinesterase neuromuscular blockers (only Arms A\u002FD).\n\n  10\\. Rare hereditary galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption (only Arm B).\n\n  11\\. Other serious uncontrolled medical, psychiatric, or familial\u002Fendemic conditions that may interfere with study assessments, adherence, or safety (investigator's assessment).\n\n  12\\. Any condition that, in the investigator's opinion, makes study participation not in the patient's best interest or confounds study evaluations.","74 Years",{"count":52,"type":20},120,[23],"This is an open-label, multicenter, Phase Ib trial designed to evaluate the safety, tolerability, and preliminary efficacy of EMB-01 in combination with chemotherapy in patients with unresectable or metastatic colorectal cancer (CRC), and to determine the recommended Phase II combination dose (RP2CD). The study consists of a dose escalation phase followed by a dose expansion phase. Approximately 30 patients are planned to be enrolled in each combination treatment group across both phases, with a maximum total enrollment of approximately 120 patients.",[56],"Unresectable\u002FMetastatic Colorectal Cancer","NOT_YET_RECRUITING","2026-06-10",{"date":60,"type":34},"2026-06-16",{"date":62,"type":20},"2026-07",{"date":64,"type":20},"2028-12-31",{"name":40,"class":41},{"id":67,"slug":68,"hasResults":11,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":4,"eligibilityCriteria":72,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":73,"targetDuration":4,"studyType":21,"phases":75,"briefSummary":77,"conditions":78,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":88},"100617105","phase-2-phase-ii-study-of-emb-01-in-recurrentmetastatic-colorectal-cancer-patients-100617105","NCT07314294","Phase II Study of EMB-01 in Recurrent\u002FMetastatic Colorectal Cancer Patients","A Randomized, Open-label, Phase II Study of EMB-01 in Patients With Recurrent\u002FMetastatic Colorectal Cancer","Inclusion Criteria:\n\n1. Able to understand and willing to sign the informed consent form (ICF).\n2. Male or female aged ≥ 18 years.\n3. Histologically or cytologically confirmed unresectable or metastatic left-sided colorectal cancer (primary tumor from splenic flexure to rectum) with at least one measurable lesion according to RECIST v1.1.\n4. ECOG performance status ≤ 1.\n5. Willing to provide a fresh tumor biopsy sample or a stored sample obtained within the past 2 years.If no eligible archived tumor tissue sample is available and the patient's clinical condition is not suitable for biopsy, the patient may still be allowed to participate in screening upon confirmation and agreement between the investigator and the sponsor.\n6. Adequate organ function prior to the first study treatment.\n7. Prior anti-cancer treatment:\n\n   1. Must have progressed on or been intolerant to at least first- or second-line systemic therapy for metastatic colorectal cancer. Prior therapy must include fluoropyrimidine, oxaliplatin, and irinotecan-based chemotherapy, and bevacizumab with or without cetuximab. Patients should not have received TAS-102, fruquinitinib, or regorafenib.\n   2. Any approved or investigational anti-cancer therapy (chemotherapy, immunotherapy, hormone therapy except for replacement therapy, testosterone, or oral contraceptives, biological therapy, targeted therapy) must be discontinued ≥ 4 weeks or 5 half-lives (whichever is shorter) before first study treatment.\n   3. Local radiotherapy, bone metastasis radiotherapy, or oral fluoropyrimidines (e.g., tegafur, capecitabine) must be stopped ≥ 2 weeks before first study treatment; therapeutic radiopharmaceuticals must not have been administered within 8 weeks prior to the first dose of EMB-01.\n8. Women of childbearing potential or male patients with partners of childbearing potential must use one or more contraceptive methods from clinical screening and continue during study treatment until 3 months after the last EMB-01 dose.\n\nExclusion Criteria:\n\n1. Presence of KRAS\u002FNRAS exon 2, 3, 4 mutations, BRAF V600 mutation, HER2 positivity (IHC3+ or amplification), RET fusion, NTRK fusion, or other molecular mutations affecting anti-EGFR or cMET efficacy(Investigator and sponsor discussion recommended if applicable), based on central lab testing or prior treatment history.\n2. Life expectancy \\\u003C 3 months.\n3. Residual adverse events (AEs) from prior anti-cancer therapy \\> CTCAE grade 1.\n4. Primary CNS malignancy or symptomatic CNS metastases (brain, leptomeningeal, or arachnoid). Patients with asymptomatic CNS metastases may be eligible if no local radiotherapy is needed, or radiotherapy was completed ≥ 4 weeks prior to study treatment.\n5. Pregnant or breastfeeding women.\n6. Major surgery within 28 days prior to screening. Surgical wounds must be fully healed.\n7. Idiopathic pulmonary fibrosis, unresolved active or chronic inflammatory lung disease, or history of interstitial lung disease (ILD). Patients with resolved radiation pneumonitis may be eligible.\n8. History of Stevens-Johnson syndrome, toxic epidermal necrolysis, or severe skin infections.\n9. Prior dual anti-EGFR and cMET therapy or bispecific antibody-drug conjugates (ADCs).\n10. Prior EGFR inhibitor therapy discontinued due to severe skin toxicity.\n11. Other significant medical conditions, psychiatric or psychological disorders, or familial\u002Fendemically high-risk diseases that may interfere with study assessments, treatment, follow-up, adherence, or increase risk of treatment-related complications.\n12. Any condition deemed by the investigator to make study participation not in the patient's best interest or likely to interfere, limit, or confound study assessments.",{"count":74,"type":20},54,[76],"PHASE2","This study is testing different dosing schedules of EMB-01 in patients with advanced colorectal cancer whose disease has recurrent or progressed on previous treatments. Patients will be randomly assigned to one of two dosing schedules: EMB-01 once weekly, or once weekly for 6 weeks then every two weeks.",[79],"Metastatic Colorectal Cancer","2026-03-02",{"date":82,"type":34},"2026-03-03",{"date":84,"type":34},"2025-12-18",{"date":86,"type":20},"2028-06-30",{"name":40,"class":41},2,{"id":90,"slug":91,"hasResults":11,"nctId":92,"briefTitle":93,"officialTitle":94,"acronym":4,"eligibilityCriteria":95,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":96,"targetDuration":4,"studyType":21,"phases":98,"briefSummary":99,"conditions":100,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":111,"locationsCount":4},"100626160","phase-1-a-phase-iii-study-to-evaluate-the-safety-tolerability-and-preliminary-efficacy-of-the-emb-07-combination-therapy-in-patients-with-aggressive-b-cell-non-hodgkin-lymphoma-100626160","NCT07432022","A Phase I\u002FII Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of the EMB-07 Combination Therapy in Patients With Aggressive B-Cell Non-Hodgkin Lymphoma","A Phase I\u002FII, Open-label, Multicenter Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of EMB-07 (a Bispecific Antibody Targeting CD3 and Receptor-tyrosine-kinase-like Orphan Receptor 1 [ROR1]) Combination Therapy in Patients With Aggressive B-cell Non-Hodgkin Lymphoma","Inclusion Criteria:\n\n1. Ability to understand and voluntarily sign the Informed Consent Form (ICF);\n2. Patients aged ≥18 years;\n3. Life expectancy \\> 12 weeks;\n4. ECOG performance status score: ≤1 point during the dose escalation phase, ≤2 points during the dose expansion phase.\n5. Cohort A: Pathologically confirmed aggressive R\u002FR B-NHL, including DLBCL, not otherwise specified (NOS), or DLBCL transformed from indolent lymphoma (e.g., follicular lymphoma) (t-DLBCL), or other aggressive B-NHL judged to potentially benefit from study treatment by the investigator and sponsor (e.g., high-grade B-cell lymphoma \\[HGBL\\], Richter transformation, other large B-cell lymphoma subtypes).\n\nCohort B: Newly diagnosed, treatment-naïve DLBCL NOS confirmed by pathology, or t-DLBCL not previously treated with adequate (at least 2 cycles) R-CHOP therapy (excluding Richter transformation or HGBL with BCL2\u002FMYC±BCL6 rearrangements). Patients with newly diagnosed DLBCL NOS should have an International Prognostic Index (IPI) score ≥2 and Ann Arbor stage ≥2. The sponsor will reserve the right to limit the number of t-DLBCL patients enrolled in the study. Other aggressive B-NHLs patients who may benefit from the study treatment can be enrolled after careful risk\u002Fbenefit assessment by the sponsor and investigator.\n\nExclusion Criteria:\n\n1. Current or prior central nervous system (CNS) or meningeal involvement related to the underlying disease.\n2. Cohort A: Prior exposure to any ROR1-targeted agent (e.g., biologic or CAR-T); or Cohort A1: Prior exposure to Gemcitabine-based chemotherapy (≥ 2 consecutive cycles); or Cohort A2: Prior exposure to Polatuzumab Vedotin; or Cohorts A3 and A4: Refractory to prior Lenalidomide\u002FZanubrutinib or Chidamide therapy, respectively.\n3. Contraindications to any agent included in the combination therapy regimen.\n4. Cohort A: Candidates suitable for ASCT or CAR-T cell therapy.\n5. Cohort A: Use of any standard or investigational therapy for the underlying disease within 28 days before C1D1 or 5 half-lives (whichever is shorter), including chemotherapy, immunotherapy, radioimmunotherapy, non-palliative radiotherapy, or any other anti-tumor therapy. Only palliative radiotherapy to non-target lesions will be permitted.\n6. Cohort B: B-NHL with prior receipt of at least 2 consecutive cycles of R-CHOP (prior lymph node biopsy or local radiotherapy will not be an exclusion criterion).\n7. Major surgery or live vaccine administration within 28 days prior to C1D1.\n8. History of allogeneic hematopoietic stem cell transplantation or solid organ transplantation (except corneal transplantation). In addition, patients who received ASCT within 3 months before C1D1, CAR-T within 6 months before C1D1, or diagnosed with graft-versus-host disease (GVHD) will be excluded.\n9. Any AE related to prior therapy (excluding alopecia) that has not resolved to Grade ≤ 1 (per the Common Terminology Criteria for Adverse Events \\[CTCAE\\], Version 5.0) or baseline at C1D1.\n10. Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection at screening. Patients with positive HBsAg and\u002For positive HBcAb but negative HBV DNA will be eligible for enrollment. Patients with positive HCV antibody but negative HCV RNA are also eligible for enrollment.\n11. Known positive HIV serology or history of active viral infection\n12. Active infection requiring parenteral antibiotics, antivirals, or antifungals within 14 days before C1D1; prophylactic use of these agents (including parenteral administration) will be permitted.\n13. Prior malignancy requiring treatment or with evidence of recurrence within 5 years before C1D1 (except non-melanoma skin cancer or adequately treated carcinoma in situ of the cervix). Patients with a history of cancer treated with curative intent \\> 5 years before C1D1 and no evidence of recurrence will be eligible.\n14. Ischemic or hemorrhagic stroke of Grade ≥ 3, or gastrointestinal bleeding of Grade ≥ 3, within 6 months before C1D1.\n15. Active, unstable cardiovascular function:\n\n    * Myocardial infarction within 6 months before C1D1;\n    * Unstable angina within 3 months before C1D1;\n    * Clinically significant uncontrolled arrhythmias (e.g., sustained ventricular tachycardia, ventricular fibrillation, torsades de pointes);\n    * Mobitz type II second-degree or third-degree atrioventricular block;\n    * Congestive heart failure at class ≥ 3 per New York Heart Association (NYHA)\n    * Known left ventricular ejection fraction (LVEF) \\\u003C 50%.\n16. Known or suspected history of hemophagocytic lymphohistiocytosis (HLH);\n17. Known history of progressive multifocal leukoencephalopathy;\n18. Active autoimmune disease requiring treatment\n\n    * Patients with a history of autoimmune hypothyroidism on a stable dose of thyroid hormone replacement will be eligible.\n    * Type 1 diabetes mellitus well-controlled with insulin therapy will be permitted.\n    * Patients with a history of autoimmune hepatitis, systemic lupus erythematosus, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, granulomatosis with polyangiitis, Sjögren's syndrome, multiple sclerosis, or glomerulonephritis will be excluded.\n    * Patients with a history of immune thrombocytopenic purpura, autoimmune hemolytic anemia, Guillain-Barré syndrome, myasthenia gravis, myositis, rheumatoid arthritis, vasculitis, or other autoimmune diseases are excluded unless no systemic therapy has been required in the past 12 months.\n19. Prior systemic immunosuppressive medication (including but not limited to cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor agents) within 28 days before C1D1.\n20. Systemic corticosteroid use within 2 weeks before study treatment at a dose equivalent to \\> 10 mg\u002Fday Prednisone. Inhaled, topical, or ophthalmic steroids will be permitted. Short-term corticosteroid use (e.g., prophylaxis for intravenous contrast) will be permitted.\n21. Any other severe underlying medical condition (e.g., active gastric ulcer, uncontrolled seizures, cerebrovascular event, gastrointestinal bleeding, coagulation\u002Fthrombotic disorders with severe signs\u002Fsymptoms, cardiac disease), or psychiatric, psychological, familial, or geographic factors that, in the investigator's judgment, possibly interfere with scheduled disease assessments, treatment, and follow-up, compromise patient compliance, or place the patient at high risk of treatment-related complications.\n22. Female patients who are pregnant or breastfeeding. Abuse of alcohol, cannabis-derived products, or other controlled substances.",{"count":97,"type":20},115,[23,76],"This is an open-label, multicenter, Phase I\u002FII study designed to evaluate the safety, tolerability, pharmacokinetic characteristics, and preliminary efficacy of EMB-07 combination therapy in adult patients with aggressive B-cell non-Hodgkin lymphoma (B-NHL). The study consists two phases: Phase I of dose escalation and Phase II of dose expansion. Approximately 115 patients will be enrolled in this study (i.e., 5 cohorts of approximately 23 patients per cohort). Multiple EMB-07-based combination regimens will be evaluated in patients with relapsed\u002Frefractory (R\u002FR) aggressive B-NHL (Cohort A) and patients with newly diagnosed aggressive B-NHL (Cohort B).",[101,102,103,104],"Combination Therapy","Aggressive B-Cell Non-Hodgkin Lymphoma","EMB07","phaseI\u002FII","2026-02-24",{"date":107,"type":34},"2026-02-25",{"date":109,"type":20},"2026-03-01",{"date":86,"type":20},{"name":40,"class":41},{"id":113,"slug":114,"hasResults":11,"nctId":115,"briefTitle":116,"officialTitle":117,"acronym":4,"eligibilityCriteria":118,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":119,"targetDuration":4,"studyType":21,"phases":121,"briefSummary":122,"conditions":123,"keywords":127,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":133,"lastUpdatePostDateStruct":134,"startDateStruct":136,"completionDateStruct":138,"leadSponsor":140,"locationsCount":141},"100452834","phase-1-emb-01-in-patients-with-advancedmetastatic-gastrointestinal-cancers-100452834","NCT05176665","EMB-01 in Patients With Advanced\u002FMetastatic Gastrointestinal Cancers","Phase Ib\u002FII, Open-Label Study of EMB-01 in Patients With Advanced\u002FMetastatic Gastrointestinal Cancers","Inclusion Criteria:\n\nMolecular Pre-screening Inclusion criteria\n\n1. cMET amplification in tumor sample; OR\n2. cMET overexpression in tumor sample; OR\n3. EGFR overexpression in tumor sample; OR\n4. Other EGFR or cMET gene alteration in blood sample (circulating tumor DNA, ctDNA).\n\nIn Phase II, CRC patients must provide blood sample for NGS test, but may not provide tumor samples at prescreening visit. CRC patients don't need to meet the above criteria of EGFR\u002FcMET amplification, overexpression or gene aberration.\n\nScreening Inclusion Criteria\n\n1. Able to understand and willing to sign the Informed Consent Form (ICF).\n2. Histologically\u002Fcytologically confirmed advanced\u002Fmetastatic gastric cancer, HCC, BTC, and colorectal cancer with measurable disease (RECIST V1.1). To be eligible, patients must meet following criteria:\n\n   1. Have failed all standard of care therapies known to confer clinical benefit. Patients who is not tolerable on standard of care therapies, or no standard of care therapies available, or refused standard of care therapies are eligible.\n   2. Have measurable disease as defined by RESIST v 1.1.\n3. Archival tumor tissue (formalin-fixed or paraffin-embedded, collected within 1 year) or a new biopsy collected in the molecular pre-screening visit.\n4. Must have adequate organ function.\n5. Regarding prior anti-tumor therapy:\n\n   1. Patients who have received any anticancer drugs approved or investigational, including chemotherapy, immune therapy, hormonal therapy (Exceptions: hormone-replacement therapy, testosterone or oral contraceptives), biologic therapy, must have stopped treatment at least 4 weeks or within 5 half -lives whichever shorter before first dose of EMB-01.\n   2. Local radiotherapy or radiation therapy for bone metastases must have stopped 2 weeks before first dose of EMB-01. No therapeutic radiopharmaceuticals are taken within 8 weeks before first dose of EMB-01.\n   3. Patients who have received prior targeted therapies must have stopped treatment for at least 4 weeks or within 5 half-lives, whichever is shorter before first dose of EMB-01.\n6. Female patient with fertility or male patient whose partner has fertility should use one or more contraceptive methods for contraception starting from screening period and continue throughout the study treatment and for 3 months.\n7. ECOG score ≤1.\n\nExclusion Criteria:\n\nMolecular Pre-screening Exclusion Criteria\n\nSubject who meets any of the following criteria can't be proceeded to clinical screening:\n\n1. Patients who are unwilling to sign the molecular pre-screening ICF.\n2. Patients for whom the results of central laboratory testing do not meet the molecular pre-screening inclusion criteria.\n3. Patients with a documented gene alteration including but not limited to HER2, KRAS, NRAS, BRAF, NTRK, ALK, RET, ROS1, and FGFR, etc. that is known to confer resistance to EGFR and\u002For cMET inhibitors.\\* \\* In Phase II, CRC patients with activated KRAS, NRAS or BRAF mutation should be excluded, but patients with other gene alterations do not need to be excluded.\n\nScreening Exclusion Criteria\n\n1. Life expectancy \\\u003C 3 months.\n2. Patients with primary central nervous system (CNS) malignancy or symptomatic CNS (leptomeningeal or brain) metastases are not allowed. Patients with asymptomatic CNS metastases are eligible.\n3. Pregnant or nursing females.\n4. Patients who have had major surgery within the 28 days from the screening. Surgical wounds must be completely healed.\n5. Any other serious underlying medical (e.g. uncontrolled diabetes mellitus, active uncontrolled infection, active gastric ulcer, uncontrolled seizures, cerebrovascular incidents, gastrointestinal bleeding, severe signs and symptoms of coagulation and clotting disorders, cardiac conditions), psychiatric, psychological, familial or geographical condition that, in the judgment of the investigator, may interfere with the planned staging, treatment and follow-up, affect patient compliance or place the patient at high risk from treatment-related complications.",{"count":120,"type":20},152,[23,76],"This study is to evaluate the safety and antitumor activity of EMB-01 in advanced\u002Fmetastatic gastrointestinal cancers, including gastric cancer, hepatocellular cancer, cholangiocarcinoma and colorectal cancer.",[124,125,126],"Neoplasms","Neoplasm Metastasis","Metastatic Gastrointestinal Carcinoid Tumor",[128,129,130,131,125,132],"Human Bispecific antibody","Epidermal Growth Factor Receptor (EGFR)","c-Mesenchymal-Epithelial Transition (cMet)","Neoplasms， Neoplasm Metastasis","EMB-01，Tyrosine Kinase Inhibitor (TKI) Resistant","2024-08-22",{"date":135,"type":34},"2024-08-26",{"date":137,"type":34},"2021-10-21",{"date":139,"type":20},"2025-12-31",{"name":40,"class":41},14,""]