[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Canwell Biotech Limited\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":63},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,41],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100644013","phase-1-cw-301-fih-study-of-can016-100644013",false,"NCT07664150","CW-301 FIH Study of CAN016","A Phase I\u002FII, Open-Label, Non-Randomized, Multi-Centre First-in-Human Study of CAN016 in Patients With Advanced Solid Tumors","Inclusion Criteria:\n\n1. Provide informed consent voluntarily\n2. Male or female patients ≥18 years of age.\n3. Patients must have a histologically or cytologically confirmed diagnosis of recurrent or metastatic HER2 expression or mutation advanced solid tumor that has failed to or intolerable with standard treatment.\n\n   1. For Phase I dose escalation, patients must have had progression of disease on an HER2 targeted ADC and should be refractory to or intolerant of exiting therapy(ies) known to provide clinical benefit for their condition;\n   2. For Phase II, patients with advanced\u002Funresectable or metastatic HER2 positive (IHC 3+, 2+\u002FISH+) breast cancer, HER2 low\u002Fultralow expression (IHC 1+, 2+\u002FISH-, IHC 0 with membrane staining) breast cancer and other HER2 expression or mutation advanced solid tumors are eligible. Patients must have had progression of disease on prior HER2 targeted ADC.\n4. At least one measurable lesion as per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.\n5. Adequate organ function with 7 days before registration\n6. Eastern Cooperative Oncology Group (ECOG) performance status ≤1.\n7. LVEF ≥50% by either echocardiogram (ECHO) or multigated acquisition scan (MUGA) within 28 days before registration.\n8. Life expectancy of ≥3 months.\n\nExclusion Criteria\n\n1. Patient has received any anticancer therapy (including chemotherapy, targeted therapy, hormonal therapy, biotherapy, immunotherapy, or other investigational agents.) within 28 days or 5 times of half-lives (whichever is shorter) prior to the first dose of the study treatment or who have not recovered from the side effect of such therapy.\n2. Radical radiation therapy (including radiation therapy for over 25% bone marrow) within 4 weeks prior to the first dose of the investigational product or received local palliative radiation therapy for bone metastases within 2 weeks.\n3. Patients have autologous transplantation within 3 months.\n4. Major surgery or had significant traumatic injury within 60 days prior to the first dose of the investigational product or has not recovered from major side effects.\n5. Multiple primary malignancies within 5 years, except adequately resected non-melanoma skin cancer, curatively treated in-situ disease.\n6. Any toxicities from prior treatment that have not recovered to baseline or ≤CTCAE Grade 1 before the start of study treatment, with exception of hair loss.","ALL","18 Years",{"count":19,"type":20},90,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE1","PHASE2","A Phase I\u002FII, Open-Label, Non-Randomized, Multi-Centre First-in-Human Study of CAN016 in Patients with Advanced Solid Tumors",[27],"Patients With Advanced Solid Tumors","RECRUITING","2026-06-29",{"date":31,"type":32},"2026-07-01","ACTUAL",{"date":34,"type":20},"2026-06-18",{"date":36,"type":20},"2029-12-30",{"name":38,"class":39},"Canwell Biotech Limited","INDUSTRY",1,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":48,"targetDuration":4,"studyType":21,"phases":50,"briefSummary":51,"conditions":52,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":55,"lastUpdatePostDateStruct":56,"startDateStruct":58,"completionDateStruct":60,"leadSponsor":62,"locationsCount":40},"100541635","phase-1-intratumoral-can2109-in-subjects-with-solid-tumors-100541635","NCT06332430","Intratumoral CAN2109 in Subjects With Solid Tumors","A Phase 1, Dose Escalation, Open-Label Study of Intratumoral CAN2109 in Subjects With Unresectable or Metastatic Advanced Solid Tumors.","Inclusion Criteria:\n\n1. Able and willing to provide written informed consent and willing to comply with the study's requirements.\n2. Male or female age ≥ 18 years at screening.\n3. Metastatic or locally advanced solid tumor that has progressed on, is refractory to, or for which there is no efficacious standard of care therapy. Preferred tumor types include the following:\n\n   a. Carcinoma of skin, melanoma, Merkel cell carcinoma (MCC), breast cancer, head and neck squamous cell carcinoma (HNSCC), sarcoma, cervical carcinoma, and colorectal cancer\n4. Performance status of 0-1 on the ECOG Performance Scale.\n\nExclusion Criteria:\n\n1. Unresolved toxicities from prior therapy, defined as having not resolved to Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 (v5.0) Grade 0 or 1, with exception of endocrinopathies from prior therapy, alopecia, and vitiligo.\n2. Treatment with systemic corticosteroids at doses exceeding 10 mg\u002Fday prednisone or equivalent.\n3. Has an active infection requiring systemic therapy.\n4. Unstable\u002Finadequate cardiac function defined as follows:\n\n   1. New York Heart Association Class 3 or 4 congestive heart failure\n   2. uncontrolled hypertension\n   3. acute coronary syndrome within 6 months\n   4. clinical important cardiac arrhythmia\n   5. mean corrected QT (QTc) interval corrected for heart rate \\> 480 ms.\n5. A history of interstitial lung disease.\n6. A history of coagulopathy resulting in uncontrolled bleeding or other bleeding disorders.\n7. Participated in a clinical study of an investigational agent within 30 days of screening.\n8. Has known psychiatric, substance abuse, or other disorders that would interfere with cooperation with the requirements of the study in the opinion of the investigator.\n9. Is pregnant or breastfeeding.",{"count":49,"type":20},27,[23],"A phase 1, dose escalation, open-label study of intratumoral CAN2109 in subjects with unstable or metastatic advanced solid tumors or lymphomas.",[53,54],"Solid Tumor","Lymphoma","2024-12-16",{"date":57,"type":32},"2024-12-19",{"date":59,"type":32},"2024-05-28",{"date":61,"type":20},"2026-05-30",{"name":38,"class":39},""]