[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Shanghai Allink Biotherapeutics Co., Ltd.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":112},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,43,70,90],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":4},"100649903","phase-2-phase-ii-clinical-study-to-evaluate-the-safety-tolerability-pharmacokinetics-and-antitumor-activity-of-alk201-for-injection-in-combination-with-ivonescimab-injection-in-sqnsclc-participants-100649903",false,"NCT07742956","Phase II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Antitumor Activity of ALK201 for Injection in Combination With Ivonescimab Injection in sqNSCLC Participants.","An Open-label, Multicenter Phase II Clinical Trial to Evaluate ALK201 for Injection Combined With Ivonescimab Injection in Subjects With Locally Advanced or Metastatic Squamous Non-Small Cell Lung Cancer","Inclusion Criteria:\n\n1. The subject fully understands and agrees to comply with all study procedures, and voluntarily signs the pre-screening informed consent form and main study informed consent form.\n2. Aged ≥18 years and ≤75 years at the time of informed consent signature, with no gender restriction.\n3. Expected overall survival ≥3 months.\n4. At least one measurable lesion per RECIST Version 1.1. Lesions previously treated with radiotherapy or other local therapies may serve as target lesions if radiological evidence of disease progression in such lesions is confirmed.\n5. Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0 or 1.\n6. Subjects must have adequate organ function, and have not received blood transfusion or hematopoietic growth factor support within 14 days prior to the first administration of ALK201.\n7. Serum pregnancy test result is negative for female subjects of childbearing potential during the screening period.\n\nExclusion Criteria:\n\n1. Adverse events related to prior anti-tumor therapy have not recovered to Grade ≤1 per NCI-CTCAE Version 6.0. Exceptions include alopecia, hypothyroidism stabilized with hormone replacement therapy, and Grade 2 toxicities judged by the Investigator to pose no safety risk (Grade 2 neuropathy is excluded).\n2. Use of strong cytochrome P450 (CYP) 3A4 inhibitors, strong CYP3A4 inducers, or relevant foods within 2 weeks or 5 half-lives prior to the first administration of ALK201 and combination therapy, whichever is longer.\n3. History of other malignancies besides the study disease within 5 years prior to enrollment, except malignancies cured by radical treatment without evidence of recurrence, such as basal cell carcinoma or squamous cell carcinoma of the skin, superficial bladder carcinoma, cervical carcinoma in situ, low-risk prostate cancer, and ductal carcinoma in situ of the breast.\n4. Presence of clinically symptomatic, poorly controlled, or recurrently drained pleural effusion, pericardial effusion, or ascites.\n5. Planned major surgery during study treatment, or subjects within the postoperative recovery period following major surgery. Subjects with prior major surgery must fully recover from surgical toxicities and\u002For complications to Grade ≤1 per CTCAE v6.0 before the first study drug administration; otherwise, they will be excluded.\n6. Evidence of severe or uncontrolled systemic diseases (e.g., decompensated respiratory, hepatic, or renal disorders).\n7. History of solid organ transplantation or hematopoietic stem cell transplantation.\n8. Administration of live attenuated vaccines within 4 weeks before the first dose of ALK201.\n9. Female subjects who are pregnant or breastfeeding.","ALL","18 Years","75 Years",{"count":20,"type":21},156,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","This is an open-label, multicenter, Phase II clinical study to evaluate the safety, tolerability, pharmacokinetics, and anti-tumor activity of ALK201 for Injection combined with Ivonescimab Injection in adult patients with locally advanced or metastatic squamous non-small cell lung cancer (sqNSCLC) who are FGFR2b-positive, EGFR mutation-negative, and ALK-negative. The study consists of two parts: Part A (dose escalation) and Part B (dose optimization).\n\nPart A Dose Escalation Stage: This stage includes three dose levels. Eligible patients with locally advanced or metastatic sqNSCLC who have failed standard therapy will be enrolled to complete DLT assessment.\n\nPart B Dose Optimization Stage: This stage comprises two cohorts, enrolling eligible patients with locally advanced or metastatic sqNSCLC satisfying the respective cohort criteria:\n\nPrimary cohort: PD-L1 expression ≥1% Exploratory cohort: PD-L1 expression \\\u003C1%",[27],"NSCLC (Advanced Non-small Cell Lung Cancer)",[29,30],"NSCLC","sqNSCLC","NOT_YET_RECRUITING","2026-07-29",{"date":34,"type":35},"2026-08-03","ACTUAL",{"date":37,"type":21},"2026-08-20",{"date":39,"type":21},"2029-12-31",{"name":41,"class":42},"Shanghai Allink Biotherapeutics Co., Ltd.","INDUSTRY",{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":50,"targetDuration":4,"studyType":22,"phases":52,"briefSummary":54,"conditions":55,"keywords":58,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":69},"100566531","phase-1-a-study-to-evaluate-the-safety-tolerability-pharmacokinetics-pk-and-antitumor-activity-of-alk201-in-participants-with-advanced-solid-tumors-100566531","NCT06656390","A Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), and Antitumor Activity of ALK201 in Participants With Advanced Solid Tumors","A First-in-Human, Open-Label, Multi-Center Phase I\u002FII Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of ALK201 for Injection in Adult Participants With Advanced Solid Tumors","Inclusion Criteria:\n\n* Men and women ≥18 and ≤75 years old on the day of signing the ICF\n* At least 1 measurable lesion per RECIST v1.1\n* Expected survival ≥3 months\n* Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 or 1\n* Adequate organ function\n* Female participants of childbearing potential or male participants whose partner is a female of childbearing potential agree to use medically effective contraceptive methods from the date of signing the ICF until at least 6 months after the last dose of the IP, and during this period, male participants are not allowed to donate sperms\n\nExclusion Criteria:\n\n* Active or pre-existing autoimmune diseases that may relapse\n* Pleural effusion, pericardial effusion, or intraperitoneal effusion accompanied with clinical symptoms, clinically poorly controlled, or requiring repeated drainage\n* Allergies to any component of ALK201 or other monoclonal antibodies\n* Primary central nervous system malignancies, or active metastases to central nervous system and\u002For metastases to meninges\n* Combined with ≥ Grade 2 stomatitis and\u002For nose bleeding at screening\n* Vaccinated with live vaccines within 4 weeks prior to the first dose\n\nNote: Other protocol defined Inclusion\u002FExclusion criteria may apply",{"count":51,"type":21},202,[53,24],"PHASE1","This is a first-in-human (FIH), open-label, multicenter dose escalation and expansion study of ALK201. The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and antitumor activity of ALK201 as a monotherapy in adult participants with Advanced Solid Tumors. The study will also identify recommended dose(s) for subsequent clinical studies of ALK201.",[56,57],"Advanced Cancer","Advanced Solid Tumors",[59],"First-in-human","RECRUITING","2026-05-20",{"date":63,"type":35},"2026-05-22",{"date":65,"type":35},"2024-10-24",{"date":67,"type":21},"2028-04-22",{"name":41,"class":42},38,{"id":71,"slug":72,"hasResults":11,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":4,"eligibilityCriteria":76,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":77,"targetDuration":4,"studyType":22,"phases":79,"briefSummary":80,"conditions":81,"keywords":82,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":4},"100640597","phase-2-phase-ii-clinical-study-to-evaluate-the-safety-tolerability-pharmacokinetics-and-antitumor-activity-of-alk202-for-injection-in-combination-with-drugs-in-nsclc-participants-100640597","NCT07603791","Phase II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Antitumor Activity of ALK202 for Injection in Combination With Drugs in NSCLC Participants.","An Open, Multicenter Phase II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Antitumor Activity of ALK202 for Injection in Combination With Different Drugs in NSCLC Participants.","Inclusion Criteria:\n\n1. The trial Participants themselves (and\u002For guardians) have understood and agreed to follow the study procedures and voluntarily signed the ICF;\n2. Men and women ≥18 and ≤75 years old on the day of signing the ICF;\n3. The trial participants agree to provide fresh or archived tumor tissues for the detection of the expression status of driving genes or proteins (such as EGFR expression, c-MET expression, and PD-L1 expression status, etc.). If the trial participants are unable to provide the required tumor tissues for testing, their participation in the trial must be approved by the sponsor;\n4. The presence of at least one measurable lesion is required according to the RECIST v1.1 criteria. A neoplastic lesion that has received local treatment, such as radiotherapy, can be taken as a target lesion if disease progression is proved by imaging;\n5. Expected survival ≥ 3 months;\n\nExclusion Criteria:\n\n1. Previously received EGFR- and\u002For MET-targeting ADCs and\u002For ADCs with topoisomerase I inhibitor as the payload;\n2. Participated in other interventional clinical trials within 4 weeks or 5 drug half-lives before the first dose of ALK202 (whichever is shorter). Note: Patients who have participated in another interventional clinical trial, even if they are still in the survival follow-up period of the previous trial, may be enrolled in this study provided that the first dose of ALK202 is to be administered ≥5 half-lives or 4 weeks from the last dose of the trial drug (whichever is shorter);\n3. Received chemotherapy, targeted therapy, immunotherapy, interventional procedure, or other systemic antitumor therapy within 4 weeks (Note: 6 weeks for nitrosourea or mitomycin C, 2 weeks or 5 half-lives of the drugs \\[whichever is shorter\\] for oral fluorouracil and small-molecule targeted drugs, and 2 weeks for Chinese medicines with anti-tumor indications) prior to the first dose of ALK202;\n4. Received radical radiotherapy, whole-brain radiotherapy, or bone marrow irradiation \\> 30% within 4 weeks before the first dose of ALK202; or palliative radiation (including stereotactic radiotherapy) of non-target lesions for symptom relief purposes within 2 weeks prior to the first dose;\n5. Took drugs or food that strongly inhibit or induce the cytochrome P450 (CYP) isoenzyme, CYP3A4 within 2 weeks or within 5 half-lives prior to the first dose of ALK202, whichever is longer.",{"count":78,"type":21},252,[24],"This study is an open, multicenter, phase II clinical study for evaluating the safety, tolerability, pharmacokinetics and anti-tumor activity of ALK202 for injection combined with different drugs in participants with locally advanced or metastatic NSCLC. The study consists of two phases: the Phase IIa (dose escalation) and the Phase IIb (efficacy extension).\n\nPhase IIa (dose escalation) :This stage consists of 3 cohorts, which will respectively recruit participants meeting the criteria for each cohort who have locally advanced or metastatic NSCLC, to complete the dose escalation for each combination regimen.\n\nThe Escalation cohort 1: participants with locally advanced or metastatic EGFR mutation (EGFRmut) non-squamous NSCLC who have failed previous EGFR-TKI treatment, and they will receive ALK202 combined with Osimertinib Mesylate Tablets.\n\nThe Escalation cohort 2: participants with locally advanced or metastatic EGFR wild-type (EGFRwt) NSCLC who have failed previous standard treatment, and they will receive ALK202 combined with Ivonescimab Injection.\n\nThe Escalation cohort 3: participants with locally advanced or metastatic EGFRwt NSCLC who have failed previous standard treatment, and they will receive ALK202 combined with Ivonescimab Injection and Carboplatin Injection.\n\nPhase IIb (Efficacy Extension ) In this phase, three cohorts are initially planned. They will respectively recruit participants with locally advanced or metastatic NSCLC who meet the criteria of each combination regimen, to evaluate the efficacy of ALK202 combined with different drugs, and further assess its safety.\n\nExtension Cohort 1:participants with EGFRmut non-squamous NSCLC that has not received systemic palliative treatment; Extension Cohort 2: participants with NSCLC driver gene negative NSCLC and PD-L1 expression ≥ 1% and high c-MET expression that has not received systemic treatment; Extension Cohort 3: participants with NSCLC driver gene negative NSCLC and PD-L1 expression \\\u003C 1% and high c-MET expression that has not received systemic treatment.",[27],[29],"2026-05-17",{"date":63,"type":35},{"date":86,"type":21},"2026-06-30",{"date":88,"type":21},"2028-12-30",{"name":41,"class":42},{"id":91,"slug":92,"hasResults":11,"nctId":93,"briefTitle":94,"officialTitle":95,"acronym":4,"eligibilityCriteria":96,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":97,"targetDuration":4,"studyType":22,"phases":99,"briefSummary":100,"conditions":101,"keywords":103,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":5},"100570466","phase-1-a-study-to-evaluate-the-safety-tolerability-pharmacokinetics-pk-and-antitumor-activity-of-alk202-in-participants-with-advanced-solid-tumors-100570466","NCT06707610","A Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), and Antitumor Activity of ALK202 in Participants with Advanced Solid Tumors","A First-in-Human, Open-Label, Multi-Center Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of ALK202 for Injection in Adult Participants with Advanced Solid Tumors","Inclusion Criteria:\n\n* Men and women ≥18 and ≤75 years old on the day of signing the ICF\n* At least 1 measurable lesion per RECIST v1.1\n* Expected survival ≥3 months\n* ECOG PS score of 0 or 1\n* Adequate organ function\n* Female participants of childbearing potential or male participants whose partner is a female of childbearing potential agree to use medically effective contraceptive methods (abstinence, birth control pills, barrier contraception, intra-uterine contraceptive device, etc.) from the date of signing the ICF until at least 6 months after the last dose of ALK202, and during this period, male participants are not allowed to donate sperms.\n\nExclusion Criteria:\n\n* Received organ transplant or hematopoietic stem cell transplant previously\n* Vaccinated with live vaccines within 4 weeks prior to the first dose\n* Primary central nervous system malignancies, or active metastases to central nervous system and\u002For metastases to meninges\n* Pregnant or lactating women\n* Pleural effusion, pericardial effusion, or intraperitoneal effusion accompanied with clinical symptoms, clinically poorly controlled, or requiring repeated drainage.\n* Evidence of other severe or uncontrolled systemic diseases (e.g., decompensated respiratory disorder, hepatic disease, or renal disease).\n\nNote: Other protocol defined Inclusion\u002FExclusion criteria may apply.",{"count":98,"type":21},234,[53],"TThis is a first-in-human (FIH), open-label, multicenter dose escalation and expansion study of ALK202. The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and antitumor activity of ALK202 as a monotherapy in adult participants with Advanced Solid Tumors. The study will also identify recommended dose(s) for subsequent clinical studies of ALK202.",[56,102],"Advanced Solid Tumor",[59],"2025-03-09",{"date":106,"type":35},"2025-03-12",{"date":108,"type":35},"2025-02-10",{"date":110,"type":21},"2028-12",{"name":41,"class":42},""]