[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"adult-solid-tumor\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:adult-solid-tumor":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,45,67,96],{"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":28,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100600553","phase-2-trial-investigating-visugromab-in-combination-with-immunochemotherapy-in-1l-treatment-of-participants-with-metastatic-nsclc-100600553",false,"NCT07098988","Trial Investigating Visugromab in Combination With Immunochemotherapy in 1L Treatment of Participants With Metastatic NSCLC","A Ph2, Randomized, Blinded, Placebo-Controlled Trial Investigating the Efficacy and Safety of Visugromab Versus Placebo, in Combination With Pembrolizumab, Pemetrexed, and Carboplatin, in 1L Treatment of Participants With Metastatic NSCLC (GDFATHER-NSCLC-01)","Main Inclusion Criteria:\n\n* Histologically confirmed, newly diagnosed stage IV non-squamous NSCLC.\n* Demonstrated absence of actionable mutations (e.g., EGFR, ALK, among others) that suggest\u002Frequire treatment with available targeted agent.\n* Measurable disease determined by the local site Investigator\u002Fradiology by their assessment per RECIST v1.1.\n* Have not received prior systemic treatment for advanced\u002Fmetastatic NSCLC. Participants who received adjuvant or neoadjuvant therapy are eligible if the adjuvant\u002Fneoadjuvant therapy was completed at least 12 months prior to the development of metastatic disease and did not contain any PD 1\u002FPD L1 directed CPI therapy.\n* Availability of locally determined PD L1 TPS, determined with a test validated for this purpose, from a tumor tissue biopsy obtained after any potential prior systemic treatment for this disease. Participants with PD-L1 TPS ≥ 50% can only be enrolled in case CPI monotherapy is not clinically indicated.\n* Availability of a tissue\u002Fhistological biopsy for translational research investigations and Informed Consent Form (ICF) for biopsy release for translational research signed by participant. The biopsy has to be obtained after any potential prior systemic treatment for this disease and be available for shipment. A cytological sample is not accepted.\n* Age ≥ 18 years on the day of signing the informed consent.\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-1.\n* Adequate organ function (bone marrow, hepatic, renal function and coagulation).\n\nMain Exclusion Criteria:\n\n* Presence of predominantly squamous cell histology or predominantly neuroendocrine histology NSCLC (mixed tumors will be categorized by the predominant cell type) or presence of small cell lung cancer elements (ineligibility independent of percentage).\n* Any acute or chronic major tissue injury that may require maintained GDF 15 function for tissue protection as per Investigator assessment (diagnosed with myocardial infarction, or liver, kidney or other major organ failure, all within \\\u003C 3 months prior to planned treatment start).\n* Major surgery (defined as a surgery which requires general anesthetic and\u002For involves opening of body cavities), within 4 weeks of the first dose of study drug.\n* Received potentially curative radiation therapy to the lung that is \\> 30 Gy within 6 months prior to the first dose of study drug.\n* Received or completed any focal radiotherapy for symptoms within 28 days of the first dose of study drug.\n* Expected to require any other form of antineoplastic therapy while on trial.\n* Clinically active inflammatory bowel disease, active diverticulitis, intra-abdominal abscess, and\u002For gastrointestinal obstruction.\n* Known history of prior malignancy with the exception that the participant has undergone potentially curative therapy with no evidence of that disease recurrence for 5 years since initiation of that therapy.\n* Known or detected clinically active central nervous system (CNS) involvement by NSCLC or other tumors, e.g., with symptomatic metastases and\u002For carcinomatous meningitis. Participants with CNS involvement may be enrolled with mandatory regular imaging of the brain under protocol-defined conditions.\n* Have one of the following cardiovascular risk factors: myocardial infarction in the past 3 months before planned treatment start; uncontrolled heart failure; uncontrolled ventricular arrhythmia; QT interval corrected for heart rate using Fridericia's formula interval ≥ 470 ms regardless of sex; peri\u002Fmyocarditis in the past 3 months before planned treatment start; history of ischemic stroke in the past 3 months before planned treatment start.\n* Any active autoimmune that has required systemic treatment in the past 3 months before planned treatment start (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs).\n* Comedication with metformin or metformin-containing antidiabetics in participants with type II diabetes.\n* Has interstitial lung disease or a history of non-infectious pneumonitis that required systemic steroids or current pneumonitis.\n* Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the trial.","ALL","18 Years",{"count":19,"type":20},107,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","This is an exploratory, signal finding, randomized, placebo-controlled, blinded, multi-center Phase 2b trial of the anti GDF-15 antibody Visugromab (CTL-002) versus Placebo, combined with Immunochemotherapy (ICT: Pembrolizumab, Pemetrexed, Carboplatin) in the first-line treatment of participants with newly diagnosed metastatic non-squamous NSCLC. The trial consists of 3 Parts, a non-randomized Safety-run-in part (Part A) and the subsequent randomized Ph2b trial with 2 treatment arms. After the treatment of 15 participants with visugromab at the expansion dose, an interim safety and preliminary efficacy analysis will be conducted (Part B), followed by the treatment of the remaining participants (Part C).",[26,27],"Metastatic Non-Squamous Non-Small Cell Lung Cancer","Adult Solid Tumor",[29,30,31],"CTL-002","Visugromab","GDF-15","RECRUITING","2026-06-30",{"date":35,"type":36},"2026-07-01","ACTUAL",{"date":38,"type":36},"2025-08-01",{"date":40,"type":20},"2031-03-31",{"name":42,"class":43},"CatalYm GmbH","INDUSTRY",40,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":21,"phases":54,"briefSummary":55,"conditions":56,"keywords":57,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":66},"100611921","phase-2-trial-investigating-visugromab-and-nivolumab-with-or-without-docetaxel-in-2l-treatment-of-participants-with-metastatic-nsclc-100611921","NCT07246863","Trial Investigating Visugromab and Nivolumab With or Without Docetaxel in 2L Treatment of Participants With Metastatic NSCLC","Ph 2, Randomized, Blinded, Placebo-Controlled Trial Investigating the Efficacy and Safety of Visugromab and Nivolumab With or Without Docetaxel Versus Docetaxel in 2L Treatment of Participants With Metastatic NSCLC (GDFATHER-NSCLC-02)","Main Inclusion Criteria:\n\n* Participants must have histologically or cytologically confirmed diagnosis of stage IV non-squamous NSCLC.\n* Participants must have demonstrated absence of actionable mutations (e.g. EGFR, ALK, among others) that suggest\u002Frequire treatment with available targeted agent.\n* Participants must have failed one line of prior systemic treatment for metastatic NSCLC containing an approved anti PD (L)1 checkpoint inhibitor (CPI). The minimum treatment duration on this regimen must have been 12 weeks exposure for the CPI with no documented progression in this period. Failure of the prior line of systemic treatment for metastatic NSCLC must have occurred under ongoing CPI treatment. Discontinuation of the prior CPI and line of treatment due to AEs, or any other reason than progression\u002Frelapse does not permit enrollment.\n* Participants must have measurable disease determined by the local site Investigator by their assessment per RECIST v1.1.\n* Participants must have life expectancy of at least 3 months as assessed by the Investigator.\n* Participants must have ECOG performance status ≤1.\n\nMain Exclusion Criteria:\n\n* Participants must not have received more than one line of prior systemic treatment for advanced\u002Fmetastatic NSCLC.\n* Participants must not have a prior malignancy requiring treatment.\n* Participants must not have a known or detected clinically active central nervous system (CNS) involvement by NSCLC or other tumors, e.g., with symptomatic metastases and\u002For carcinomatous meningitis\n* Participants must not have any active autoimmune disease that has required systemic treatment in past 3 months before planned treatment start (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs).\n* Participants must not have interstitial lung disease or a history of (non-infectious) pneumonitis that required systemic steroids or current pneumonitis.",{"count":53,"type":20},131,[23],"This is an exploratory, signal-finding, randomized, placebo-controlled, blinded, multi-center phase 2b trial of the anti-GDF-15 antibody Visugromab (CTL-002) at two different dose levels plus Nivolumab with Docetaxel versus Visugromab at the higher dose plus Nivolumab with placebo versus double-placebo with Docetaxel, in participants that receive second-line treatment for non-squamous NSCLC after failure of prior first-line treatment including a CPI (checkpoint inhibitor).\n\nThe trial consists of 3 Parts: an open-label Safety Run-in part (Part A) followed by a subsequent randomized phase 2b part with 4 treatment arms. After the treatment of 15 participants with visugromab at the expansion dose, an interim safety and preliminary efficacy analysis will be conducted (Part B), followed by the treatment of the remaining participants (Part C).",[26,27],[29,30,31],"2026-06-08",{"date":60,"type":36},"2026-06-09",{"date":62,"type":36},"2025-10-07",{"date":64,"type":20},"2031-10-01",{"name":42,"class":43},25,{"id":68,"slug":69,"hasResults":11,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":4,"eligibilityCriteria":73,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":74,"targetDuration":4,"studyType":21,"phases":76,"briefSummary":78,"conditions":79,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":95},"100497077","phase-1-study-to-determine-the-safety-and-pharmacokinetics-of-do-2-in-patients-with-advanced-or-refractory-solid-tumours-100497077","NCT05752552","Study to Determine the Safety and Pharmacokinetics of DO-2 in Patients With Advanced or Refractory Solid Tumours","A Phase 1 Study to Determine the Safety, and Pharmacokinetics of the Selective MET Kinase Inhibitor, DO-2 in Patients With Advanced or Refractory Solid Tumours","Inclusion Criteria:\n\n* 18 years or older\n* histologically or cytologically confirmed locally advanced, unresectable or metastatic NSCLC, no longer eligible for approved, available standard therapies. To be entered patients must have proven MET exon 14 skipping mutation, determined by local next generation sequencing (NGS), whole exome sequencing (WES), whole transcriptome sequencing (WTS) or other genomic analysis methods, from an assessment not older than 3 months\n* measurable disease in accordance with RECIST 1.1\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1\n* adequate bone marrow function, without the support of cytokines\n* adequate liver function\n* adequate renal function with serum creatinine \\\u003C1 x institutional UNL and GFR within normal range\n* agree to follow the contraception requirements of the trial\n* signed informed consent, indicating study patients understand the purpose of and procedures required for the study and are willing to participate in the study.\n\nExclusion Criteria:\n\n* tumour harbouring other known oncogenic mutations promoting tumour growth\n* major surgery within 3 weeks before enrolment\n* chemotherapy (in the case of nitrosoureas and mitomycin C within 6 weeks), radiotherapy, immunotherapy, or any other study drug within 3 weeks before study drug administration\n* antibody based cancer therapy within 4 weeks before administration of the first dose of DO-2\n* patients who became progressive on previous treatment with a MET-kinase inhibitor\n* patients with brain metastases are excluded unless all of the following criteria are met:\n\n  1. CNS lesions are asymptomatic and previously treated\n  2. No ongoing requirement for corticosteroids as therapy for CNS metastases\n  3. Imaging demonstrates stability of disease \\> 28 days from last treatment for CNS metastases\n* leptomeningeal involvement (leptomeningeal carcinomatosis)\n* history of uncontrolled heart disease including unstable angina, congestive heart failure, myocardial infarction within preceding 12 months, clinically significant rhythm or conduction abnormality, congenital long QT syndrome, obligate use of a cardiac pacemaker, QTc at screening greater than 450 milliseconds in males and greater than 470 milliseconds in females\n* uncontrolled arterial hypertension despite appropriate therapy\n* positive pregnancy test (urinary beta-hCG) at screening (applicable to women of child-bearing potential who are sexually active)\n* mental status alteration or history of major psychiatric illness, which may potentially impair patient's compliance with study procedures\n* signs and symptoms of active infection requiring systemic therapy\n* other medical condition (e.g. pre-existing kidney dysfunction) that in the opinion of the investigator makes it undesirable for a patient to participate\n* inability or unwillingness to swallow capsules and malabsorption syndrome or other condition that would interfere with enteral absorption",{"count":75,"type":20},55,[77],"PHASE1","This study is a first-in-human, open-label, 2-part, Phase 1 dose escalation study of DO-2, administered orally to patients with advanced or refractory solid tumours, with MET aberrations, and no available, approved therapeutic alternative. The dose escalation is completed, Part 2 of the study is ongoing.",[27,80,81,82,83,84,85],"Advanced Solid Tumor","Refractory Tumor","Non-small Cell Lung Cancer","Non-small Cell Carcinoma","Lung Cancer","Hereditary Renal Papillary Cancer","2026-03-30",{"date":88,"type":36},"2026-04-03",{"date":90,"type":36},"2022-12-20",{"date":92,"type":20},"2028-09",{"name":94,"class":43},"DeuterOncology",13,{"id":97,"slug":98,"hasResults":11,"nctId":99,"briefTitle":100,"officialTitle":101,"acronym":4,"eligibilityCriteria":102,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":103,"enrollmentInfo":104,"targetDuration":4,"studyType":21,"phases":106,"briefSummary":107,"conditions":108,"keywords":4,"overallStatus":109,"whyStopped":4,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":111,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":117,"locationsCount":4},"100537436","phase-1-a-phase-i-study-of-ltc004-combin-with-fc-in-patients-with-advancedmetastatic-malignancies-tumor-100537436","NCT06277804","A Phase I Study of LTC004 Combin With FC in Patients With Advanced\u002FMetastatic Malignancies Tumor","A Phase I Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LTC004 in Combination With Cyclophosphamide and Fludarabine in Patients With Advanced or Metastatic Malignancies Tumor","Inclusion Criteria:\n\n1. Aged 18 to 75 years；\n2. Subjects with a histologically or cytologically confirmed diagnosis of a locally advanced or metastatic solid tumor or lymphoma that is not amenable to surgical treatment at the time of screening and that has failed after standard treatment as recommended by existing clinical standards of care or guidelines or that is not refractory to standard treatment and\u002For for which there is no currently effective standard of care.\n\n   The current open indication population is patients with soft tissue sarcoma, with the following specific requirements:\n\n   Histologically\u002Fcytologically confirmed diagnosis of unresectable or metastatic soft tissue sarcoma with failure of existing standard therapy or lack of effective treatment, as follows: 1) For pathological subtypes other than adenovascular soft tissue sarcoma and epithelioid sarcoma, failure of, or intolerance to, at least standard chemotherapy regimens of adriamycin or adriamycin in combination with isocyclophosphamide; and 2) For adenovascular soft tissue sarcoma and epithelioid sarcoma. Prior treatment failure or intolerance to a targeted agent \\[anti-angiogenic class such as amlotinib, pezopanib, etc.\\] is required; Note: Disease progression \\\u003C6 months after the end of treatment in neoadjuvant or adjuvant patients is considered first-line treatment;\n3. At least one measurable tumor lesion based on RECIST V1.1 criteria；\n4. ECOG PS ≤1；\n5. Expected survival ≥12 weeks；\n6. Adequate organ function；\n7. Patients who have received any chemotherapy or anti-tumor monoclonal antibody drugs within 4 weeks prior to the first dose of study drug (excluding mitomycin and nitrosoureas within 6 weeks prior to the first dose of study drug）; small molecule targeted drugs within 2 weeks prior to the first dose of study drug; Chinese medicine therapy (Chinese medicine therapy with clear anti-tumor indications in the package insert ）within 4 weeks prior to the first dose of study drug；\n8. Patients, both females and males, of reproductive potential must agree to use adequate contraception during and for 6 months after the last infusion of LTC004.\n9. Understands and provides written informed consent and willing to follow the requirements specified in protocol.\n\nExclusion Criteria:\n\n1. History of severe hypersensitivity reactions to other mAbs.\n2. Untreated, unstable or uncontrolled central nervous system (CNS) metastases with following exceptions:A. Clinically stable MRI scans and no progressive or uncontrolled neurologic symptoms or signs for at least 4 weeks prior to the first study treatment;\n3. Patients with uncontrolled pleural effusion, pericardial effusion or abdominal effusion as judged by the investigator at screening;\n4. Patients with untreated or clinically symptomatic spinal cord compression that has not been controlled.\n5. Previous immunotherapy, including IL-2, IL-15, PD-1\u002FL1 inhibitors, NK, and TCR-T cell therapy；\n6. ≥2 malignant tumors within 5 years prior to first dose of drug；\n7. Moderate to severe dyspnea at rest, severe primary lung disease, current need for continuous oxygen therapy, or clinically active interstitial lung disease (ILD) or pneumonia due to advanced cancer or its complications; Grade ≥3 interstitial pneumonia during prior antineoplastic therapy；\n8. Persons with active tuberculosis infection within 1 year prior to enrollment by history or screening, or persons with a history of active tuberculosis infection more than 1 year ago without regular treatment；\n9. Presence of severe infection within 4 weeks prior to first dose of medication，Presence of active infection requiring systemic antibiotic therapy with CTCAE grade ≥2 within 2 weeks prior to first dose\n10. History of serious cardiovascular disease；\n11. Active hepatitis B (hepatitis B virus titer \\> lower limit of detection) or hepatitis C at the time of screening；\n12. Syphilis-positive patients at screening；\n13. Active, or previous autoimmune disease with potential for recurrence at the time of screening；\n14. Immunodeficiency diseases or history of such diseases, including a positive serologic test for human immunodeficiency virus (HIV)；\n15. Those who have experienced clinically significant bleeding symptoms within 3 months prior to the first dose of the drug；\n16. Those who have received systemic immunosuppressive therapy (including but not limited to glucocorticoids, cyclophosphamide, azathioprine, methotrexate, thalidomide, etc.) within 2 weeks prior to the first dose;\n17. Immunomodulatory medications within 2 weeks prior to first dose；\n18. Those who received radical radiation therapy within 4 weeks prior to the first dose and those who received palliative radiation within 14 days prior to the first dose；\n19. Tumor invasion into peripheral vital organs (e.g., aorta and trachea) or risk of esophageal-tracheal fistula or esophageal-pleural fistula; history of gastrointestinal perforation and\u002For fistula within 6 months prior to the first dose of the drug；\n20. Received other unlisted clinical investigational drug or treatment within 4 weeks prior to first dose；\n21. Use of live or attenuated vaccines within 4 weeks prior to the first dose, or anticipated need for live or attenuated vaccines during the study period；\n22. Major surgery (other than surgery for diagnostic purposes) within 4 weeks prior to the first dose, anticipation of major surgery (other than surgery for diagnostic purposes) during the study period, or diagnostic or low-invasive surgery within 7 days prior to the first dose (excluded for puncture biopsies).\n23. Adverse effects of prior antitumor therapy have not recovered to CTCAE version 5.0 grade rating ≤1；\n24. Patients who have received a previous allogeneic bone marrow\u002Fhematopoietic stem cell transplant or solid organ transplant；\n25. Pregnant and lactating women；\n26. Subjects who in the judgment of the investigator, have a history of other serious systemic disease or are unfit to participate in this trial for any other reason (the presence of psychiatric disorders in the patient that may affect compliance with the trial, alcohol, drug or substance abuse, etc.)","75 Years",{"count":105,"type":20},48,[77],"This was a multicenter, open PHASE I study of LTC004 in Combination With Cyclophosphamide and Fludarabine in Patients With Advanced\u002FMetastatic Malignancies Tumor, the study design consisting of 2 phases: Phase Ia (Phase Ia dose escalation) and Phase Ib (Phase Ib expansion). The objective of this study was to evaluate combination safety, tolerability, pharmacokinetic,pharmacodynamics characteristics, and initial efficacy in advanced malignant tumors.",[27],"NOT_YET_RECRUITING","2024-02-18",{"date":112,"type":36},"2024-02-26",{"date":114,"type":20},"2024-03-01",{"date":116,"type":20},"2027-07-01",{"name":118,"class":43},"Letolab"]