[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"CatalYm GmbH\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":122},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,45,72,94],{"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":51,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":53,"enrollmentInfo":54,"targetDuration":4,"studyType":21,"phases":56,"briefSummary":57,"conditions":58,"keywords":62,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":71},"100609813","phase-2-visugromab-nivolumab-and-lenvatinib-compared-to-double-placebo-and-lenvatinib-in-unresectable-or-metastatic-hepatocellular-carcinoma-post-anti-pd-l1-failure-100609813","NCT07219459","Visugromab, Nivolumab and Lenvatinib Compared to Double Placebo and Lenvatinib in Unresectable or Metastatic Hepatocellular Carcinoma Post Anti-PD-(L)1 Failure","A Phase 2b, Randomized, Blinded Trial Investigating the Efficacy and Safety of Visugromab in Combination With Nivolumab and Lenvatinib Compared to Double Placebo and Lenvatinib in Participants With Unresectable or Metastatic Hepatocellular Carcinoma and Compensated Liver Function (Child-Pugh A) After Failure of First-Line Treatment That Included an Approved Anti PD-(L)1 Compound (GDFATHER HCC-01)","GDFATHERHCC01","Main Inclusion Criteria:\n\n* Histologically confirmed diagnosis of unresectable or metastatic HCC, not amenable to a curative treatment approach.\n* Measurable disease as per RECIST v1.1 as determined by the Investigator based upon local radiologist assessment.\n* Must have failed one line of prior systemic treatment for unresectable or metastatic HCC containing an approved anti PD (L)-1 checkpoint inhibitor (CPI) with a minimum treatment duration of 12 weeks exposure for the CPI with no documented progression in this period.\n* Age ≥ 18 years on the day of signing the informed consent.\n* Life expectancy of at least 3 months as assessed by the Investigator.\n* ECOG performance status ≤1.\n* Child-Pugh score of A6 or better.\n\nMain Exclusion Criteria:\n\n* Known fibrolamellar HCC, sarcomatoid HCC or mixed cholangiocarcinoma.\n* More than 1 line of prior systemic treatment for unresectable or metastatic HCC.\n* Received or completed any palliative radiotherapy for symptoms within 28 days of the first dose of IMP.\n* Expected to require any other form of antineoplastic therapy during the trial.\n* Clinically active inflammatory bowel disease, active diverticulitis, intra-abdominal abscess, and\u002For gastrointestinal obstruction.\n* Known history of other prior malignancy unless 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 HCC or other tumors.\n* Have one of the following cardiovascular risk factors: myocardial infarction, peri\u002Fmyocarditis, or history of ischemic stroke 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.\n* An active autoimmune disease that has required systemic treatment in past 3 months before planned treatment start.\n* Comedication with metformin or metformin-containing antidiabetics in participants with type II diabetes.\n* Chronic systemic corticosteroid treatment for other reasons.\n* Prior liver or other organ transplantation.","100 Years",{"count":55,"type":20},104,[23],"This is a Phase 2b, randomized, blinded clinical trial investigating the efficacy and safety of visugromab in combination with nivolumab and Lenvatinib compared to double placebo and Lenvatinib in participants with unresectable or metastatic HCC and compensated liver function (Child-Pugh A) after failure of 1L treatment that included an anti-PD-(L)1 compound. The trial consists of 2 Parts: a non-randomized Safety-run-in part (Part 1) and the subsequent randomized part (Part 2) with 2 treatment arms (A and B). Randomization of participants into Treatment Arm A and B will continue until 40 efficacy-evaluable participants are enrolled into each Treatment Arm.",[59,60,61],"Unresectable or Metastatic Hepatocellular Carcinoma","Child-Pugh A Hepatocellular Carcinoma","Failure of First-Line Treatment That Included an Approved Anti PD-(L)1 Compound",[29,30,31],"2026-06-23",{"date":65,"type":36},"2026-06-24",{"date":67,"type":36},"2026-03-19",{"date":69,"type":20},"2031-09",{"name":42,"class":43},12,{"id":73,"slug":74,"hasResults":11,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":4,"eligibilityCriteria":78,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":79,"targetDuration":4,"studyType":21,"phases":81,"briefSummary":82,"conditions":83,"keywords":84,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":93},"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":80,"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":87,"type":36},"2026-06-09",{"date":89,"type":36},"2025-10-07",{"date":91,"type":20},"2031-10-01",{"name":42,"class":43},25,{"id":95,"slug":96,"hasResults":11,"nctId":97,"briefTitle":98,"officialTitle":99,"acronym":100,"eligibilityCriteria":101,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":102,"targetDuration":4,"studyType":21,"phases":104,"briefSummary":106,"conditions":107,"keywords":109,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":115,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":121},"100601569","phase-2-visugromab-in-cachexia-international-trial-100601569","NCT07112196","Visugromab in Cachexia International Trial","Adaptive, Phase 2\u002F3, Randomized, Double-Blind Trial Investigating the Efficacy and Safety of Visugromab Versus Placebo in Patients With Cancer-associated Cachexia","VINCIT","Inclusion Criteria:\n\n* Weight loss\n* Advanced cancer\n\nExclusion Criteria:\n\n* Participation in another interventional clinical trial, receipt of any investigational therapy or use of any investigational device within 4 weeks prior to screening and between screening and the first dose of investigational product",{"count":103,"type":20},518,[23,105],"PHASE3","A study of how well and safely a new drug called visugromab works in people with certain kinds of cancer (including lung and bowel cancer) and unintended weight loss known as cachexia. The main questions it aims to answer are:\n\n* Does visugromab help participants put weight back on and have a better appetite?\n* Does visugromab help participants move more and better?\n* What medical problems do participants have when taking visugromab? Researchers will compare visugromab to a placebo (a look-alike substance that contains no drug).\n\nParticipants will visit the hospital or clinic once every 4 weeks to receive visugromab or placebo via a drip into a vein and to undergo checkups and tests.",[108],"Cancer-associated Cachexia",[110,111,112,113,114],"Cachexia","Cancer","Weight loss","Wasting","Anorexia",{"date":87,"type":36},{"date":117,"type":36},"2026-04-16",{"date":119,"type":20},"2030-12",{"name":42,"class":43},35,""]