[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Merus B.V.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":111},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,42,72],{"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":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100554214","phase-3-a-phase-3-study-to-evaluate-petosemtamab-compared-with-investigators-choice-monotherapy-in-previously-treated-head-and-neck-squamous-cell-carcinoma-patients-liger-hn2-100554214",false,"NCT06496178","A Phase 3 Study to Evaluate Petosemtamab Compared With Investigator's Choice Monotherapy in Previously Treated Head and Neck Squamous Cell Carcinoma Patients (LiGeR-HN2)","A Phase 3 Open-label, Randomized Controlled Study to Evaluate the Efficacy and Safety of Petosemtamab Compared With Investigator's Choice Monotherapy Treatment in Previously Treated Patients With Incurable, Metastatic\u002FRecurrent Head and Neck Squamous Cell Carcinoma","Inclusion Criteria:\n\n* Signed ICF before initiation of any study procedures.\n* Age ≥ 18 years at signing of ICF.\n* Histologically previously confirmed HNSCC with evidence of metastatic or locally advanced disease not amenable to standard therapy with curative intent.\n* HNSCC participants progressed on or after anti-PD-1 therapy and platinum-containing therapy.\n* The eligible HNSCC primary tumor locations are oropharynx, oral cavity, hypopharynx, and larynx.\n* Documentation of p16 status (positive or negative) by local laboratory IHC for participants with primary oropharyngeal cancer.\n* A baseline new tumor sample unless the participant has an available tumor sample as an FFPE block with sufficient material.\n* Measurable disease as defined by RECIST v1.1 by radiologic methods.\n* ECOG PS of 0 or 1\n* Life expectancy ≥ 12 weeks, as per investigator\n* Adequate organ function (as per protocol)\n\nExclusion Criteria:\n\n* Central nervous system metastases that are untreated or symptomatic, or require radiation, surgery, or continued steroid therapy to control symptoms within 14 days prior to randomization.\n* Known leptomeningeal involvement\n* Any systemic anticancer therapy within 4 weeks prior to randomization.\n* Major surgery within 3 weeks or palliative radiotherapy within 2 weeks prior to randomization.\n* Persistent Grade \\>1 clinically significant toxicities related to prior antineoplastic therapies\n* History of hypersensitivity reaction to any of the excipients of treatment required for this study.\n* Unstable angina; history of congestive heart failure of Class II-IV New York Heart Association (NYHA) criteria, or serious cardiac arrhythmia requiring treatment or history of myocardial infarction within 6 months of study entry\n* History of prior malignancies with the exception of localized cancer with curative resection (e.g. cervical intraepithelial neoplasia or nonmelanoma skin cancer)\n* Current dyspnea at rest of any origin, or other diseases requiring continuous oxygen therapy\n* Current serious illness or medical conditions including, but not limited to, uncontrolled active infection, clinically significant pulmonary, metabolic or psychiatric disorders\n* Participants with known infectious diseases (as per protocol)\n* Pregnant or breastfeeding participants\n* Participant has a primary tumor site of nasopharynx (any histology).","ALL","18 Years",{"count":19,"type":20},600,"ESTIMATED","INTERVENTIONAL",[23],"PHASE3","This is a phase 3 open-label, randomized, controlled, multicenter study to compare petosemtamab vs investigator's choice monotherapy in HNSCC patients for the second- and third-line treatment of incurable metastatic\u002Frecurrent disease.",[26],"Head and Neck Squamous Cell Carcinoma",[28],"HNSCC","RECRUITING","2026-06-02",{"date":32,"type":33},"2026-06-03","ACTUAL",{"date":35,"type":33},"2024-06-25",{"date":37,"type":20},"2029-03",{"name":39,"class":40},"Merus B.V.","INDUSTRY",216,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":49,"targetDuration":4,"studyType":21,"phases":51,"briefSummary":52,"conditions":53,"keywords":54,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":71},"100556447","phase-3-a-phase-3-study-to-evaluate-petosemtamab-plus-pembrolizumab-vs-pembrolizumab-in-first-line-treatment-of-head-and-neck-cancer-liger---hn1-100556447","NCT06525220","A Phase 3 Study to Evaluate Petosemtamab Plus Pembrolizumab vs Pembrolizumab in First-line Treatment of Head and Neck Cancer (LiGeR - HN1)","A Phase 3 Randomized, Open-label Study to Evaluate the Efficacy and Safety of Petosemtamab Plus Pembrolizumab vs Pembrolizumab in First-line Treatment of Recurrent or Metastatic PD-L1+ Head and Neck Squamous Cell Carcinoma","Inclusion Criteria:\n\n1. Signed ICF before initiation of any study procedures\n2. Age ≥ 18 years at signing of ICF\n3. Histologically confirmed HNSCC with evidence of metastatic or locally recurrent disease not amenable to local therapy with curative intent.\n4. The eligible HNSCC primary tumor locations are oropharynx, oral cavity, hypopharynx, and larynx.\n5. HNSCC patients eligible to receive pembrolizumab as 1L monotherapy with tumors expressing PD-L1, CPS ≥1.\n6. HNSCC patients should not have had previous systemic therapy administered in the incurable recurrent or metastatic setting\n7. A new tumor biopsy, unless the patient has an available archival tumor sample with sufficient material\n8. Measurable disease per Investigator assessment as defined by RECIST v1.1 by radiologic methods\n9. ECOG Performance Status (PS) of 0-1\n10. Life expectancy ≥ 12 weeks, as per investigator assessment.\n11. Left ventricular ejection fraction (LVEF) ≥50% by echocardiogram (ECHO) or multigated acquisition (MUGA) scan\n12. Adequate organ function as defined per protocol.\n13. HIV-positive patients are eligible only if the cluster of differentiation 4 (CD4+) count is ≥ 300\u002Fµl, viral load is undetectable, and the patient is currently receiving highly active antiretroviral therapy\n\nExclusion Criteria:\n\n1. Central nervous system metastases that are untreated or already treated but symptomatic, or require radiation, surgery, or continued steroid therapy to control symptoms within 21 days prior to randomization\n2. Known leptomeningeal involvement\n3. Any systemic anticancer therapy or investigational drug within 4 weeks or 5 half-lives, whichever is shorter, before randomization\n4. Requirement for immunosuppressive medication\n5. Major surgery or radiotherapy within 3 weeks of randomization\n6. Clinically significant toxicities related to prior anticancer therapies that have not returned to ≤ Grade 1 or baseline except for Grade ≤2- myalgia, neuropathy, alopecia, and any prior therapy related endocrinopathies\n7. History of hypersensitivity reaction to any of the excipients of petosemtamab or pembrolizumab.\n8. Unstable angina; history of congestive heart failure of Class II-IV New York Heart Association (NYHA) criteria, or serious cardiac arrhythmia requiring treatment; or history of myocardial infarction within 6 months prior to randomization\n9. History of prior malignancies within the last 5 years, with the exception of excised local cancer\n10. Current dyspnea at rest of any origin, or other diseases requiring continuous oxygen therapy\n11. Current serious illness or medical conditions including, but not limited to, uncontrolled active infection, clinically significant pulmonary, metabolic or psychiatric disorders\n12. Patients with known infectious diseases as per protocol.\n13. Pregnant or breastfeeding patients.\n14. The patient has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy of prednisone \\>10 mg\u002Fday or equivalent, or any other form of immunosuppressive therapy\n15. The patient has an active autoimmune disease that has required systemic immune suppressive treatment in the past 2 years; replacement therapy is not considered immune suppressive treatment\n16. The patient has had an allogeneic tissue\u002Fsolid organ transplant.\n17. Patient has a primary tumor site of nasopharynx, or sinonasal carcinoma (any histology)\n\nOther protocol defined inclusion\u002Fexclusion criteria may apply.",{"count":50,"type":20},700,[23],"This is a Phase 3 randomized, open-label study to evaluate the efficacy and safety of petosemtamab plus pembrolizumab vs pembrolizumab in first-line treatment of recurrent or metastatic PD-L1+ head and neck squamous cell carcinoma.",[26],[28,55,56,57,58,59,60,61,62,63],"PD-L1+","Head and Neck cancer","Petosemtamab","Pembrolizumab","Liger","Oral Cavity","Oropharynx","Larynx","Hypopharynx","2026-06-01",{"date":30,"type":33},{"date":67,"type":33},"2024-09-25",{"date":69,"type":20},"2030-07",{"name":39,"class":40},205,{"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":84,"conditions":85,"keywords":92,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":110},"100326192","phase-1-a-study-of-bispecific-antibody-mcla-158-in-patients-with-advanced-solid-tumors-100326192","NCT03526835","A Study of Bispecific Antibody MCLA-158 in Patients With Advanced Solid Tumors","Phase 1\u002F2 Dose Escalation and Cohort Expansion Study Evaluating MCLA-158 (Petosemtamab) as Single Agent or in Combination in Advanced Solid Tumors","Inclusion Criteria:\n\n* Histologically or cytologically confirmed solid tumors with evidence of metastatic or locally advanced disease not amenable to standard therapy with curative intent.\n* A baseline fresh tumor sample (FFPE) from a metastatic or primary site (if safe\u002Ffeasible).\n* Amenable for biopsy (if safe\u002Ffeasible).\n* Measurable disease as defined by RECIST version 1.1 by radiologic methods.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Life expectancy ≥ 12 weeks, as per investigator.\n* Left ventricular ejection fraction (LVEF) ≥ 50% by echocardiogram (ECHO) or multiple gated acquisition scan (MUGA).\n* Adequate organ function\n* Expansion cohorts: patients with locally advanced unresectable or metastatic disease for the following indications:\n\nSINGLE AGENT:\n\n* SECOND-\u002FTHIRD-LINE HNSCC PATIENTS (cohort closed to enrolment): patients who have progressed on or after, or are intolerant to, anti-PD-(L)1 therapy and platinum therapy as monotherapy or in combination with other agents and no previous exposure to EGFR inhibitors. Patients treated with platinum-containing therapy only in the adjuvant setting, or in the context of multimodal therapy for locally advanced disease should have disease progression within 6 months of the last dose of platinum containing therapy. Patients with no more than 2 prior lines of treatment in recurrent or metastatic disease.\n\n  * Human papilloma virus (HPV) status determined by p16 immunohistochemistry (IHC) or molecular HPV test for all oropharyngeal tumors should be reported when available.\n  * The eligible HNSCC primary tumor locations are oropharynx, oral cavity, hypopharynx, and larynx.\n* 3L+ mCRC (cohort open to enrolment) patients must have:\n\n  * No oncogenic missense mutations in KRAS, NRAS, BRAF, or EGFR ectodomain, and no HER2 (ERBB2) amplification, as detected in plasma by ctDNA NGS central testing performed during screening.\n  * A microsatellite stable (MSS) tumor.\n\nCOMBINATION:\n\n* FIRST-LINE HNSCC (cohort closed to enrolment): patients eligible to receive pembrolizumab as first-line monotherapy with tumors expressing programmed cell death protein ligand 1 (PD-L1), combined positive score (CPS) ≥1, as determined by a Food and Drug Administration (FDA) approved test in the US, or by an approved equivalent test in other countries; patients should not have previous systemic therapy administered in the recurrent or metastatic setting, although previous systemic therapy as part of multimodal treatment for locally advanced disease is allowed if ended ≥6 months prior to signing the ICF. The eligible HNSCC primary tumor locations are oropharynx, oral cavity, hypopharynx, and larynx. Previous treatments with anti PD-(L)1 or anti-EGFR therapies are not allowed.\n* mCRC (cohorts open to enrolment): Patients should have been previously diagnosed with histologically or cytologically confirmed unresectable or metastatic adenocarcinoma of the colon or rectum. Patients must be RAS\u002FRAF WT as determined using tumor tissue (primary or metastatic) by an appropriate tumor tissue based assay, to be confirmed by the sponsor, and must have an MSS tumor. Patients must be naive to prior anti-EGFR therapy.\n\n  * Cohort to be treated with petosemtamab and FOLFIRI: patients may have received up to 1 prior chemotherapy regimen for the metastatic setting, consisting of 1L fluoropyrimidine-oxaliplatin-based chemotherapy ± bevacizumab.\n  * Cohort to be treated with petosemtamab and FOLFOX: patients may have received up to 1 prior chemotherapy regimen in the metastatic setting consisting of 1L fluoropyrimidine-irinotecan-based chemotherapy ± bevacizumab.\n\nExclusion Criteria:\n\n* Central nervous system metastases that are untreated or symptomatic, or require radiation, surgery, or continued steroid therapy to control symptoms within 14 days of study entry.\n* Known leptomeningeal involvement.\n* Participation in another clinical study or treatment with any investigational drug within 4 weeks prior to study entry.\n* Any systemic anticancer therapy within 4 weeks or 5 half-lives whichever is shorter of the first dose of study treatment. For cytotoxic agents that have major delayed toxicity ( e.g. mitomycin C,nitrosoureas), or anticancer immunotherapies, a washout period of 6 weeks is required.\n* Requirement for immunosuppressive medication (e.g. methotrexate, cyclophosphamide)\n* Major surgery or radiotherapy within 3 weeks of the first dose of study treatment. Patients who received prior radiotherapy to ≥25% of bone marrow are not eligible, irrespective of when it was received.\n* Persistent grade \\>1 clinically significant toxicities related to prior antineoplastic therapies (except for alopecia); stable sensory neuropathy ≤ grade 2 NCI-CTCAE v4.03 is allowed.\n* History of hypersensitivity reaction to any of the excipients of petosemtamab, human proteins or any non-IMP treatment required for this study.\n* Uncontrolled hypertension (systolic blood pressure \\[BP\\] \\> 150 mmHg and\u002For diastolic BP \\> 100 mmHg) with appropriate treatment or unstable angina.\n* History of congestive heart failure of Class II-IV New York Heart Association (NYHA) criteria, or serious cardiac arrhythmia requiring treatment (except atrial fibrillation, paroxysmal supraventricular tachycardia).\n* History of myocardial infarction within 6 months of study entry.\n* History of prior malignancies with the exception of excised cervical intraepithelial neoplasia or nonmelanoma skin cancer, or curatively treated cancer deemed at low risk for recurrence with no evidence of disease for 3 years.\n* Current dyspnea at rest of any origin, or other diseases requiring continuous oxygen therapy.\n* Patients with a history of interstitial lung disease (e.g., pneumonitis or pulmonary fibrosis) or evidence of ILD on baseline chest computerized tomography (CT) scan.\n* Current serious illness or medical conditions including, but not limited to uncontrolled active infection,clinically significant pulmonary, metabolic or psychiatric disorders.\n* Patients with known infectious diseases:\n\n  * Active hepatitis B infection ((hepatitis B surface antigen \\[HBsAg\\] positive) without receiving antiviral treatment.\n  * Positive test for hepatitis C ribonucleic acid (HCV) RNA).\n* Pregnant or breastfeeding patients; patients of childbearing potential must use highly effective contraception methods prior to study entry, for the duration of study participation, and for 6 months after the last dose of MCLA-158.",{"count":80,"type":20},523,[82,83],"PHASE1","PHASE2","This is a Phase 1\u002F2 open-label, multi-center, multi-national study with an initial dose escalation part to determine the recommended Phase II dose (RP2D) of MCLA-158 single agent in patients with mCRC.\n\nThe dose escalation part has been completed and the RP2D will be further evaluated in an expansion part of the study. Cohorts of selected solid tumor indications for which there is evidence of EGFR dependency and potential sensitivity to EGFR inhibition will be evaluated including head and neck cancer and metastatic colorectal cancer (mCRC).\n\nThe study will further assess the safety, tolerability, PK, PD, immunogenicity, and anti-tumor activity of MCLA-158 in monotherapy or in combination with other therapies.",[86,87,88,89,90,28,26,91],"Advanced\u002FMetastatic Solid Tumors","Colorectal Cancer","Gastric Cancer","Gastroesophageal-junction Cancer","NSCLC","Esophageal Cancer",[93,94,95,96,97,98,99,100,101],"Bispecific antibody","First-in-human","MCLA-158","Antibodies","Bispecific","immunologic factors","Cytokines","EGFR","LGR5","2025-01-27",{"date":104,"type":33},"2025-01-29",{"date":106,"type":33},"2018-05-02",{"date":108,"type":20},"2027-11",{"name":39,"class":40},45,""]