[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"solid-tumor-in-advanced-stage\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:solid-tumor-in-advanced-stage":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,43],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":5},"100647988","phase-1-investigating-the-combination-of-bexmarilimab-and-nivolumab-in-solid-tumours-melanoma-and-nsclc-100647988",false,"NCT07718243","Investigating the Combination of Bexmarilimab and Nivolumab in Solid Tumours, Melanoma and NSCLC","A Phase I\u002FII Trial of Bexmarilimab and Nivolumab in Patients With Solid Tumours, Non-Small Cell Lung Cancer and Melanoma","BLAZE","Inclusion Criteria:\n\n1. Part A:\n\n   Histologically proven solid tumour, refractory to conventional treatment, or for which no conventional therapy exists or is declined by the patient\n\n   Part B1: Histologically proven NSCLC.\n   * Patient has received at least one but not more than three lines of systemic anticancer therapy for metastatic disease.\n   * Patient has received at least two cycles of immune checkpoint inhibitor and has demonstrated disease progression within 12 weeks of last dose.\n   * Patient has had a benefit to prior immune checkpoint inhibitor defined as greater than 6 months of treatment or partial response.\n   * Patients with actionable EGFR, ALK, or other known genomic alterations must have received at least 1 relevant targeted therapy treatment if available.\n\n   Part B2: Histologically proven cutaneous melanoma.\n   * Patient has received at least one but not more than three lines of systemic anticancer therapy for metastatic disease.\n   * Patient has received at least two cycles of immune checkpoint inhibitor and has demonstrated disease progression within 12 weeks of last dose.\n   * Patients with BRAF mutations must have received relevant targeted therapy.\n   * Patient has had a benefit to prior immune checkpoint inhibitor defined as greater than 6 months of treatment or partial response\n2. Life expectancy of at least 12 weeks\n3. World Health Organisation (WHO) performance status of 0-1 (Appendix 2)\n4. Measurable disease as assessed by iRECIST\n5. Biologically female patients are eligible to participate in the trial if they are not pregnant, not breast feeding and meet one of the following criteria:\n\n   1. a biological woman of childbearing potential (WOCB) who has a negative serum or urine pregnancy test before enrolment and agrees to use a highly effective form of contraception (refer to Appendix 3) from signing the consent form, throughout the trial and for six months afterwards. A biological woman is considered of childbearing potential (WOCBP), i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy.\n   2. A biological woman of non-childbearing potential; a postmenopausal state is defined as no menses for 12 months without an alternative medical cause. A high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a postmenopausal state in biological women not using hormonal contraception or hormonal replacement therapy. However, in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient.\n6. Biologically male patients are eligible to participate in the trial if they meet one of the following criteria:\n\n   1. is fertile and agrees to use and ensure their partners (if WOCBP) use a highly effective form of contraception (refer to Appendix 3) from signing the consent form, throughout the trial and for six months afterwards. Biological men with pregnant or lactating partners must be advised to use barrier method contraception (refer to Appendix 3) to prevent exposure of the foetus or neonate; a biological man is considered fertile after puberty unless permanently sterile by bilateral orchidectomy\n   2. is infertile\n7. Negative serology for human immunodeficiency virus (HIV), hepatitis B virus (HBV), and hepatitis C virus (HCV)\n8. Haematological and biochemical indices within the ranges shown below. These measurements must be performed within one week (Day -7 to Day 1) prior to the patient's first dose of IMP\n\n   Laboratory Test Value required Haemoglobin (Hb) ≥ 9.0 g\u002FdL Absolute neutrophil count ≥ 1.5 x 109\u002FL Platelet count ≥ 100 x 109\u002FL\n\n   Serum bilirubin ≤ 1.5 x ULN; with the following exception:\n\n   Patients with known Gilbert disease who have serum bilirubin level ≤ 3 × ULN may be enrolled\n\n   ALT ≤ 2.5 x ULN unless raised due to tumour in which case up to 5 x ULN is permissible AST ≤ 2.5 x ULN unless raised due to tumour in which case up to 5 x ULN is permissible Renal function Calculated creatinine clearance (using the Wright, Cockcroft \\& Gault formula) Glomerular filtration rate ≥ 30 mL\u002Fmin (uncorrected value)\n9. 18 years or over\n10. Written (signed and dated) informed consent and be capable of co-operating with treatment and follow-up\n\nExclusion Criteria:\n\n1. Radiotherapy (except for palliative reasons), endocrine therapy, immunotherapy or chemotherapy during the previous four weeks (six weeks for nitrosoureas, Mitomycin-C) and 4 weeks for investigational medicinal products) before treatment.\n2. Ongoing toxic manifestations of previous treatments. Exceptions to this are alopecia\u002Fvitiligo, treated endocrinopathies (i.e. on physiological doses of endocrine replacement) or certain Grade 1 toxicities, which in the opinion of the Investigator and the CI should not exclude the patient.\n3. Known untreated or active central nervous system (CNS) metastases (progressing or requiring corticosteroids for symptomatic control). Patients with a history of treated CNS metastases are eligible, provided they meet all of the following criteria:\n\n   * Evaluable or measurable disease outside the CNS is present.\n   * Radiographic stability upon the completion of CNS-directed therapy and no evidence of interim progression between the completion of CNS-directed therapy and the baseline disease assessment\n   * Not requiring corticosteroids.\n4. Major thoracic or abdominal surgery from which the patient has not yet recovered.\n5. At high medical risk because of non-malignant systemic disease including active uncontrolled infection.\n6. Known to be serologically positive for hepatitis B, hepatitis C or human immunodeficiency virus.\n7. Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 14 days prior to the first dose of trial treatment\n8. Has an active autoimmune disease that has required systemic treatment in past 3 months (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs) or is at risk of recurrence. Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment. Patients with a history of inflammatory bowel diseases such as Crohn's disease or ulcerative colitis will be excluded from the study. Patients with Sjogren's syndrome will not be excluded from the study.\n9. Are receiving chronic systemic steroids (\\> 10 mg\u002Fday prednisone equivalent). Use of topical, inhalational, intranasal, and intraocular steroids will be permitted.\n10. Patients that experienced a Grade 3 or higher immune-related AEs from prior treatment with immunotherapy will be excluded from the study.\n11. Has received a live vaccine within 30 days of planned start of study therapy. Note: The inactivated virus vaccines used for seasonal influenza vaccines for injection are allowed; however intranasal influenza vaccines (e.g. FluMist®) are live attenuated vaccines and are not allowed.\n12. Any of the following cardiac criteria:\n\n    * Mean resting corrected QT interval (QTc) \\> 470 msec obtained from 3 consecutive electrocardiograms (ECGs) within 5 minutes of each other.\n    * Known congenital QT syndrome or history of torsades de pointes. Any clinically significant abnormalities in rhythm, conduction or morphology of resting ECG, e.g. complete left bundle branch block, third degree heart block. Controlled atrial fibrillation is allowed.\n    * Experience of any of the following procedures or conditions in the preceding 6 months: coronary artery bypass graft, angioplasty, vascular stent, myocardial infarction, angina pectoris, congestive heart failure New York Heart Association \\[NYHA Grade 2 or above\\], severe valvular disease, uncontrolled hypertension despite optimal therapy.\n13. Prior bone marrow transplant, allogenic tissue\u002Fsolid organ transplant or have had extensive radiotherapy to greater than 25% of bone marrow within eight weeks.\n14. Current malignancies of other types, with the exception of adequately treated cone biopsied in situ carcinoma of the cervix uteri and basal or squamous cell carcinoma of the skin. An exception to this criteria are cancer survivors, who have undergone potentially curative therapy for a prior malignancy, have no evidence of that disease for three years or more and are deemed at negligible risk for recurrence, are eligible for the trial.\n15. Is a patient or plans to participate in another interventional clinical trial, whilst taking part in this study. Participation in an observational trial would be acceptable.\n16. Any other condition which in the Investigator's opinion would not make the patient a good candidate for the clinical trial.\n17. Symptoms of COVID-19 and\u002For documented COVID-19 infection\n18. Hypersensitivity to the active substance or to any of the IMP excipients\n19. Active or known pre-existing or history of non-infectious\u002Finterstitial lung disease\u002Fpneumonitis","ALL","18 Years",{"count":20,"type":21},62,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE1","PHASE2","The trial will test if the combination of bexmarilimab and nivolumab can help patients whose cancers have stopped responding to immunotherapy treatment. It will focus on two cancers: non-small cell lung cancer and melanoma. Early research suggests bexmarilimab may change some immune cells inside the tumour so they create a stronger \"attack\" signal, which could help other immune cells recognise and kill cancer cells more effectively. This may make it easier for PD-1 immunotherapy drugs to work again by helping the immune system stay active against the tumour.\n\nThis is a Phase I\u002FII clinical trial. In Phase I, researchers will give increasing doses of bexmarilimab together with a standard (fixed) dose of nivolumab to patients with solid tumours, to find the safest and most suitable dose to use going forward (the recommended Phase 2 dose). In Phase II, the study will treat two groups of patients-one with non-small cell lung cancer and one with melanoma-using that selected dose.",[28,29,30],"Melanoma (Skin Cancer)","Non Small Cell Lung Cancer","Solid Tumor in Advanced Stage","RECRUITING","2026-08-14",{"date":34,"type":35},"2026-08-18","ACTUAL",{"date":37,"type":21},"2026-08",{"date":39,"type":21},"2030-01-31",{"name":41,"class":42},"Institute of Cancer Research, United Kingdom","OTHER",{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":17,"minAge":51,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":22,"phases":54,"briefSummary":55,"conditions":56,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":73},"100586127","phase-1-ad1208-in-subjects-with-any-progressive-locally-advanced-or-metastatic-solid-tumors-100586127","NCT06911333","AD1208 in Subjects With Any Progressive, Locally Advanced or Metastatic Solid Tumors","A Phase I\u002FIIa Trial of AD1208, a Cell Cycle Inhibitor\u002FMASTL Inhibitor, as a Single Agent or a Combination in Subjects With Any Progressive, Locally Advanced(Unresectable) or Metastatic Solid Tumors","AD1208","Inclusion Criteria:\n\n* Male or female subjects ≥19 years of age\n* Willing to consent to participate in study and ability to comply with scheduled visits, treatment plan, laboratory tests and other study procedures\n* Histologically and\u002For cytologically confirmed any progressive, locally advanced (unresectable), or metastatic solid tumors that have relapsed or are refractory following the last line of treatment and for which prior standard therapy has been ineffective, standard therapy does not exist or is not considered appropriate.\n* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1\n* Life expectancy of at least 12 weeks\n* Subjects with adequate hematologic, hepatic, and renal functions confirmed based on the screening laboratory test within 2 weeks prior to the first administration of IP.\n* Female subject who is surgically sterile, is postmenopausal, or agrees to use a highly effective method of birth control (2 methods strongly recommended) during the study and for 6 months following the last dose of IP.\n* Male subject with a pregnant or breastfeeding partner(s) must agree to remain abstinent or use a condom for the duration of the pregnancy or for the time the partner is breastfeeding throughout the study period and for 6 months after the final administration of IP.\n\nExclusion Criteria:\n\n* Untreated active brain metastases.\n* has leptomeningeal disease.\n* unrecovered \\> Grade 1 from the adverse event of prior therapy except for alopecia.\n* has an active autoimmune disease requiring systemic treatment within the past 2 years.\n* Active interstitial lung disease (ILD) or pneumonitis or a history of ILD.\n* Subject has received the following treatment;\n\n  * prior anticancer monoclonal antibody treatment or investigational therapy\n  * prior any chemotherapy\n  * prior radiotherapy\n  * Major surgery\n* Clinically significant (i.e., active) cardiovascular disease\n* known positive of human immunodeficiency virus (HIV) infection.\n* Active hepatitis B or C subjects.\n* known allergic reaction for active ingredients or inactive ingredients such as excipients of Investigational product.\n* Live vaccine administered against infectious disease.\n* Gastrointestinal (GI) track disease causing the inability to take oral medication, malabsorption syndrome or uncontrolled inflammatory GI disease.\n* having psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n* women with a positive pregnancy test at screening test.\n* women who are breast feeding.\n* subject has any condition because of which, in the opinion of the investigator, the participation would not be in the best interest of the subject.","19 Years",{"count":53,"type":21},36,[24,25],"The goal of this clinical trial is to evaluate the safety and tolerability of AD1208 to determine the maximum tolerated dose(MTD) or maximumly administered dose(MAD) in any progressive, locally advanced (unresectable) or metastatic solid tumors. The main questions it aims to answer are:\n\n* Which dosage of AD1208 is safe and tolerable for participants?\n* What medical problems do participants have when taking AD1208?\n\nParticipants will:\n\n* Take drug AD1208 every day up to 1 cycle at the least.\n* Visit the site once every 1 weeks for checkups and tests during cycle 1 and every 3 weeks from cycle 2 onwards.\n* Keep a diary of any adverse events and administrated drug",[57,58,59,60,61,62,30],"Solid Tumor, Adult","Tumor, Solid","Solid Tumor","Solid Tumor, Unspecified, Adult","Solid Tumor Cancer","Solid Tumors Refractory to Standard Therapy","2025-03-28",{"date":65,"type":35},"2025-04-04",{"date":67,"type":35},"2025-03-11",{"date":69,"type":21},"2030-02-20",{"name":71,"class":72},"Avelos Therapeutics Inc.","INDUSTRY",3]