[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Filamon LTD\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":81},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,48],{"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":29,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100651811","phase-1-first-in-human-study-of-beta-tt8-in-wetage-related-macular-degeneration-wetamd-100651811",false,"NCT07766473","First in Human Study of BETA-TT8 in wetAge-related Macular Degeneration (wetAMD)","A Phase Ib\u002FIIa, First-in-Human, Open-Label Study to Evaluate the Safety, Tolerability, and Exploratory Activity of BETA-TT8 Ophthalmic Gel 3.8% in Patients With Neovascular (Wet) Age-related Macular Degeneration (wetAMD)","BEyOND","Inclusion Criteria:\n\n* Age 50 years or older.\n* Subfoveal or juxtafoveal choroidal neovascularisation (CNV) secondary to AMD in the study eye(s).\n* Stable disease having received three (3) or more previous intravitreal aflibercept 2mg as standard-of-care.\n* Total CNV lesion area no greater than 12-disc areas.\n* BCVA in the study eye between 24 and 78 ETDRS letters inclusive.\n* Suitable for intravitreal aflibercept rescue per its approved label.\n* Able to self-administer eye drops or has a trained caregiver able to administer drops at home.\n* Willing and able to comply with the protocol-defined visit schedule.\n* Signed informed consent.\n\nExclusion Criteria:\n\n* Ocular Exclusion Criteria\n\n  * Contraindication to intravitreal aflibercept per its approved label, including active ocular or peri-ocular infection or active intraocular inflammation.\n  * Dense fibrosis or scarring within the study eye(s) lesion limiting OCT interpretation.\n  * Severe atrophy involving the fovea.\n  * Subretinal haemorrhage involving or obscuring the fovea.\n  * Subretinal fibrosis involving more than 50% of the lesion area.\n  * Pigment epithelial detachment involving more than 50% of the CNV lesion.\n  * Confounding retinal disease, including diabetic retinopathy, retinal vein occlusion, or myopic degeneration.\n  * Significant corneal disease that would complicate topical safety interpretation.\n  * Prior subfoveal laser photocoagulation, photodynamic therapy, or ocular radiation in the study eye.\n  * Uncontrolled glaucoma or IOP greater than 25 mmHg at screening.\n* Systemic Exclusion Criteria\n\n  * Clinically meaningful ECG abnormality or QTcF concern at baseline (QTcF greater than 460 ms in men or greater than 480 ms in women).\n  * Current use of QT-prolonging medications per a pre-specified list\n  * Current use of medications with known MEK or MAPK pathway activity.\n  * Clinically significant hepatic, renal, cardiovascular, or haematological disease.\n  * Known hypersensitivity to any component of the BETA-TT8 formulation or to aflibercept.\n  * Active malignancy or history of malignancy requiring treatment within the prior 5 years. Cancers considered to be cured (eg. prostatectomy or radiation for prostate cancer, adjuvant treatment for breast cancer) or treated non-metastatic skin or melanoma are excepted.\n  * Pregnancy, breastfeeding, or inadequate contraception during the study and for 30 days after last dose of BETA-TT8.\n* Other Exclusion Criteria\n\n  * Inability or unwillingness to comply with study procedures or dosing requirements.\n  * Cognitive impairment or insufficient home support that may compromise proper administration of study treatment.\n  * Participation in another investigational study within 30 days of screening.","ALL","50 Years",{"count":20,"type":21},24,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE1","PHASE2","This is a first-in-human clinical trial evaluating the safety and tolerability of BETA-TT8 Ophthalmic Gel in people with wet age-related macular degeneration (AMD). Approximately 24 participants with stable wet AMD who have previously received at least three anti- Vascular Endothelial Growth Factor (anti -VEGF) injections will use the eye gel for up to 12 weeks at one of three dosing schedules (once, twice, or three times daily). Standard anti-VEGF treatment (aflibercept) will remain available if needed during the study. Participants who complete the initial 12-week treatment period may be invited to continue in an extension phase for up to 12 months to collect additional safety and treatment information.",[28],"Neovascular (Wet) Age-Related Macular Degeneration",[30,31,32,33,34],"BETA-TT8","wetAMD","Ophthalmic gel","neovascular AMD","ophthalmology","NOT_YET_RECRUITING","2026-08-11",{"date":38,"type":39},"2026-08-14","ACTUAL",{"date":41,"type":21},"2026-09",{"date":43,"type":21},"2027-09",{"name":45,"class":46},"Filamon LTD","INDUSTRY",4,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":54,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":17,"minAge":56,"maxAge":4,"enrollmentInfo":57,"targetDuration":4,"studyType":22,"phases":59,"briefSummary":60,"conditions":61,"keywords":69,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":80},"100587260","phase-1-early-phase-study-of-kesonotidein-participants-with-solid-tumours-100587260","NCT06926075","Early Phase Study of KESONOTIDE™in Participants With Solid Tumours","An Adaptive Phase I\u002FII Study of KESONOTIDE™, a Novel hGIIA-vimentin Inhibitor, in Participants With Solid Tumours","ADVICE","Inclusion Criteria:\n\n* Male or female adults (defined as ≥ 18 years of age or acceptable age according to local regulations at the time of voluntarily signing of informed consent).\n* Has an ECOG performance status score of 0 or 1.\n* Has a life expectancy of \\> 12 weeks in the opinion of the investigator.\n* Measurable or evaluable disease by CT\u002FMRI according to RECIST v1.1, except for prostate and breast cancer (bone only metastases are acceptable) and glioma.\n* Histologically or cytologically confirmed locally advanced\u002Fmetastatic solid cancers.\n* Has adequate organ function within 7 days prior to Day 1 of Cycle 1, defined as below:\n* Laboratory Value\n* Hematology\n* Platelet count \\> 100 x 109\u002FL\n* Hb \\> 9.0 g\u002FdL\n* ANC \\> 1.5 x 109\u002FL\n* Renal Function\n* Creatinine \\\u003C 1.5 x ULN\n* Hepatic Function\n* AST and ALT \\\u003C 3 x ULN for the reference laboratory or \\\u003C 5 x ULN in the presence of liver metastases\n* Total bilirubin ≤ 1.5 x ULN\n* Serum albumin ≥ 2.5 g\u002FdL\n* INR\u002FPT and APTT ≤ 1.5 x ULN\n* Male and female participants of reproductive\u002Fchildbearing potential must agree to use adequate contraceptive methods (e.g., double barrier or intrauterine contraceptive) for at least 90 days during the study and after the last dose of study drug.\n* Male participants must not freeze or donate sperm starting at screening and throughout the study period, and at least 90 days after the final study drug administration.\n* Female participants must not donate, or retrieve for their own use, ova from the time of screening and throughout the study treatment period, and at least 90 days after the final study drug administration.\n* Has failed standard of care or refused next line therapy at the present time and if approved treatment options are still available, can delay approved treatments without harm as judged by the investigator (e.g., patients requesting a break between lines of therapy).\n\nAdditional Inclusion Criteria for Parts 2 and 3:\n\n* Measurable disease (as defined for Part 1) or recognised and abnormal biomarker levels (e.g., PSA for prostate cancer, CA15.3 for breast cancer).\n* Defined diseases or disease states of interest, suitable for dose expansion.\n* Patients who have enrolled in Part 1 of the study (dose-escalation), and in the opinion of the investigator, are benefitting from treatment, may be eligible for Parts 2 and 3.\n\nExclusion Criteria:\n\n* Participants who are unable to cease any anti-inflammatory medications or statins prior to and during the study, including non-steroidal anti-inflammatories, oral steroids at any dose; topical steroids and anti-inflammatories are allowable.\n* Participants who have participated in other clinical trials and received investigational products within 4 weeks, or within five half-lives of the treatment, whichever is longer, before Cycle 1 Day 1 of the study period.\n* Previous adverse reactions which have not returned to Grade 0 or 1 according to NCI-CTCAE v5.0 (except alopecia and fatigue) at the screening visit.\n* A clinically significant active infection determined by the investigator.\n* Significant or recurrent third space accumulation (e.g., ascites or pleural effusions) according to the investigator.\n* Has a medical history of myocardial infraction or unstable angina within 6 months before enrolment.\n* Has a medical history of symptomatic CHF (New York Heart Association (NYHA) classes II-IV) or serious cardiac arrhythmia requiring treatment.\n* Has a history or presence of uncontrolled mental illness.\n* The participant is expected to be non-compliant with critical trial procedures and is not willing or able to adhere to the trial requirements during the study.\n* Participants are deemed inappropriate for this clinical trial at the discretion of the investigator.\n\nAdditional Exclusion Criteria for Parts 2 and 3:\n\n\\- Patients must not have more than 2 prior lines of therapy.","18 Years",{"count":58,"type":21},80,[24,25],"This clinical trial is an adaptive study of a novel vimentin inhibitor in cancers.\n\nIt is an open label, multicentre, single ascending dose level in phase I and cohort exploration in phase II.\n\nPrimary objective is to evaluate safety and tolerability of KESONOTIDE™ as a monotherapy in participants with advanced\u002Fmetastatic solid cancers.\n\nSecondary objective is to characterise the pharmacokinetics of KESONOTIDE™. Phase I study will enrol 20-32 participants and Phase II approximately 80 participants.",[62,63,64,65,66,67,68],"Prostate Cancers","Breast Cancer","Lung Cancers","Ovarian Cancer","Glioblastoma Multiforme (GBM)","Pancreas Cancer","Skin Cancer",[70],"kesonotide, vimentin inhibotor","RECRUITING","2026-03-15",{"date":74,"type":39},"2026-03-17",{"date":76,"type":39},"2025-11-07",{"date":78,"type":21},"2027-10-26",{"name":45,"class":46},3,""]