[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Intra-IMMUSG Pte Ltd\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":71},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,47],{"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":25,"conditions":26,"keywords":28,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100635018","phase-1-a-study-of-prl3-zumab-in-neovascular-age-related-macular-degeneration-namd-100635018",false,"NCT07547228","A Study of PRL3-zumab in Neovascular Age-related Macular Degeneration (nAMD)","Phase I\u002FII Study to Assess Safety and Efficacy of PRL3-zumab in Patients With Neovascular Age-related Macular Degeneration (nAMD)","Inclusion Criteria:\n\n1. Patients with Neovascular Age-related Macular Degeneration (nAMD).\n2. Willing to provide written informed consent for the study.\n3. Patients undergoing intravitreal treatment having failed at least two Standard-of care treatments and be receiving ongoing intravitreal treatment at intervals of ≤ 8 weeks including Ranibizumab, Aflibercept, or Faricimab.\n4. Participants receiving intravitreal treatment at screening must complete a wash-out period before enrolment. This wash-out period should be calculated based on five half-lives of the specific intravitreal treatment the participant is receiving.\n\n   Below is the washing out period for some standard of care treatments.\n   1. Ranibizumab (half-life: 9 days) requires a wash-out period of 45 days (7 weeks)\n   2. Aflibercept (half-life: 11 days) requires a wash-out period of 55 days (8 weeks)\n   3. Faricimab (half-life: 7.5 days) requires a wash-out period of 37.5 days (5 weeks)\n   4. Bevacizumab (half-life: 6 days) requires a wash-out period of 30 days (4weeks)\n5. Subfoveal CNV or juxtafoveal\u002Fextrafoveal CNV with a subfoveal component related to the CNV activity identified by FFA or OCT (where CNV activity is defined as showing evidence of subretinal fluid, subretinal hyperreflective material, or leakage).\n6. BCVA ETDRS letter score of 78 to 24 (corresponding to a Snellen equivalent of approximately 20\u002F32 to 20\u002F320) in the study eye.\n7. Decrease in BCVA determined to be primarily the result of nAMD or DR\u002FDME in the study eye.\n8. Presence of pigment epithelium detachment (PED), intraretinal fluid (IRF) and\u002For subretinal fluid (SRF) affecting the central subfield of the study eye on OCT.\n9. Adequate organ (liver and renal) and hematological functions as evidenced by the laboratory results obtained within 7 days of treatment which are within the normal range for the study population, or with abnormalities deemed not clinically significant by the investigators.\n\nExclusion Criteria:\n\n1. Scar, fibrosis, atrophy, or retinal pigment epithelial tears involving the central fovea in the study eye.\n2. Uncontrolled glaucoma (defined as IOP \\>25 mmHg despite treatment with antiglaucoma medication) in the study eye.\n3. History of idiopathic or autoimmune uveitis in the study eye.\n4. Myopia of a spherical equivalent of at least 8 diopters in the study eye prior to any refractive or cataract surgery.\n5. Evidence of extraocular or periocular infection or inflammation (including infectious blepharitis, keratitis, scleritis, or conjunctivitis) in either eye at the time of screening\u002Frandomization.\n6. Uncontrolled blood pressure (defined as systolic \\>160 mmHg or diastolic \\>95 mmHg).\n7. Patient is receiving systemic glucocorticoids (only if higher than 10mg or equivalent of prednisolone daily) or other immunosuppressive treatment for autoimmune disease or any other medical condition.","ALL","18 Years",{"count":19,"type":20},15,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE1","PHASE2","Study Design This is a Single-center, Phase I\u002FII placebo-controlled study to assess the safety and efficacy of PRL3-zumab in patients with Neovascular Age-related Macular Degeneration (nAMD).\n\nPRL3-zumab will be administered intravenously in 2-week interval for 3 doses. Normal saline (0.9% Sodium Chloride w\u002Fv) will be used in placebo treatment. The study will consist of 3 arms.\n\nArm-1: PRL3-zumab 3mg\u002Fkg intravenously will be administered in 2 week interval followed by 20 weeks of monitoring (n=6) Arm-2: PRL3-zumab 6mg\u002Fkg intravenously will be administered in 2 week interval followed by 20 weeks of monitoring (n=6) Arm-3: Placebo (normal saline 0.9% sodium chloride w\u002Fv) intravenously will be administered in 2 week interval followed by 20 weeks of monitoring (n=3)\n\nInitial 3 arms will be conducted on patients who failed Standard-of-Care (SOC) therapy. Response assessment will be done at every 4 weeks from last dose of treatment till 24-week.\n\nRandomization:\n\nRandomization will be done in 2:2:1 manner on PRL3-zumab (Arm 1), 3mg\u002Fkg (n=6); PRL3-zumab (Arm 2), 6mg\u002Fkg (n=6); and placebo group (Arm 3) (n=3). Randomization can be achieved using random number table which will be prepared before the commencement of clinical trial.\n\nThe allocation of participants will be done by Investigator and will be concealed from the participants.\n\nBlinding:\n\nSingle blinding will be done for this trial in which all participants are unaware of their treatment assignment. No blinding will be done on Investigator.\n\nPrimary Endpoints:\n\n1. Safety:\n\n   • Adverse Events: Frequency and severity of adverse events throughout the primary outcome assessment period will be assessed by the Investigator for severity according to Common Terminology Criteria for Adverse Events (CTCAE) version 5 or later\n2. RP2D:\n\n   • This study will confirm Recommended Phase 2 DOse (RP2D) established from Phase I Clinical Trial in Cancer patients conducted in National University Hospital Singapore (MC\u002F03\u002F0616).\n3. Efficacy:\n\n   * Change From Baseline in Best Corrected Visual Acuity (BCVA) Measured by the Early Treatment Diabetic Retinopathy Study (ETDRS) Letter Score. Change in BCVA letter gain of 0-4 will be considered as primary end point.\n   * Change From Baseline in Central Subfield Retinal Thickness (CST) measured by Optical Coherence Tomography (OCT).\n\n\\[Assessment Time Frame: 4 weekly through 24 weeks\\]\n\nSecondary endpoints:\n\n* Change in visual Acuity (Best Corrected Visual Acuity) of 5 or more letters.\n* Proportion of patients gaining ≥15, ≥10, ≥5, or ≥0 ETDRS letters in BCVA from baseline over time\n* Proportion of patients avoiding a loss of ≥15, ≥10, or ≥5 ETDRS letters in BCVA from baseline over time\n* Proportion of patients with absence of intraretinal fluid measured by OCT\n* Proportion of patients with absence of subretinal fluid measured by OCT \\[Assessment Time Frame: 4 weekly through 24 weeks\\]\n\nCriteria for additional Therapy:\n\nOnce the treatment is stopped after the third dose, patients from all groups are eligible for additional therapy as open-label treatment if there is recurrence of disease activity, as defined by presence of any of the following criteria:\n\n1. Decrease of ≥5 letters in BCVA compared with average BCVA value over the previous two scheduled visits, owing to nAMD disease activity (as determined by the investigator).\n2. Increase of \\>50 µm in OCT-measured CST compared with the average CST value over the previous two scheduled visits.\n3. Recurrence of intra-retinal or sub-retinal fluid (if resolved previously)\n4. New macular hemorrhage\n\nPatients in the placebo group will be given PRL3-zumab (6mg\u002Fkg) if they fulfil the criteria for additional therapy. Additional therapy will be continued in subsequent monitoring visit until the progression of disease, or end of the trial. If patients show clinical benefit from the treatment, additional doses could be given based on investigators' judgment.\n\nCriteria for progression of disease:\n\n1. BCVA decreases by 15 letters or more from best recorded BCVA because of nAMD disease activity.\n2. an increase in OCT central retinal thickness 150 µm or more from lowest recorded measurement after 2 consecutive additional therapy occurring 1 month apart.",[27],"Neovascular Age Related Macular Degeneration",[29,30,31,32,33],"PRL3","PRL3-zumab","nAMD","Neovasclar Age Related Macular Degeneration","Wet AMD","RECRUITING","2026-04-23",{"date":37,"type":38},"2026-04-29","ACTUAL",{"date":40,"type":38},"2025-10-11",{"date":42,"type":20},"2027-07-07",{"name":44,"class":45},"Intra-IMMUSG Pte Ltd","INDUSTRY",1,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":30,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":54,"enrollmentInfo":55,"targetDuration":4,"studyType":21,"phases":57,"briefSummary":59,"conditions":60,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":70},"100615244","phase-2-phase-iiiii-trial-of-prl3-zumab-in-advanced-solid-tumor-patients-100615244","NCT07290088","Phase II\u002FIII Trial of PRL3-Zumab in Advanced Solid Tumor Patients","An Open Label, Multicenter, Safety and Efficacy Phase II\u002FIII Study of PRL3-Zumab in Solid Tumor Patients","Inclusion Criteria:\n\n1. Men and women aged 18 - 75 years with solid tumors\n2. Willing to provide written informed consent for the study.\n3. Histopathological diagnosis and metastatic status cancer at study entry.\n4. Stage 1-3 patients with no more than 3 prior lines of treatment\n5. Life expectancy of more than 6 months (especially for Pancreatic cancer patients).\n6. Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1.\n7. Patient should have recovered from toxicity of prior treatment regimen to Grade 1 level except for alopecia or peripheral neuropathy or fatigue as defined by Common Terminology Criteria for Adverse Events (CTCAE) version 5.\n8. Women of childbearing potential (WOCBP) must have a negative serum pregnancy test at study entry and must follow highly effective contraception\n9. Adequate organ and hematological function as evidenced by the following laboratory studies within 10 days of treatment:\n\n   * Absolute neutrophil count ≥ 1.0 x 109\u002FL.\n   * Platelet count ≥ 75 x 109\u002FL. Hemoglobin ≥ 90 g\u002FL (9 g\u002FdL).\n   * Prothrombin time and activated partial thromboplastin time ≤ 1.5 x upper limit of normal (ULN) per institutional laboratory normal range.\n   * Total bilirubin ≤ 1.5x ULN.\n   * Aspartate aminotransferase and alanine aminotransferase ≤ 2.5 x upper limit of normal (ULN) (≤ 5 x ULN in the presence of liver metastases).\n   * For patients with hepatocellular carcinoma (HCC) Child Pugh score of ≤ B7.\n   * Creatinine \\\u003C 1.5x ULN.\n10. Measurable disease by iRECIST.\n11. No history of active hepatitis B or C infection.\n\nExclusion Criteria:\n\n1. Patient has known untreated or symptomatic central nervous system metastasis.\n2. Female patient is pregnant, breastfeeding, or expecting to conceive children while receiving study treatment and for 150 days (for pregnancy or conception) or 30 days (for breastfeeding) after the last dose of study treatment.\n3. Patient has known history of human immunodeficiency virus (HIV) infection (HIV-1 or HIV-2 antibodies).\n4. Patient is receiving systemic glucocorticoids (only if higher than 10 mg or equivalent of prednisolone daily) or other immunosuppressive treatment for autoimmune disease or any other medical condition.\n5. Patient has experienced a severe hypersensitivity reaction to another monoclonal antibody.\n6. Patient has received treatment with any systemic anti-cancer therapies within 3 weeks prior to starting study treatment.\n7. Patient has undergone radiotherapy ≤ 4 weeks or limited field radiation for palliation ≤ 2 weeks prior to starting study treatment.\n8. Patient is unable to provide informed consent.\n9. Patient has received a prior stem cell or bone marrow transplant.\n10. Patient with abnormal cachexia.\n11. Patient with distended abdomen from ascites.\n12. Patient is currently participating in a treatment study or has participated in a study of an investigational agent within 4 weeks prior to the anticipated first dose of study treatment in this study.","75 Years",{"count":56,"type":20},52,[24,58],"PHASE3","This is a Multi-Center, Phase II\u002FIII, open-label, single dose level (6 mg\u002Fkg) basket trial of PRL3-zumab monotherapy in solid cancer patients.\n\nThe study will consist of a Screening Period (Day - 14 to Day -1) for completion of all screening assessments before the first administration of study treatment, a Treatment Period during which visits will occur every 2-week (PK T1\u002F2 = 12 days ±2 days), once the decision to discontinue treatment for any reason, an End of Treatment (EOT) visit will be performed within 14 days ±4 days after last dose of study treatment. Safety Follow-up\u002FEOS visit will be performed 28 days ±2 days after last dose of study treatment and survival follow-up call will be performed every month up to 6 months after EOS visit.\n\nPRL3-zumab will be administered by intravenous (i.v.) infusion till patient meets discontinuation criteria (progressive disease, clinically or per iRECIST, intolerable toxicity or withdrawal of consent). One cycle of treatment will be 4-weeks (2 infusions, 12 days±2 days apart). Patients will undergo safety assessment including laboratory tests prior to each infusion. Efficacy will be assessed by iRECIST at baseline and every 4 doses after study treatment. QoL assessments will be performed at Screening and every 4 doses ±7 days during treatment. A patient will be discontinued from study treatment if the patient progress clinically or per iRECIST criteria, or for intolerable toxicity, or if the patient withdraws consent. An EOT visit will be performed within14 days ±4 days after last study treatment dose.",[61],"Advanced Solid Cancers","2026-04-14",{"date":64,"type":38},"2026-04-16",{"date":66,"type":38},"2023-01-09",{"date":68,"type":20},"2026-12",{"name":44,"class":45},4,""]