[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"uveal-melanoma-metastatic\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:uveal-melanoma-metastatic":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,42,69,97],{"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":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100428161","phase-1-safety-and-preliminary-efficacy-of-mbs81v270-in-cancer-patients-with-advanced-solid-tumours-100428161",false,"NCT04855435","Safety and Preliminary Efficacy of MBS8(1V270) in Cancer Patients With Advanced Solid Tumours","A Phase I Multicentre, Open-label, Dose Escalation Study to Determine the Safety and Preliminary Efficacy of MBS8(1V270) Administered Intravenously to Cancer Patients With Advanced Solid Tumours","Stage I Inclusion Criteria\n\n1. Male or female aged ≥18 years.\n2. Diagnosis of a histologically or cytologically confirmed solid tumour that was advanced and with progression. No standard treatment existed, or the participant refused standard treatment. Experimental immunotherapy appeared as a feasible exploratory treatment option as per Investigator's assessment.\n3. Tumour lesion(s) accessible to serial biopsies.\n4. Was willing and able to comply with scheduled visits, treatment schedule, laboratory tests, and tumour biopsies. Mandatory Baseline and on-treatment tumour biopsies were required. However, a biopsy may have been omitted if the procedure was deemed medically unsafe or not feasible, based on the Investigator's clinical judgment and after discussion with the Medical Monitor (or Sponsor's designee).\n5. Measurable disease according to RECIST v1.1. Previously irradiated lesions were measurable if subsequent progression was documented.\n6. Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1.\n7. Life expectancy \\>3 months as assessed by the Investigator.\n8. Adequate bone marrow, cardiopulmonary, renal and hepatic functions:\n\n   • Haemoglobin ≥5.6 mmol\u002FL (≥90 g\u002FdL) (without transfusion or erythropoietin therapy within 4 weeks prior to therapy)\n\n   • Neutrophils ≥1.5×109\u002FL, without growth factor stimulation within 3 weeks prior to the blood test\n\n   • Platelet count ≥75×109\u002FL\n\n   • Serum creatinine ≤1.25×ULN or creatinine clearance ≥50 mL\u002Fmin (by CKD-EPI formula)\n\n   • Hepatic function: AST and ALT ≤2.5×ULN; (5×ULN in the case of liver metastases); bilirubin ≤1.5×ULN except in the case of Gilbert's syndrome and 2×ULN in the case of liver metastases.\n9. All participants of childbearing potential (defined as \\\u003C2 years after last menstruation or not surgically sterile) must have had a negative highly sensitive pregnancy test at Screening (urine\u002Fserum) and agreed to use highly effective method for contraception according to the European Union (EU) Clinical Trial Facilitation Group guidance from time of signing the informed consent form (ICF) until at least 120 days after the last administration of trial drug. The partners of participants with childbearing potential must have also applied contraceptive methods and were recommended not to donate sperm.\n10. Ability to understand and sign the ICF.\n\nStage II General Inclusion Criteria The following general inclusion criteria apply to all participants unless cohort criteria specify otherwise.\n\n1. Male and female aged ≥18 years.\n2. Eastern Cooperative Oncology Group performance status 0 to 1.\n3. Life expectancy ≥3 months as assessed by the Investigator.\n4. Adequate organ function within 7 to 14 days prior to Day 1. • Absolute neutrophil count ≥1.5×10⁹\u002FL; platelets ≥100×10⁹\u002FL; haemoglobin ≥9 g\u002FdL (transfusion allowed per site's policy) • Aspartate transaminase\u002FALT ≤3×ULN (≤5×ULN in case of liver metastases)\n\n   • Total bilirubin ≤1.5×ULN (≤3×ULN in case of Gilbert's syndrome)\n   * Creatinine clearance ≥50 mL\u002Fmin (Cockcroft-Gault or measured)\n   * International normalised ratio (INR)\u002Factivated partial thromboplastin time (APTT) within institutional limits (unless on stable anticoagulation).\n5. Prior systemic anti-cancer therapy with a washout period of ≥14 days plus resolution of drug-related AEs before C1D1. Participants should have recovered from prior therapy-related toxicities to Baseline or Grade ≤1 (except alopecia and other non-clinically significant AEs) and meet all Baseline laboratory criteria. Any deviation requires documented approval from the Sponsor\u002FMedical Monitor with justification in the source record.\n6. Major surgery ≥4 weeks, palliative radiotherapy ≥2 weeks, stereotactic body radiation therapy to lung\u002Fliver ≥3 weeks.\n7. No systemic steroids \\>10 mg\u002Fday prednisone-equivalent within 14 days before C1D1.\n\n   Note: Physiologic\u002Freplacement doses (e.g., adrenal insufficiency) up to 10 mg\u002Fday prednisone-equivalent, topical, inhaled, intra-articular, intranasal, or ophthalmic steroids are allowed.\n8. All participants of childbearing potential (defined as \\\u003C2 years after last menstruation or not surgically sterile) must have a negative highly sensitive pregnancy test at Screening (urine\u002Fserum) and agree to use highly effective method for contraception according to the EU Clinical Trial Facilitation Group guidance from the time of signing the ICF until at least 120 days after the last administration of trial drug. The partners of participants with childbearing potential must also apply contraceptive methods and are recommended not to donate sperm.\n9. Ability to provide informed consent and comply with trial procedures.\n10. Lactate dehydrogenase ≤2.0×ULN at Screening (single repeat allowed, if confounded).\n\nStage II - Cohort A (Cutaneous Melanoma; Pembrolizumab in Combination with MBS8(1V270)) Specific Inclusion Criteria The following inclusion criteria apply specifically to Stage II - Cohort A. 11A. Histologically\u002Fcytologically confirmed metastatic cutaneous melanoma. 12A. Prior exposure to pembrolizumab, nivolumab, nivolumab + ipilimumab, or nivolumab + relatlimab with documented SD lasting ≥6 months, or any CR or PR followed by disease progression.\n\n13A. No untreated or unstable brain metastases. Participants with treated\u002Fstable CNS metastasis are eligible if the condition is radiographically stable for ≥4 weeks, no new\u002Fworsening neurologic symptoms, and off steroids or on stable\u002Fdeclining ≤10 mg\u002Fday prednisone-equivalent for ≥14 days.\n\n14A. Last dose of pembrolizumab, nivolumab, nivolumab + ipilimumab, or nivolumab + relatlimab was given ≤12 weeks prior to Screening, and with no other therapy started.\n\n15A. No prior Grade ≥3 irAE leading to permanent discontinuation of prior anti-PD1\u002FPD L1.\n\n16A. Willing to receive pembrolizumab per SmPC\u002Flabel-concordant schedule. Stage II - Cohort B (Uveal Melanoma; MBS8(1V270) Monotherapy) Specific Inclusion Criteria The following inclusion criteria apply specifically to Stage II - Cohort B. 11B. Histologically\u002Fcytologically confirmed metastatic uveal (ocular) melanoma. 12B. Prior tebentafusp exposure with subsequent progression.\n\n* With documented SD lasting ≥6 months, or any CR or PR\n* RECIST v1.1 progression on tebentafusp.\n* Washout ≥14 days from the last tebentafusp dose, tebentafusp-related AEs recovered to Grade ≤1\u002FBaseline.\n* No new organ crisis (e.g., hepatic failure risk, spinal cord compromise) in the prior 4 weeks.\n* No escalation of corticosteroids for tumour-related symptoms within 14 days. 13B. Prior exposure to pembrolizumab, nivolumab, or nivolumab + ipilimumab with documented SD lasting ≥6 months, or any CR or PR followed by disease progression, independent of prior tebentafusp therapy.\n\nExclusion Criteria A participant was not eligible for the trial if any of the following applied. Stage I Exclusion Criteria\n\n1. Have had biologic, hormonal, anti-neoplastic chemotherapy, or radiation therapy within 4 weeks prior to Screening (6 weeks required for nitrosourea or mitomycin) except for medications with half-lives \\\u003C5.5 days.\n2. Metastatic disease that involved major airways or blood vessels or centrally located mediastinal tumour masses of large volume with close relation to the major airways, where tumour necrosis may have caused perforation or severe bleeding episodes. Primary or metastatic intestinal disease in situ where tumour necrosis may have caused gastrointestinal perforation.\n3. Use of investigational agent in the 4 weeks or 5 half-lives prior to the first dose of MBS8(1V270), whichever was shortest.\n4. Major surgical procedure within 14 days prior to the first dose of trial treatment.\n5. Had a history of another primary malignancy, except for:\n\n   • Malignancy treated with curative intent and with no known active disease within 2 years prior to the first dose of MBS8(1V270)\n\n   • Adequately treated non-invasive basal skin cancer or squamous cell skin carcinoma\n\n   • Adequately treated uterine cervical cancer Stage 1B or less.\n6. Treatment with systemic immunosuppressive medication (including, but not limited to, corticosteroids \\[\\>10 mg prednisone per day or equivalent, except topical or inhaled\\] cyclophosphamide, azathioprine, methotrexate, thalidomide, anti-IL-6 receptor agents, and anti-tumour necrosis factor \\[TNF\\]α agents) within 2 weeks prior to initiation of trial treatment, or anticipation of need for systemic immunosuppressive medication during trial treatment.\n7. Treatment with androgen deprivation therapies such as luteinizing hormone-releasing hormone (LHRH) (gonadotropin-releasing hormone \\[GnRH\\]) agonists within 2 weeks prior to initiation of trial treatment.\n8. Ongoing irAEs and\u002For AEs Grade ≥2 not resolved from previous therapies except vitiligo, resolved atopy, limited psoriasis, stable neuropathy Grade 2, hair loss, and stable endocrinopathies with substitutive hormone therapy.\n9. Had uncontrolled intercurrent or chronic illness, but not limited to, ongoing or active infection such as hepatitis B or C, human immunodeficiency virus (HIV), immune dysfunction such as autoimmune disease, psychiatric illness such as depression or suicidal tendency or social situations that would have limited compliance with trial requirements.\n10. Had active or history of immunologic-mediated disease, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener granulomatosis, Sjögren's syndrome, or Guillain-Barré syndrome.\n11. Had clinically significant cardiac disease, including:\n\n    • Known congestive heart failure Grade III or IV by the New York Heart Failure Association (see Appendix A)\n    * Myocardial infarction within 6 months prior to signing the ICF\n    * Onset of unstable angina within 6 months prior to signing the ICF.\n12. History of severe allergic episodes.\n13. Known hypersensitivity to any component of MBS8(1V270).\n14. Had a history of seizure disorders uncontrolled on medication.\n15. Had a history of clinically significant coagulation or bleeding disorders or abnormalities.\n16. Abnormal or clinically significant coagulation parameters (i.e., INR and APTT) at the discretion of the Investigator.\n\n    Participants treated with anticoagulants were excluded if the coagulation parameters were outside the therapeutic intervals as described in the SmPC for the administered treatment.\n17. Women of childbearing potential who denied remaining abstinent (refrain from heterosexual intercourse) or did not use a highly effective form of contraception that resulted in a failure rate of \\\u003C1% per year during the Treatment period and up to 120 days after the last trial drug administration.\n18. Men of reproductive potential who denied following accepted contraception methods during the Treatment and up to 120 days after the last trial drug administration.\n19. Pregnant or lactating women.\n20. Had a history or current evidence of any condition, therapy, or laboratory abnormality that might have confounded the results of the trial, interfered with the participant's participation for the full duration of the trial, made administration of the trial drugs hazardous, or made it difficult to monitor adverse effects such that it was not in the best interest of the participant to participate, and in the opinion of the treating Investigator.\n21. Had an autoimmune disorder requiring immune-modulating treatment (\\>10 mg prednisone per day or equivalent, except topical or inhaled) during the last 2 years prior to the first dose of MBS8(1V270).\n\nStage II General Exclusion Criteria The following general exclusion criteria apply to all participants unless cohort criteria specify otherwise.\n\n1. Uncontrolled intercurrent illness: active infection requiring IV therapy, uncontrolled congestive heart failure, unstable angina, significant arrhythmia, recent myocardial infarction (≤6 months), or uncontrolled hypertension.\n2. Known active HIV with uncontrolled viraemia, active hepatitis B virus (HBV)\u002Fhepatitis C virus (HCV) with high viral load (HBV \\>20,000 IU\u002FmL and HCV \\>800,000 IU\u002FmL) despite therapy (enrol per local guidelines, if controlled).\n3. Pregnant or breastfeeding.\n4. Second malignancy requiring active therapy (except adequately treated non-melanoma skin cancers, in situ cancers, or malignancies in remission ≥2 years)\n5. Allergy\u002Fhypersensitivity to trial drug components.\n6. Live vaccines within 28 days prior to C1D1.\n7. QTcF \\>500 ms.\n8. Any condition that, in the Investigator's judgement, compromises safety or compliance.\n9. Active autoimmune disease requiring systemic treatment in the past 2 years (topicals\u002Finhaled\u002Fphysiologic replacement allowed).\n10. Any prior exposure to systemic or IT immunotherapy (except tebentafusp, pembrolizumab, nivolumab, ipilimumab, and relatlimab), but including Montanide, TLR7, TLR8, and TLR9 agonists, polyinosinic:polycytidylic acid, cationic adjuvant formulation, messenger ribonucleic acid -based vaccines, T cell therapy, and oncolytic viruses.\n11. Participants who have been previously treated with experimental anti-cancer vaccines.\n\nStage II - Cohort A (Cutaneous Melanoma; Pembrolizumab in Combination with MBS8(1V270)) Specific Exclusion Criteria The following exclusion criteria apply specifically to Stage II - Cohort A. 12A. Prior life-threatening or Grade ≥3 immune-related toxicity to immune checkpoint inhibitors requiring permanent discontinuation of these therapies (exception: controlled endocrinopathies on replacement).\n\n13A. Interstitial lung disease\u002Fpneumonitis (current or history requiring steroids).\n\n14A. Concurrent anti-cancer therapy other than trial-allowed supportive care. 15A. Histologically\u002Fcytologically confirmed cutaneous acral melanoma and mucosal melanoma.\n\nStage II - Cohort B (Uveal Melanoma, MBS8(1V270) Monotherapy) Specific Exclusion Criteria The following exclusion criteria apply specifically to Stage II - Cohort B. 12B. Active, uncontrolled hepatic dysfunction not attributable to tumour (e.g., acute hepatitis).\n\n13B. Any contraindication specific to MBS8(1V270) per IB (e.g., known hypersensitivity to excipients, cohort-specific risk factors).\n\n14B. Brain metastases.","ALL","18 Years",{"count":19,"type":20},106,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","The Phase I trial is evaluating safety, tolerability, pharmacokinetics and preliminary efficacy of MBS8(1V270) in subjects with advanced solid tumours. The trial is designed to provide data for further clinical development of MBS8(1V270)",[26,27,28],"Advanced Solid Tumor","Uveal Melanoma, Metastatic","Cutaneous Melanoma","RECRUITING","2026-06-09",{"date":32,"type":33},"2026-06-11","ACTUAL",{"date":35,"type":33},"2021-04-12",{"date":37,"type":20},"2027-06",{"name":39,"class":40},"MonTa Biosciences ApS","INDUSTRY",5,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":21,"phases":52,"briefSummary":53,"conditions":54,"keywords":55,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":68},"100608579","phase-1-tebentafusp-and-roginolisib-in-uveal-melanoma-to-prolong-t-cell-homeostasis-100608579","NCT07203391","Tebentafusp and Roginolisib in Uveal Melanoma to Prolong T-cell Homeostasis","TRIUMPH - Tebentafusp and Roginolisib in Uveal Melanoma to Prolong T-cell Homeostasis","TRIUMPH","Inclusion Criteria:\n\n1. Male or female participants must be aged 18 years or over at the time, to be eligible to participate in this study.\n2. Histologically or cytologically confirmed metastatic UM or unresectable UM patients\n3. HLA-A\\*02:01 positive\n4. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1\n5. Currently undergoing first-line treatment for mUM with tebentafusp\n6. Tebentafusp related toxicity, including cytokine release syndrome that has resolved to grade ≤ 1 as per CTCAE v5.0.\n7. Male and female participants of childbearing potential who are sexually active with a non-sterilized partner must agree to use highly effective methods of birth control (eg double barrier) from the trial screening date until 6 months after the final dose of the program intervention; cessation of birth control after this point shall be discussed with a responsible physician.\n8. Pregnant or lactating women are prohibited from enrolling on this program.\n9. Male participants are not allowed to donate sperm from the time of enrolment until 6 months post- administration of program interventions.\n\nExclusion Criteria:\n\n1. Presence of untreated or symptomatic central nervous system (CNS) metastases, leptomeningeal disease, or cord compression. NOTE: Participants with treated CNS lesions may enroll provided all of the following apply:\n\n   1. Treated CNS lesions must be radiographically stable for ≥ 4 weeks after intervention (surgery and\u002For radiation).\n   2. Participants must be neurologically stable off systemic corticosteroids for at least 2 weeks prior to trial entry\n2. Ongoing Grade 2 or greater treatment related toxicity due to tebentafusp\n3. Prior treatment with a PI3Kδ inhibitor\n4. Prior Grade 4 cytokine release syndrome related to Tebentafusp\n5. Systemic treatment with steroids or any other immunosuppressive drug use within 2 weeks of the planned first dose of program intervention, with the following exceptions:\n\n   1. Treatment for well-controlled and asymptomatic adrenal insufficiency is permitted, but replacement dosing is limited to prednisone ≤ 10 mg daily or the equivalent.\n   2. Local or topical steroid therapies (eg, optic, ophthalmic, intra- articular, or inhaled medications) are acceptable.\n   3. Premedication for allergy to contrast reagent.\n6. Any relevant medical condition, which in the opinion of the treating physician, would prevent the participant enrolling into the Program due to concerns related to safety, compliance with procedures, or interpretation of program results.\n7. Inability to swallow food or any condition of the upper gastrointestinal tract that precludes administration of oral medications.\n8. Chronic viral infections as indicated below. NOTE: Testing for human immunodeficiency virus (HIV), hepatitis B virus (HBV), and hepatitis C virus (HCV) status prior to enrollment is not necessary unless clinically indicated.\n9. Known HIV infection unless all of the following are applicable:\n\n   1. Receiving an approved, stable, effective combination antiretroviral therapy regimen for ≥3 months prior to the planned first study intervention\n   2. CD4 T-cell count \\>350 cells\u002Fµl\n   3. CD4 T-cell nadir (lowest historical count) \\\u003C 350 cells\u002Fµl\n   4. Viral load confirmed as \\\u003C50 copies\u002Fml during Screening.\n10. Known HBV infection, unless on stable anti-viral therapy for \\> 4 weeks prior to the planned first dose of program intervention and viral load confirmed as undetectable during Screening.\n11. Known HCV infection, unless the participant has received curative treatment, and viral load was confirmed as undetectable during Screening.\n12. Participant with an out-of-range Screening laboratory values defined as shown below. NOTE: Hematology evaluations must be performed ≥ 7 days from any blood or blood product transfusion and ≥ 14 days from any dose of hematologic growth factor.\n\n    1. Creatinine clearance (calculated using Cockcroft-Gault formula, or measured) \\\u003C 30 mL\u002Fminute.\n    2. Total bilirubin \\> 1.5 × ULN, except for patients with Gilbert's syndrome who are excluded if total bilirubin \\> 3.0 × ULN or direct bilirubin \\> 1.5 × ULN.\n    3. Alanine aminotransferase \\> 5 × ULN in the presence of liver metastases; \\> 3 X ULN if not\n    4. Aspartate aminotransferase \\> 5 × ULN in the presence of liver metastases ; \\> 3 X ULN if not\n    5. Platelet count \\\u003C 75 × 109\u002FL\n    6. Hemoglobin \\\u003C 9 g\u002FdL\n13. Clinically significant cardiac disease or impaired cardiac function, including any of the following:\n\n    1. Congestive heart failure (New York Heart Association Class ≥ 3)\n    2. QTcF\\>470msec at baseline\n    3. Uncontrolled hypertension defined as systolic blood pressure \\[BP\\] \\> 160 mmHg or diastolic BP \\> 110 mmHg with the following requirements:\n    4. If initial measurement is elevated, additional assessments should be taken where each assessment is the mean value of 3 measurements taken at least 5 minutes apart.\n    5. Eligibility is based on the average of at least 2 assessments taken at least 1 hour apart.\n    6. Acute myocardial infarction or unstable angina pectoris \\\u003C 6 months prior to the planned first dose of program intervention.",{"count":51,"type":20},8,[23],"This is a combination study of Tebentafusp and the PI3Kdelta inhibitor, Roginolisib",[27],[56,57],"tebentafusp","Roginolisib","2026-04-22",{"date":60,"type":33},"2026-04-23",{"date":62,"type":33},"2026-02-01",{"date":64,"type":20},"2029-12-01",{"name":66,"class":67},"St Vincent's Hospital, Sydney","OTHER",2,{"id":70,"slug":71,"hasResults":11,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":4,"eligibilityCriteria":75,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":76,"targetDuration":4,"studyType":21,"phases":78,"briefSummary":79,"conditions":80,"keywords":83,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":5},"100598827","phase-1-a-phase-1-1b-study-to-evaluate-the-safety-efficacy-and-dosimetry-of-study-drug-a9-3408-in-subjects-with-metastatic-melanoma-100598827","NCT07076550","A Phase 1-1b Study to Evaluate the Safety, Efficacy and Dosimetry of Study Drug A9-3408 in Subjects With Metastatic Melanoma","A Phase 1-1b Study to Evaluate the Safety, Efficacy and Dosimetry of [225Ac]Ac-A9-3408 in Subjects With Unresectable or Metastatic Melanoma","Inclusion Criteria:\n\n* Able to provide written informed consent\n* \\[68Ga\\]Ga-A9T-3202 uptake in at least one measurable lesion (per RECIST v1.1) on PET scan\n* Histologically or cytologically confirmed unresectable or metastatic melanoma with disease progression on prior standard of care therapy\n* Adequate ECOG performance status\n* Adequate baseline organ function within 14 days of first dose of investigational product\n* Recovered from side effects of prior anticancer therapy\n* Women of childbearing potential (WOCBP) must have a negative pregnancy test and follow adequate birth control method(s) during the treatment period and for at least 6 months after last dose of \\[225Ac\\]Ac-A9-3408. Sexually active males with partners who are WOCBP must agree to adequate birth control method(s) during the treatment period and for at least 3 months after last dose of \\[225Ac\\]Ac-A9-3408\n\nExclusion Criteria:\n\n* Previous treatment with radioactive nuclides except radioactive imaging tracers\n* Treatment with another investigational product shortly prior to first dose of \\[225Ac\\]Ac-A9-3408 with exception of anti-PD-1\u002FPD-L1 agents.\n* Concurrent anticancer therapy\n* Major surgery within 4 weeks of first dose of investigational product\n* Second malignancy within 2 years\n* Active, clinically serious infection\n* Known infusion reactions to components of the investigational product\n* Other clinically serious health conditions including cardiovascular and or severe infectious diseases\n* Significant central nervous system metastatic disease\n* Pregnant, breastfeeding or unwilling to practice adequate birth control method(s)\n* Any condition per the opinion of the investigator that would impact the safety of the subject, protocol adherence or ability to provide informed consent",{"count":77,"type":20},50,[23],"The goal of this trial is to see if this investigational drug is safe for adult patients with melanoma that has spread to other parts of the body or cannot be removed by surgery. It will also see if this investigational drug can shrink melanoma tumors in the body. The main questions this study aims to answer are:\n\n* What are the side effects of this investigational drug?\n* What is the highest dose of this investigational drug that can be given safely?\n\nParticipants will:\n\n* Take the investigational drug once every 6 weeks, for up to 6 times in total\n* Visit a doctor's office on a regular basis for checkups and tests",[81,27,82],"Melanoma Metastatic","Mucosal Melanoma",[84,85,86,87],"Metastatic Melanoma","Melanoma","Radiopharmaceuticals","Theranostic","2026-03-12",{"date":90,"type":33},"2026-03-16",{"date":92,"type":33},"2025-11-19",{"date":94,"type":20},"2028-01",{"name":96,"class":40},"Alpha-9 Oncology USA Inc.",{"id":98,"slug":99,"hasResults":11,"nctId":100,"briefTitle":101,"officialTitle":102,"acronym":103,"eligibilityCriteria":104,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":105,"targetDuration":4,"studyType":21,"phases":107,"briefSummary":109,"conditions":110,"keywords":115,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":123,"lastUpdatePostDateStruct":124,"startDateStruct":126,"completionDateStruct":128,"leadSponsor":130,"locationsCount":132},"100603412","phase-1-evaluation-of-the-safety-efficacy-and-pharmacokinetics-of-nbm-bmx-in-patients-with-metastatic-uveal-melanoma-100603412","NCT07136181","Evaluation of the Safety, Efficacy, and Pharmacokinetics of NBM-BMX in Patients With Metastatic Uveal Melanoma","A Multicenter Phase Ib\u002FII Study to Evaluate the Safety, Efficacy and Pharmacokinetics of NBM-BMX in Patients With Metastatic Uveal Melanoma","NBM-BMX-UM","Inclusion Criteria:\n\n\\- Patients must meet the following criteria to be eligible for study entry:\n\n1. Signed, written IRB-approved informed consent.\n2. Men and women age ≥ 18 years\n3. ECOG Performance status ≤ 2\n4. Have measurable disease based on RECIST 1.1\n5. Histologic or cytologic confirmation of metastatic uveal melanoma\n6. Previous Therapy\n\n   * Surgery: Previous surgery is permitted provided that a minimum of 28 days (4 weeks) has elapsed between any major surgery and date of registration, and that wound healing has occurred.\n   * Cytotoxic Chemotherapy: There is no limit to the number of prior regimens received.\n   * Other Systemic Therapy: There is no limit to the number of prior therapies received for metastatic uveal melanoma. Prior treatment with tebentafusp is required for HLA-A\\*02:01-positive patients unless unavailable or clinically inappropriate, as determined by the investigator. Prior HDAC inhibitor treatment is not permitted.\n\n   Patients must have recovered (to baseline or ≤ grade 1) from all reversible toxicity related to prior chemotherapy or systemic therapy and have adequate washout as follows:\n\n   Longest of one of the following:\n   * Two weeks,\n   * 5 half-lives for investigational agents,\n\n     o For anti-cancer therapies with half-lives \\> 8 days, a washout period of at least 28 days will be acceptable,\n   * Standard cycle length of standard therapies.\n7. QTcF \\\u003C= 480 msec\n8. Adequate hematopoietic capacity, as defined by the following:\n\n   * Hemoglobin ≥ 9.0 g\u002FdL and not transfusion dependent\n   * Platelets ≥ 100,000\u002Fmm3\n   * Absolute neutrophil count ≥ 1,500 cells\u002Fmm3\n9. Adequate hepatic function, as defined by the following:\n\n   * AST and ALT ≤ 2.5 times upper limit of normal (ULN) or ≤ 5 times ULN if liver metastases are present\n   * Total bilirubin ≤ 1.5 x ULN or within 3x the ULN for patients with Gilbert disease\n   * Albumin ≥ 3.0 g\u002FdL\n10. Adequate renal function, as defined by the following:\n\n    \\- Renal: calculated creatinine clearance \\>45 mL\u002Fmin for patients between 18 and 70 years old with abnormal, increased, creatinine levels (Cockcroft-Gault formula; Appendix F). For patients who are greater than 70 years old, investigator judgment may be used to assess the renal risk of study participation.\n11. Women\u002Fmen of childbearing potential must have agreed to use two effective contraceptive methods while on study and for 6 months after the last dose of NBM-BMX.\n12. Willingness and ability to comply with the study scheduled visits, treatment plans, laboratory tests and other procedures.\n\nExclusion Criteria:\n\nPatients who meet the following criteria will be excluded from study entry:\n\n1. Pregnant or nursing women. NOTE: Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; or abstinence) prior to study entry and for the duration of study participation and for at least 6 months after the last dose of NBM-BMX. Should a man father a child, or a woman become pregnant or suspect she is pregnant while participating in this study, he or she should inform the treating physician immediately.\n2. Concurrent non-protocol-specified anti-tumor therapy (e.g., chemotherapy, other targeted therapy, radiation therapy, or photodynamic therapy)\n3. History of other malignancies within 3 years of Day 1, except for tumors with a negligible risk for metastasis or death, such as adequately treated squamous-cell carcinoma of the skin, ductal carcinoma in situ of the breast, or carcinoma in situ of the cervix.\n4. Active or uncontrolled infections or with serious illnesses or medical conditions which would not permit the patient to be managed according to the protocol.\n5. History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates use of an investigational drug or that might affect interpretation of the results of the study or renders the patient at high risk from treatment complications.\n6. Difficulty with swallowing oral medications.\n7. Currently taking moderate and strong inhibitors (e.g., gemfibrozil) or inducers of CYP2C8.\n8. A positive test for hepatitis B (HBsAg) and\u002For hepatitis C (anti-HCV antibody), unless the HBV DNA level and\u002For HCV RNA level is below the limit of detection.\n9. Any of the following within 3 months of the first dose of NBM-BMX: myocardial infarction, severe\u002Funstable angina, coronary\u002Fperipheral artery bypass graft, congestive heart failure, or cerebrovascular accident including transient ischemic attack.\n10. Current use or anticipated need for P-gp or BCRP inhibitors during the study period.\n11. Use of proton pump inhibitors (PPIs), H2-receptor antagonists, or other systemic acid-reducing agents within 7 days prior to Cycle 1 Day 1 or planned use during the study treatment period, unless the patient can be switched to local antacids (e.g., calcium carbonate or aluminum hydroxide) taken at least 2 hours before or after NBM-BMX dosing.\n\nPatients unable or unwilling to comply with this restriction should be excluded. Exceptions must be discussed with and approved by the Medical Monitor.",{"count":106,"type":20},36,[23,108],"PHASE2","This study is being done to find the best dose of an investigational drug called NBM-BMX for people with metastatic uveal melanoma, a type of eye cancer that has spread to other parts of the body.\n\nThe study will help doctors learn about the side effects of NBM-BMX, how the drug is processed in the body, and whether it may slow down or shrink tumors.\n\nParticipants will take NBM-BMX as a capsule by mouth twice daily on an empty stomach with at least six ounces (180 mL) of water. No food or drink (other than water) should be consumed for at least two hours after each dose.\n\nParticipants will visit the clinic about once every week or two for exams and blood tests while taking NBM-BMX. After stopping treatment, a follow-up visit will occur about 30 days later.\n\nTreatment may continue as long as the cancer does not get worse and side effects remain manageable.",[111,27,112,113,114],"Metastatic Uveal Melanoma","Uveal Melanoma, Recurrent","Eye Cancer, Intraocular Melanoma","Eye Cancer",[111,116,114,117,118,119,120,121,122],"Uveal Melanoma","Intraocular Melanoma","Choroidal Melanoma","NBM-BMX","Histone Deacetylase Inhibitor (HDAC inhibitor)","Phase 1b\u002F2 Study","Pharmacokinetics","2025-11-21",{"date":125,"type":33},"2025-11-28",{"date":127,"type":33},"2025-11-20",{"date":129,"type":20},"2029-08-30",{"name":131,"class":40},"Novelwise Pharmaceutical Corporation",3]