[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Biocon Biologics UK PLC\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":98},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,46,72],{"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":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100629565","phase-1-pharmacokinetics-safety-and-immunogenicity-comparison-of-bmab1700-and-opdivo-as-adjuvant-monotherapy-in-participants-with-melanoma-100629565",false,"NCT07476326","Pharmacokinetics, Safety, and Immunogenicity Comparison of Bmab1700 and Opdivo® as Adjuvant Monotherapy in Participants With Melanoma","A Randomized, Double-Blind, Parallel, Multicenter, Two-Arm Study to Compare the Pharmacokinetics, Safety, and Immunogenicity Between Bmab1700 and Opdivo® After Complete Resection of Stage IIB\u002FC, Stage III, or Stage IV Melanoma","Inclusion Criteria:\n\n1. Participants greater than or equal to (\\>=)18 years of age on the day of signing informed consent (follow local regulatory requirements if the legal age of consent for study participation is \\>18 years old).\n2. Able to understand and willing to provide consent using the study Informed Consent Form (ICF). The voluntarily signed ICF must be obtained before any study-specific procedures are performed.\n3. Histologically or cytologically confirmed Stage IIB, Stage IIC, Stage III, or Stage IV melanoma (per American Joint Committee on Cancer, 8th edition) that was completely surgically resected. Complete surgical resection requires removal of all clinically or radiographically evident regional disease. Completion of lymph node dissection is not required unless clinically indicated. Participants must have been surgically rendered free of disease with negative margins on resected specimens documented by appropriate pathology and surgical reports.\n4. Complete surgical resection of melanoma must have been performed within 12 weeks before randomization.\n5. All participants must have disease-free status documented by a complete physical examination and imaging studies before randomization.\n6. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.\n7. Participants must have recovered from melanoma related surgery and its complications before randomization, as per investigator.\n\nExclusion Criteria:\n\n1. History of ocular\u002Fuveal melanoma.\n2. Participants with an active, known, or suspected autoimmune disease are to be excluded from participation. Participants who have received systemic treatment for an autoimmune disease within the past 2 years before randomization (eg, with disease-modifying agents, corticosteroids, or immunosuppressive drugs) are also excluded.\n3. History of active malignancy other than melanoma under study within 3 years before randomization, except for locally curable early-stage cancers (carcinoma in situ or Stage I) that have been curatively treated, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast.\n4. Participants with a condition requiring systemic treatment with either corticosteroids \\>10 mg daily prednisone or equivalent or other immunosuppressive medications within 14 days before randomization. Inhaled or topical steroids, and adrenal replacement steroid doses \\\u003C=10 mg daily prednisone or equivalent, are permitted in the absence of active autoimmune disease\n5. Female participants who are pregnant or breastfeeding at the screening visit, or who intend to become pregnant or breastfeed at any time during the study and for 150 days after the last dose of study intervention.\n6. Use of an investigational agent or an investigational device within 28 days or 5 half-lives (if half-life is known for the investigational agent), whichever is longer, before randomization or have not recovered from AEs associated with such therapies to Grade 1 or below (based on CTCAE Version 6.0).\n7. Any antineoplastic therapy after the complete resection of melanoma under study (eg, chemotherapy, radiation therapy, targeted agents, biotherapy, or limb perfusion).\n8. Participants who have received a live\u002Fattenuated vaccine within 28 days before randomization. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella\u002Fzoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin, and typhoid vaccine.\n9. Expected to receive any other form of antineoplastic therapy during the clinical study.\n10. Participants who received previous systemic therapy with any of the following: anti-programmed cell death-protein 1 (PD-1), anti programmed cell death-ligand 1 (PD-L1), anti-programmed cell death-ligand 2 (PD-L2), anti-CD137, anti-cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) antibodies (including nivolumab or pembrolizumab or ipilimumab or other CTLA-4 targeting agents), chimeric antigen receptor T-cell therapy cells, or any agents targeting the IL-2 pathway or other T-cell co-stimulation\u002F checkpoint pathways.\n11. Treatment with complementary medications (eg, herbal supplements or traditional medicines) with an antineoplastic intent to treat the melanoma within 2 weeks before randomization. Such medications are permitted if they are used as supportive care.\n12. Participants will be excluded if clinical assessment or laboratory investigations before randomization demonstrate any of the following:\n\n    1. White blood cells: less than (\\\u003C) 2000 per microliter\n    2. Neutrophils: \\\u003C1500 per microliter\n    3. Platelets: \\\u003C100 \\*103 per microliter\n    4. Hemoglobin: \\\u003C9.0 gram per deciliter (g\u002FdL)\n    5. Participants with estimated creatinine clearance (CrCl) (measured or calculated) less than or equal to (\\\u003C=) 40 milliliter per minute (mL\u002Fmin).\n\n       • CrCl: using the Cockroft-Gault formula:\n       * Female CrCl = \\[(140 - age in years) \\* weight in kilogram (kg) \\* 0.85\\] divided by (72 \\* serum creatinine in milligram per deciliter \\[mg\u002FdL\\])\n       * Male CrCl = \\[(140 - age in years) \\* weight in kg \\* 1.00\\] divide by (72 \\* serum creatinine in mg\u002FdL)\n    6. Aspartate aminotransferase: greater than (\\>) 2.5 \\* upper limit of normal (ULN)\n    7. Alanine aminotransferase: \\>2.5 \\* ULN\n    8. Total bilirubin \\>1.5 \\* ULN (except participants with Gilbert Syndrome who must have a total bilirubin level of \\\u003C3.0 \\* ULN)\n13. Participants positive for human immune deficiency virus (HIV-1 and HIV-2) tests. Screening for HIV infection must adhere to local regulatory guidelines and confirm the absence of HIV-1 and HIV-2 infection.\n\n    Note: Participants with documented HIV infection may be enrolled where required by local regulatory or ethics committee guidance, provided all the following criteria are met:\n    * The participant is on stable antiretroviral therapy for at least 12 weeks prior to the first dose of study treatment, and no planned change in antiretroviral therapy regimen during the PK sampling period.\n    * Adequate immune function, defined as: CD4+ T cell count greater than or equal to (\\>=) 350 cells per millimeter cube (cells\u002Fmm\\^3) at screening\n    * No history of uncontrolled or recent Acquired Immunodeficiency Syndrome (AIDS) defining illness, that is \\[ie\\], no active AIDS defining condition within the past 12 months\n    * Undetectable viral RNA load\n14. Participants having positive test result for hepatitis B virus (HBV) or hepatitis C virus (HCV) indicating presence of virus, eg, hepatitis B surface antigen (Australia antigen) positive, or hepatitis C antibody (anti- HCV) positive (except if HCV RNA negative).\n15. Participants with history or current evidence of any clinically significant medical condition (including but not limited to physical examination, vital signs, electrocardiogram \\[ECG\\] findings, laboratory results), or ongoing therapy, that could confound study results, increase participation risk, or are deemed not in the participant's best interest by the treating investigator.\n16. Known history of allergy or hypersensitivity to IMP components.\n17. Known history of severe hypersensitivity reaction (Grade \\>=3) to any monoclonal antibody.\n18. Participants who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness.\n19. Has documented or known current alcohol\u002Fdrug abuse that precludes the participant's ability to adhere to the protocol.\n20. Prisoners or participants who are involuntarily incarcerated.","ALL","18 Years",{"count":19,"type":20},120,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","The purpose of this study is to investigate the pharmacokinetics (PK) similarity of Bmab1700 (an intended nivolumab biosimilar), compared with United States (US)-licensed Opdivo, in participants after complete surgical removal of melanoma.",[26],"Melanoma",[28,29,30,31,32],"Neoplasm","Programmed cell death-protein 1(PD-1)","Cytotoxic T-lymphocyte-associated protein 4 (CTLA-4)","Monoclonal antibody","Immunoglobulins","NOT_YET_RECRUITING","2026-08-11",{"date":36,"type":37},"2026-08-13","ACTUAL",{"date":39,"type":20},"2026-08",{"date":41,"type":20},"2028-02-16",{"name":43,"class":44},"Biocon Biologics UK PLC","INDUSTRY",48,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":53,"enrollmentInfo":54,"targetDuration":4,"studyType":21,"phases":56,"briefSummary":57,"conditions":58,"keywords":60,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":4},"100637427","phase-1-pharmacokinetics-safety-and-immunogenicity-of-bmab1800-and-keytruda-as-adjuvant-monotherapy-in-patients-with-melanoma-100637427","NCT07581509","Pharmacokinetics, Safety, and Immunogenicity of Bmab1800 and Keytruda® as Adjuvant Monotherapy in Patients With Melanoma","A Randomized, Double-blind, Two-arm, Parallel Comparative Multi-center Study to Assess and Compare the Pharmacokinetics, Safety, and Immunogenicity of Bmab1800 and Keytruda® as Adjuvant Monotherapy in Patients With Melanoma","Inclusion Criteria:\n\n* Male or female patients aged ≥18 years (or legal adult age per local regulations)\n* ECOG Performance Status of 0 or 1 at screening and prior to randomization.\n* Histologically confirmed melanoma that is completely surgically resected with negative margins (per local standard), classified as: Stage IIB, IIC, or Stage III melanoma per AJCC Cancer Staging Manual, 8th edition.\n* Patients must have undergone definitive melanoma resection ≥28 days prior to signing informed consent, and randomization must occur within 12 weeks after surgery.\n* All patients must have disease-free status (ie, no evidence of locoregional recurrence or distant metastasis); no clinical evidence of brain metastases.\n\nExclusion Criteria:\n\n* History of ocular\u002Fuveal and mucosal melanoma.\n* Active autoimmune disease that has necessitated chronic systemic treatment within 2 years before the first study treatment\n* Active, known, or suspected autoimmune disease that has required systemic treatment in past 2 years.\n* Prior malignancy active within the previous 3 years, except for early-stage cancers (carcinoma in situ or Stage 1) treated with curative intent, basal cell carcinoma of the skin, squamous cell carcinoma of the skin, in situ cervical cancer, in situ prostate cancer, or in situ breast cancer that has undergone potentially curative therapy.\n* Prior therapy with anti-PD-1 (including pembrolizumab), anti PD-L1, anti PD L2, anti CD137, or anti-CTLA-4 antibody (including ipilimumab or any other antibody) or agents that target interleukin-2 (IL-2) pathway any other antibody or drug specifically targeting T cell co-stimulation or checkpoint pathways.\n* Requirement for systemic treatment corticosteroids (\\>10 mg daily prednisone or equivalent) or other immunosuppressive medications within 14 days of randomization. Inhaled or topical steroids, and adrenal replacement steroid doses \\> 10 mg daily prednisone or equivalent, are permitted in the absence of active autoimmune disease.\n* History of ocular\u002Fuveal and mucosal melanoma.\n* Active autoimmune disease that has necessitated chronic systemic treatment within 2 years before the first study treatment\n* Active, known, or suspected autoimmune disease that has required systemic treatment in past 2 years.\n* Prior malignancy active within the previous 3 years, except for early-stage cancers (carcinoma in situ or Stage 1) treated with curative intent, basal cell carcinoma of the skin, squamous cell carcinoma of the skin, in situ cervical cancer, in situ prostate cancer, or in situ breast cancer that has undergone potentially curative therapy.\n* Prior therapy with anti-PD-1 (including pembrolizumab), anti PD-L1, anti PD L2, anti CD137, or anti-CTLA-4 antibody (including ipilimumab or any other antibody) or agents that target interleukin-2 (IL-2) pathway any other antibody or drug specifically targeting T cell co-stimulation or checkpoint pathways.\n* Requirement for systemic treatment corticosteroids (\\>10 mg daily prednisone or equivalent) or other immunosuppressive medications within 14 days of randomization. Inhaled or topical steroids, and adrenal replacement steroid doses \\> 10 mg daily prednisone or equivalent, are permitted in the absence of active autoimmune disease.\n* Receipt of treatment directed against the resected melanoma (eg, chemotherapy, targeted agents, biotherapy, or limb perfusion) administered after the complete resection.\n* History of allergy or hypersensitivity to pembrolizumab or its excipients.\n* History of severe hypersensitivity reaction (Grade ≥3) to any monoclonal antibody.\n* Received prior anticancer therapy including mAb, chemotherapy, or an investigational agent or device within 5 half-lives before first dose of study intervention or not recovered (ie, \\> Grade 1 or at baseline) from AEs due to previously administered agents at screening and before randomization.\n* Patients with ≤ Grade 2 neuropathy are an exception and may qualify for the study.\n* Received a live vaccine within 30 days prior to the first dose of study intervention.","99 Years",{"count":55,"type":20},138,[23],"The purpose of the study is to evaluate the pharmacokinetic (PK) equivalence of Bmab1800 as compared with reference product Keytruda® in a randomized, double-blind, two-arm, parallel comparative, multi-center study in patients with resected melanoma (Stage IIB, or Stage IIC, or Stage III) as an adjuvant treatment. This study also compares the safety and immunogenicity of Bmab1800 and Keytruda.",[59],"Adult Patients With Stage IIB, IIC, and Stage III Melanoma Following Complete Resection (Adjuvant Settings)",[61,26,62,63],"Pembrolizumab","Biosimilar","Adjuvant Therapy","2026-05-13",{"date":66,"type":37},"2026-05-14",{"date":68,"type":20},"2026-08-01",{"date":70,"type":20},"2028-06-21",{"name":43,"class":44},{"id":73,"slug":74,"hasResults":11,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":4,"eligibilityCriteria":78,"healthyVolunteers":79,"sex":80,"minAge":17,"maxAge":81,"enrollmentInfo":82,"targetDuration":4,"studyType":21,"phases":84,"briefSummary":85,"conditions":86,"keywords":4,"overallStatus":88,"whyStopped":4,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},"100616003","phase-1-a-phase-1-comparative-study-to-evaluate-pharmacokinetics-immunogenicity-safety-and-tolerability-of-bmab3000-and-herceptin-hylecta-after-a-single-600-mg-sc-injection-in-healthy-male-volunteers-100616003","NCT07299955","A Phase 1 Comparative Study to Evaluate Pharmacokinetics, Immunogenicity, Safety and Tolerability of Bmab3000 and Herceptin Hylecta® After a Single 600 mg SC Injection in Healthy Male Volunteers","A Phase 1, Randomized, Double-Blind, Two-arm, Parallel Design, Comparative Study to Assess Pharmacokinetics, Immunogenicity, Safety and Tolerability of Bmab3000 and Herceptin Hylecta® Following a Single Dose of 600 mg Subcutaneous Injection in Healthy Male Volunteers","Inclusion Criteria:\n\n1. Healthy male volunteers aged between 18 to 65 years; both inclusive.\n2. Body weight ≥50 kg and ≤100 kg with body mass index (BMI) between 18.5 and 30 kg\u002Fm2, both inclusive.\n3. Participants should have Left ventricular ejection fraction (LVEF) ≥55%.\n4. Male participants must be using an acceptable method of contraception for the entire duration of the trial, and for at least three months after the trial drug administration. Participants must refrain from fathering a child or donating sperm in the next three months following the last trial drug administration or undergoing vasectomy.\n5. All non-prescription medications must have been discontinued at least 14 days prior to dosing.\n6. All non-topical prescription medications must have been stopped at least 30 days prior to admission to the clinical research center.\n7. Absence of significant findings in the vital signs, 12 lead ECG, and clinical laboratory tests of blood and urine.\n8. Willing and able to sign the informed consent form (ICF).\n\nExclusion Criteria:\n\n1. History of previous exposure to trastuzumab.\n2. Presence of clinically significant medical history and clinically significant findings in the physical examination.\n3. Allergy or hypersensitivity to trastuzumab, other recombinant human or humanized antibodies, other related products, or any excipients\u002F ingredients (e.g. hyaluronidase).\n4. Sick sinus syndrome or known long QT syndrome (QTcF \\>450 msec).\n5. Pronounced sinus bradycardia (\\\u003C40 bpm), even if elicited by sport.\n6. History of relevant drug and\u002For food allergies.\n7. Positive urine drug and breath alcohol screen.\n8. Consumption of any foods containing poppy seeds within 48 hours (2 days) prior to screening\u002Fadmission to the clinical research center.\n9. Positive screen for hepatitis B surface antigen (HBsAg), anti-hepatitis virus (HCV) antibodies, anti-human immunodeficiency virus (HIV) 1 and 2 antibodies.\n10. Donation or loss of blood prior to drug administration.",true,"MALE","65 Years",{"count":83,"type":20},150,[23],"This phase I study is to compare the pharmacokinetics (PK), immunogenicity, safety, and tolerability of Bmab3000 (test) and Herceptin Hylecta (reference) after a single subcutaneous (s.c.) dose in healthy male volunteers.",[87],"Healthy Male Participants","RECRUITING","2026-04-02",{"date":91,"type":37},"2026-04-08",{"date":93,"type":37},"2026-02-28",{"date":95,"type":20},"2026-06-30",{"name":43,"class":44},1,""]