[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"BioInvent International AB\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":89},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,41,67],{"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":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100379336","phase-1-a-study-of-bi-1206-in-combination-with-pembrolizumab-in-subjects-with-advanced-solid-tumors-100379336",false,"NCT04219254","A Study of BI-1206 in Combination With Pembrolizumab in Subjects With Advanced Solid Tumors","A Phase 1\u002F2a Clinical Trial of BI-1206, a Monoclonal Antibody to CD32b (FcγRIIB), in Combination With Pembrolizumab in Subjects With Advanced Solid Tumors","Inclusion Criteria:\n\n* Is willing and able to provide written informed consent for the trial.\n* Is ≥18 years of age on day of signing informed consent.\n* Phase I only: Has a histologically confirmed advanced solid tumor. Subjects must have received at least 2 doses of an approved anti-PD-1\u002FL1 mAb, and have documented progression on or within 12 weeks from the last dose of anti-PD-1\u002FL1 mAb.\n* For patients with NSCLC (phase 2A SC cohorts):\n\nHave a histologically confirmed diagnosis of advanced or metastatic NSCLC and not have an EGFR sensitizing (activating) mutation or an ALK translocation.\n\nHave a PD-L1 positive (TPS≥50%) tumor as determined by IHC at a local laboratory.\n\nHave not received prior systemic immunotherapy or chemotherapy treatment for their advanced\u002Fmetastatic NSCLC.\n\nHave provided formalin-fixed tumor tissue sample from a biopsy of a tumor lesion either at the time of or after the diagnosis of advanced or metastatic disease has been made and from a lesion not previously irradiated to perform biomarker analysis.\n\n• For patients with uveal melanoma (phase 2A SC cohort): Have a histologically confirmed diagnosis of advanced or metastatic uveal melanoma\n\nHave a PD-L1 positive (TPS≥1%) tumor as determined by IHC at a local laboratory.\n\nHave not received prior systemic immunotherapy or chemotherapy treatment for their advanced\u002Fmetastatic uveal melanoma. Subjects who have received previous treatment with tebentafusp and\u002For liver directed therapy are allowed.\n\nHave provided formalin-fixed tumor tissue sample from a biopsy of a tumor lesion either at the time of or after the diagnosis of advanced or metastatic disease has been made and from a site not previously irradiated to perform biomarker analysis.\n\n* Phase I only: Is intolerant of, refuses, or is not eligible for standard antineoplastic therapy.\n* Has at least 1 measurable disease lesion as defined by Response Evaluation Criteria in Solid Tumors (RECIST v1.1)\n* Phase IIa only: Is willing to provide an archival tumor tissue sample or newly obtained \\[core, incisional, OR excisional\\] biopsy of a tumor lesion not previously irradiated.\n* Is able to safely undergo a baseline tumor tissue biopsy prior to first dose of BI-1206.\n* Has a life expectancy of ≥12 weeks.\n* Has an ECOG performance status of 0-1.\n* Has adequate organ function as confirmed by laboratory values listed in the main body of the protocol\n* Phase IIa only: Participants who are HBsAg positive are eligible if they have received HBV antiviral therapy for at least 4 weeks and have undetectable HBV viral load prior to enrolment\n* Phase IIa only: Participants with history of HCV infection are eligible if HCV viral load is undetectable at Screening\n* Phase IIa only: Has adequate hematological and biochemical indices as listed in the main body of the protocol\n\nExclusion Criteria:\n\n* Needs doses of prednisolone \\>10 mg daily (or equipotent doses of other corticosteroids) while on the study, other than as premedication.\n* Has known active central nervous system (CNS) metastases and\u002For carcinomatous meningitis.\n* Has known or suspected hypersensitivity to pembrolizumab or BI-1206 or any of their excipients.\n* Has cardiac or renal amyloid light-chain (AL) amyloidosis.\n* Has received radiotherapy within 2 weeks of the first dose of BI-1206.\n* Has not recovered from AEs to at least Grade 1 by CTCAE v5.0 (or higher) due to prior anticancer therapies• Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis\n* Has an active, known or suspected autoimmune disease.\n* Is a female subject and has the ability to become pregnant (or already pregnant or lactating\u002Fbreastfeeding)\n* Is a male subject with partner(s) of childbearing potential (unless he agrees to use a barrier method of contraception during the study and for 12 months after completing treatment)\n* Has had major surgery from which the subject has not yet recovered Is at high medical risk because of non-malignant systemic disease, including severe active infections on treatment with antibiotics, antifungals, or antivirals\n* Has presence of chronic graft-versus-host disease.\n* Has had an allogenic tissue\u002Fsolid organ transplant.\n* Has a known history of HIV infection\n* Has a history of active tuberculosis (Bacillus tuberculosis)\n* Has received a live vaccine within 30 days before the first dose of study treatment\n* Has uncontrolled or significant cardiovascular disease as listed in the main body of the protocol\n* Has a known psychiatric or substance abuse disorder that would interfere with the subject's ability to cooperate with the requirements of the study\n* Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or lead to participation not being in the best interest of the subject, in the opinion of the treating Investigator.\n* Is participating or planning to participate in another interventional clinical study or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study drug\n* Has a known additional malignancy of another type, with the exception of adequately treated cone-biopsied carcinoma in situ (e.g., breast carcinoma, cervical cancer in situ) and basal or squamous cell carcinoma of the skin\n* Has a diagnosis of primary or acquired immunodeficiency disorder or has taken any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug.\n* Is unable to attend the study site to receive the study treatment\n\nAdditional exclusion criteria are described in the protocol.","ALL","18 Years",{"count":19,"type":20},197,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE1","PHASE2","Phase 1\u002F2a Clinical Trial of BI-1206, a Monoclonal Antibody to CD32b (FcγRIIB), in Combination with Pembrolizumab in Subjects with Advanced Solid Tumors",[27],"Solid Tumor, Adult","RECRUITING","2026-06-22",{"date":31,"type":32},"2026-06-25","ACTUAL",{"date":34,"type":32},"2020-06-29",{"date":36,"type":20},"2027-11",{"name":38,"class":39},"BioInvent International AB","INDUSTRY",26,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":48,"targetDuration":4,"studyType":21,"phases":50,"briefSummary":51,"conditions":52,"keywords":57,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":66},"100420291","phase-1-bi-1808-as-a-single-agent-and-with-pembrolizumab-keytruda--in-treatment-of-advanced-malignancieskeynote-d20-100420291","NCT04752826","BI-1808 as a Single Agent and With Pembrolizumab (KEYTRUDA® ) in Treatment of Advanced Malignancies(Keynote-D20)","Phase 1\u002F2a Open-Label, Dose-Escalation, Multicenter, FIH, Consecutive-Cohort, Clinical Trial of BI-1808, a Monoclonal Antibody to TNFR 2 as a Single Agent and in Combination With Pembrolizumab (MK-3475-D20) in Subjects With Advanced Malignancies","Inclusion Criteria:\n\n1. Is willing and able to provide written informed consent for the trial.\n2. Is ≥18 years of age on the day of signing informed consent.\n3. Has a histologically confirmed advanced malignancy. Subjects with CTCL \\[MF or SS\\] who satisfy the Phase 2a, Cohort 3-specific eligibility criteria may be enrolled into the Phase 1 part of the study.\n4. Is intolerant of, refuses, or is not eligible for standard antineoplastic therapy.\n5. Has at least 1 measurable disease lesion as defined by RECIST.\n6. Is able to safely undergo a baseline tumor tissue biopsy prior to first dose of BI-1808 (on non previously irradiated lesions only). The biopsy must be performed at least 4 weeks following the last dose of tumor directed therapy.\n7. Has a life expectancy of ≥12 weeks.\n8. Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.\n9. Has adequate organ function as confirmed by laboratory values.\n\nPhase 2a Expansion Cohort-Specific Inclusion Criteria:\n\nOvarian Cancer:\n\nHistologically confirmed and documented recurrent ovarian, fallopian tube, and peritoneal cancer.\n\nTCL:\n\n1. histologically confirmed diagnosis\n2. Stable doses of systemic steroids (≤20 mg prednisone equivalent) and of low-to-medium potency topical steroids permitted (no change in preceding 4 weeks).\n3. Stage IB-IV with failure of at least 1 systemic therapy.\n4. No current large cell transformation for subjects with CTCL.\n5. Prior therapy - No prior allo hematopoietic stem cell transplantation (HSCT); \\>90 days since auto HSCT; \\>4 weeks since systemic therapy and \\>2 weeks since skin-directed therapy.\n6. Stable doses of systemic steroids (≤20 mg prednisone equivalent) and of low-to-medium potency topical steroids permitted (no change in preceding 4 weeks).\n7. Previous systemic therapies include brentuximab vedotin, bexarotene, extracorporeal photopheresis (ECP), methotrexate, mogamulizumab, romidepsin, vorinostat, or systemic therapy with localized radiation treatment or skin-directed therapy.\n\nMelanoma:\n\n1. Histologically confirmed diagnosis of unresectable or metastatic melanoma.\n\n   Subjects in Part A:\n2. Required prior therapies will include anti-programmed death-ligand 1 (PD-1) therapy either as monotherapy or as part of a combination regimen.\n3. For subjects with a known BRAF V600-activating mutation combination targeted therapy will be required in addition to anti-PD-1\u002Fprogrammed death-ligand 1 (PD-L1) therapy.\n\n   Subjects in part B:\n4. Subjects with prior lines of treatment are not eligible.\n\nAll Tumor Types:\n\nLocally advanced unresectable, recurrent or metastatic immune checkpoint inhibitor-naïve solid tumors, likely to benefit from immune checkpoint inhibitor treatment, based on Investigator opinion.\n\nb. Subjects must have received prior standard therapy appropriate for their tumor type and stage of disease, or in the opinion of the Investigator, would be unlikely to tolerate or derive clinical benefit from appropriate standard of care therapy.\n\nc. Subjects with known activation mutations must have prior target therapy.\n\nExclusion Criteria:\n\n1. Needs doses of prednisolone \\>10 mg daily (or equipotent doses of other corticosteroids) while on the trial other than as premedication.\n2. Has known active central nervous system (CNS) metastases and\u002For carcinomatous meningitis.\n3. Has known or suspected hypersensitivity to BI-1808 or pembrolizumab\n4. Has cardiac or renal amyloid light-chain amyloidosis.\n5. Has received the following:\n\n   1. Chemotherapy or small molecule products within 4 weeks of first dose of BI-1808.\n   2. Radiotherapy within 2 weeks of first dose of BI-1808. A 1-week washout is permitted for palliative radiation (≤2 weeks of radiotherapy) for non-CNS disease. Subjects who have previously had radiation pneumonitis are not allowed.\n   3. Immunotherapy within 4 weeks prior to the first dose of BI-1808.\n6. Has not recovered from AEs to at least Grade 1 by NCI CTCAE\n7. Has had Grade ≥3 autoimmune manifestations of previous immune checkpoint inhibitor treatments (eg, anti-PD-1, anti-PD-L1, or anti-CTLA-4).\n8. Has a history of (noninfectious) pneumonitis that required steroids or has current pneumonitis.\n9. Has an active, known, or suspected autoimmune disease.\n10. Is a female subject and has the ability to become pregnant (or already pregnant or lactating\u002Fbreastfeeding). However, those female subjects who have a negative serum or urine pregnancy test before enrollment and agree to use a highly effective method of birth control for 4 weeks before entering the trial, during the trial, and for 12 months after last dose of BI-1808, are considered eligible.\n11. Is a male subject with partner(s) of childbearing potential (unless he agrees to take measures not to father children by using 1 form of highly effective contraception \\[condom plus spermicide gel\\] during the trial and for 12 months after completing treatment).\n12. Has had major surgery from which the subject has not yet recovered.\n13. Is at high medical risk because of nonmalignant systemic disease including severe active infections on treatment with antibiotics, antifungals, or antivirals.\n14. Has presence of chronic graft versus host disease.\n15. Has had an allogenic tissue\u002Fsolid organ transplant.\n16. Has known human immunodeficiency (HIV) and\u002For history of hepatitis B or C infections, or has a positive test for HIV antibody, hepatitis B antigen\u002Fhepatitis B virus DNA or hepatitis C antibody or RNA.\n17. Has a history of active tuberculosis (Bacillus tuberculosis).\n18. Has received a live vaccine within 30 days before the first dose of study treatment.\n19. Has uncontrolled or significant cardiovascular disease.\n20. Has a known psychiatric or substance abuse disorder that would interfere with the subject's ability to cooperate with the requirements of the trial.\n21. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating Investigator.\n22. Is participating or planning to participate in another interventional clinical trial, or has participated in a trial of an investigational agent or has used an investigational device within 4 weeks prior to first dose of study drug.\n23. Has a known additional malignancy of another type, with the exception of adequately treated cone biopsied carcinoma in situ (eg, breast carcinoma, cervical cancer in situ) and basal or squamous cell carcinoma of the skin. Male subjects with asymptomatic prostate cancer without known metastatic disease and with no requirement for therapy or requiring only hormonal therapy and with normal prostate-specific antigen for \\>1 year prior to start of trial therapy are eligible.\n24. Has a diagnosis of primary or acquired immunodeficiency disorder or taking any other form of immunosuppressive therapy within 7 days prior the first dose of study drug.\n25. Has symptomatic ascites or pleural effusion, requires surgical intervention of additional medication",{"count":49,"type":20},176,[23,24],"The goal of this first in human clinical trial is to test BI-1808 administered as single agent and in combination with pembrolizumab in subjects with advanced malignancies whose disease has progressed after standard therapy.\n\nThe main questions it aims to answer are:\n\n* how safe and tolerable is BI-1808\n* what is maximum tolerated or administrated dose\n* to determine recommended dose for further clinical trials. Participants will receive infusions of BI-1808 alone or combination with pembrolizumab every 3 weeks.\n\nFor the purpose of this study, subjects with advanced malignancies includes subjects with advanced solid tumors and subjects with T-cell lymphoma (TCL),",[53,54,55,56],"Advanced Malignancies","Ovarian Cancer","T-cell Lymphoma","Melanoma",[53,55],"2026-02-16",{"date":60,"type":32},"2026-02-18",{"date":62,"type":32},"2021-01-25",{"date":64,"type":20},"2028-01-15",{"name":38,"class":39},25,{"id":68,"slug":69,"hasResults":11,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":4,"eligibilityCriteria":73,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":74,"targetDuration":4,"studyType":21,"phases":76,"briefSummary":77,"conditions":78,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":88},"100329618","phase-1-a-study-of-bi-1206-in-combination-with-rituximab-with-or-without-acalabrutinib-in-subjects-with-indolent-b-cell-nhl-100329618","NCT03571568","A Study of BI-1206 in Combination With Rituximab With or Without Acalabrutinib in Subjects With Indolent B-Cell NHL","Phase 1\u002F2a Trial of BI-1206, a Monoclonal Antibody to CD32b (FcyRIIB), in Combination With Rituximab With or Without Acalabrutinib in Subjects With Indolent B-Cell Non-Hodgkin Lymphoma That Has Relapsed or is Refractory to Rituximab","Inclusion Criteria:\n\n1. Are ≥ 18 years of age by initiation of study treatment.\n2. Have B-cell NHL proven by histology, with histological subtypes limited to follicular lymphoma (FL) (except FL grade 3B), MCL and marginal zone lymphoma (MZL)\n3. Have measurable nodal disease\n4. Are willing to undergo lymph node biopsies or biopsies of other involved tissue\n5. Have relapsed disease or disease refractory to conventional treatment or for which no standard therapy exists\n6. Have received at least one line of conventional previous therapy which must include at least one rituximab-based regimen\n7. Have a life expectancy of at least 12 weeks\n8. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2\n9. Have CD20+ malignancy\n10. Have hematological and biochemical indices within prespecified ranges\n\nExclusion Criteria:\n\n1. Have had an allogenic bone marrow or stem cell transplant within 12 months\n2. Have presence of active chronic graft versus host disease\n3. Have current leptomeningeal lymphoma or compromise of the central nervous system\n4. Have transformed lymphoma from a pre-existing indolent lymphoma\n5. Have Waldenstrom's Macroglobulinemia or FL grade 3B,\n6. Need systemic doses of prednisolone \\>10 mg daily (or equipotent doses of other corticosteroids) while on the study trial other than as pre-medication.\n7. Have known or suspected hypersensitivity to rituximab or BI-1206\n8. Have cardiac or renal amyloid light-chain amyloidosis\n9. Have received any of the following:\n\n   1. Chemotherapy or small molecule products with 2 weeks of first dose of BI-1206\n   2. Radiotherapy (except for focal symptomatic control of lymphadenopathy) within 4 weeks\n   3. Immunotherapy within 8 weeks\n   4. Previous lines of treatment containing BTK inhibitors for Subjects receiving BI-1206 in combination with rituximab and acalabrutinib\n10. Have ongoing toxic manifestations of previous treatments.\n11. Have the ability to become pregnant (or already pregnant or lactating\u002Fbreastfeeding).\n12. Have had major surgery from which the subject has not yet recovered.\n13. Are at high medical risk because of non-malignant systemic disease including active infection on treatment with antibiotics, antifungals or antivirals.\n14. Are serologically positive for hepatitis B, hepatitis C or human immunodeficiency virus (HIV).\n15. Have an active, known or suspected autoimmune disease.\n16. Have concurrent congestive heart failure, prior history of class III\u002F IV cardiac disease (New York Heart Association \\[NYHA\\])\n17. Have current malignancies of other types",{"count":75,"type":20},140,[23,24],"Phase 1\u002F2a Clinical Trial of BI-1206, a Monoclonal Antibody to CD32b (FcyRIIB), in Combination with Rituximab with or without Acalabrutinib in Subjects with Indolent B-Cell Non-Hodgkin Lymphoma That has Relapsed or is Refractory to Rituximab",[79],"Indolent B-Cell Non-Hodgkin Lymphoma","2025-04-23",{"date":82,"type":32},"2025-04-24",{"date":84,"type":32},"2018-05-16",{"date":86,"type":20},"2026-09-30",{"name":38,"class":39},27,""]