[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"MacroGenics\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":147},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,50,81,106],{"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":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100572213","phase-2-a-study-of-lorigerlimab-in-participants-with-advanced-solid-tumors-100572213",false,"NCT06730347","A Study of Lorigerlimab in Participants With Advanced Solid Tumors","A Phase 2 Multicohort Study to Evaluate Lorigerlimab in Participants With Advanced Solid Tumors","Inclusion Criteria:\n\n* Histologically confirmed high-grade serous epithelial ovarian cancer, including primary peritoneal, or fallopian tube cancer, resistant to platinum based chemotherapy. OR\n* Histologically confirmed clear cell carcinoma of the ovary (including primary peritoneal and fallopian tube), endometrium, vagina, vulva, or cervix.\n* Persistent or recurrent disease with documented disease progression.\n* Participants with PROC must have received at least 1 but not more than 3 prior lines of therapy for PROC.\n* Participants with CCGC must have received at least 1 prior line of therapy for CCGC.\n* Participants with a known breast cancer (BRCA) mutation (germline or somatic) must have received a Poly ADP-ribose polymerase (PARP) inhibitor, if locally approved and available, and experienced disease progression or intolerance on the PARP inhibitor.\n* Participants must have at least one lesion that meets the definition of measurable disease by RECIST v1.1.\n* Participants must have an available archival or formalin-fixed paraffin-embedded tumor tissue, or be willing to undergo a biopsy procedure to obtain a fresh tumor sample.\n* Participants have acceptable physical condition and laboratory values.\n* Participants of childbearing potential must agree to use highly effective methods of birth control.\n* Participants must not be pregnant, planning to be pregnant, or breastfeeding.\n\nExclusion Criteria:\n\n* Any underlying medical or psychiatric condition impairing participant's ability to receive, tolerate, or comply with the planned treatment or study procedures.\n* Primary platinum-refractory disease, defined as disease that did not respond to (CR or PR) or has progressed within 3 months of the last dose of first-line platinum- containing chemotherapy.\n* Prior treatment with a checkpoint inhibitor (e.g., anti-PD-1\u002FPD-L1, anti-PD-L2, anti-CTLA-4). Prior use of immune checkpoint inhibitors (e.g., anti-PD-1, anti-PD-L1, anti-CTLA-4) is allowed for clear cell endometrial and clear cell cervical cancer.\n* Active brain metastases or leptomeningeal metastases.\n* Prior stem cell, tissue, or solid organ transplant.\n* Paracentesis (removal of fluid from the abdomen) within 4 weeks prior to initiation of study treatment.\n* Another hematologic or solid tumor ≥ stage 1 malignancy that completed surgery, last dose of radiotherapy, or last dose of systemic anti-cancer therapy ≤ 3 years from first dose of study treatment. Participants with another tumor that has a negligible risk for metastasis or death such as, adequately controlled basal-cell carcinoma or squamous-cell carcinoma of the skin, or carcinoma in situ of the cervix or breast are eligible.","FEMALE","18 Years",{"count":19,"type":20},80,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","Study CP-MGD019-03 is an open-label study of lorigerlimab in participants with platinum-resistant ovarian cancer (PROC) or clear cell gynecologic cancer (CCGC). Approximately 80 participants will be enrolled. The study will assess the efficacy and safety of lorigerlimab in participants with PROC or CCGC.\n\nParticipants will receive lorigerlimab by intravenous (IV) infusion on Day 1 of every 21-day treatment cycle. Treatment cycles will continue until progression of cancer, unacceptable side effects, withdrawal of consent by the participant, or the study ends.\n\nParticipants will be monitored closely for side effects by physical exam and routine laboratory tests every cycle. Tumor status will be checked approximately every 9 weeks for the first year, then every 12 weeks for the duration of treatment. Participants will have a safety followup performed within 30 days after treatment discontinuation. Participants who discontinue study treatment for reasons other than progression of cancer, will continue CA-125 and tumor assessments every 12 weeks. Participants who discontinue study treatment for progression of cancer will enter the 6-month survival follow up portion of the study.",[26,27,28,29,30,31,32,33,34,35,36],"Platinum-resistant Ovarian Cancer","Platinum-Resistant Fallopian Tube Carcinoma","Platinum-Resistant Primary Peritoneal Carcinoma","Clear Cell Adenocarcinoma of Ovary","Clear Cell Adenocarcinoma of Vulva","Clear Cell Adenocarcinoma of Vagina","Clear Cell Adenocarcinoma of Cervix","Clear Cell Adenocarcinoma of Uterus","Clear Cell Adenocarcinoma of Fallopian Tube","Clear Cell Adenocarcinoma of Peritoneum","Endometrial Cancer","RECRUITING","2026-05-29",{"date":40,"type":41},"2026-06-02","ACTUAL",{"date":43,"type":41},"2025-05-01",{"date":45,"type":20},"2027-12",{"name":47,"class":48},"MacroGenics","INDUSTRY",16,{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":4,"eligibilityCriteria":56,"healthyVolunteers":11,"sex":57,"minAge":17,"maxAge":4,"enrollmentInfo":58,"targetDuration":4,"studyType":21,"phases":60,"briefSummary":62,"conditions":63,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":80},"100467132","phase-1-a-study-of-mgd024-in-patients-with-relapsed-or-refractory-hematologic-malignancies-100467132","NCT05362773","A Study of MGD024 in Patients With Relapsed or Refractory Hematologic Malignancies","A Phase 1, First-in-Human, Dose Escalation Study of MGD024, a CD123 x CD3 Bispecific DART Molecule, in Patients With Select Relapsed or Refractory Hematologic Malignancies","Inclusion Criteria:\n\n* Adult patients at least 18 years of age, able to provide informed consent and willing to comply with all study procedures.\n* Participants with\n\n  * primary or secondary acute myeloid leukemia (AML) except acute promyelocytic leukemia,\n  * primary or secondary myelodysplastic syndrome (MDS) with prognostic score of \\>3 and \\\u003C20% bone marrow blasts,\n  * classical Hodgkin lymphoma (cHL),\n  * chronic myelogenous leukemia (CML),\n  * b-cell acute lymphocytic leukemia (B-ALL),\n  * hariy cell leukemia (HCL),\n  * advanced systemic mastocytosis (ASM), or\n  * blastic plasmacytoid dendritic cell neoplasm (BPDCM)\n* Relapsed after or refractory to at least one prior line of therapy and with no available potentially curative treatment option.\n* Evidence of at least 20% of malignant cells with CD123 expression.\n* Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2.\n* Life expectancy of at least 12 weeks.\n* Acceptable laboratory values, and heart function.\n* Continuing side effects of prior treatment are mild\n* Women and men of childbearing potential must agree to use highly effective forms of contraception throughout the study through 4 months after the last dose of MGD024.\n\nExclusion Criteria:\n\n* Prior treatment with an anti-CD123-directed agent (except patients with BPDCN, who are allowed to have received prior tagraxofusp).\n* Known involvement of central nervous system (CNS) by the disease under investigation.\n* History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the patient's participation for the full duration of the trial, or is not in the best interest of the patient.\n* Systemic anti-cancer therapy, investigational therapy, corticosteroids or other immune suppressive drugs within 14 days of first dose\n* Vaccination with any live virus vaccine within 4 weeks prior to first dose. Inactivated annual influenza and SARS-CoV-2 vaccination are allowed.","ALL",{"count":59,"type":20},130,[61],"PHASE1","CP-MGD024-01 is a Phase 1, open-label, multi-center study of MGD024 as a single agent in participants with select blood cancers that have not responded to treatment with standard therapies or who have relapsed after treatment. The study is designed to determine the safety, tolerability, pharmacokinetics (affect of the body on the drug), pharmacodynamic (affect of the drug on the body), immunogenicity (development of antibodies against the drug), and preliminary anti-cancer effect of MGD024.\n\nParticipants will receive treatment with MGD024 in consecutive 28-day cycles for a study treatment period of up to 12 cycles (approximately 1 year) or until treatment or study discontinuation criteria are met. Response assessments will be performed after Cycle 1 and then after every even numbered cycle starting with Cycle 2 until progression or study treatment discontinuation. Participants will be checked for side effects throughout the study.",[64,65,66,67,68,69,70,71],"Leukemia, Acute Myeloid","Myelodysplastic Syndromes","Classical Hodgkin Lymphoma","Leukemia, B-cell","Leukemia, Hairy Cell","Mastocytosis, Aggressive Systemic","Blastic Plasmacytoid Dendritic Cell Neoplasm","Chronic Myeloid Leukemia","2026-05-20",{"date":74,"type":41},"2026-05-22",{"date":76,"type":41},"2022-07-13",{"date":78,"type":20},"2027-05",{"name":47,"class":48},7,{"id":82,"slug":83,"hasResults":11,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":4,"eligibilityCriteria":87,"healthyVolunteers":11,"sex":57,"minAge":17,"maxAge":4,"enrollmentInfo":88,"targetDuration":4,"studyType":21,"phases":90,"briefSummary":91,"conditions":92,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":80},"100571667","phase-1-a-study-of-mgc028-in-participants-with-advanced-solid-tumors-100571667","NCT06723236","A Study of MGC028 in Participants With Advanced Solid Tumors","A Phase 1, First-in-Human, Open Label, Dose Escalation and Cohort Expansion Study of MGC028 in Participants With Advanced Solid Tumors","Inclusion Criteria:\n\n* Participants in dose escalation or supplemental cohorts must have histologically proven unresectable, locally advanced or metastatic solid tumor limited to one of the following types: NSCLC adenocarcinoma, cholangiocarcinoma, colorectal carcinoma (CRC), or pancreatic carcinoma that is refractory to standard therapy, or for which standard therapy does not exist, has proven to be intolerable, or has been refused by the participant.\n* Participants in expansion cohorts must have either\n\n  * NSCLC adenocarcinoma with\n\n    * progression on or following anti-PD-1\u002FPD-L1 inhibitor, unless contraindicated\n    * progression on or following therapy for actionable mutations (e.g. EGFR or ALK mutations), if present\n    * no more than 2 prior lines of cytotoxic chemotherapy for advanced or metastatic disease.\n  * Pancreatic cancer\n\n    * following at least 1 systemic therapy\n    * no more than 2 prior lines of cytotoxic therapy for advanced or metastatic disease.\n  * Colorectal adenocarcinoma with\n\n    * Progression during or following standard therapy with a fluoropyrimidine-based chemotherapy, oxaliplatin and irinotecan unless contraindicated, refused or unavailable\n    * Progression after prior targeted treatment for CRC with actionable mutations such as EGFR, KRAS, BRAF and MSI- H\u002FdMMR, if present.\n    * No more that 2 lines of cytotoxic chemotherapy for advanced or metastatic disease\n    * No more than 4 lines of systemic regimens for advanced or metastatic disease\n* Participants must have at least one lesion that meets the definition of measurable disease by RECIST v1.1.\n* Participants must have an available archival or formalin-fixed paraffin-embedded tumor tissue or be willing to undergo a biopsy procedure to obtain a fresh tumor sample.\n* Participants have acceptable physical condition and laboratory values.\n* Participants of childbearing potential must agree to use highly effective methods of birth control.\n* Participants must not be pregnant, planning to be pregnant, or breastfeeding.\n\nExclusion Criteria:\n\n* Any underlying medical or psychiatric condition impairing participant's ability to receive, tolerate, or comply with the planned treatment or study procedures.\n* Active brain metastases or leptomeningeal metastases.\n* Prior stem cell, tissue, or solid organ transplant.\n* Another malignancy that required treatment within the past 2 years, with the exception of those with a negligible risk of metastasis or death such as adequately treated non-melanomatous skin cancer, localized prostate cancer (Gleason Score \\\u003C 6), or carcinoma in situ.\n* Active viral, bacterial, or fungal infection\n* Prior treatment with ADAM9 targeted agent for cancer.\n* Prior treatment with major surgery, mediastinal or lung radiation, vaccination with live virus vaccines, systemic cancer treatment, chimeric antigen receptor (CAR)-T cell therapy, or experimental treatment within 4 weeks of the start of study treatment.",{"count":89,"type":20},124,[61],"The goal of this clinical trial is to characterize the safety, tolerability, dose-limiting toxicities (DLT), and maximum tolerated dose (MTD) or maximum administered dose of MGC028 (if no MTD is defined). The study will enroll adult participants with relapsed or refractory, unresectable, locally advanced of metastatic solid tumors known to express ADAM9.\n\nThe main question the study aims to answer is:\n\n* What types of side effects will participants experience when receiving MGC028?\n* Can MGC028 cause cancer to shrink, remain stable, or able to control disease progression of participants with advanced solid tumors?\n\nParticipants will\n\n* Undergo screening procedures to determine eligibility\n* Receive study treatments initially every 3 weeks.\n* Have blood samples taken for routine and research tests\n* Have other examinations to check heart and lung function, and general health status\n* Be asked about any side effects that may be happening or other medications you are taking. The study doctor will provide treatment for side effects, if necessary.\n* Have the study doctor assess your tumor status at regular intervals to determine how you are responding to treatment.",[93,94,95,96,97],"Advanced Solid Tumors","NSCLC Adenocarcinoma","Cholangiocarcinoma","Pancreatic Carcinoma","Colorectal Carcinoma","2026-04-23",{"date":100,"type":41},"2026-04-27",{"date":102,"type":41},"2025-02-13",{"date":104,"type":20},"2027-04",{"name":47,"class":48},{"id":107,"slug":108,"hasResults":11,"nctId":109,"briefTitle":110,"officialTitle":111,"acronym":4,"eligibilityCriteria":112,"healthyVolunteers":11,"sex":57,"minAge":17,"maxAge":4,"enrollmentInfo":113,"targetDuration":4,"studyType":21,"phases":115,"briefSummary":116,"conditions":117,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":138,"lastUpdatePostDateStruct":139,"startDateStruct":141,"completionDateStruct":143,"leadSponsor":145,"locationsCount":146},"100534718","phase-1-a-study-of-mgc026-in-participants-with-advanced-solid-tumors-100534718","NCT06242470","A Study of MGC026 in Participants With Advanced Solid Tumors","A Phase 1\u002F1b First-in-Human, Open Label, Dose Escalation and Cohort Expansion Study of MGC026 in Participants With Advanced Solid Tumors","Inclusion Criteria:\n\n* Adults ≥ 18 years old, able to provide informed consent\n* Adequate performance and laboratory parameters\n* Availability of archival or formalin-fixed paraffin-embedded tumor tissue sample. Participants may undergo a fresh tumor biopsy to obtain a specimen for testing if an archival tumor sample is not available. Participants with no available archival tissue sample who cannot safely undergo a fresh biopsy as determined by consultation between the sponsor and investigator are eligible\n* Unresectable, locally advanced or metastatic solid tumors including: squamous cell cancer (SCC) of the head and neck, esophageal SCC, squamous and non-squamous non-small cell lung cancer, small cell lung cancer, bladder cancer, sarcoma, endometrial cancer, melanoma, castration resistant prostate cancer, breast cancer, ovarian cancer, cervical cancer, colorectal cancer gastric or gastroesophageal cancer, pancreatic carcinoma, clear cell renal cell cancer or hepatocellular cancer.\n* Measurable disease per RECIST v1.1. Participants with metastatic CRPC without measurable disease are eligible.\n* Must be willing to use highly effective methods of birth control from the time of consent through 7 months after discontinuation of MGC026.\n* Not pregnant or breastfeeding.\n\nExclusion Criteria:\n\n* Any underlying medical or psychiatric condition impairing participant's ability to receive, tolerate, or comply with the planned treatment or study procedures.\n* Another cancer that required treatment within the past 2 years, with the exception of those with low risk of cancer spreading or death such as adequately treated non melanomatous skin cancer, localized prostate cancer (Gleason Score \\\u003C 6), or carcinoma in situ.\n* Patients with history of prior central nervous system (CNS) metastasis must have been treated, be asymptomatic, and not have concurrent treatment for CNS disease, progression of CNS metastases on magnetic resonance imaging, computed tomography or positron emission tomography, or history of leptomeningeal disease or cord compression at the time of enrollment.\n* Treatment with surgery, systemic cancer therapy, immunotherapy, chimeric antigen receptor-T therapy, or anti-hormonal within protocol specified intervals.\n* Prior treatment with any B7-H3 targeted agent for cancer or any ADC with a topoisomerase payload.\n* Prior autologous or allogeneic stem cell or solid organ transplant.\n* Clinically significant cardiovascular, pulmonary, or gastrointestinal disorders.\n* Active viral, bacterial, or systemic fungal infection requiring parenteral treatment within 1 week of first study drug administration.\n* Known history of hepatitis B or C infection or known positive test for hepatitis B surface antigen or core antigen, or hepatitis C polymerase chain reaction.\n* Known positive testing for human immunodeficiency virus or history of acquired immune deficiency syndrome.\n* History of primary immunodeficiency.\n* Major trauma or major surgery within 4 weeks of first study drug administration.\n* Known hypersensitivity to recombinant proteins.",{"count":114,"type":20},250,[61],"The study is designed to understand the safety, tolerability, pharmacokinetics, immunogenicity, and preliminary antitumor activity of MGC026 in participants with relapsed or refractory, unresectable, locally advanced or metastatic solid tumors The study has a dose escalation portion and a cohort expansion portion of the study.\n\nParticipants will receive MGC026 by intravenous (IV) infusion. The dose of MGC026 will be assigned at the time of enrollment. Participants may receive up to 35 treatments if there are no severe side effects and as long as the cancer does not get worse. Participants will be monitored for side effects, and progression of cancer, have blood samples collected for routing laboratory work, and blood samples collected for research purposes.",[118,119,120,121,122,123,124,125,36,126,127,128,129,130,131,132,133,134,26,135,136,137],"Advanced Solid Tumor","Advanced Cancer","Metastatic Cancer","Squamous Cell Carcinoma of Head and Neck","Non Small Cell Lung Cancer","Small-cell Lung Cancer","Bladder Cancer","Sarcoma","Melanoma","Castration Resistant Prostatic Cancer","Cervical Cancer","Colorectal Cancer","Gastric Cancer","Gastro-esophageal Cancer","Pancreas Cancer","Clear Cell Renal Cell Carcinoma","Hepatocellular Carcinoma","Breast Cancer","Ovarian Cancer","Esophageal Squamous Cell Cancer (SCC)","2026-02-03",{"date":140,"type":41},"2026-02-05",{"date":142,"type":41},"2024-03-06",{"date":144,"type":20},"2028-10",{"name":47,"class":48},12,""]