[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Dren Bio\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":112},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,68,79],{"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":40,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":67},"100475822","phase-1-a-study-of-dr-01-in-subjects-with-large-granular-lymphocytic-leukemia-or-cytotoxic-lymphomas-100475822",false,"NCT05475925","A Study of DR-01 in Subjects With Large Granular Lymphocytic Leukemia or Cytotoxic Lymphomas","A Multicenter, Open-Label, First-In-Human, Multiple Expansion Cohort, Phase 1\u002F2 Study to Evaluate the Safety and Efficacy of DR-01 in Adult Subjects With Large Granular Lymphocytic Leukemia or Cytotoxic Lymphomas","Inclusion Criteria (All Subjects):\n\n1. ≥18 years of age.\n2. Able to understand and comply with protocol-required study procedures and voluntarily sign a written informed consent document.\n3. Sufficient key organ performance and coagulation.\n4. Female subjects of childbearing potential (postmenarcheal, has an intact uterus and at least one ovary, and is \\\u003C1 year postmenopausal) must agree to use a highly effective method of contraception from enrollment through at least 12 months after last dose of DR-01.\n5. Male subjects must agree to use acceptable effective method(s) of contraception.\n\n   Subjects with LGLL must also meet inclusion criteria 6 and 7.\n6. Must have discontinued at least one prior line of systemic therapy.\n7. Additional immunophenotypic and symptomatic criteria must be met.\n\n   Disease-specific Inclusion Criteria (Cytotoxic Lymphomas):\n\n   Subjects with cytotoxic lymphomas must also meet inclusion criteria 8,9, and 10.\n8. Subjects must have failed at least one prior systemic regimens.\n9. Availability of post-progression tissue sample or willingness to consent to a baseline biopsy.\n10. Histologically confirmed diagnosis of a cytotoxic lymphoma by a hematopathologist (according to the WHO 2016 classification \\[Swerdlow 2016\\]).\n11. For Part A only, evaluable disease is acceptable.\n12. For Part B2 only, evaluable by the following response criteria as documented during Screening:\n\n    1. For cytotoxic PTCL-NOS, ENKTL, MEITL, EATL, SPTCL - Subjects must have radiographically measurable disease by computed tomography (CT) or CT\u002Fpositron emission tomography (PET) scan defined as at least one node measuring \\>1.5 cm or measurable extranodal lesion of at least 1.0 cm in longest diameter to be evaluated by Lugano criteria (Cheson 2014).\n    2. For PCGDTCL, ET-CTCL, HVLPD, cytotoxic CuPTCL-NOS - Subjects with primary cutaneous variants must have at least 1 measurable lesion that is evaluable using the Olsen criteria (Olsen 2021) or have leukemic involvement that can be evaluated using modified TPLL response criteria (Staber 2019).\n    3. For HSTCL, ANKL, SysEBV TCL - Subjects with hepatosplenic disease without measurable disease by Lugano criteria (Cheson 2014) or leukemic involvement in BM or peripheral blood that is evaluable for response using a modified TPLL response criteria (Staber 2019).\n\nExclusion Criteria:\n\nDisease-specific Exclusion Criteria; LGLL and ANKL:\n\n1. A reactive LGL lymphocytosis to a viral infection or LGL associated with myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML).\n\n   The following exclusion criteria apply to all subjects:\n2. Active systemic infection or severe localized infection requiring systemic antibiotics, antivirals or antifungals.\n3. Active or suspected malignant central nervous system involvement.\n4. Life-threatening, severe complications of malignancy (e.g., uncontrolled bleeding, pneumonia with hypoxia or shock, and\u002For disseminated intravascular coagulation).\n5. Active known second malignancy.\n6. Infection with human immunodeficiency virus (HIV) type 1 or 2 (HIV-1 or HIV-2).\n7. Hepatitis B infection (hepatitis B virus surface antigen \\[HBsAg\\] positive), or hepatitis C (hepatitis C virus \\[HCV\\] antibody positive, confirmed by HCV ribonucleic acid). Subjects with HCV with undetectable virus after treatment are eligible.\n8. History of clinically significant cardiac disease or congestive heart failure greater than New York Heart Association (NYHA) Class II.\n9. Use of systemic corticosteroids at prohibited dose levels within 15 days prior to C1D1 (except for prophylaxis for radiodiagnostic contrast reactions and study-defined premedication) or use of other non-biological immunosuppressive drugs within 15 days or 5 half-lives (whichever is less) prior to C1D1.\n10. Any condition requiring hormonal therapy (except for contraception, hormone replacement therapy and hormonal prophylaxis for a prior malignancy).\n11. Any other medical or psychiatric condition, or laboratory abnormality that would increase the risk associated with study participation, in the opinion of the Investigator or Medical Monitor.\n12. Toxicities from previous anticancer therapies must have resolved to baseline levels or to Grade 1 (except for alopecia, peripheral neuropathy, or hematologic parameters meeting inclusion criteria).\n13. Autologous HSCT within 40 days of C1D1, allogeneic HSCT within 90 days\n14. Any immunosuppressive therapy for GVHD for subjects who are post allogeneic HSCT.\n15. Major surgery within 28 days of C1D1 (requires more than local anesthesia or plexus blockade).","ALL","18 Years",{"count":19,"type":20},200,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE1","PHASE2","This is a multicenter, first-in-human, Phase 1\u002F2 study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and anti-tumor activity of DR-01 in adult patients with large granular lymphocytic leukemia or cytotoxic lymphomas",[27,28,29,30,31,32,33,34,35,36,37,38,39],"LGLL - Large Granular Lymphocytic Leukemia","Primary Cutaneous Gamma-Delta T-Cell Lymphoma","Primary Cutaneous CD8+ Aggressive Epidermotropic T-Cell Lymphoma","Hepatosplenic T-cell Lymphoma","Subcutaneous Panniculitis-Like T-Cell Lymphoma","Aggressive NK Cell Leukemia","Systemic EBV1 T-cell Lymphoma, if CD8 Positive","Hydroa Vacciniforme-Like Lymphoproliferative Disorder","Extranodal NK\u002FT Cell Lymphoma, Nasal Type","Enteropathy-Associated T-Cell Lymphoma","Monomorphic Epitheliotropic Intestinal T-Cell Lymphoma","Cytotoxic PTCL-NOS (CD8+ or CD56+ and Cytotoxic Marker)","Cutaneous PTCL-NOS (CD8+ or CD56+ and Cytotoxic Marker)",[41,42,43,44,45,46,47,48,49,50,51,52,53,54],"LGLL","Cytotoxic","Lymphoma","ANKL","EATL","MEITL","ENKL","HSTCL","Leukemia","SPTCL","ENKTL","CTCL","PTCL-NOS","TCL","RECRUITING","2026-06-15",{"date":58,"type":59},"2026-06-17","ACTUAL",{"date":61,"type":59},"2022-07-13",{"date":63,"type":20},"2026-12",{"name":65,"class":66},"Dren Bio","INDUSTRY",37,{"id":69,"slug":70,"hasResults":11,"nctId":71,"briefTitle":72,"officialTitle":4,"acronym":4,"eligibilityCriteria":4,"healthyVolunteers":11,"sex":4,"minAge":4,"maxAge":4,"enrollmentInfo":4,"targetDuration":4,"studyType":73,"phases":4,"briefSummary":74,"conditions":4,"keywords":4,"overallStatus":75,"whyStopped":4,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":4,"completionDateStruct":4,"leadSponsor":78,"locationsCount":4},"100642522","availability-of-dibotatug-dr-01-outside-clinical-trials-via-expanded-access-for-eligible-participants-100642522","NCT07647627","Availability of Dibotatug (DR-01) Outside Clinical Trials Via Expanded Access for Eligible Participants","EXPANDED_ACCESS","This is an expanded access program (EAP) for eligible participants designed to provide access to Dibotatug (DR-01). Physician-requested expanded access will generally only be considered for patients not otherwise eligible for an ongoing clinical study sponsored by Dren Bio and provided that other program eligibility criteria are also met.","AVAILABLE","2026-06-09",{"date":56,"type":59},{"name":65,"class":66},{"id":80,"slug":81,"hasResults":11,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":4,"eligibilityCriteria":85,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":86,"targetDuration":4,"studyType":21,"phases":88,"briefSummary":89,"conditions":90,"keywords":4,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":111},"100592880","phase-1-a-study-of-dr-0202-in-patients-with-locally-advanced-or-metastatic-relapsed-or-refractory-carcinomas-100592880","NCT06999187","A Study of DR-0202 in Patients With Locally Advanced or Metastatic, Relapsed or Refractory Carcinomas","A Phase 1a\u002F1b, Multicenter, Open-label, Dose Escalation\u002FExpansion, Multiple-dose Study to Evaluate the Safety and Activity of DR-0202 in Patients With Locally Advanced or Metastatic, Relapsed or Refractory Carcinomas","Inclusion Criteria:\n\n* Histologically confirmed epithelial cancer of the following tumor types: breast (TNBC, HR+\u002FHER2-\u002F+BC), NSCLC, cervical, CRPC, PDAC, HNSCC, endometrial, ovarian, gastric\u002FGEJ, or urothelial that is unresectable, locally advanced or metastatic\n* Relapsed or refractory with at least 2 prior lines of therapy and for which no standard of care treatment options are available\n* Radiographically measurable disease\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-1\n* Life expectancy, in the opinion of the Investigator, of ≥ 3 months\n* Adequate marrow reserve, renal function, and hepatic function\n* Taper of ≥ 2 weeks from high-dose systemic corticosteroids (however, low dose corticosteroids ≤ 25 mg prednisone or equivalent daily are permitted in consultation with the Medical Monitor)\n* Willing to provide archival tumor tissue samples or agree to a baseline biopsy if not available\n* Willing to undergo an on-treatment biopsy if clinically feasible and not contraindicated at the time of procedure\n\nExclusion Criteria:\n\n* Major surgery within 28 days prior to Day 1\n* Have not had an appropriate washout period from systemic therapy, including investigational agents, prior to C1D1:\n\n  1. Systemic chemotherapy and anticancer therapies within 4 weeks or 5 half-lives of the drug, whichever is shorter.\n  2. Antibody-based anticancer therapy: ≥ 4 weeks. Note: Treatment with systemic corticosteroids ≤ 25 mg\u002Fday (prednisone or equivalent) and inhaled or topical steroids are allowed. For participants with CRPC, LHRH agents are allowed.\n* Radiation therapy within 21 days prior to C1D1. Palliative radiation therapy may be allowed following discussion with Medical Monitor\n* Brain metastases either untreated and symptomatic or requiring therapy with steroids or anticonvulsants to control associated symptoms. Brain metastases that have been treated and are no longer symptomatic are allowed if use of high-dose systemic corticosteroids (\\> 25 mg\u002Fday of prednisone or equivalent) is stopped ≥ 12 weeks prior to C1D1.\n* Active Grade ≥ 2 anorexia, nausea or vomiting, and\u002For signs of intestinal obstruction.\n* Another malignancy (except for adequately resected non-melanoma skin cancer, curatively treated in situ disease, or other solid tumors curatively treated with no evidence of disease for ≥ 1 year)\n* Evidence of significant, uncontrolled concomitant disease that could affect compliance with study.\n* Current or past history of CNS disease, such as stroke, epilepsy, central nervous system vasculitis or neurodegenerative disease (participants with a history of stroke who have not experienced a stroke or transient ischemic attack in the past 6 months and have no residual neurologic deficits may be eligible).\n* QT interval for heart rate using Fridericia's formula (QTcF) \\> 480 msec or history of additional risk factors for Torsades de Pointes\n* Uncontrolled or significant cardiovascular disease\n* History or presence of an abnormal ECG that is clinically significant in the Investigator's opinion or myocardial infarction within 6 months prior to C1D1.\n* Prior solid organ transplantation.\n* Known infection with HIV, HBV, or HCV. The following participants may be enrolled in this study (the Sponsor reserves the right to restrict enrollment of these participants):\n\n  1. Participants who are HIV-positive with undetectable HIV RNA and at least 3 months on antiretroviral therapy.\n  2. Participants with a positive serologic test for HBV (i.e., positive HBcAb and negative HBsAg) and have a negative PCR test.\n  3. Participants who are HCV-positive who have completed at least 1 month of highly effective antiviral therapy and have a negative PCR test.\n* Active infection requiring systemic treatment, defined as requiring IV antimicrobial, antifungal, or antiviral agents within 2 weeks prior to C1D1. Prophylactic antimicrobial treatment is allowed. Infections eligible per Exclusion Criterion 16 may be enrolled.\n* Active clinical interstitial pneumonitis (e.g., shortness of breath, requirement of supplemental oxygen, dry cough) or as confirmed by means of diagnostic imaging within 6 months prior to C1D1.\n* Other concurrent medical or psychiatric conditions that, in the Investigator's opinion, may be likely to confound study interpretation or prevent completion of study procedures and follow-up examinations.",{"count":87,"type":20},96,[23],"A phase 1a\u002F1b, multicenter, open-label, dose escalation\u002Fexpansion, multiple-dose study to evaluate the safety and activity of DR-0202 in patients with locally advanced or metastatic, relapsed or refractory carcinomas",[91,92,93,94,95,96,97,98,99,100,101,102],"Triple Negative Breast Cancer","HER2-negative Breast Cancer","Non Small Cell Lung Cancer","Cervical Cancer","Castrate Resistant Prostate Cancer","Pancreatic Ductal Adenocarcinoma","Head-and-neck Squamous Cell Carcinoma","Endometrial Cancer","Ovarian Cancer","Gastric Cancer","Gastroesophageal-junction Cancer","Urothelial Carcinoma","2026-01-05",{"date":105,"type":59},"2026-01-07",{"date":107,"type":59},"2025-06-03",{"date":109,"type":20},"2027-12",{"name":65,"class":66},10,""]