[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"TORL Biotherapeutics, LLC\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":156},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,44,67,94,108,133],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100054111","phase-1-catalina-4-a-study-to-investigate-the-safety-and-efficacy-of-torl-1-23-with-chemotherapy-given-before-initial-surgery-in-women-with-advanced-stage-ovarian-cancer-100054111",false,"NCT07322094","CATALINA-4: A Study to Investigate the Safety and Efficacy of TORL-1-23 With Chemotherapy Given Before Initial Surgery in Women With Advanced Stage Ovarian Cancer","CATALINA-4: Phase 1B\u002F2 Study of TORL-1-23 With Neoadjuvant Chemotherapy and Interval Cytoreductive Surgery in Newly Diagnosed Patients With Advanced Stage Ovarian Cancer","Inclusion Criteria:\n\n* Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1\n* Histologically or cytologically confirmed diagnosis of epithelial ovarian, primary peritoneal or fallopian tubes cancer\n* FIGO Stage III or IV\n* Positive for claudin 6 (CLDN6) expression\n* Adequate organ function\n\nExclusion Criteria:\n\n* Clear cell, mucinous, sarcomatous, mixed histology, low-grade\u002Fborderline, or non-epithelial ovarian cancers\n* Prior systemic treatment for the disease under study\n* Prior surgery\n* Prior radiation therapy to the abdomen or pelvis\n* Current recipient or receipt within 5-half-lives of C1D1 of any of the following: chemotherapy, biologic\u002Ftargeted therapy, herbal medications or supplements, immunomodulator therapy for any disease indication.\n* History of noninfectious pneumonitis\u002Finterstitial lung disease (ILD) within 6 months of first dose of study drug.\n* Active, progressive, or symptomatic brain metastases\n* Participants considered poor medical risks due to serious, uncontrolled medical conditions, active infections, or nonmalignant systemic diseases\n* Pregnant or breastfeeding women","FEMALE","18 Years","75 Years",{"count":20,"type":21},60,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE1","PHASE2","A Phase 1B\u002F2 Study to Investigate the Safety and Efficacy of TORL-1-23 with Chemotherapy Given Before Initial Surgery in Women with Advanced Stage Ovarian Cancer",[28,29,30],"FIGO Stage III and IV Ovarian Cancer","Fallopian Tube Cancers","Primary Peritoneal Cancer","RECRUITING","2026-07-09",{"date":34,"type":35},"2026-07-13","ACTUAL",{"date":37,"type":35},"2025-12-10",{"date":39,"type":21},"2028-01",{"name":41,"class":42},"TORL Biotherapeutics, LLC","INDUSTRY",7,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":51,"minAge":17,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":22,"phases":54,"briefSummary":55,"conditions":56,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":66},"100626747","phase-1-a-study-of-torl-5-700-in-relapsedrefractory-non-hodgkins-lymphoma-100626747","NCT07439653","A Study of TORL-5-700 in Relapsed\u002FRefractory Non Hodgkin's Lymphoma","A Phase 1\u002F2, First-in-Human, Open-Label, Multicenter Study of TORL-5-700 as a Monotherapy and in Combination for Participants With Relapsed or Refractory Non-Hodgkin Lymphoma","Inclusion Criteria:\n\n* Confirmed B-NHL, including but not limited to de novo DLBCL; FL, Grades 1 to 3A; MCL; transformed lymphoma (tFL, RT) and FL Grade 3B; MZL and MALT.\n* Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2.\n* At least 1 measurable lesion per Lugano criteria.\n* Tumor tissue is available.\n* Adequate organ function\n\nExclusion Criteria:\n\n* T-cell lymphoma\n* CLL or SL\n* Burkitt lymphoma and high-grade B-cell lymphoma\n* CNS involvement\n* Peripheral neuropathy \\> Grade 2\n* Uncontrolled medical conditions\n* Viral infections","ALL",{"count":53,"type":21},155,[24,25],"A Phase 1\u002F2 study to evaluate safety, tolerability, and anticancer activity of TORL-5-700 as a monotherapy and in combination in R\u002FR NHL",[57],"Histologically Confirmed Relapsed or Refractory B-cell Non-Hodgkin Lymphoma","2026-06-09",{"date":60,"type":35},"2026-06-11",{"date":62,"type":35},"2026-03-31",{"date":64,"type":21},"2029-09-30",{"name":41,"class":42},3,{"id":68,"slug":69,"hasResults":11,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":4,"eligibilityCriteria":73,"healthyVolunteers":11,"sex":51,"minAge":17,"maxAge":4,"enrollmentInfo":74,"targetDuration":4,"studyType":22,"phases":76,"briefSummary":77,"conditions":78,"keywords":83,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":93},"100447226","phase-1-first-in-human-study-of-torl-1-23-in-participants-with-advanced-cancer-100447226","NCT05103683","First in Human Study of TORL-1-23 in Participants With Advanced Cancer","A Phase 1, First in Human, Dose-Escalation Study of TORL-1-23 in Participants With Advanced Cancer","Inclusion Criteria:\n\n* Advanced solid tumor\n* Measurable disease, per RECIST v1.1\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-1\n* Adequate organ function\n\nExclusion Criteria:\n\n* Has not recovered \\[recovery is defined as NCI CTCAE, version 5.0, grade ≤1\\] from the acute toxicities of previous therapy, except treatment-related alopecia or laboratory abnormalities otherwise meeting eligibility requirements\n* Received prior chemotherapeutic, investigational, or other therapies for the treatment of cancer within 14 days with small molecule and within 28 days with biologic before the first dose of TORL-1-23\n* Progressive or symptomatic brain metastases\n* Serious, uncontrolled medical disorder, nonmalignant systemic disease, or active, uncontrolled infection\n* History of significant cardiac disease\n* History of myelodysplastic syndrome (MDS) or AML\n* History of another cancer within 3 years before Day 1 of study treatment, with the exception of basal or squamous cell carcinoma of the skin that has been definitively treated. A history of other malignancies with a low risk of recurrence, including appropriately treated ductal carcinoma in situ (DCIS) of the breast and prostate cancer with a Gleason score less than or equal to 6, are also not excluded\n* If female, is pregnant or breastfeeding",{"count":75,"type":21},90,[24],"This first-in-human study will evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of TORL-1-23 in patients with advanced cancer",[79,80,81,82],"Advanced Solid Tumor","Ovarian Cancer","Endometrial Cancer","NSCLC",[84],"claudin6","2026-02-11",{"date":87,"type":35},"2026-02-13",{"date":89,"type":35},"2021-11-17",{"date":91,"type":21},"2026-11-15",{"name":41,"class":42},14,{"id":95,"slug":4,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":96,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":97,"enrollmentInfo":98,"targetDuration":4,"studyType":22,"phases":99,"briefSummary":26,"conditions":100,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":104,"completionDateStruct":105,"leadSponsor":106,"locationsCount":107},"100617705","Inclusion Criteria:\n\n* Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2.\n* Histologically or cytologically confirmed diagnosis of epithelial ovarian, primary peritoneal or fallopian tubes cancer\n* FIGO Stage III or IV\n* Positive for claudin 6 (CLDN6) expression\n* Adequate organ function\n\nExclusion Criteria:\n\n* Clear cell, mucinous, sarcomatous, mixed histology, low-grade\u002Fborderline, or non-epithelial ovarian cancers\n* Prior systemic treatment for the disease under study\n* Prior surgery\n* Prior radiation therapy to the abdomen or pelvis\n* Current recipient or receipt within 5-half-lives of C1D1 of chemotherapy, biologic\u002Ftargeted therapy, immunomodulator therapy for any disease indication\n* Active, progressive, or symptomatic brain metastases\n* Participants considered poor medical risks due to serious, uncontrolled medical conditions, active infections, or nonmalignant systemic diseases\n* Pregnant or breastfeeding women","70 Years",{"count":20,"type":21},[24,25],[28,29,30],"2026-01-05",{"date":103,"type":35},"2026-01-07",{"date":37,"type":35},{"date":39,"type":21},{"name":41,"class":42},1,{"id":109,"slug":110,"hasResults":11,"nctId":111,"briefTitle":112,"officialTitle":113,"acronym":4,"eligibilityCriteria":114,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":115,"targetDuration":4,"studyType":22,"phases":117,"briefSummary":118,"conditions":119,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":124,"lastUpdatePostDateStruct":125,"startDateStruct":127,"completionDateStruct":129,"leadSponsor":131,"locationsCount":132},"100569171","phase-2-catalina-2-a-clinical-study-of-torl-1-23-in-platinum-resistant-ovarian-cancer-100569171","NCT06690775","CATALINA-2: A Clinical Study of TORL-1-23 in Platinum-resistant Ovarian Cancer.","Catalina-2: A Phase 2 Study Evaluating the Efficacy and Safety of TORL-1-23 in Women With Advanced Platinum-Resistant Epithelial Ovarian Cancer (Including Primary Peritoneal and Fallopian Tube Cancers) Expressing Claudin 6","Inclusion Criteria:\n\nParticipants are eligible to be included in the study only if all the following criteria apply:\n\n1. Females ≥18 years of age (or the legal age of consent in the jurisdiction in which the study is taking place) at the time of signing the informed consent.\n2. Participants must sign the informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.\n3. Disease Type:\n\n   * Histologically or cytologically confirmed diagnosis of advanced (unresectable) or metastatic high grade serous ovarian, primary peritoneal (i.e, of primary origin), or fallopian tube cancer. High-grade endometrioid ovarian cancer is permitted for enrollment.\n   * Participant's tumor must be positive for CLDN6 expression as defined by the CLDN6 reference laboratory assay. Tumor tissue will be required for submission for CLDN6 testing prior to Cycle 1 Day 1.\n   * Participants must have platinum-resistant disease, defined as the following:\n   * If participants received only 1 line of platinum-based therapy, they must have completed 4 or more cycles of platinum-containing therapy, must have achieved a CR or PR, and progressed \\>3 months but ≤6 months after the last dose of platinum.\n   * Participants who have received more than 1 line of platinum- based therapy must have progressed on or within 6 months after the last dose of platinum.\n   * NOTE: This should be calculated from the date of the last administered dose of platinum therapy to the date of the radiographic imaging showing progression (per RECIST v1.1).\n   * Participants who are platinum-refractory during front-line treatment are excluded.\n   * Participants must have received at least 1 but no more than 3 prior systemic lines of anticancer therapy, and for whom single- agent therapy is appropriate as the next line of treatment. Study rules for evaluation of number of prior systemic lines of therapy:\n   * Adjuvant ± neoadjuvant is considered one line of therapy\n   * Maintenance therapy (eg, bevacizumab or PARP inhibitors) will be considered part of the preceding line of therapy (ie, not counted independently)\n   * Therapy changed due to toxicity in the absence of progression will be considered part of the same line (ie, not counted independently)\n   * Hormonal therapy will not be counted as a separate line of therapy\n4. Measurable disease, per RECIST v1.1\n5. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1.\n6. Adequate organ function, based on the following laboratory values:\n\n   * ANC: ≥1,500\u002FmcL\n   * Platelets: ≥100,000\u002FmcL without transfusion within 4 weeks of first dose\n   * Hemoglobin: 9 g\u002FdL with transfusion or EPO support up to 14 days before eligibility assessment\n   * Measured or calculated creatinine clearance with a validated formula\\*: ≥30 mL\u002Fmin\n   * Serum total bilirubin: ≤1.5 X ULN (participants with known Gilbert disease or liver metastases who have serum bilirubin level ≤3×ULN may be enrolled\n   * AST (SGOT) and ALT (SGPT): ≤3 X ULN (participants with active liver metastases who have ALT\u002FAST ≤5 X ULN may be enrolled)\n   * Albumin: ≥2.5 g\u002FdL\n   * ECG: 12-Lead ECG with normal tracing or non-clinically significant changes that do not require medical intervention and QTcF interval\n\n     * 470 msec and without history of Torsades des Pointes or other symptomatic QTc abnormality.\n7. Participants of childbearing potential must have a negative serum pregnancy test within 72 hours before starting study drug treatment. The serum pregnancy test must be negative for the participant to be eligible.\n8. Participants must agree to use a highly effective birth control method from the time of the first study drug treatment through 7 months after the last study drug treatment, or be of nonchildbearing potential.\n9. Participants must agree not to donate eggs from the first study drug treatment through 7 months after the last study drug treatment.\n10. Participants must agree to not breastfeed from the first dose of study treatment through 90 days after the last dose of study treatment.\n\nExclusion Criteria:\n\nParticipants are excluded from the study if any of the following criteria apply:\n\n1. Has not recovered \\[recovery is defined as National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 5.0, Grade ≤1\\] from the acute toxicities of previous therapy, except treatment-related alopecia or laboratory abnormalities otherwise meeting eligibility requirements.\n2. Participants with clear cell, mucinous, sarcomatous (including carcinosarcoma), mixed histology, or low-grade, borderline ovarian tumors or non-epithelial ovarian cancers.\n3. Participants with primary platinum-refractory ovarian, primary peritoneal (i.e. of primary origin) or fallopian tube cancer, defined as disease that did not respond to or has progressed within 3 months of the last dose of first line platinum-containing chemotherapy.\n4. Received prior chemotherapeutic, investigational, radiotherapy, or other therapies for the treatment of cancer within 14 days with small molecule and within 28 days with biologic before the first dose of TORL-1-23. There is no waiting period required for stereotactic radiosurgery.\n5. Prior treatment with a CLDN6-targeting agent or an MMAE-containing ADC.\n6. Progressive or symptomatic brain metastases. Brain metastases that have been radiated, are asymptomatic, and on a stable or decreasing dose of steroids are allowed. Leptomeningeal disease is excluded.\n7. Grade 2 or greater peripheral neuropathy.\n8. History of non-infectious pneumonitis\u002FILD within 6 months of first dose of study drug.\n9. Participants must not be considered a high medical risk due to a serious, uncontrolled medical disorder, nonmalignant systemic disease, or active, uncontrolled infection. Examples include, but are not limited to, uncontrolled major seizure disorder, unstable spinal cord compression, superior vena cava syndrome, or any psychiatric disorder that prohibits obtaining informed consent.\n10. History of significant cardiac disease:\n\n    1. Congestive heart failure \\>New York Heart Association class 2 within last year\n    2. Unstable angina (angina symptoms at rest), new-onset angina (begun within the last 3 months)\n    3. Myocardial infarction less than 6 months before start of study drug\n    4. Anti-arrhythmic therapy (beta blockers are permitted)\n    5. Any unstable ischemic disease or untreated arrhythmia\n11. Known history of myelodysplastic syndrome or acute myeloid leukemia.\n12. History of another cancer within 3 years before Day 1 of study treatment, with the exception of basal or squamous cell carcinoma of the skin that has been definitively treated. Participants with malignancies with a low risk of recurrence, including appropriately treated ductal carcinoma in situ of the breast are not excluded.\n13. Uncontrolled infection; active, clinically serious infections (CTCAE Grade \\>2).\n14. Participants with seizure disorder requiring medication.\n15. Known hypersensitivity or intolerance to any of the study drugs, study drug classes, or excipients in the formulation.\n16. History of having an allogeneic bone marrow or organ transplant.\n17. Any condition (concurrent disease, infection, or comorbidity) that interferes with ability to participate in the study, causes undue risk, or complicates the interpretation of safety data, in the opinion of the Investigator.\n18. Participants who are taking any drugs that are strong inducers and\u002For strong inhibitors of CYP3A4 enzymes.\n19. Participants who are taking any drugs that are inhibitors of P-glycoprotein.",{"count":116,"type":21},230,[25],"A Phase 2 study to evaluate the safety and efficacy of TORL-1-23 in patients with advanced ovarian cancer.",[120,121,122,123],"Epithelial Ovarian Cancer","Primary Peritoneal","Fallopian Tube Cancer","Endometrioid Ovarian Cancer","2025-12-19",{"date":126,"type":35},"2025-12-23",{"date":128,"type":35},"2024-11-20",{"date":130,"type":21},"2027-12",{"name":41,"class":42},66,{"id":134,"slug":135,"hasResults":11,"nctId":136,"briefTitle":137,"officialTitle":137,"acronym":4,"eligibilityCriteria":138,"healthyVolunteers":11,"sex":51,"minAge":17,"maxAge":4,"enrollmentInfo":139,"targetDuration":4,"studyType":22,"phases":141,"briefSummary":142,"conditions":143,"keywords":145,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":147,"lastUpdatePostDateStruct":148,"startDateStruct":150,"completionDateStruct":152,"leadSponsor":154,"locationsCount":155},"100516532","phase-1-a-phase-1-first-in-human-study-of-torl-4-500-in-patients-with-advanced-cancer-100516532","NCT06005740","A Phase 1, First in Human Study of TORL-4-500 in Patients With Advanced Cancer","Inclusion Criteria:\n\n* Advanced solid tumor\n* Measurable disease, per RECIST v1.1\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-1\n* Adequate organ function\n\nExclusion Criteria:\n\n* Has not recovered \\[recovery is defined as NCI CTCAE, version 5.0, grade ≤1\\] from the acute toxicities of previous therapy, except treatment-related alopecia or laboratory abnormalities otherwise meeting eligibility requirements\n* Received prior chemotherapeutic, investigational, or other therapies for the treatment of cancer within 14 days with small molecule and within 28 days with biologic before the first dose of TORL-4-500\n* Progressive or symptomatic brain metastases\n* Serious, uncontrolled medical disorder, nonmalignant systemic disease, or active, uncontrolled infection\n* History of significant cardiac disease\n* History of myelodysplastic syndrome (MDS) or AML\n* History of another cancer within 3 years before Day 1 of study treatment, with the exception of basal or squamous cell carcinoma of the skin that has been definitively treated. A history of other malignancies with a low risk of recurrence, including appropriately treated ductal carcinoma in situ (DCIS) of the breast and prostate cancer with a Gleason score less than or equal to 6, are also not excluded\n* If female, is pregnant or breastfeeding",{"count":140,"type":21},70,[24],"This first-in-human study will evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of TORL-4-500 in patients with advanced cancer.\n\nFor Part 1, any advanced or metastatic solid tumor malignancy will be evaluated including, for example, adrenocortical carcinoma (ACC).",[79,144],"Hepatocellular Carcinoma",[146],"ADC","2025-02-27",{"date":149,"type":35},"2025-03-04",{"date":151,"type":35},"2023-12-04",{"date":153,"type":21},"2026-10-31",{"name":41,"class":42},10,""]