[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"primary-peritoneal\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:primary-peritoneal":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,45,70,94],{"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":29,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100623921","phase-1-drug-drug-interaction-study-with-azd5335-and-itraconazole-in-participants-with-ovarian-primary-peritoneal-or-fallopian-tube-cancer-100623921",false,"NCT07402915","Drug-drug Interaction Study With AZD5335 and Itraconazole in Participants With Ovarian, Primary Peritoneal, or Fallopian Tube Cancer","An Open-label, Fixed Sequence Phase I Study to Evaluate the Effect of Itraconazole (a Strong CYP3A Inhibitor) on the Pharmacokinetics of AZ14170132, the TOP1 Inhibitor Payload of the Antibody Drug Conjugate AZD5335, in Participants With Ovarian, Primary Peritoneal, or Fallopian Tube Cancer","Inclusion Criteria:\n\n* Participants with Platinum-resistant, relapsed, high- grade epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer and: (a) have received at least 1 prior line of platinum-containing chemotherapy and have progressed on or within 6 months after the date of the last dose of platinum; (b) must have received prior bevacizumab and\u002For Poly (ADP-ribose) polymerase (PARP) inhibitors according to local guidelines, unless ineligible.\n* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.\n\nExclusion Criteria:\n\n* Spinal cord compression or a history of leptomeningeal carcinomatosis.\n* Unresolved toxicities of Grade ≥ 2 (National Cancer Institute-Common Terminology Criteria for Adverse Events v5.0) from prior therapy.\n* History of (non-infectious) interstitial lung disease (ILD)\u002Fpneumonitis that required oral or IV steroids or supplemental oxygen, or where suspected ILD\u002Fpneumonitis cannot be ruled out by imaging at screening.\n* Uncontrolled intercurrent illness within 12 months prior to screening.\n* Any other contraindication for receiving itraconazole according to the prescribing information and the Investigator.","FEMALE","18 Years",{"count":19,"type":20},24,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","The purpose of this study is to assess the effect of itraconazole on the pharmacokinetics (PK) of AZ14170132.",[26,27,28],"Fallopian Tube Cancer","Ovarian Cancer","Primary Peritoneal",[30,31],"CYP3A inhibitor","TOP1 inhibitor payload","RECRUITING","2026-05-19",{"date":35,"type":36},"2026-05-20","ACTUAL",{"date":38,"type":36},"2026-01-26",{"date":40,"type":20},"2027-10-15",{"name":42,"class":43},"AstraZeneca","INDUSTRY",9,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":21,"phases":54,"briefSummary":56,"conditions":57,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":69},"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":53,"type":20},230,[55],"PHASE2","A Phase 2 study to evaluate the safety and efficacy of TORL-1-23 in patients with advanced ovarian cancer.",[58,28,26,59],"Epithelial Ovarian Cancer","Endometrioid Ovarian Cancer","2025-12-19",{"date":62,"type":36},"2025-12-23",{"date":64,"type":36},"2024-11-20",{"date":66,"type":20},"2027-12",{"name":68,"class":43},"TORL Biotherapeutics, LLC",66,{"id":71,"slug":72,"hasResults":11,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":4,"eligibilityCriteria":76,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":77,"targetDuration":4,"studyType":21,"phases":79,"briefSummary":81,"conditions":82,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":93},"100580236","phase-3-study-of-ibi354-versus-investigators-choice-of-chemotherapy-in-patients-with-platinum-resistant-ovarian-primary-peritoneal-or-fallopian-tube-cancer-100580236","NCT06834672","Study of IBI354 Versus Investigator's Choice of Chemotherapy in Patients With Platinum-resistant Ovarian, Primary Peritoneal, or Fallopian Tube Cancer","A Multicenter, Randomized, Open-label Phase III Study of IBI354 Versus Investigator's Choice of Chemotherapy in Patients With Platinum-resistant Ovarian, Primary Peritoneal, or Fallopian Tube Cancer","Inclusion Criteria\n\n1. Participants have the ability to understand and give written informed consent Form (ICF) for participation in this trial, including all evaluations and procedures as specified by this protocol;\n2. Female participants ≥ 18 years old;\n3. Expected life time ≥ 12 weeks\n4. Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1.\n5. Histologically or cytologically confirmed locally advanced unresectable or metastatic ovarian, primary peritoneal, or fallopian tube cancer.\n6. Must have confirmed disease progression during or after the most recent anticancer therapy.\n7. Must have at least 1 measurable target lesion per RECIST v1.1 criteria.\n8. Left Ventricular Ejection Fraction (LVEF) ≥ 50% within 28 days prior to the first dose of study drug.\n9. Adequate bone marrow and organ function.\n10. Female participants of childbearing potential must have a negative serum pregnancy test within 7 days prior to the first dose of study drug and use effective contraception throughout the treatment period and for 6 months after the treatment period.\n\nExclusion Criteria:\n\n1. Patients with histological or cytological findings meet any of the following criteria:\n\n   1. Endometrioid tumor, clear cell tumor, mucinous tumor, mesenchymal tumor, or contains any of the above components.\n   2. Low-grade or borderline tumor, or contains any of the above components.\n2. Participation in any other interventional clinical study, except observational (non-interventional) study.\n3. Paclitaxel, gemcitabine, liposomal doxorubicin, and topotecan listed in the control arm were either ineligible or had previously received and progressed.\n4. Prior therapy to first dose of study drug:\n\n   1. Participants who have been treated with Intravenous infusion of chemotherapeutic drugs, macromolecular targeted drugs, immunotherapy, intraperitoneal chemotherapy, tumor embolization or interventional chemotherapy, within 4 weeks.\n   2. Participants who have been treated with oral chemotherapeutic drugs, small molecular targeted drugs, endocrine therapy, and Chinese herbal medicine for anticancer treatment indications, within 2 weeks or 5 half-lives (whichever is longer).\n   3. Participants who have been treated with radical radiotherapy within 4 weeks, palliative radiotherapy within 2 weeks.\n   4. Participants who have been treated with strong cytochrome P450 3A4 (CYP3A4) inhibitors or inducers within 2 weeks or 5 half-lives (whichever is longer).\n   5. Participants who have been treated with Major surgery (craniotomy, thoracotomy or laparotomy and other types of surgery considered \"major\" by the investigator, excluding needle biopsy) within 4 weeks; Laparoscopic exploration surgery within 2 weeks. Or participants have serious non-healing wound, trauma or ulcer.\n   6. Participants who have been treated with live vaccines (mRNA and non-replicating adenovirus vaccines are not considered live vaccines) within 4 weeks.\n5. Have adverse reactions caused by previous anti-tumor therapy that have not been resolved to Grade 0 or 1 according to NCI-CTCAE v5.0 criteria.\n6. Presence of symptomatic central nervous system (CNS) metastases, spinal cord compression, carcinomatous meningitis, or history of leptomeningeal carcinoma.\n7. Participants with pneumonitis requiring corticosteroid treatment, or a history of other clinically significant lung disease.\n8. Uncontrolled or significant cardiovascular and cerebrovascular disease.\n9. Use of immunosuppressive medications within 14 days prior to the first dose of study treatment.\n10. Tumor invades surrounding important tissues or organs.\n11. Bleeding within 3 months prior to the first dose of study treatment.\n12. Symptomatic abdominal or pelvic effusion requiring intervention.\n13. Esophageal or gastric varices that require immediate intervention (e.g., ligation or sclerotherapy), or have high risk of bleeding considered by the investigator or gastroenterology and hepatology specialists; participants with evidence of portal hypertension.\n14. Unhealed gastrointestinal obstruction, perforation, or fistula, or participants at risk for gastrointestinal obstruction or perforation.\n15. Have intraluminal stenting of the digestive tract or trachea.\n16. Participants with biliary obstruction will be excluded.\n17. Participants with hepatic encephalopathy, hepatorenal syndrome, or cirrhosis of Child-Pugh class B or above.\n18. Significant malnutrition.\n19. Uncontrolled active infection.\n20. Concomitant other primary malignancies within 3 years or other malignancies with active or risk of recurrence before the first dose of study treatment.\n21. History of immunodeficiency disease, including congenital or acquired immunodeficiency disease.\n22. History of allogeneic organ transplantation, allogeneic bone marrow transplantation, or autologous hematopoietic stem cell transplantation.\n23. Allergy to other anti-HER2 antibodies\u002FADC or any component of IBI354.\n24. Participants who are pregnant or lactating, or those who plan to become pregnant.\n25. Other acute or chronic diseases or laboratory abnormalities that may increase the risk of participation in the study or administration of the study treatment, interfere with the interpretation of the study results, or lead the investigator to determine that the participant is inappropriate for participation in the study.\n26. The participant has neurological, psychiatric, or social conditions that affect trial compliance, significantly increase the risk of adverse events, or affect the participant's ability to provide written informed consent.",{"count":78,"type":20},450,[80],"PHASE3","This is a multiregional, multicenter, randomized, open-label, phase III study to compare the efficacy, safety, and tolerability of IBI354 monotherapy with investigator's choice of chemotherapy (paclitaxel, gemcitabine, liposomal doxorubicin, or topotecan) in patients with HER2-expressing, platinum-resistant ovarian, primary peritoneal, or fallopian tube cancer.\n\nParticipants with advanced ovarian, primary peritoneal, fallopian tube cancer who have failed or are intolerant to first-line or more platinum-based chemotherapy will be randomly assigned in a 2:1 ratio to two treatment arms:\n\nExperimental Arm: IBI354 monotherapy arm, 12 mg\u002Fkg IBI354 on Day 1 of each 3-week cycle; Control Arm: Investigator's choice chemotherapy (paclitaxel, gemcitabine, liposomal doxorubicin, or topotecan)",[83,28,26],"Ovarian","2025-04-10",{"date":86,"type":36},"2025-04-13",{"date":88,"type":36},"2025-03-17",{"date":90,"type":20},"2029-11-28",{"name":92,"class":43},"Innovent Biologics (Suzhou) Co. Ltd.",1,{"id":95,"slug":96,"hasResults":11,"nctId":97,"briefTitle":98,"officialTitle":99,"acronym":4,"eligibilityCriteria":100,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":101,"targetDuration":4,"studyType":21,"phases":103,"briefSummary":104,"conditions":105,"keywords":107,"overallStatus":109,"whyStopped":4,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":111,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":117,"locationsCount":4},"100573838","phase-3-jskn003-in-platinum-resistant-relapsed-epithelial-ovarian-cancer-100573838","NCT06751485","JSKN003 in Platinum-Resistant, Relapsed Epithelial Ovarian Cancer","A Randomized, Open-Label, Parallel-Controlled, Multi-center Phase Ⅲ Study of JSKN003 Versus Investigator-Choice Chemotherapy for Platinum-Resistant, Relapsed Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer","Inclusion Criteria:\n\n* Voluntary participation and written informed consent.\n* ≥18 years;\n* Histologically confirmed epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer.\n* Confirmed platinum-resistant relapse.\n* According to RECIST 1.1 criteria, there must be at least one measurable lesion in the baseline.\n* Expected survival of more than 3 months.\n* ECOG performance status score of 0 or 1.\n* Adequate organ function.\n* Capable and willing to comply with the study protocol, treatment plan, laboratory tests, and other related study procedures.\n\nExclusion Criteria:\n\n* Primary platinum-refractory disease.\n* Active central nervous system metastases.\n* Uncontrolled pleural effusion.\n* Previous treatment with topoisomerase I inhibitor ADCs.\n* Other malignant tumors within 5 years.\n* Interstitial pneumonia\u002Flung disease requiring systemic corticosteroids or suspected interstitial pneumonia\u002Flung disease.\n* Uncontrolled comorbidities.\n* Toxicity from previous anti-cancer treatments not recovered to CTCAE Grade ≤1.\n* History of allogeneic bone marrow or organ transplantation.\n* Allergic reactions or hypersensitivity to antibody drugs.\n* Conditions affecting study drug treatment safety or compliance, including psychiatric disorders, alcohol abuse, or drug abuse.",{"count":102,"type":20},430,[80],"This study is a randomized, open-label, controlled, phase III study to evaluate the efficacy and safety of JSKN003 versus investigator's choice of chemotherapy in patients with platinum-resistant, relapsed epithelial Ovarian, primary peritoneal, or fallopian tube cancer.",[27,28,106],"Fallopian Tube Cancers",[108],"JSKN003-306","NOT_YET_RECRUITING","2024-12-27",{"date":112,"type":36},"2024-12-31",{"date":114,"type":20},"2025-01-15",{"date":116,"type":20},"2027-12-30",{"name":118,"class":43},"Jiangsu Alphamab Biopharmaceuticals Co., Ltd"]