[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"parp-inhibitor\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:parp-inhibitor":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,43,77,104,129],{"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":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100480600","phase-2-vismodegib-combined-with-atezolizumab-in-platinum-resistant-ovarian-fallopian-tube-and-primary-peritoneal-cancer-100480600",false,"NCT05538091","Vismodegib Combined With Atezolizumab in Platinum Resistant Ovarian, Fallopian Tube, and Primary Peritoneal Cancer","Phase II Clinical Trial Combining the Hedgehog Inhibitor Vismodegib With the PD-L1 Inhibitor Atezolizumab in Patients With Platinum Resistant Ovarian, Fallopian Tube, and Primary Peritoneal Cancer","Inclusion Criteria:\n\n* Signed Informed Consent Form\n* Ability to comply with the study protocol, in the investigator's judgment\n* Histologically or cytologically confirmed epithelial ovarian, fallopian tube or primary peritoneal cancer\n* Platinum status, defined by disease progression during or following treatment with platinum-based chemotherapy within 6 months of completing therapy\n* Measurable or non-measurable but evaluable disease per RECIST v1.1 {Previously irradiated lesions can be considered as measurable disease only if progressive disease has been unequivocally documented at that site since radiation.}\n* Availability of a representative tumor specimen for exploratory biomarker research will be required for 12 patients (see Section 5.4.5 for information on tumor specimens)\n* ECOG Performance Status of 0-1\n* Life expectancy ≥ 3 months\n* Adequate hematologic and end-organ function, defined by the following laboratory test results, obtained within 14 days prior to initiation of study treatment: ANC ≥ 1.5 ⋅ 109\u002FL (1500\u002FμL) without granulocyte colony-stimulating factor support; Lymphocyte count ≥ 0.5 ⋅ 109\u002FL (500\u002FμL); Platelet count ≥ 100 ⋅ 109\u002FL (100,000\u002FμL) without transfusion; Hemoglobin ≥ 80 g\u002FL (8 g\u002FdL) (Patients may be transfused to meet this criterion.)\n\n  * AST, ALT, and alkaline phosphatase (ALP) ≤ 2.5 ⋅ upper limit of normal (ULN), with the following exceptions:\n\n    * Patients with documented liver metastases: AST and ALT ≤ 5 ⋅ ULN\n    * Patients with documented liver or bone metastases: ALP ≤ 5 ⋅ ULN\n  * Serum bilirubin ≤ 1.5 ⋅ ULN with the following exception:\n\n    * Patients with known Gilbert disease: serum bilirubin ≤ 3 ⋅ ULN\n  * Serum creatinine ≤ 1.5 ⋅ ULN\n  * Serum albumin ≥ 25 g\u002FL (2.5 g\u002FdL)\n  * For patients not receiving therapeutic anticoagulation: INR or aPTT ≤ 1.5 ⋅ ULN\n  * For patients receiving therapeutic anticoagulation: stable anticoagulant regimen\n* Negative HIV test at screening, with the following exception: patients with a positive HIV test at screening are eligible if they are stable on anti-retroviral therapy, have a CD4 count \\> 200, and have an undetectable viral load.\n* Negative hepatitis B surface antigen (HBsAg) test at screening\n* For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods as defined below:\n\n  * Women must remain abstinent or use contraceptive methods with a failure rate of \\\u003C 1% per year during the treatment period and for 5 months after the final dose of atezolizumab and for 24 months after the final dose of vismodegib. Women must refrain from donating eggs during this same period.\n  * A woman is considered to be of childbearing potential if she is postmenarchal, has not reached a postmenopausal state (≥ 12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries and\u002For uterus). The definition of childbearing potential may be adapted for alignment with local guidelines or requirements.\n  * Examples of contraceptive methods with a failure rate of \\\u003C 1% per year include bilateral tubal ligation, male sterilization, hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices.\n  * The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not adequate methods of contraception.\n\nExclusion Criteria:\n\n* Inability or unwillingness to swallow capsules\n* Inability or unwillingness to comply with study procedures\n* History of leptomeningeal disease\n* Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently)\n\n  o Patients with indwelling catheters (e.g., PleurX→) are allowed.\n* Uncontrolled or symptomatic hypercalcemia (ionized calcium \\> 1.5 mmol\u002FL, calcium \\> 12 mg\u002FdL or corrected serum calcium \\> ULN)\n* Active or history of autoimmune disease or immune deficiency, including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener granulomatosis, Sjögren syndrome, Guillain-Barré syndrome, or multiple sclerosis (see Appendix 9) for a more comprehensive list of autoimmune diseases and immune deficiencies), with the following exceptions:\n\n  * Patients with a history of autoimmune-related hypothyroidism who are on thyroid-replacement hormone are eligible for the study.\n  * Patients with controlled Type 1 diabetes mellitus who are on an insulin regimen are eligible for the study.\n  * Patients with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis are excluded) are eligible for the study provided all of following conditions are met:\n* Rash must cover \\\u003C 10% of body surface area\n* Disease is well controlled at baseline and requires only low-potency topical corticosteroids\n* No occurrence of acute exacerbations of the underlying condition requiring psoralen plus ultraviolet A radiation, methotrexate, retinoids, biologic agents, oral calcineurin inhibitors, or high-potency or oral corticosteroids within the previous 12 months\n* History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan (History of radiation pneumonitis in the radiation field (fibrosis) is permitted).\n* Active tuberculosis\n* Significant cardiovascular disease (such as New York Heart Association Class II or greater cardiac disease, myocardial infarction, or cerebrovascular accident) within 3 months prior to initiation of study treatment, unstable arrhythmia, or unstable angina\n* Major surgical procedure, other than for diagnosis, within 4 weeks prior to initiation of study treatment, or anticipation of need for a major surgical procedure during the study\n* History of malignancy other than ovarian cancer within 5 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death (e.g., 5-year OS rate \\> 90%), such as adequately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, localized prostate cancer, ductal carcinoma in situ, or Stage I uterine cancer\n* Severe infection within 4 weeks prior to initiation of study treatment, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia\n* Treatment with therapeutic oral or IV antibiotics within 2 weeks prior to initiation of study treatment\n\n  * Patients receiving prophylactic antibiotics (e.g., to prevent a urinary tract infection or chronic obstructive pulmonary disease exacerbation) are eligible for the study.\n* Prior allogeneic stem cell or solid organ transplantation\n* Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of an investigational drug, may affect the interpretation of the results, or may render the patient at high risk from treatment complications\n* Treatment with a live, attenuated vaccine within 4 weeks prior to initiation of study treatment, or anticipation of need for such a vaccine during atezolizumab treatment or within 5 months after the final dose of atezolizumab\n* Current treatment with anti-viral therapy for HBV\n* Treatment with investigational therapy within 28 days prior to initiation of study treatment\n* Treatment with systemic immunostimulatory agents (including, but not limited to, interferon and interleukin 2 \\[IL-2\\]) within 4 weeks or 5 half-lives of the drug (whichever is longer) prior to initiation of study treatment\n* Treatment with systemic immunosuppressive medication (including, but not limited to, corticosteroids, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-TNF-α agents) within 2 weeks prior to initiation of study treatment, or anticipation of need for systemic immunosuppressive medication during study treatment, with the following exceptions:\n\n  * Patients who received acute, low-dose systemic immunosuppressant medication or a one-time pulse dose of systemic immunosuppressant medication (e.g., 48 hours of corticosteroids for a contrast allergy) are eligible for the study after Principal Investigator confirmation has been obtained.\n  * Patients who received mineralocorticoids (e.g., fludrocortisone), corticosteroids for chronic obstructive pulmonary disease (COPD) or asthma, or low-dose corticosteroids for orthostatic hypotension or adrenal insufficiency are eligible for the study.\n* History of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins\n* Known hypersensitivity to Chinese hamster ovary cell products or to any component of the atezolizumab formulation\n* Known allergy or hypersensitivity to any component of the vismodegib formulation\n* Agreement not to donate blood or blood products during the study and for 24 months after discontinuation of vismodegib.\n* Pregnancy or breastfeeding, or intention of becoming pregnant during study treatment or within 5 months after the final dose of atezolizumab and for 24 months after the final dose of vismodegib.\n\n  * Women of childbearing potential must have a negative serum pregnancy test result within 14 days prior to initiation of study treatment.","FEMALE","18 Years",{"count":19,"type":20},48,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","This trial will treat patients with platinum resistant ovarian, fallopian tube or primary peritoneal cancer as defined by a progression free interval within six months of completion of most recent platinum-based treatment with a combination of vismodegib and atezolizumab. Despite recent improvements in treatment of ovarian cancer with the introduction of PARP inhibitors, response rates to therapy in the platinum resistant setting remain dismal with response rates of only 10-20% reported for single agent cytotoxic therapies. Given the poor prognosis and limited treatment options for these patients, this population is considered appropriate for trials of novel therapeutic candidates.",[26,27,28,29],"Platinum-Resistant Fallopian Tube Carcinoma","Platinum-Resistant Primary Peritoneal Carcinoma","PARP Inhibitor","Hedgehog Inhibitor","RECRUITING","2026-06-16",{"date":33,"type":34},"2026-06-18","ACTUAL",{"date":36,"type":34},"2023-05-15",{"date":38,"type":20},"2032-09-30",{"name":40,"class":41},"Ronald Buckanovich","OTHER",1,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":21,"phases":52,"briefSummary":54,"conditions":55,"keywords":62,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":76},"100570692","revitalize-rct-to-reduce-fatigue-in-adults-with-ovarian-cancer-on-parp-inhibitors-100570692","NCT06710548","REVITALIZE: RCT to Reduce Fatigue in Adults With Ovarian Cancer on PARP Inhibitors","Randomized Trial of REVITALIZE: A Telehealth Intervention to Reduce Fatigue Interference Among Adults With Advanced Ovarian Cancer on PARP Inhibitors","Inclusion Criteria:\n\n* Adult patients (age ≥ 18 years) with ovarian, fallopian tube, or primary peritoneal cancers (hereafter ovarian cancer) who have completed primary therapy (surgery and chemotherapy).\n* Treated with a PARP inhibitor as maintenance therapy for ≥2 months and plan to continue for at least 7 months.\n* English-speaking.\n* Mean fatigue severity level ≥4 on the first three items of the Fatigue Symptom Inventory.\n* ECOG performance status of 0-2.\n* Willing to use a wireless pill bottle for PARP inhibitor medication.\n\nExclusion Criteria:\n\n* Untreated clinical condition or comorbid condition that pre-dates PARP inhibitor use and could explain fatigue, as evaluated by their treating oncologist.\n* Patients with severe psychiatric conditions (e.g. untreated trauma unrelated to cancer, high or imminent suicidality) as evaluated by their treating oncologist, which require more intensive psychiatric treatment than the study can provide.\n* Patients with cognitive conditions (e.g. dementia), determined by their treating oncologist, such that they could not provide informed consent or complete the study procedures.\n* Inability to complete the first questionnaire within one week of consent.",{"count":51,"type":20},240,[53],"NA","The purpose of this study is to see whether a supportive intervention (REVITALIZE) reduces fatigue and its impact on daily life and activities for participants with ovarian cancer taking PARP inhibitors.\n\nThe name of the study groups in this research study are:\n\n1. REVITALIZE\n2. Educational Materials",[56,57,58,59,28,60,61],"Ovarian Cancer","Advanced Ovarian Carcinoma","Fallopian Tube Carcinoma","Primary Peritoneal Cancer","Fatigue Related to Cancer Treatment","Fatigue in Cancer Survivors",[56,57,63,59,64,65,61,66],"Advanced Ovarian Cancer","Fallopian Tube Cancer","Fatigue related to cancer treatment","PARP inhibitor","2026-04-07",{"date":69,"type":34},"2026-04-13",{"date":71,"type":34},"2025-03-17",{"date":73,"type":20},"2029-01-31",{"name":75,"class":41},"Dana-Farber Cancer Institute",6,{"id":78,"slug":79,"hasResults":11,"nctId":80,"briefTitle":81,"officialTitle":81,"acronym":4,"eligibilityCriteria":82,"healthyVolunteers":11,"sex":83,"minAge":17,"maxAge":4,"enrollmentInfo":84,"targetDuration":4,"studyType":21,"phases":86,"briefSummary":88,"conditions":89,"keywords":91,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":103},"100620549","phase-1-an-open-label-first-in-human-dose-escalation-and-dose-expansion-phase-iii-study-to-evaluate-the-safety-tolerability-pharmacokinetics-and-preliminary-efficacy-of-spr1020-in-patients-with-advanced-solid-tumors-100620549","NCT07359066","An Open-label, First-in-Human, Dose-Escalation and Dose-Expansion Phase I\u002FII Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of SPR1020 in Patients With Advanced Solid Tumors","Inclusion Criteria:\n\n1. Male or female subjets ≥ 18 years old.\n2. Phase I Dose-Escalation Part: Patients with histologically or cytologically confirmed, surgically unresectable, locally advanced or metastatic malignant solid tumors, who have experienced failure of standard therapy, or for whom no standard therapy exists, or who are intolerant to standard therapy. (Priority will be given to enrolling patients with breast, ovarian, prostate, or pancreatic cancer harboring homologous recombination deficiency (HRD)-related gene mutations such as BRCA1\u002F2, PALB2, RAD51C\u002FD).\n\nPhase I Dose Backfill Portion: Patients with HER2-negative breast cancer (BC), advanced epithelial ovarian cancer (OC)\u002Ffallopian tube cancer (FTC)\u002Fprimary peritoneal cancer (PPC), or castration-resistant prostate cancer (CRPC), who have a documented pathogenic or likely pathogenic BRCA mutation (BRCAm, germline or somatic) as detected by a local or central laboratory, and who have experienced failure of at least one prior line of standard anticancer therapy (refer to the protocol section for the Phase II dose expansion for specific standard therapy requirements); Or patients with other tumor types harboring homologous recombination deficiency (HRD) related gene mutations (including but not limited to esophageal cancer, small cell lung cancer, or pancreatic cancer) who have experienced failure of at least one prior line of standard therapy.\n\nPhase II Dose Expansion Study: Allows prior treatment with a pan-PARP inhibitor (no more than 1 type). Specific requirements for each cohort are as follows:\n\nCohort 1: Breast Cancer (BC):\n\n1. Histologically or cytologically confirmed HER2-negative (HR+\u002FHER2- or triple-negative) advanced or metastatic breast cancer.\n2. Presence of a predicted loss-of-function BRCA1\u002F2 mutation in germline or tumor tissue.\n3. Received at least \\> 1 line of systemic therapy for advanced disease (must have received at least one line of chemotherapy; if HR+, must have received endocrine therapy), with recent radiological confirmation of disease progression.\n\nCohort 2: Ovarian Cancer (OC):\n\n1. Histologically confirmed high-grade serous or endometrioid ovarian cancer, fallopian tube cancer, or primary peritoneal cancer.\n2. Presence of a predicted loss-of-function BRCA1\u002F2 mutation in germline or tumor tissue.\n3. Received at least \\> 1 line of systemic therapy for advanced disease (must have received at least one platinum-based chemotherapy regimen for advanced disease), with recent radiological confirmation of disease progression.\n4. Subjects must have a response duration of ≥ 6 months after the last platinum-based chemotherapy (platinum-sensitive population).\n\nCohort 3: Prostate Cancer (PC):\n\n1. Histologically or cytologically confirmed prostatic adenocarcinoma, which has progressed to the castration-resistant stage.\n2. Ongoing androgen deprivation therapy (ADT) with a gonadotropin-releasing hormone analog or status post bilateral orchiectomy, with serum testosterone \\\u003C 50 ng\u002FdL (\\\u003C 1.73 nmol\u002FL) within 28 days prior to study enrollment. Patients receiving ADT at the time of enrollment should continue this therapy throughout the study period.\n3. Presence of a predicted loss-of-function BRCA1\u002F2 mutation in germline or tumor tissue.\n4. Received at least \\> 2 lines of systemic therapy for advanced disease (must have received a novel hormonal agent \\[NHA\\] and chemotherapy), with recent radiological confirmation of disease progression.\n\nCohort 4:\n\n1\\) The aforementioned tumor types (from Cohorts 1-3) harboring HRRm (excluding BRCA mutations), or other tumor types harboring HRRm (including but not limited to esophageal cancer, small cell lung cancer, or pancreatic cancer, etc.), which have failed after first-line or later standard therapy.\n\n3\\. Presence of at least one measurable lesion according to RECIST v1.1. 4. For both Phase I backfill and Phase II expansion, patients must provide tumor tissue (archived specimen from within 12 months pre-ICF preferred; fresh biopsy if unavailable) and peripheral blood for BRCAm\u002FHRRm testing. Provision of specimens is also encouraged for Phase I dose-escalation patients when feasible. Testing will be conducted at a Sponsor-designated central laboratory. The samples provided shall comply with the following requirements:\n\n* Option 1 : 8-10 sections of surgically resected tumor tissue specimens, or 10-15 sections of core needle biopsy specimens; fine needle aspiration specimens are not acceptable; plus approximately 2 mL of peripheral blood.\n* Option 2 : If tumor tissue samples cannot be provided, a peripheral blood sample of approximately 10 mL may be provided instead.\n\nNote:BRCAm\u002FHRRm results must meet eligibility criteria. A prior positive local laboratory report is acceptable for enrollment without awaiting central lab results; the central report will serve for retrospective validation. If sample quantity is insufficient, Sponsor consultation is required for enrollment eligibility.\n\n5\\. ECOG Performance Status of 0-1. 6. Expected survival time ≥ 3 months. 7. Adequate organ function:\n\na. Hematopoietic system (Has not received blood transfusion or hematopoietic growth factor therapy within 14 days): i. Platelet count ≥ 100 × 10\\^9\u002FL ii. Absolute neutrophil count (ANC) ≥ 1.5 × 10\\^9\u002FL iii. White blood cell count ≥ 3.0 × 10\\^9\u002FL iv. Hemoglobin ≥ 90 g\u002FL b. Hepatic function: i. Total bilirubin ≤ 1.5 × ULN ii. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN (in the absence of liver metastases) iii. ALT and AST ≤ 5.0 × ULN (In subjects with liver metastases) c. Renal function: i. Creatinine clearance (Ccr) \\> 50 mL\u002Fmin (calculated by the Cockcroft-Gault formula) d. Coagulation function: i. Activated partial thromboplastin time (APTT) ≤ 1.5 × ULN ii. International normalized ratio (INR) ≤ 1.5 × ULN 8. Both PARPi-pretreated and PARPi-naive patients are eligible for enrollment. For PARPi-pretreated patients, they are allowed to have received a maximum of one prior line of PARPi-containing therapy (whether as monotherapy or as maintenance therapy).\n\n9\\. Women of childbearing potential (WOCBP) (defined as those not surgically sterile or from menarche until 1 year after menopause) must have a negative serum pregnancy test result within 7 days prior to the first dose of the IP. WOCBP must agree to practice abstinence or use highly effective contraceptive methods from the time of signing the informed consent form until 3 months after the last dose of the IP. Similarly, male subjects (including those post-vasectomy) must agree to use effective contraception or practice abstinence from the time of signing the informed consent until 3 months after the last dose of the IP, and must refrain from sperm donation during this period.\n\n10\\. The subject must provide informed consent for the study prior to any trial-related procedures and voluntarily sign the written informed consent form.\n\nExclusion Criteria:\n\n1. Have received systemic anti-tumor therapy (including chemotherapy, biotherapy, endocrine therapy, immunotherapy, etc.) within 4 weeks prior to the first dose of the investigational product, with the following specifics: mitomycin and nitrosoureas within 6 weeks from the last dose; oral fluorouracil drugs (such as tegafur and capecitabine) within 2 weeks from the last dose; small molecule targeted agents within 2 weeks or 5 half-lives from the last dose, whichever is shorter; have received any herbal or botanical products with purported anti-tumor effects within 2 weeks prior to the first dose of the investigational product.\n2. Have received radiotherapy (with the exception of palliative radiotherapy) within 3 weeks prior to the initiation of study treatment, or have a history of radiation pneumonitis. Note: With the exception of a history of radiation pneumonitis, subjects must have recovered from all radiation-related toxicities.\n3. Have received other unapproved investigational drugs within 4 weeks prior to the first dose of the investigational product, or within 5 half-lives of the other drug(s), whichever is shorter.\n4. Have undergone major organ surgery (excluding Puncture Biopsy) within 4 weeks prior to the first dose of the investigational product, or have experienced significant trauma, or require elective surgery during the trial period.\n5. Prior treatment with a PARP1 inhibitor. Note: For subjects enrolling in the dose-escalation phase, enrollment may be considered following discussion with and agreement from the sponsor's medical representative.\n6. Have received or are anticipated to require long-term systemic glucocorticoid therapy (prednisone \\>10 mg\u002Fday or equivalent) or other immunosuppressive therapy within 14 days prior to the first dose of the investigational product. The following are exceptions: topical, intra-articular, intranasal, and inhaled corticosteroids; corticosteroid administration as premedication for contrast-enhanced imaging studies to prevent allergic reactions; short-term (≤ 7 days) use of corticosteroids for the prevention or treatment of non-autoimmune allergic conditions; and glucocorticoids used during the treatment stage for castration-resistant prostate cancer (CRPC).\n7. Have used immunomodulatory agents, including but not limited to thymic peptides, interleukin-2 (IL-2), interferon, etc., within 14 days prior to the first dose of the investigational product.\n8. Have received a live or attenuated live vaccine within 4 weeks prior to the first dose of the investigational product. Inactivated vaccines are permitted.\n9. Have used within 7 days prior to the first dose of the investigational product or require concomitant use during the study treatment period of medications, herbal supplements, or foods known to be strong cytochrome P450 3A4 (CYP3A4) inhibitors or inducers (refer to Appendix 4 a summary list of common CYP3A4 enzyme inducers and inhibitors).\n10. Have a prior history of allogeneic bone marrow transplantation or solid organ transplantation.\n11. Patients with myelodysplastic syndrome (MDS)\u002Facute myeloid leukemia (AML) or presenting with features suggestive of MDS\u002FAML.\n12. Have difficulty swallowing oral medications, or have malabsorption syndrome or any other poorly controlled gastrointestinal disease that may affect bioavailability.\n13. Adverse reactions from prior anti-tumor therapy have not recovered to ≤ Grade 1 per CTCAE v5.0 (except for alopecia, hyperpigmentation, and other tolerable events judged by the investigator) or to the level specified in the protocol inclusion\u002Fexclusion criteria.\n14. Patients with central nervous system (CNS) metastases meeting any of the following criteria: (a) requiring local therapy (surgery, radiotherapy, or other); (b) CNS metastases requiring or currently being treated with corticosteroids at a dose \\>10 mg prednisone or equivalent; (c) unstable CNS metastases or a stability duration of less than 14 days after the last treatment prior to enrollment; (d) presence of spinal cord compression or leptomeningeal metastasis.\n15. Presence of severe chronic or active infection requiring systemic antibacterial, antifungal, or antiviral therapy within 14 days prior to the first dose (including tuberculosis infection).\n16. Have a known history of a positive human immunodeficiency virus (HIV) test or acquired immunodeficiency syndrome (AIDS).\n17. Patients with active hepatitis B (if hepatitis B surface antigen is positive, HBV-DNA testing is required; subjects with positive HBsAg and HBV-DNA \\> 500 copies\u002FmL or \\> 100 IU\u002FmL are considered to have active hepatitis B and must be excluded). Subjects who test positive for HBV-DNA may be enrolled if, after receiving antiviral therapy, their HBV-DNA level decreases to below the lower limit of detection for ≥ 2 weeks, and they must continue to receive antiviral therapy during the study period; patients with hepatitis C (if the HCV antibody test is positive, HCV-RNA testing is required; subjects with a positive HCV antibody test and a positive HCV RNA result are considered to have hepatitis C and must be excluded); patients with active syphilis (if the Treponema pallidum antibody test is positive, an antibody titer test is required; patients with active syphilis should be excluded according to the central laboratory's testing standards).\n18. History of other malignancies within the past 3 years, except for adequately treated basal cell carcinoma of the skin, superficial bladder cancer, or carcinoma in situ of the cervix.\n19. Have a history of severe cardiovascular or cerebrovascular diseases, including but not limited to:\n\n    1. Severe cardiac rhythm or conduction abnormalities, such as ventricular arrhythmias requiring clinical intervention, second- or third-degree atrioventricular block, QTcF interval ≥ 470 ms, etc.\n    2. Acute coronary syndrome, congestive heart failure, aortic dissection, stroke, or other Grade 3 or higher cardiovascular or cerebrovascular events occurring within 6 months prior to the first dose of the investigational product.\n    3. For patients with chronic cardiac disease, New York Heart Association (NYHA) functional class \\> II or left ventricular ejection fraction (LVEF) \\\u003C 50%.\n    4. Poorly controlled hypertension, defined as systolic blood pressure (SBP) ≥ 160 mmHg and\u002For diastolic blood pressure (DBP) ≥ 100 mmHg despite clinical therapy.\n    5. History of severe hemorrhage or thrombotic diseases within 6 months prior to the investigational product administration, or use of anticoagulants (such as warfarin) or similar agents requiring therapeutic International Normalized Ratio (INR) monitoring.\n20. Have clinically significant severe pulmonary impairment, including but not limited to infectious pneumonia or requiring continuous supplemental oxygen to maintain adequate oxygenation.\n21. Subjects with active autoimmune disease, or a history of autoimmune disease that may recur (including but not limited to systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vasculitis, psoriasis, autoimmune thyroid disease), or subjects with related risks (e.g., those who have undergone organ transplantation requiring immunosuppressive therapy). Subjects with skin diseases that do not require systemic therapy (e.g., vitiligo, psoriasis) may be enrolled.\n22. Known hypersensitivity or allergy to any component of the investigational product.\n23. Clinically uncontrolled pericardial effusion, pleural effusion, or ascites requiring repeated drainage.\n24. Have dementia or altered mental status that may affect the understanding and provision of informed consent.\n25. Pregnant or lactating women.\n26. Have underlying disease conditions (including laboratory abnormalities), or alcohol\u002Fdrug abuse or dependence, which may interfere with the administration of the investigational product, affect the interpretation of drug toxicity or adverse events, or lead to inadequate or reduced compliance with study procedures.\n27. Any other significant condition that, in the judgment of the investigator, would substantially increase the risk associated with the patient's participation in the study, or affect the patient's ability to receive the investigational product or complete the study.","ALL",{"count":85,"type":20},210,[87,23],"PHASE1","This study is a multicenter, open-label study designed to evaluate SPR1020 in adult patients with advanced solid tumors. The study aims to characterize the safety, tolerability, pharmacokinetic (PK) profile, and preliminary antitumor activity of SPR1020 monotherapy in this population.\n\nThe study consists of two parts: Phase I component (dose escalation and backfill) and Phase II component (dose expansion). The primary objectives of the Phase I part are to investigate the safety, tolerability, and PK profile of SPR1020 and to determine the Recommended Phase II Dose (RP2D) and\u002For the Maximum Tolerated Dose (MTD), if attainable. The Phase II part will be initiated once the RP2D and\u002For MTD is established in the Phase I part.\n\nAs a new-generation, highly selective PARP1 inhibitor, SPR1020 demonstrates a competitive clinical benefit-risk profile, combining potential intracranial activity with a differentiated safety profile. By leveraging a \"synthetic lethality\" mechanism, SPR1020 is expected to demonstrate significant efficacy against tumors harboring BRCA mutations or homologous recombination repair (HRR) pathway gene alterations (e.g., breast cancer, prostate cancer). Owing to its high selectivity for PARP1 over PARP2, SPR1020 may circumvent the hematological toxicities associated with PARP2 inhibition by first-generation pan-PARP inhibitors (e.g., olaparib), potentially resulting in an improved safety profile. This enhanced safety may provide greater flexibility for use in combination therapies. Furthermore, SPR1020's ability to penetrate the blood-brain barrier could offer a new treatment option for patients with advanced disease and brain metastases, addressing a high unmet medical need in this population with limited therapeutic choices. Preclinical data support this differentiated profile in terms of both efficacy and toxicity.\n\nHypothesis: SPR1020 represents a novel anticancer therapeutic with the potential for enhanced efficacy and an improved safety profile. The overall assessment indicates that its clinical benefits outweigh the potential risks.\n\nThis study has been approved by the IEC and adheres to the principles of the Declaration of Helsinki.",[90,28],"Advanced Solid Tumors",[92],"SPR1020","2026-02-03",{"date":95,"type":34},"2026-02-05",{"date":97,"type":34},"2026-01-08",{"date":99,"type":20},"2028-06",{"name":101,"class":102},"Shanghai SciBrunch Therapeutics Co., Ltd.","INDUSTRY",2,{"id":105,"slug":106,"hasResults":11,"nctId":107,"briefTitle":108,"officialTitle":109,"acronym":4,"eligibilityCriteria":110,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":111,"enrollmentInfo":112,"targetDuration":4,"studyType":114,"phases":4,"briefSummary":115,"conditions":116,"keywords":4,"overallStatus":118,"whyStopped":4,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":126,"locationsCount":4},"100580525","parpi-and-ovarian-cancer-survival-100580525","NCT06838429","PARPi and Ovarian Cancer Survival","Effect of PARP Inhibitors Maintenance Therapy on the Survival Rate of Advanced or Relapsed Epitherlial Ovarian Cancer: an Observational Cohort Study","Inclusion Criteria:\n\nGroup 1:\n\n* Patients newly diagnosed with stage IIIC or IV primary epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer between December 2013 and December 2024.\n* Complete data on first-line treatment and maintenance therapy.\n* Availability of follow-up data.\n\nGroup 2:\n\n* Patients with platinum-sensitive first recurrence of any stage of epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer, diagnosed between December 2013 and December 2024.\n* Disease progression occurring at least 6 months after the completion of the last platinum-based chemotherapy regimen.\n* Complete data on second-line treatment and maintenance therapy.\n* Availability of follow-up data.\n\nExclusion Criteria:\n\nGroup 1:\n\n* Non-epithelial tumors, borderline tumors, clear cell carcinoma, mucinous carcinoma.\n* Missing first-line or follow-up data.\n\nGroup 2:\n\n* Non-epithelial tumors, borderline tumors, clear cell carcinoma, mucinous carcinoma.\n* Patients with second relapse.\n* Platinum-resistant patients, such as those who had disease progression during chemotherapy or within 6 months after platinum-based chemotherapy.\n* Missing second-line or follow-up data.","80 Years",{"count":113,"type":20},6000,"OBSERVATIONAL","With the widespread use of PARP inhibitors (PARPi) as maintenance therapy in ovarian cancer, there is still a lack of real-world data from large samples regarding their impact on survival outcomes in advanced and recurrent ovarian cancer. This study aims to conduct a pragmatic cohort study to evaluate the impact of first-line and second-line maintenance treatment with PARPi on survival rates in patients with advanced and recurrent ovarian cancer. The genetic status, different PARPi drugs, and the use of anti-angiogenic inhibitor maintenance therapy or not is used as confounding factors.",[117,28],"Epithelial Ovarian Cancer, Fallopian Tube or Peritoneum","NOT_YET_RECRUITING","2025-02-17",{"date":121,"type":34},"2025-02-20",{"date":123,"type":20},"2025-03",{"date":125,"type":20},"2026-03",{"name":127,"class":128},"Shanghai Gynecologic Oncology Group","OTHER_GOV",{"id":130,"slug":131,"hasResults":11,"nctId":132,"briefTitle":133,"officialTitle":133,"acronym":134,"eligibilityCriteria":135,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":136,"enrollmentInfo":137,"targetDuration":4,"studyType":21,"phases":139,"briefSummary":140,"conditions":141,"keywords":149,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":156,"lastUpdatePostDateStruct":157,"startDateStruct":159,"completionDateStruct":161,"leadSponsor":163,"locationsCount":42},"100531268","safety-assessment-of-concurrent-radiotherapy-and-novel-systemic-therapy-for-breast-cancer-100531268","NCT06197581","Safety Assessment of Concurrent Radiotherapy and Novel Systemic Therapy for Breast Cancer","RADIOCOM","Inclusion Criteria:\n\nECOG 0-2. Aged 18-70 years old. Pathologically diagnosed as breast cancer. Need to receive radiotherapy according to guidelines. Radiotherapy target volume included chest wall\u002Fbreast with or without lymph node regions.\n\nNeed to receive one of the following therapies according to guidelines, capetabine, CDK4\u002F6 inhibitor, PARP inhibitor , ICIs , HER2 inhibitors.\n\nExclusion Criteria:\n\nMale breast cancer. Allergy to the upper medicines before. Will receive trastuzumab alone during and\u002For after radiotherapy. With severe other disease.","70 Years",{"count":138,"type":20},148,[53],"Radiation therapy is a crucial part in the comprehensive treatment of breast cancer. In recent years, emerging systemic treatment regimens such as HER 2 inhibitors, CDK 4\u002F6 inhibitors, PARP inhibitors, capecitabine and PD1 inhibitors have greatly improved the prognosis of breast cancer and has become the standard treatment for specific populations. A considerable number of patients require both radiotherapy and maintenance systemic therapy. However, it is not clear whether systemic therapy should be synchronized or suspended in radiotherapy，despite that previous basic research shows that some molecular drug therapy and radiotherapy has a clear synergy mechanism. There is an agent need for a definite evidence to evaluate the safety of synchronous treatment, to support clinical diagnosis and treatment and the next step of comprehensive treatment. The implementation of the new radiotherapy technology represented by IMRT takes into account the prescription dose homogenization and the minimization of normal tissue dosage, which provides a certain basis for the combination therapy. Based on the above conditions, this study intends to enroll patients between 18 and 70 years old with chest wall \u002F breast ± lymphatic drainage area and requiring capecitabine, CDK 4\u002F 6 inhibitor, HER2 targeted therapy or immunotherapy. Radiation and novel systemic therapies would be delivered concurrently. The study aimed at evaluating the safety of combined treatments.",[142,143,144,145,146,147,148,28],"Breast Cancer, Familial Male","Radiotherapy; Complications","Chemotherapeutic Toxicity","Immune Checkpoint Inhibitor","CDK4\u002F6 Inhibitor","Trastuzumab","Pertuzumab",[150,151,152,153,147,148,154,155,66],"Breast Cancer","Radiotherapy","Adverse events","Capecitabine","Immune checkpoint inhibitor","CDK4\u002F6 inhibitor","2024-08-19",{"date":158,"type":34},"2024-08-21",{"date":160,"type":34},"2024-01-12",{"date":162,"type":20},"2027-01-15",{"name":164,"class":41},"Cancer Institute and Hospital, Chinese Academy of Medical Sciences"]