[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"metastatic-castration-resistant-prostate-cancer-patients\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:metastatic-castration-resistant-prostate-cancer-patients":108},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,40,87],{"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":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":39},"100632467","phase-1-tsl2109-capsules-in-advanced-solid-tumor-patients-safety-tolerability-pk-and-preliminary-efficacy-100632467",false,"NCT07514065","TSL2109 Capsules in Advanced Solid Tumor Patients: Safety, Tolerability, PK and Preliminary Efficacy","Multicenter, Dose-Escalation & Dose-Expansion, Single-Arm, Open-Label Phase I Trial: Safety, Tolerability, PK and Preliminary Antitumor Efficacy of TSL2109 Capsules in Advanced Solid Tumor Patients","Inclusion Criteria:\n\n1. Age ≥18 years.\n2. Histologically or cytologically confirmed advanced solid tumors, with failure of prior standard therapy, or no available standard therapy, or currently unsuitable for standard therapy, and not amenable to surgery or radiotherapy with curative intent. Priority will be given to patients with metastatic castration-resistant prostate cancer (mCRPC) and HR+\u002FHER2- advanced breast cancer.\n3. (Dose-Escalation Phase) At least one evaluable or measurable tumor lesion per RECIST Version 1.1; (Dose-Expansion Phase) At least one measurable tumor lesion per RECIST Version 1.1 (tumor lesions located in prior radiation fields or other locally treated sites generally do not qualify as measurable lesions unless there is clear progression or persistence three months after radiotherapy).\n4. Life expectancy ≥3 months.\n5. ECOG performance status score of 0 to 1.\n\nMetastatic Castration-Resistant Prostate Cancer (mCRPC):\n\nCastration status at screening: (1) Currently receiving androgen deprivation therapy (ADT) with luteinizing hormone-releasing hormone (LHRH) agonist\u002Fantagonist or history of bilateral orchiectomy. (2) Serum total testosterone ≤1.7 nmol\u002FL (50 ng\u002FdL) at screening. Additionally, progression documented by one or more of the following three criteria: ① PSA progression defined as PSA \\>1 ng\u002FmL with two consecutive increases \\>50% from baseline at least 1 week apart; ② Soft tissue disease progression per RECIST 1.1; ③ Bone disease progression per PCWG3, defined as two or more new bone lesions on bone scan. Priority will be given to end-line patients who have received prior androgen receptor inhibitors and have received chemotherapy or are chemotherapy-intolerant or chemotherapy-refusing.\n\nHR+\u002FHER2- Breast Cancer:\n\n① Histologically or cytologically confirmed HR-positive, HER2-negative breast cancer (determined from the most recent tumor sample \\[primary or metastatic\\] with histological confirmation of HR+\u002FHER2- status. To meet HR+ disease requirements, breast cancer must express estrogen receptor \\[ER\\], with or without progesterone receptor co-expression), locally advanced or recurrent\u002Fmetastatic breast cancer in female patients. ② Prior exposure to CDK4\u002F6 inhibitors (e.g., abemaciclib, palbociclib, etc.).\n\nExclusion Criteria:\n\n1. Clinically symptomatic central nervous system (CNS) metastases or leptomeningeal metastases, or other evidence indicating uncontrolled CNS or leptomeningeal metastases, judged by the investigator as unsuitable for enrollment.\n2. Diagnosis of another invasive malignancy within the past 2 years, except for radically treated non-melanomatous skin cancer or superficial urothelial carcinoma, cutaneous basal cell or squamous cell carcinoma, superficial bladder cancer, prostate carcinoma in situ, papillary thyroid carcinoma, cervical carcinoma in situ, or breast carcinoma in situ.\n3. Clinically significant gastrointestinal dysfunction that may affect drug intake, transport, or absorption, such as inability to take oral medications, uncontrolled nausea or vomiting, history of extensive gastrointestinal resection, unresolved recurrent diarrhea, untreated gastric conditions requiring long-term proton pump inhibitor therapy, Crohn's disease, ulcerative colitis, intestinal obstruction, etc.\n4. Imaging (CT or MRI) showing tumor invasion of major blood vessels (e.g., aorta, pulmonary arteries\u002Fveins, vena cava, etc.) with assessed bleeding risk.\n5. Interstitial lung disease, pneumonitis, or pulmonary fibrosis, assessed by the investigator as unsuitable for enrollment.\n6. History of deep vein thromboembolism.","ALL","18 Years",{"count":19,"type":20},78,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","TSL2109 is a novel CDK4\u002F6-DYRK2 dual-target inhibitor developed by Jiangsu Tasly Diyee Pharmaceutical Co., Ltd. for solid tumor treatment. Preclinical studies confirm its selective targeting of CDK4\u002F6 and DYRK2, a eukaryotic CMGC family kinase.\n\nIn palbociclib-resistant cell lines, TSL2109 downregulates cell cycle-related proteins and DYRK2 pathway ribosomal synthesis regulators (RRS1, CDK2), and upregulates p53, thus exerting synergistic antitumor effects and overcoming resistance to enzalutamide and palbociclib.\n\nAs a small-molecule inhibitor with novel targets, structure and mechanism, TSL2109 blocks tumor cell cycle progression independently of hormonal signaling. Preclinical studies show it overcomes AR inhibitor resistance, meeting unmet needs for prostate cancer patients progressing after AR inhibitor therapy. It also reduces CDK2 activity and blocks CDK4\u002F6 compensatory mechanisms, reversing resistance to CDK4\u002F6 inhibitors, providing a new option for HR+\u002FHER2- advanced breast cancer patients.\n\nParticipants Dose-Escalation Phase: Advanced solid tumor patients, prioritizing metastatic castration-resistant prostate cancer (mCRPC) and HR+\u002FHER2- advanced breast cancer.\n\nDose-Expansion Phase:\n\nCohort A\u002FC: mCRPC; Cohort B\u002FD: HR+\u002FHER2- advanced breast cancer. Treatment Regimens C0 Cycle (3 days): Single oral dose on Day 1 morning under fasting, followed by 72-hour observation.\n\nC1 Cycle (28 days): Daily fasting oral dosing (QD) for 3 weeks, then 1-week rest. Participants may continue treatment if no DLT and potential clinical benefit.\n\nDose escalation to a pre-established tolerable level is allowed per investigator-sponsor agreement if well-tolerated and likely beneficial. Treatment continues until disease progression, intolerable toxicity or new antitumor therapy. The Dose-Expansion Phase uses the same regimen as C1.\n\nMissed Dose: Make-up within 8 hours; skip if delayed over 8 hours. Notes: Once MTD is determined, participants dosed above MTD will be adjusted to MTD. All doses are administered orally under fasting conditions.",[26],"Metastatic Castration-Resistant Prostate Cancer Patients","RECRUITING","2026-03-31",{"date":30,"type":31},"2026-04-07","ACTUAL",{"date":33,"type":31},"2026-02-20",{"date":35,"type":20},"2026-12-31",{"name":37,"class":38},"Tasly Pharmaceutical Group Co., Ltd","INDUSTRY",1,{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":46,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":48,"minAge":17,"maxAge":4,"enrollmentInfo":49,"targetDuration":4,"studyType":21,"phases":51,"briefSummary":52,"conditions":53,"keywords":58,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":86},"100600863","phase-1-a-clinical-study-of-ktx-2001-in-subjects-with-metastatic-castration-resistant-prostate-cancer-strike-001-100600863","NCT07103018","A Clinical Study of KTX-2001 in Subjects With Metastatic Castration-Resistant Prostate Cancer (STRIKE-001)","Phase 1, Dose-Escalation Study of KTX2001 (an NSD2 Inhibitor) Alone and in Combination With Darolutamide for Metastatic Castration-Resistant Prostate Cancer","STRIKE-001","Inclusion Criteria:\n\n1. Age ≥18 years.\n2. Eastern Cooperative Oncology Group (ECOG) score of 0 or 1.\n3. Male participants with mCRPC as defined by PCWG3 criteria.\n4. Metastatic disease documented using bone scan for bone metastases (PCWG3 criteria) or by computed tomography (CT) or magnetic resonance imaging (MRI) for soft-tissue metastases. Evidence of metastasis on prostate-specific membrane antigen positron emission tomography alone will not be sufficient for confirmation of metastatic disease.\n5. Willingness to undergo a baseline and on-treatment biopsy of a metastatic site if safe and feasible. If tissue from a biopsy of a metastatic site (including bone) obtained within the previous 6 months (prior to treatment start) is available, this tissue may be used, and the baseline biopsy may be omitted.\n6. Participants should have progressed on or after receiving an ARPI (eg, abiraterone, enzalutamide, darolutamide, or apalutamide).\n7. Adequate renal function (creatinine clearance \\>50 mL\u002Fmin by serum creatinine).\n8. Adequate hepatic function (total bilirubin ≤1.5× ULN, total bilirubin \\\u003C3× ULN for participants with documented Gilbert's syndrome, AST and ALT ≤2.5× ULN). In case of liver metastases, AST and ALT \\\u003C5× ULN is allowed.\n9. Adequate hematological function (neutrophils \\>1 × 109\u002FL, platelet count \\>100 × 109\u002FL, hemoglobin \\>9 g\u002FdL) with no prior transfusions within 2 weeks.\n\nExclusion Criteria:\n\n1. Presence of symptomatic or uncontrolled brain metastases unless adequately treated, not requiring steroids and stable for the last 28 calendar days before signing the ICF. Participants with leptomeningeal disease are excluded without exception.\n2. Symptomatic or impending cord compression that has not been treated or stabilized.\n3. Life-threatening illness, medical condition, active uncontrolled infection, or organ system dysfunction (such as coagulopathy or encephalopathy), or other reasons which, in the investigator's opinion, could compromise the participant's safety or interfere with or compromise the integrity of the study outcomes.\n4. Presence of a drug-related toxicity from prior cancer therapy that has not resolved to Grade ≤1 (with the exception of alopecia and Grade 2 neuropathy) according to NCI-CTCAE Version 5.0.\n5. Active, uncontrolled, bacterial, fungal, or viral infection, including hepatitis B virus (HBV), hepatitis C virus (HCV), known human immunodeficiency virus (HIV), or acquired immunodeficiency syndrome (AIDS)-related illness. In equivocal cases, participants with a negative viral load may be eligible. Eligibility criteria for HIV-positive participants currently on highly active antiretroviral therapy should be evaluated and discussed with the medical monitor and will be based on current and past CD4 and T cell counts, history (if any) of AIDS-defining conditions (eg, opportunistic infections), and status of HIV treatment. Participants with previously treated HBV and HCV with negative viral load are eligible.\n6. A significant history of renal, neurologic, psychiatric, pulmonary, endocrinologic, metabolic, immunologic, cardiovascular, or hepatic disease that, in the opinion of the investigator, would adversely affect participation in this study.\n\n   1. QT interval corrected by Fridericia's formula \\>470 msec at screening.\n   2. Unstable cardiovascular function defined as:\n   3. Symptomatic ischemia, or\n   4. Uncontrolled clinically significant conduction abnormalities (ie, ventricular tachycardia on antiarrhythmic agents are excluded; first-degree atrioventricular block or asymptomatic left anterior fascicular block\u002Fright bundle branch block are not excluded), or\n   5. Congestive heart failure New York Heart Association Class ≥3, or\n   6. Myocardial infarction within 3 months of the screening visit.\n   7. Hypertension that cannot be controlled (persistent \\>150\u002F90 mmHg despite optimal medical therapy).\n7. Current use or anticipated need for food or drugs that are known strong CYP3A inducers or inhibitors, including their administration within 10 days or 5 half-lives of the CYP3A inhibitor, whichever is longer prior to first dose of study drug.\n8. Treatment with anticancer therapies including radiotherapy or AR-targeted therapy\u002Fandrogen biosynthesis inhibitor) within 2 weeks prior to initial study drug dose or within 4 weeks for systemic chemotherapy, radioligand therapy, or other systemic anticancer therapies.\n9. Treatment with another investigational agent in the 4 weeks prior to the initial dose of study drug.\n10. Major surgical procedures ≤28 days prior to the initial dose of study drug. Participants must have recovered from any of the effects of any major surgery. No waiting period is required following central venous access placement, biopsy collection, or minor surgeries as long as the investigator assesses the impact on study participation.\n11. Initiation of hormonal agents with antitumor activity against prostate cancer including 5alpha reductase inhibitors, androgens (eg, testosterone), cytoproterone acetate, etc during study participation (from the time of consent to off-study); however, stable use of 5-alpha reductase inhibitors is permitted, if continuous use for ≥6 months.\n12. Use of herbal products or alternative therapies that may decrease PSA levels or that may have hormonal anti-prostate cancer activity (eg, saw palmetto, PC-SPES, PC-HOPE, St. John's wort, selenium supplements, grape seed extract, etc) within 4 weeks of study drug initiation or plans to initiate treatment with these products\u002Falternative therapies at any point during the study.\n\nFor Part B only (KTX-2001 + darolutamide): Current use or anticipated need for drugs that are known as combined P-glycoprotein (P-gp) and strong or moderate CYP3A4 inducers including their administration within 10 days or 5 half-lives of the combined Pgp\u002FCYP3A4 inducer, whichever is longer prior to first dose of darolutamide.","MALE",{"count":50,"type":20},144,[23],"Study K36-MCRPC-001 is the first in human clinical trial testing KTX-2001 alone and with darolutamide in men with metastatic castration-resistant prostate cancer. The study aims to assess whether the drug is safe, increasing doses alone and in combination with darolutamide, whether it is effective in treating metastatic castration-resistant prostate cancer, and measuring how the drug(s) behaves in the body.",[54,26,55,56,57],"Metastatic Castration-resistant Prostate Cancer","Metastatic Castration-resistant Prostate Cancer, mCRPC","mCRPC","mCRPC (Metastatic Castration-resistant Prostate Cancer)",[56,59,60,61,62,63,64,65,66,67,68,69,70,71,72,73,74,75,76],"Metastatic Castration-Resistant Prostate Cancer","castration-resistant prostate cancer","NSD2 inhibitor","efficacy","safety","pharmacokinetics","pharmacodynamics","Darolutamide","NUBEQA","Metastatic Disease","Neoplasms","prostatic Diseases","Prostatic Neoplasms","Urogenital Neoplasms","Neoplasms by Site","Urogenital Diseases","Male Urogenital Diseases","Epigenetics","2026-03-19",{"date":79,"type":31},"2026-03-23",{"date":81,"type":31},"2025-11-21",{"date":83,"type":20},"2028-09",{"name":85,"class":38},"K36 Therapeutics, Inc.",13,{"id":88,"slug":89,"hasResults":11,"nctId":90,"briefTitle":91,"officialTitle":91,"acronym":4,"eligibilityCriteria":92,"healthyVolunteers":11,"sex":48,"minAge":17,"maxAge":4,"enrollmentInfo":93,"targetDuration":4,"studyType":21,"phases":95,"briefSummary":96,"conditions":97,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":39},"100603329","phase-1-a-clinical-study-to-evaluate-the-safety-tolerability-and-preliminary-efficacy-of-225acac-psma-xt-injection-in-patients-with-metastatic-castration-resistant-prostate-cancer-100603329","NCT07135102","A Clinical Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of [225Ac]Ac-PSMA-XT Injection in Patients With Metastatic Castration-resistant Prostate Cancer","Inclusion Criteria:\n\n1. have the ability to understand and sign an approved informed consent form (ICF).\n2. \\>= 18 years old.\n3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n4. have a life expectancy \\>6 months.\n5. have histological, pathological, and\u002For cytological confirmation of prostate cancer.\n6. PSMA Positron Emission Tomography (PET)\u002FComputed Tomography (CT) scan positive\n7. have a castrate level of serum\u002Fplasma testosterone (\\\u003C50 ng\u002FdL or \\\u003C1.7 nmol\u002FL).\n8. have received at least one NAAD (such as enzalutamide and\u002For abiraterone)； patients must have been previously treated undergone at least 1-2 prior taxane-based chemotherapy regimens or be unsuitable for taxane therapy (unsuitability includes contraindications, investigator-determined ineligibility, or patient refusal) in mCRPC stage.\n9. progressive mCRPC.\n10. have adequate organ function。\n11. Subjects of childbearing potential voluntarily use an effective method of contraception, such as condoms, oral or injectable contraceptives, Intra-uterine device（IUD）,etc., during treatment and within 6 months of the last use of the trial drug.\n\nExclusion Criteria:\n\n1. Previous treatment with any of the following within 6 months of enrollment: Strontium-89, Samarium-153, Rhenium-186, Rhenium-188, Radium-223, hemi-body irradiation. Previous PSMA-targeted radioligand therapy is not allowed.\n\n   Known other malignancies.\n2. Any systemic anti-cancer therapy (e.g. chemotherapy, immunotherapy or biological therapy within 28 days prior to day of enrollment.\n3. Known hypersensitivity to the components of the study therapy or its analogs.\n4. A superscan as seen in the baseline bone scan.\n5. Patients with a history of Central Nervous System (CNS) metastases.\n6. Uncontrolled, intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, cardiac arrhythmia, or other severe complications.",{"count":94,"type":20},40,[23],"The purpose of this study is to determine the safety and efficacy of 225Ac -labeled PSMA ligand(PSMA-XT) in the treatment of mCRPC",[26],"2025-08-21",{"date":100,"type":31},"2025-08-24",{"date":102,"type":31},"2024-10-14",{"date":104,"type":20},"2027-06-01",{"name":106,"class":107},"Xiaorong Sun","OTHER","Metastatic Castration Resistant Prostate Cancer Patients"]