[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"mcrpc-or-advancedmetastatic-solid-tumors\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:mcrpc-or-advancedmetastatic-solid-tumors":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,40],{"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},"100633978","phase-1-a-phase-i-clinical-study-of-hlx3902-in-patients-with-mcrpc-and-other-advanced-tumours-100633978",false,"NCT07533708","A Phase I Clinical Study of HLX3902 in Patients With mCRPC and Other Advanced Tumours","A Phase Ia Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetic Characteristics of HLX3902 (a STEAP1xCD3xCD28 Trispecific Antibody) in Patients With Metastatic Castration-Resistant Prostate Cancer and Other Advanced Solid Tumours","Inclusion Criteria\n\n1. Voluntarily signed written informed consent and willing to comply with study procedures.\n2. Age: ≥ 18 years, regardless of gender.\n3. Histologically confirmed advanced or metastatic solid tumours (e.g., metastatic castration-resistant prostate cancer (mCRPC), non-small cell lung cancer, or gastric cancer) following failure of standard therapy.\n4. mCRPC specifics: 1）Progression or refractory status after ≥ 1 novel anti-androgen agent and failure of 1-2 taxane-based regimens.\n\n2）Ongoing surgical or medical castration (gonadotropin-releasing hormone agonist or antagonist) with serum testosterone ≤ 50 ng\u002FdL.\n\n3）Documented disease progression (prostate-specific antigen, nodal, visceral, or bone) .\n\n5\\. Presence of at least one measurable lesion per RECIST criteria version 1.1. 6. ECOG Performance Status of 0-1. 7. Expected survival exceeding 3 months. 8. Agreement to provide archived or fresh tumour tissue. 9. Adequate organ function. 10. Agreement to use effective contraception for both genders and negative pregnancy test for females of childbearing potential.\n\nExclusion Criteria\n\n1. Presence of histological types other than adenocarcinoma in mCRPC; or neuroendocrine or small cell differentiation in other solid tumours.\n2. Active or symptomatic central nervous system metastases, carcinomatous meningitis, or spinal cord compression (stable treated brain metastases meeting protocol criteria are allowed).\n3. Active malignancies within two years prior to the first dose, except cured carcinoma in situ or basal cell carcinoma of the skin.\n4. Prior STEAP1-targeted therapy, or Radium-223\u002FPSMA radionuclide therapy within 6 months.\n5. Major surgery, radiotherapy, chemotherapy, biological therapy, immunotherapy, or endocrine therapy (excluding LHRH\u002FGnRH analogues) within 28 days; small molecule drugs within 14 days.\n6. Vaccination with live vaccines within 28 days.\n7. Systemic corticosteroids (\\> 10 mg\u002Fday Prednisone equivalent) or other immunosuppressants within 14 days.\n8. Currently participating in another interventional study or within 4 weeks of the end of treatment in such a study.\n9. Adverse events from prior therapy not resolved to Grade ≤ 1, except for alopecia, ear toxicity, or stable Grade ≤ 2 taxane-related neurotoxicity.\n10. History of Grade ≥ 2 immune-related pneumonitis or myocarditis, or severe\u002Flife-threatening immune-mediated adverse events during prior immunotherapy.\n11. Poorly controlled cardiovascular disease within 6 months, unstable angina, stroke, thromboembolic events, or uncontrolled hypertension or arrhythmia.\n12. Evidence of interstitial lung disease, or active non-infectious pneumonitis.\n13. Active or suspected autoimmune disease, hypophysitis, or unstable pituitary dysfunction requiring systemic therapy.\n14. Active systemic infectious diseases requiring intravenous antibiotics within 2 weeks, active tuberculosis, or positive for HIV, active HBV (HBV DNA ≥ 500 IU\u002FmL), or HCV.\n15. History of organ transplantation, central nervous system diseases within 12 months (e.g., seizures, dementia), or any condition that makes the participant unsuitable per Investigator.","ALL","18 Years",{"count":19,"type":20},48,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","This study is an open-label first-in-human phase I clinical study to evaluate the safety, tolerability, and pharmacokinetic characteristics of HLX3902 in patients with mCRPC and other advanced solid tumours.",[26],"mCRPC or Advanced\u002FMetastatic Solid Tumors","RECRUITING","2026-08-07",{"date":30,"type":31},"2026-08-11","ACTUAL",{"date":33,"type":31},"2026-07-30",{"date":35,"type":20},"2028-05-24",{"name":37,"class":38},"Shanghai Henlius Biotech","INDUSTRY",5,{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":47,"minAge":17,"maxAge":4,"enrollmentInfo":48,"targetDuration":4,"studyType":21,"phases":50,"briefSummary":51,"conditions":52,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":70},"100648366","phase-1-a-study-in-patients-with-metastatic-castration-resistant-prostate-cancer-100648366","NCT07719361","A Study in Patients With Metastatic Castration-Resistant Prostate Cancer","A Phase 1, First-in-Human, Dose-Finding Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of FX-111 in Patients With Metastatic Castration-Resistant Prostate Cancer","Inclusion Criteria:\n\n* Confirmed adenocarcinoma of the prostate.\n* PSA levels ≥ 2 ng\u002FmL at screening visit.\n* Progressing PSA, defined as two consecutive increases in the most recent PSA measurements taken at least 1 week apart.\n* Progressed on Androgen Deprivation Therapy (ADT) and at least one prior potent Androgen Receptor (AR) pathway inhibitor given in castration-sensitive prostate cancer setting or approved for castration-resistant prostate cancer (eg, apalutamide, darolutamide, abiraterone, enzalutamide).\n* Ongoing primary ADT with gonadotropin-releasing hormone agonist or antagonist in the absence of bilateral orchiectomy.\n* Acceptable physical functioning and laboratory measurements, per the study protocol.\n* Discontinued prior therapies within protocol-specified timeframes.\n* Commit to use of highly-effective contraception while on study and for 90 days after.\n* Willing and able to adhere to the study visit schedule and other protocol defined requirements.\n\nExclusion Criteria:\n\n* Predominance of small cell carcinoma of the prostate\u002Fneuroendocrine prostate cancer in most recent tumor biopsy.\n* Participants with brain metastases that require ongoing treatment with radiation or high-dose steroids.\n* Not recovered from side effects of prior surgery or cancer treatments.\n* Evidence of active viral, bacterial, or fungal infection requiring treatment with antivirals, antibiotics, or anti-fungal medications.\n* Prior treatment with AR degraders and molecules with an AR ligand such as AR Regulated Induced Proximity Targeting Chimera (RIPTAC).\n* Blood clots ≤ 4 weeks prior to start of treatment.\n* Concurrent malignancy requiring treatment or history of prior malignancy active within 2 years prior to the first dose of study drug. Patients may be eligible if the malignancy is clinically stable or has been treated with curative intent.\n* Any evidence of severe or uncontrolled systemic diseases.\n* Any condition that, in the opinion of the Investigator, would interfere with evaluation of the investigational product or interpretation of the patient's safety or study results.","MALE",{"count":49,"type":20},60,[23],"The goal of this clinical trial is to find out if FX-111 is safe enough to permit further studies in adult male participants with metastatic castration-resistant prostate cancer (mCRPC). It will also study the drug's pharmacokinetics (how the body breaks down FX-111) and how well FX-111 treats mCRPC. The main questions it aims to answer are:\n\nWhat are the side effects of FX-111?\n\nDoes FX-111 work to reduce or prevent progression of mCRPC?\n\nThe study doctor will oversee participants' treatment with FX-111 and ask about any side effects. Participants will take FX-111 every day by mouth and will have regular physical and laboratory examinations to check health and tumor status.",[53,54,55,56,57,26,58,59,60],"Metastatic Castration Resistant Prostate Cancer","mCRPC","mCRPC (Metastatic Castration-resistant Prostate Cancer)","Prostatic Neoplasms","Prostatic Neoplasms, Castration-Resistant","mCRPC, Metastatic Castration Resistant Prostate Cancer","Neoplasms Prostate","Neoplasms of Prostate","2026-07-31",{"date":63,"type":31},"2026-08-04",{"date":65,"type":31},"2026-07-01",{"date":67,"type":20},"2029-02-15",{"name":69,"class":38},"Flare Therapeutics Inc.",10]