[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Beijing Tide Pharmaceutical Co., Ltd\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":187},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,7,0,[8,42,65,95,121,144,165],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100634754","phase-2-efficacy-and-safety-of-trd205-tablets-for-postoperative-analgesia-in-unilateral-total-hip-arthroplasty-phase-iib-100634754",false,"NCT07543796","Efficacy and Safety of TRD205 Tablets for Postoperative Analgesia in Unilateral Total Hip Arthroplasty (Phase IIb)","A Multicenter, Randomized, Double-Blind, Double-Dummy, Active- and Placebo-Controlled Phase IIb Study to Evaluate the Efficacy and Safety of TRD205 Tablets for Postoperative Analgesia in Unilateral Total Hip Arthroplasty","TRD205","Inclusion Criteria:\n\n* Able to provide written informed consent\n* Age 18 to 80 years, inclusive\n* BMI 18-32 kg\u002Fm²\n* ASA physical status I-II\n* Scheduled for elective unilateral total hip arthroplasty under general anesthesia\n* Able to understand study procedures and pain rating scales\n\nExclusion Criteria:\n\n* Hypersensitivity to TRD205, celecoxib, or study-related medications\n* Use of prohibited analgesics, sedatives, CYP3A4 inhibitors\u002Finducers, or analgesic herbs within specified washout periods\n* Inability to take oral medications postoperatively\n* Ipsilateral hip surgery within 1 year; contralateral hip surgery within 1 month\n* Hip revision surgery, developmental dysplasia Crowe type IV, or tumor involving hip\n* Clinically significant hemodynamic instability or cardiac arrhythmia\n* Severe hepatic, renal, cardiovascular, or metabolic disease\n* History of NSAID-induced asthma, active peptic ulcer disease\n* Drug or alcohol abuse within 1 year\n* Pregnancy, breastfeeding, or lack of effective contraception\n* Participation in another interventional clinical trial within 3 months","ALL","18 Years","80 Years",{"count":21,"type":22},200,"ESTIMATED","INTERVENTIONAL",[25],"PHASE2","This is a phase IIa, multicenter ,randomized, double-blind, Double-Dummy, Active- and placebo-controlled study designed to evaluate the efficacy, safety and kinetic characteristics of TRD205 tablets for postoperative analgesia after unilateral hip arthroplasty",[28],"Postoperative Analgesia After Unilateral Hip Arthroplasty","RECRUITING","2026-04-14",{"date":32,"type":33},"2026-04-22","ACTUAL",{"date":35,"type":33},"2026-03-18",{"date":37,"type":22},"2026-07-27",{"name":39,"class":40},"Beijing Tide Pharmaceutical Co., Ltd","INDUSTRY",1,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":17,"minAge":49,"maxAge":19,"enrollmentInfo":50,"targetDuration":4,"studyType":23,"phases":52,"briefSummary":54,"conditions":55,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":41},"100628689","phase-3-a-adaptive-design-clinical-trial-to-evaluate-the-efficacy-and-safety-of-tdi01-suspension-in-the-treatment-of-idiopathic-pulmonary-fibrosis-ipf-100628689","NCT07464912","A Adaptive Design Clinical Trial to Evaluate the Efficacy and Safety of TDI01 Suspension in the Treatment of Idiopathic Pulmonary Fibrosis (IPF)","A Multicentre, Randomised, Double-blind, Placebo-controlled, Adaptive Design Clinical Trial to Evaluate the Efficacy and Safety of TDI01 Suspension in the Treatment of Idiopathic Pulmonary Fibrosis (IPF)","Inclusion Criteria:\n\n1. Diagnosed with IPF\n\n   1. Confirmed diagnosis before screening: Diagnosis was made according to the 2022 clinical practice guideline principles of the American Thoracic Society (ATS), European Respiratory Society (ERS), Japanese Respiratory Society (JRS), and Latin American Thoracic Society (ALAT) (see Appendix 1), confirmed by the investigators based on chest high-resolution CT (HRCT) performed within 12 months before Visit 1, and surgical lung biopsy or transbronchial lung cryobiopsy (if available);\n   2. Reconfirmation of IPF diagnosis at screening: And before Visit 2, the independent imaging review panel of experts reviewed and confirmed that the HRCT (HRCT within 3 months before randomisation in the same site was accepted) is consistent with a clinical diagnosis of usual interstitial pneumonia (UIP) or probable UIP for IPF. For subjects with an HRCT finding of \"indeterminate for UIP\", if a local (previous) surgical lung biopsy or transbronchial lung cryobiopsy has been performed, the pathological slides must be submitted for central review and assessment. If the histopathological features show \"UIP\" or \"probable UIP\", the clinical diagnosis of IPF can be confirmed;\n2. Voluntarily participates in this clinical study and signs the informed consent form before the start of the study;\n3. Age is 40-80 years (inclusive of 40 and 80 years) at the time of signing the informed consent form, regardless of sex;\n4. Female or male subjects of childbearing potential agree and commit to using highly effective contraceptive measures (see Appendix 8 in 19.8) from the time of signing the informed consent form until 90 days after the last dose of the investigational medicinal product;\n5. Stable disease for at least 8 weeks prior to Visit 1. Patients must meet one of the following two criteria:\n\n   1. Did not receive treatment with nintedanib and\u002For pirfenidone for at least 8 weeks prior to Visit 1 (including patients not treated with nintedanib\u002Fpirfenidone and those who had failed treatment with nintedanib\u002Fpirfenidone);\n   2. Or have been receiving a stable\\* regimen of nintedanib or pirfenidone for at least 12 weeks prior to Visit 1, and plan to continue receiving this background therapy stably after randomisation \\[\\*stable treatment is defined as the patient being able to generally tolerate continuous treatment with an unchanged dose of pirfenidone (400 mg TID and above) or nintedanib (100 mg BID and above)\\];\n6. At screening and baseline, forced expiratory volume in one second (FEV1)\u002FFVC ratio ≥ 0.70;\n7. At screening and baseline, FVC% of predicted is greater than 50% (inclusive);\n8. DLco (Hb-corrected) percent of predicted normal value is greater than 30% (inclusive) at screening and at baseline;\n9. Active bacterial, viral, parasitic, or fungal infection requiring systemic treatment within 4 weeks prior to screening, but the infection is judged by the investigator to be cured during the screening period;\n10. In the investigator's assessment, the subject is willing and able to comply with protocol requirements and attend visits.\n\nExclusion Criteria:\n\nInclusion criteria\n\nSubjects who meet each of the following criteria will be allowed to participate in this study:\n\n1. Diagnosed with IPF\n\n   1. Confirmed diagnosis before screening: Diagnosis was made according to the 2022 clinical practice guideline principles of the American Thoracic Society (ATS), European Respiratory Society (ERS), Japanese Respiratory Society (JRS), and Latin American Thoracic Society (ALAT) (see Appendix 1), confirmed by the investigators based on chest high-resolution CT (HRCT) performed within 12 months before Visit 1, and surgical lung biopsy or transbronchial lung cryobiopsy (if available);\n   2. Reconfirmation of IPF diagnosis at screening: And before Visit 2, the independent imaging review panel of experts reviewed and confirmed that the HRCT (HRCT within 3 months before randomisation in the same site was accepted) is consistent with a clinical diagnosis of usual interstitial pneumonia (UIP) or probable UIP for IPF. For subjects with an HRCT finding of \"indeterminate for UIP\", if a local (previous) surgical lung biopsy or transbronchial lung cryobiopsy has been performed, the pathological slides must be submitted for central review and assessment. If the histopathological features show \"UIP\" or \"probable UIP\", the clinical diagnosis of IPF can be confirmed;\n2. Voluntarily participates in this clinical study and signs the informed consent form before the start of the study;\n3. Age is 40-80 years (inclusive of 40 and 80 years) at the time of signing the informed consent form, regardless of sex;\n4. Female or male subjects of childbearing potential agree and commit to using highly effective contraceptive measures (see Appendix 8 in 19.8) from the time of signing the informed consent form until 90 days after the last dose of the investigational medicinal product;\n5. Stable disease for at least 8 weeks prior to Visit 1. Patients must meet one of the following two criteria:\n\n   1. Did not receive treatment with nintedanib and\u002For pirfenidone for at least 8 weeks prior to Visit 1 (including patients not treated with nintedanib\u002Fpirfenidone and those who had failed treatment with nintedanib\u002Fpirfenidone);\n   2. Or have been receiving a stable\\* regimen of nintedanib or pirfenidone for at least 12 weeks prior to Visit 1, and plan to continue receiving this background therapy stably after randomisation \\[\\*stable treatment is defined as the patient being able to generally tolerate continuous treatment with an unchanged dose of pirfenidone (400 mg TID and above) or nintedanib (100 mg BID and above)\\];\n6. At screening and baseline, forced expiratory volume in one second (FEV1)\u002FFVC ratio ≥ 0.70;\n7. At screening and baseline, FVC% of predicted is greater than 50% (inclusive);\n8. DLco (Hb-corrected) percent of predicted normal value is greater than 30% (inclusive) at screening and at baseline;\n9. Active bacterial, viral, parasitic, or fungal infection requiring systemic treatment within 4 weeks prior to screening, but the infection is judged by the investigator to be cured during the screening period;\n10. In the investigator's assessment, the subject is willing and able to comply with protocol requirements and attend visits.\n\nExclusion criteria\n\nSubjects who meet any of the following criteria will not be allowed to participate in this study:\n\n1. Other known causes of interstitial lung disease, such as home or occupational environmental exposure, connective tissue disease, drugs, etc.;\n2. With other clinically significant lung diseases besides IPF (such as asthma, COPD or significant airways obstruction \\[FEV1\u002FFVC ratio \\\u003C0.7\\], hypersensitivity pneumonitis, eosinophilic pneumonia, etc.);\n3. Patients who are planning to undergo a lung transplant within 12 months after screening;\n4. Active infection tuberculosis within 12 months prior to screening, or any active bacterial, viral, parasitic, or fungal infection requiring systemic treatment during the screening period;\n5. Subjects whose IPF condition is assessed by the investigator as unstable at screening, or who have had an acute exacerbation of IPF within 8 weeks before screening and\u002For during the screening period;\n6. Use of any of the following treatments within 4 weeks prior to randomisation:\n\n   1. IPF therapeutic drugs, unstable treatment with nintedanib or pirfenidone, \\> 15 mg\u002Fd prednisone or equivalent doses of other glucocorticoids, use of immunomodulatory drugs other than glucocorticoids for respiratory\u002Fpulmonary reasons; \\[Stable treatment is defined as the individual patient being able to generally tolerate continuous treatment with an unchanged dose of pirfenidone (400 mg TID and above) or nintedanib (100 mg BID and above) for at least 8 weeks\\];\n   2. Strong CYP3A4 inhibitors (including but not limited to ritonavir, clarithromycin, idelalisib, etc., see Appendix 4 for details);\n   3. Narrow therapeutic window substrates of CYP2C9 (such as warfarin, tolbutamide, and phenytoin) and sensitive substrates of P-gp (such as digoxin);\n   4. ROCK2 inhibitor (belumosudil);\n7. History of malignant tumour within 5 years prior to screening (except for patients with appropriately treated skin basal cell carcinoma or squamous cell carcinoma of skin in situ or in situ cancer of cervix);\n8. Moderate to severe hepatic insufficiency (Child-Pugh Class B or C) before screening;\n9. Laboratory test results exceeding any of the following criteria at screening and at baseline: Bilirubin total \\>1.5×ULN or AST\u002FALT\\>2×ULN, serum CK\\>1.5×ULN;\n10. Uncontrolled hepatitis B virus infection (HBsAg positive and HBV-DNA ≥ 102 IU\u002FmL) or hepatitis C virus infection (anti-HCV and HCV-RNA positive) at screening;\n11. With history of unstable or worsening cardiac disorder within 6 months prior to screening, including but not limited to the following:\n\n    1. Unstable angina;\n    2. Myocardial infarction;\n    3. CCF requiring hospitalisation or NYHA Class III\u002FIV;\n    4. Uncontrolled severe arrhythmia.\n12. Family history of long QT syndrome or sudden death, or clinically significant abnormalities on ECG at screening and baseline, including but not limited to: QTcF interval \\> 470 ms (female) or \\>450 ms (male), fibrillation atrial or flutter atrial, second-degree or third-degree AV block, left bundle branch block;\n13. SBP \\>160 mmHg or DBP \\>100 mmHg at screening and baseline (to be measured after at least 5 minutes of rest, and confirmed by one re-check to still meet this standard);\n14. Cerebrovascular event leading to hospitalisation within 12 months prior to screening, including but not limited to hematencephalon, subarachnoid haemorrhage, stroke, etc.;\n15. Creatinine clearance (CLcr) \\\u003C50 mL\u002Fmin at screening and baseline, calculated using the Cockcroft-Gault formula: \\[140 - age (years)\\] \\[weight (kg)\\] × (0.85, if female) \u002F \\[72 × blood creatinine (mg\u002FdL)\\];\n16. Unable to complete the six minute walk distance (6MWD) or pulmonary function test (PFT);\n17. History of smoking within 3 months prior to screening or unwillingness to practice cessation of smoking during the study;\n18. Frequent alcohol use \\[more than 21 units of alcohol per week (1 unit = 360 mL beer or 45 mL of 40% alcohol or 150 mL wine)\\] within 6 months before screening, or unwillingness to reduce alcohol intake to within 21 units during the study;\n19. History of drug abuse within 6 months prior to screening;\n20. Pregnancy or lactation;\n21. Human immunodeficiency virus (HIV) antibody test result is non-negative at screening;\n22. Allergy to any component of TDI01 suspension;\n23. The last dose in other clinical studies was administered within 3 months or 5 half-lives prior to screening, whichever is longer;\n24. Major surgery (general anaesthesia surgery) within 3 months prior to screening, or planned surgery during the study period that is considered by the investigator to affect the judgment of study endpoints;\n25. The investigator assesses that the subject has an unstable state of other systemic or organ diseases, which may impair their safety or compliance, affect drug absorption, or lead to other conditions that prevent them from completing the study assessments.","40 Years",{"count":51,"type":22},508,[53],"PHASE3","This study is a multicentre, randomised, double-blind, placebo-controlled, adaptive design clinical trial to evaluate the efficacy and safety of TDI01 suspension in the treatment of idiopathic pulmonary fibrosis (IPF). The study will be conducted in China and divided into two stages, both of which are multicentre, randomised, double-blind, placebo-controlled studies. Stage 1 aims to evaluate the efficacy and safety of TDI01 suspension compared to the placebo group in the treatment of IPF patients, and Stage 2 aims to further confirm the efficacy and safety of TDI01 suspension compared to the placebo group in the treatment of IPF patients.",[56],"Idiopathic Pulmonary Fibrosis (IPF)","2026-03-09",{"date":59,"type":33},"2026-03-11",{"date":61,"type":33},"2025-12-24",{"date":63,"type":22},"2029-12-30",{"name":39,"class":40},{"id":66,"slug":67,"hasResults":11,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":4,"eligibilityCriteria":71,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":72,"targetDuration":4,"studyType":23,"phases":74,"briefSummary":76,"conditions":77,"keywords":83,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":94},"100621518","phase-1-an-phase-ibii-clinical-trial-of-tcc1727-combination-therapy-in-advanced-solid-tumors-100621518","NCT07371663","An Phase Ib\u002FII Clinical Trial of TCC1727 Combination Therapy in Advanced Solid Tumors","An Open-Label, Multicenter Phase Ib\u002FII Clinical Trial of TCC1727 in Combination With Benmelstobart\u002FOlaparib\u002FTopotecan for Advanced Solid Tumors","Inclusion Criteria:\n\n* -Voluntarily participate in this study and sign the informed consent form.\n* At the time of signing the informed consent, subjects must be ≥18 years of age (inclusive).\n* Subjects must have histologically or cytologically confirmed advanced or metastatic solid tumors and have experienced disease progression following prior standard anti-tumor therapy; or subjects must have no available standard therapy, be intolerant to or refuse standard therapy, or meet the specific requirements for the corresponding phase and group as follows:\n\n  * Phase Ib :Subjects with advanced, recurrent, or refractory solid tumors, which may include (but are not limited to) the specific tumor types in Phase II.\n  * Phase II Study:Based on different combination therapy groups, subjects with the following specific tumor types (different population cohorts):\n\nTCC1727 combined with Benmelstobart Group:\n\nThe study will enroll subjects with advanced solid tumors lacking standard therapies, including but not limited to non-small cell lung cancer (NSCLC), endometrial cancer, and other advanced solid tumors (e.g., colorectal cancer, urothelial carcinoma, gastric cancer, and gastroesophageal junction cancer):\n\nCohort 1 (NSCLC):Patients with histologically or cytologically confirmed locally advanced or metastatic NSCLC who are eligible for second- or third-line therapy. Patients must have received prior therapy with an anti-PD-(L)1-containing regimen (either as monotherapy or in combination) and a platinum-based doublet regimen for locally advanced or metastatic NSCLC.\n\nSubgroup 1: ATM mutation. Subgroup 2: ATM wild-type, with or without other DDR functional defects.\n\nCohort 2 (Endometrial Cancer):Patients with histopathologically confirmed recurrent or metastatic advanced endometrial cancer who have received at least one prior platinum-based chemotherapy and immune checkpoint inhibitor (PD-1 or PD-L1) therapy (sequential or concurrent therapy allowed; sequential therapy refers to platinum-based chemotherapy followed by immune checkpoint inhibitor maintenance therapy).\n\nSubgroup 1: DDR functional defect, ATM wild-type or mutated. Subgroup 2: DDR functional normal.\n\nCohort 3 (Other Advanced Solid Tumors):Patients with histologically or cytologically confirmed advanced malignant solid tumors who have failed standard therapy, are intolerant to standard therapy, have no standard therapy available, or for whom standard therapy is currently unsuitable.\n\nSubgroup 1: DDR functional defect, ATM wild-type or mutated. Subgroup 2: DDR functional normal.\n\nTCC1727 combined with Olaparib Tablets Group:\n\nThe study will enroll subjects with histopathologically confirmed recurrent ovarian cancer:\n\nCohort 4 (Ovarian Cancer):Subjects with histopathologically confirmed recurrent epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer:\n\nSubgroup 1: Subjects who have experienced disease progression after prior Olaparib Tablets therapy (maintenance or subsequent therapy). Subjects must not have received further treatment after progression on Olaparib Tablets.\n\nSubgroup 2: Subjects who have not received Olaparib Tablets and have primary platinum-resistant\u002Frefractory disease (recurrence within 6 months of last platinum-based therapy). Subjects must have received ≤3 prior lines of therapy since developing platinum resistance.\n\nTCC1727 combined with Topotecan Hydrochloride for Injection Group:\n\nThe study will enroll subjects with histopathologically or cytologically confirmed small cell lung cancer (SCLC):\n\nCohort 5 (SCLC):Subjects who have progressed after platinum-based chemotherapy combined with PD-(L)1 therapy, or subjects with extensive-stage SCLC who have relapsed or progressed within ≤6 months after first-line therapy.\n\n* At least one measurable lesion (per RECIST v1.1; lesions previously treated with local therapy may be considered target lesions if they show clear progression per RECIST v1.1).\n* Subjects must provide sufficient tumor tissue samples, including but not limited to fresh specimens (preferred) or formalin-fixed, paraffin-embedded (FFPE) tumor tissue obtained within approximately 24 months prior to randomization, unstained FFPE slides, or core needle biopsy tissue for biomarker testing.\n* ECOG performance status score of 0-1 within 7 days prior to the first dose of study drug.\n* Expected survival ≥12 weeks.\n* Ability to swallow tablets whole and maintain this method of administration.\n* Organ function within the following ranges within 7 days prior to the first dose of study drug (no blood component or growth factor therapy within 14 days prior to the first dose):\n\n  1. Absolute neutrophil count (ANC) ≥1.5 × 10⁹\u002FL;\n  2. White blood cell count (WBC) ≥3.0 × 10⁹\u002FL;\n  3. Platelet count ≥100 × 10⁹\u002FL;\n  4. Hemoglobin (Hb) ≥90 g\u002FL;\n  5. Serum albumin ≥30 g\u002FL;\n  6. Total bilirubin ≤1.5 × ULN (≤2.0 × ULN for hepatocellular carcinoma or subjects with liver metastases);\n  7. ALT and AST ≤3 × ULN (≤5.0 × ULN for hepatocellular carcinoma or subjects with liver metastases);\n  8. Alkaline phosphatase (ALP) ≤2.5 × ULN (≤5 × ULN if bone metastases are present);\n  9. Serum creatinine ≤1.5 × ULN or creatinine clearance (CrCL) ≥60 mL\u002Fmin (Cockcroft-Gault formula);\n  10. APTT ≤1.5 × ULN and INR or PT ≤1.5 × ULN (for subjects not receiving anticoagulation therapy);\n  11. QTc \\\u003C450 ms (male) or \\\u003C470 ms (female), LVEF ≥50%.\n* For non-sterilized or fertile female subjects, medically approved contraception (e.g., intrauterine device, oral contraceptives, or condoms) must be used during the study and for 6 months after the last dose. Non-sterilized female subjects must have a negative serum HCG test within 72 hours before the first dose and must not be breastfeeding. Male subjects with fertile partners must use effective contraception during the study and for 3 months after the last dose.\n\nExclusion Criteria:\n\n* Known primary central nervous system (CNS) tumors (including meningeal tumors); symptomatic brain metastases, spinal cord compression, carcinomatous meningitis, or uncontrolled CNS metastases. Exceptions: Subjects with completely resected and\u002For irradiated CNS metastases that are stable or improved for ≥4 weeks before screening (no evidence of brain edema and no need for corticosteroids or anticonvulsants). Asymptomatic brain metastases \\\u003C1 cm in diameter without surrounding edema are also allowed.\n* Major surgery, radiotherapy, chemotherapy, or other investigational anti-tumor therapy completed \\\u003C4 weeks before the first dose (exceptions: small-molecule anti-tumor therapy completed \\>5 half-lives or \\>10 days before the first dose, whichever is longer; palliative radiotherapy completed \\>2 weeks before the first dose).\n* Use of strong CYP3A4 inhibitors or inducers within 14 days before the first dose (e.g., rifampin, rifapentine, St. John's wort, carbamazepine, phenytoin, barbiturates, ketoconazole, itraconazole, clarithromycin, voriconazole, atazanavir, ritonavir, saquinavir, grapefruit juice).\n* Any unresolved ≥Grade 2 toxicity (per CTCAE v5.0) from prior anti-tumor therapy (except alopecia, pigmentation, or laboratory abnormalities meeting inclusion criteria).\n* Inability to swallow tablets, gastrointestinal dysfunction, or any condition that may affect drug absorption (per investigator's judgment).\n* Uncontrolled severe diseases, including:\n\n  1. Poorly controlled hypertension (systolic BP ≥150 mmHg or diastolic BP ≥100 mmHg);\n  2. Clinically significant cardiovascular disease within 6 months before the first dose (e.g., myocardial infarction, severe\u002Funstable angina, stroke, ≥Grade 2 congestive heart failure \\[NYHA classification\\]);\n  3. Arrhythmia (≥Grade 2 per CTCAE v5.0, including QTcF ≥450 ms \\[male\\] or ≥470 ms \\[female\\]);\n  4. Unexplained fever ≥38.5°C within 14 days before the first dose or active infection requiring systemic therapy;\n  5. Active viral hepatitis (HBV DNA ≥500 IU\u002FmL for HBsAg-positive and\u002For anti-HBc-positive subjects; HCV RNA-positive for anti-HCV-positive subjects; antiviral therapy required for eligible HBV\u002FHCV-positive subjects);\n  6. Active syphilis;\n  7. Active tuberculosis;\n  8. Immunodeficiency (e.g., HIV-positive, congenital\u002Facquired immunodeficiency, organ transplant history);\n  9. Poorly controlled diabetes (fasting blood glucose \\>10 mmol\u002FL).\n* Uncontrolled pleural effusion, pericardial effusion, ascites, or recurrent ascites requiring drainage within 28 days before the first dose.\n* Significant bleeding symptoms or tendency within 3 months before the first dose.\n* Chronic systemic corticosteroid therapy (\\>10 mg prednisone equivalent daily) or immunosuppressive therapy within 14 days before the first dose.\n* Active autoimmune disease requiring systemic treatment within the past 2 years (e.g., immunomodulators, corticosteroids, immunosuppressants). Replacement therapy (e.g., thyroxine, insulin, physiologic corticosteroid replacement for adrenal\u002Fpituitary insufficiency) is allowed. (Applies only to Ib Phase and Phase II TCC1727 + Benmelstobart groups.)\n* History of severe allergic reactions to study drugs or their excipients.\n* Other malignancies within 3 years before screening (except cured basal cell carcinoma, cervical carcinoma in situ, or thyroid papillary carcinoma).\n* Prior ≥Grade 3 immune-mediated adverse events (imAEs) or permanent discontinuation due to imAEs during anti-PD-(L)1 therapy.\n* Prior treatment with TCC1727, other ATR inhibitors, or cell cycle checkpoint inhibitors (e.g., ATM inhibitors, WEE1 inhibitors, CHK1\u002FCHK2 inhibitors).\n* Other severe physical\u002Fmental illnesses or factors that may increase study risk or interfere with results, or any condition deemed unsuitable by the investigator.\n\nAdditional exclusions:\n\n* Phase II Cohort 1 (NSCLC):Exclude subjects with known EGFR, ALK, ROS1, BRAF, MET, RET, or RAS mutations; exclude mixed NSCLC\u002FSCLC histology.\n* Phase II Cohort 2 (Endometrial Cancer):Exclude uterine carcinosarcoma, endometrial leiomyosarcoma, or endometrial stromal sarcoma.\n* Phase II Cohort 3 (Other Solid Tumors):Exclude KRAS\u002FNRAS\u002FBRAF mutations or MSI-H status.\n* Phase II Cohort 4 (Ovarian Cancer) \\& Ib Phase TCC1727 + Olaparib Tablets: Exclude prior myelodysplastic syndrome or acute myeloid leukemia.",{"count":73,"type":22},266,[75,25],"PHASE1","This is a Phase Ib\u002FII clinical study. The Phase Ib dose-escalation study aims to evaluate and determine the recommended Phase II dose (RP2D) of TCC1727 in combination with benmelstobart \u002Folaparib \u002Ftopotecanfor patients with advanced solid tumors.\n\nThe Phase II expansion study will assess the efficacy and safety of TCC1727 combined with benmelstobart \u002Folaparib\u002Ftopotecanin selected advanced solid tumor indications.\n\nThe study pre-specifies three treatment combinations, with Combination 1 (TCC1727 + benmelstobart) being prioritized for initial evaluation. The decision to proceed with Combination 2 and Combination 3will be based on clinical data from Combination 1.",[78,79,80,81,82],"Solid Cancers","NSCLC (Advanced Non-small Cell Lung Cancer)","Gastric (Stomach) Cancer","Endometrial Cancer","Malignant Melanoma",[84,85],"Ataxia Telangiectasia and Rad3-related protein inhibitor","Advanced solid tumor","2026-01-19",{"date":88,"type":33},"2026-01-28",{"date":90,"type":33},"2025-12-03",{"date":92,"type":22},"2029-06-30",{"name":39,"class":40},3,{"id":96,"slug":97,"hasResults":11,"nctId":98,"briefTitle":99,"officialTitle":100,"acronym":4,"eligibilityCriteria":101,"healthyVolunteers":102,"sex":17,"minAge":18,"maxAge":103,"enrollmentInfo":104,"targetDuration":4,"studyType":23,"phases":106,"briefSummary":107,"conditions":108,"keywords":111,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":41},"100616099","phase-1-phase-i-study-of-cpd704-inhalation-suspension-in-healthy-subjects-100616099","NCT07301203","Phase I Study of CPD704 Inhalation Suspension in Healthy Subjects","A Phase I Study to Evaluate the Safety, Tolerability, and Pharmacokinetic Characteristics of Single and Multiple Doses of CPD704 Inhalation Suspension in Healthy Chinese Adult Subjects.","Inclusion Criteria:\n\n1. The subject can communicate well with the researchers, fully understand the purpose and requirements of this trial, voluntarily participate in the clinical trial and sign the written informed consent form;\n2. Healthy subjects aged 18-55 years (including the boundary value, subject to the time of signing the informed consent form), male or female;\n3. Body mass index (BMI) within the range of 19 \\~ 28 kg\u002Fm2 (including the critical value), male weight ≥ 50 kg, female weight ≥ 45 kg;\n4. The subject has no plans to give birth, sperm or egg donation from the signing of the informed consent form to 90 days after medication, and voluntarily takes medically approved contraceptive measures (including his partner)\n\nExclusion Criteria:\n\n1. Patients who have taken any clinical trial drugs or participated in any drug clinical trial within 3 months before signing the ICF, or participated in other medical research activities, and are not suitable for participating in this trial as judged by the investigator;\n2. Previous or combined with the following diseases, cardiovascular disease \\[such as heart failure (such as fluid retention and edema), unstable ischemic heart disease, congestive heart failure poor control of coronary artery disease, myocardial infarction, long QT syndrome history, etc.\\], respiratory, renal, neurological, endocrine, immune, skin, gastrointestinal (such as gastrointestinal ulcers or gastrointestinal bleeding, etc.), liver or blood system and other diseases\u002Fabnormal history, the investigators judge that their participation in this trial may affect the safety of subjects or affect the analysis of study results;\n3. Patients with the following mental illness: 1) Uncontrolled\u002Funstable major depressive disorder (MDD) or other serious mental disorders (such as schizophrenia, bipolar disorder or other serious mood or anxiety disorders) within 2 years before screening; 2) Suicide attempt or suicidal behavior 30 times before screening; 3) Suicidal ideation corresponding to Columbia-Suicide Severity Rating Scale (C-SSRS) category 4 or 5 in the past 30;\n4. Known hypersensitivity, immune reaction or intolerance to CPD704 Inhalation Suspension or any of the excipients in the drug product (polysorbate 80, sodium chloride, sodium citrate dihydrate, disodium edetate, sodium hydroxide or hydrochloric acid) and\u002For unsuitable for treatment with CPD704 Inhalation Suspension;\n5. Long-term oral drugs can not be stopped or suffering from gastric ulcer, gastritis affecting oral activated charcoal, or allergic to activated charcoal;\n6. Patients with severe infection, trauma or major surgery before signing the ICF, or planning to undergo surgery during the trial;\n7. Use of any live vaccines (except influenza vaccine) within 28 days before signing the ICF or plan to receive vaccines during the study;\n8. Blood loss or blood donation of more than 400 mL within 3 months before signing the ICF (excluding female menstrual blood loss), or intend to donate blood during the trial or within 1 month after the end of the trial;\n9. Smokers or those who smoke more than 5 cigarettes per day within 3 months before signing the ICF, or those who cannot comply with the provisions of prohibiting smoking during the trial, or those who test positive for urine cotinine;\n10. Pulmonary ventilation function test Forced expiratory volume in the first second (FEV1) measured value\u002FFEV1 predicted value ≤ 80% or forced vital capacity (FVC) ≤ 80% of predicted value or any other clinically significant abnormalities;\n11. Use of any drugs that inhibit or induce hepatic drug-metabolizing enzymes within 28 days before signing the ICF; or use of any prescription drugs, over-the-counter drugs, Chinese herbal medicines or health products within 14 days before signing the ICF. If the half-life of concomitant drugs is increased, the required time interval should be at least 5 half-lives of the drug;\n12. Excessive consumption of tea, coffee or caffeinated beverages (an average of more than 8 cups per day, 250 mL per cup) within 6 months before signing the ICF;\n13. Consumption of any grapefruit, caffeine-containing beverages or foods (such as grapefruit juice, coffee, strong tea, chocolate, caffeine-containing carbonated beverages, cola, cocoa, etc.) within 48 hours before the first dose;\n14. Those who have special requirements for diet and cannot abide by the unified diet;\n15. Unwilling or unable to tolerate multiple venipuncture or difficult venous blood sampling or a history of fainting;\n16. Previous history of drug abuse\u002Fdrug use, or drug abuse screening (including tetrahydrocannabinolic acid, morphine, ketamine, methamphetamine, benzodiazepine, cocaine) results were positive;\n17. Regular drinking within 6 months before signing the ICF \\[i.e., women drink more than 14 standard units of alcohol per week, men drink more than 21 standard units of alcohol per week (1 standard unit contains 14 g of alcohol, such as 360 mL of beer or 45 mL of 40% alcohol or 150 mL of wine)\\] or can not abstain from alcohol during the trial; or positive breath alcohol test;\n18. The results of physical examination, vital signs examination, ECG, laboratory tests (blood routine, blood biochemistry, coagulation function, thyroid function, urine routine, stool routine, etc.), chest X-ray, abdominal B ultrasound examination during the screening period are judged by the study doctor as abnormal and clinically significant;\n19. Abnormal ECG findings during the screening period, such as bradycardia or tachycardia (heart rate \\\u003C 50 bpm or \\> 100 bpm), QTc prolongation (QTcF interval ≥ 450 ms in males and ≥ 470 ms in females, corrected according to Fridericia's formula), arrhythmia, etc., and clinically significant as judged by the investigator;\n20. Patients with positive results of any test of hepatitis B surface antigen (HbsAg), hepatitis C virus antibody (HCV-Ab), treponema pallidum antibody (Syphilis TP) and human immunodeficiency virus test (HIV-Ag\u002FAb) during the screening period;\n21. Pregnant or lactating women, or positive blood pregnancy test results;\n22. Unwilling or unable to correctly use the nebulizer according to the nebulizer instructions Inhalation of investigational drugs or nebulizer use training failed;\n23. Any other condition that, in the opinion of the investigator, would make participation in the study inappropriate.",true,"55 Years",{"count":105,"type":22},90,[75],"This is a Phase I clinical trial evaluating the safety, tolerability, and pharmacokinetic characteristics of single and multiple doses of CPD704 inhalation suspension in healthy Chinese adult subjects.",[109,110],"Healthy","Healthy Participants",[112,113],"Phase I Study of CPD704 in Healthy Subjects","CPX201-I-01","2025-12-23",{"date":61,"type":33},{"date":117,"type":33},"2025-10-21",{"date":119,"type":22},"2026-07-18",{"name":39,"class":40},{"id":122,"slug":123,"hasResults":11,"nctId":124,"briefTitle":125,"officialTitle":126,"acronym":4,"eligibilityCriteria":127,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":128,"targetDuration":4,"studyType":23,"phases":130,"briefSummary":131,"conditions":132,"keywords":133,"overallStatus":135,"whyStopped":4,"lastUpdateSubmitDate":136,"lastUpdatePostDateStruct":137,"startDateStruct":139,"completionDateStruct":141,"leadSponsor":143,"locationsCount":41},"100602253","phase-2-to-evaluate-the-safety-efficacy-and-kinetic-characteristics-of-trd205-tablets-for-postoperative-analgesia-after-unilateral-hip-arthroplasty-100602253","NCT07121101","To Evaluate the Safety, Efficacy and Kinetic Characteristics of TRD205 Tablets for Postoperative Analgesia After Unilateral Hip Arthroplasty","A Multicenter, Randomized, Double-blind, Placebo-controlled Phase IIa Clinical Study to Evaluate the Safety, Efficacy and Kinetic Characteristics of TRD205 Tablets for Postoperative Analgesia After Unilateral Hip Arthroplasty","Inclusion Criteria:\n\n* Fully understand the purpose and significance of this study, voluntarily participate in this study, voluntarily sign the informed consent form, and voluntarily comply with the trial procedures;\n* 18 to 80 years of age, male or female;\n* 18 kg\u002Fm 2 ≤ BMI ≤ 32 kg\u002Fm 2 , Incl. Cutoff ;\n* American Society of Anesthesiologists (ASA) physical status I to II (Appendix 6);\n* Unilateral total hip arthroplasty under general anesthesia is planned, and PCIA analgesia is expected to be required within 48 hours after surgery;\n* Able to understand the study procedures and the use of various scales involved in this study, and able to communicate effectively with the investigators.\n\nExclusion Criteria:\n\n* Known allergies or contraindications to the investigational drug and other drugs that may be used during the trial, and those who are not suitable for participating in the trial judged by the investigator;\n* Use the following drugs within 5 half-lives before randomization (subject to the actual drug instructions, if the half-life is unknown, wash out according to 48h), including but not limited to: analgesic drugs (except specified in the protocol), anticonvulsants, sedative-hypnotic drugs (except used according to the protocol), anxiolytics, antidepressants, CYP3A4 enzyme inhibitors or inducers, etc., use of Chinese herbal medicine with clear analgesic effect assessed by the investigator within 7 days before randomization; sign the ICF to successfully use intra-articular injection of cocktail therapy (specific drugs include but not limited to local anesthetics such as ropivacaine, lidocaine, bupivacaine; analgesics such as morphine; steroid drugs such as dexamethasone and methylprednisolone); refer to the list of prohibited drugs for specific types;\n* Patients who cannot take oral drugs after surgery as judged by the investigator;\n* Combining the following:\n\n  1. Patients who received ipsilateral hip surgery within 1 year before randomization;\n  2. Patients who received hip surgery within 3 months before randomization;\n  3. Patients scheduled for unilateral hip revision surgery;\n  4. Patients who receive total hip arthroplasty due to developmental dysplasia of the hip Type III-IV (see Appendix 9 for Crowe classification), femoral or acetabular tumor, femoral neck fracture and\u002For femoral neck fracture (excluding old femoral neck fracture, which is treated with internal fixation removal + total hip arthroplasty), and are not suitable for this study at the investigator's discretion;\n  5. Patients planning to undergo surgery at other sites at the same time during the study;\n* Concomitant with other pain conditions that may confound the postoperative pain evaluation as judged by the investigator;\n* Sitting systolic blood pressure ≤ 90 mmHg at screening, or sitting diastolic blood pressure ≤ 50 mmHg at screening, and clinically significant abnormalities as judged by the investigator;\n* Heart rate \\\u003C 50 beats\u002Fmin or heart rate \\> 100 beats\u002Fmin during the screening period, and clinically significant abnormalities as judged by the investigator; or QTcF \\> 450 ms in males and QTcF \\> 470 ms in females \\[calculated by Fridericia's formula: QTcF = QT\u002F(RR0.33)\\]; or participants with a history of severe arrhythmia such as type II atrioventricular block or above, or a history of cardiac insufficiency;\n* Patients complicated with severe liver, kidney, cardiovascular and cerebrovascular diseases, metabolic system diseases, and should not participate in this trial at the discretion of the investigator;\n* Participants with malignant tumor who are not suitable for participating in the study as judged by the investigator;\n* Patients complicated with mental system diseases (such as schizophrenia, depression, etc.), dementia, migraine, history of epilepsy, and unsuitable for participating in the trial judged by the investigator;\n* History of psychotropic drug and narcotic drug abuse, drug abuse and alcoholism within 1 year before randomization, i.e., those who drink more than 2 units of alcohol on average per day (1 unit = 360 mL of beer or 45 mL of 40% liquor or 150 mL of wine);\n* Abnormal blood routine at screening: neutrophil count \\\u003C 1.5 × 10 9 \u002FL; platelet count \\\u003C 100 × 10 9 \u002FL; hemoglobin (Hb) \\\u003C 80 g\u002FL;\n* Abnormal liver function in the screening period: ALT and\u002For AST ≥ 1.5 times the upper limit of normal, or total bilirubin ≥ 1.5 times the upper limit of normal;\n* Abnormal renal function in the screening period: serum creatinine (Cr) ≥ 1.5 times the upper limit of normal and\u002For dialysis participants;\n* Abnormal coagulation function during screening period: prothrombin time (PT) prolonged by more than 3 seconds and\u002For activated partial thromboplastin time (APTT) prolonged by more than 10 seconds;\n* Patients with positive syphilis antibody (Syphilis TP) and human immunodeficiency virus antibody (HIV-Ab) tests during the screening period who are not suitable for participating in the trial at the investigator's discretion;\n* Pregnant or lactating women;\n* Those who are unwilling or unable to take effective contraceptive measures during the study or 30 times after the study;\n* Participated in other drug or device clinical study within 3 months before randomization (signed ICF and received the investigational drug\u002Fdevice or placebo treatment, for medication or treatment, start timing);\n* Other conditions that the investigator considers inappropriate for participation in the study.",{"count":129,"type":22},40,[25],"This is a phase IIa, multicenter ,randomized, double-blind, placebo-controlled study designed to evaluate the safety, efficacy and kinetic characteristics of TRD205 tablets for postoperative analgesia after unilateral hip arthroplasty",[28],[134],"TRD205、postoperative analgesia after unilateral hip arthroplasty","NOT_YET_RECRUITING","2025-08-07",{"date":138,"type":33},"2025-08-13",{"date":140,"type":22},"2025-09-26",{"date":142,"type":22},"2025-12-27",{"name":39,"class":40},{"id":145,"slug":146,"hasResults":11,"nctId":147,"briefTitle":148,"officialTitle":149,"acronym":15,"eligibilityCriteria":150,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":151,"enrollmentInfo":152,"targetDuration":4,"studyType":23,"phases":154,"briefSummary":155,"conditions":156,"keywords":158,"overallStatus":135,"whyStopped":4,"lastUpdateSubmitDate":136,"lastUpdatePostDateStruct":160,"startDateStruct":161,"completionDateStruct":163,"leadSponsor":164,"locationsCount":41},"100602247","phase-1-to-evaluate-the-safety-efficacy-and-kinetic-characteristics-of-trd205-tablets-for-postoperative-analgesia-after-unilateral-hallux-valgus-orthopedic-surgery-100602247","NCT07121023","To Evaluate the Safety, Efficacy and Kinetic Characteristics of TRD205 Tablets for Postoperative Analgesia After Unilateral Hallux Valgus Orthopedic Surgery","A Multicenter, Randomized, Double-blind, Placebo-controlled Phase Ib Clinical Study to Evaluate the Safety, Efficacy and Kinetic Characteristics of TRD205 Tablets for Postoperative Analgesia After Unilateral Hallux Valgus Orthopedic Surgery","Inclusion Criteria:\n\n* Fully understand the purpose and significance of this study, voluntarily participate in this study, voluntarily sign the informed consent form, and voluntarily comply with the trial procedures;\n* 18 to 75 years of age, male or female;\n* 18 kg\u002Fm 2 ≤ BMI ≤ 30 kg\u002Fm 2 , Include Cut-off value ;\n* American Society of Anesthesiologists (ASA) physical status I to II (Appendix) 6 );\n* Elective unilateral hallux valgus orthopedic surgery under general anesthesia (distal osteotomy of the first metatarsal, which can be combined with phalangeal osteotomy) , post-op NRS ≥ 4 points at rest within 4h (timed from the completion of the last suture) ;\n* Able to understand the study procedures and the use of various scales involved in this study, and able to communicate effectively with the investigators.\n\nExclusion Criteria:\n\n* Known allergies or contraindications to the investigational drug and other drugs that may be used during the trial, and those who are not suitable for participating in the trial judged by the investigator;\n* Before randomization 5 half-lives The following drugs (subject to the actual package insert, with half-life unknown, then washout at 48h) are used internally, including but not limited to: analgesic drugs (except those specified in the protocol), anticonvulsants, sedative and hypnotic drugs (except those specified in the protocol), anxiolytics, antidepressants, CYP3A4 enzyme inhibitors or inducers, etc. See the List of Prohibited Drugs for the specific types;\n* Random First 7 days Inner Use of Chinese herbal medicine with clear analgesic effect as assessed by the investigator;\n* Patients who cannot take oral drugs after surgery as judged by the investigator ;\n* Combining the following:\n\n  5a Subjects with a history of ipsilateral hallux valgus orthopedic surgery; 5b Complicated with other diseases, deformities and traumas of the foot, and unsuitable for participating in this trial as judged by the investigator; 5c Before signing the ICF 3 History of orthopedic surgery for contralateral hallux valgus within a month, and \u002F Or planning to undergo other surgical procedures (e.g., hallux valgus orthopedic surgery, first metatarsophalangeal arthrodesis) at the same time during the trial;\n* Concomitant with other pain conditions that may confound the postoperative pain evaluation as judged by the investigator;\n* Sitting systolic blood pressure ≤ 90 mmHg , and or sitting diastolic blood pressure ≤ 5 at screening 0 mmHg (does not include abnormalities between admission to the operating room and emergence from anesthesia) The investigator judged that the abnormality was clinically significant;\n* Heart rate \\\u003C 50 beats per minute or heart rate \\> 100 beats per minute (excluding Admission to the operating room until emergence from anesthesia Period abnormality), and the abnormality is clinically significant as judged by the investigator; or QTcF \\> 450 ms in males and QTcF \\> 470 ms in females \\[calculated by Fridericia's formula: QTcF = QT\u002F(RR0.33)\\]; or subjects with a history of severe arrhythmia such as type II atrioventricular block or above, or a history of cardiac insufficiency;\n* Patients complicated with severe liver, kidney, cardiovascular and cerebrovascular diseases, metabolic system diseases, and should not participate in this trial at the discretion of the investigator;\n* Patients with malignant tumor who are not suitable for participating in the study as judged by the investigator ;\n* Patients complicated with mental system diseases (such as schizophrenia, depression, etc.), dementia, migraine, history of epilepsy, and unsuitable for participating in the trial judged by the investigator;\n* The subject has a history of psychotropic drug and narcotic drug abuse, drug abuse and alcoholism within 1 year prior to randomization, which means he\u002Fshe drinks on average more than 2 units of alcohol per day (1 unit = 360 mL of beer or 45 mL of 40% liquor or 150 mL of wine);\n\nLaboratory Abnormalities:\n\n* Abnormal blood routine at screening: neutrophil count \\\u003C 1.5 × 10 9 \u002FL; platelet count \\\u003C 100 × 10 9 \u002FL; hemoglobin (Hb) \\\u003C 80 g\u002FL;\n* Abnormal liver function in the screening period: ALT and\u002For AST ≥ 1.5 times the upper limit of normal, or total bilirubin ≥ 1.5 times the upper limit of normal;\n* Abnormal renal function in the screening period: serum creatinine (Cr) ≥ 1.5 times of the upper limit of normal and\u002For dialysis subjects;\n* Abnormal coagulation function during screening period: prothrombin time (PT) prolonged by more than 3 seconds and\u002For activated partial thromboplastin time (APTT) prolonged by more than 10 seconds;\n* Syphilis antibody (SyphilisTP) and human immunodeficiency virus antibody (HIV-Ab) test positive at screening Who, in the judgment of the investigator, are not suitable for the trial ;\n* Pregnant or lactating women;\n* Those who are unwilling or unable to take effective contraceptive measures during the study or 30 times after the study;\n* Participated in other drug or device clinical studies (signed ICF and received treatment with investigational drug\u002Fdevice or placebo) within 3 months prior to randomization;\n* Other conditions that the investigator considers inappropriate for participation in the study.","75 Years",{"count":153,"type":22},32,[75],"This is a multicenter, randomized, double-blind, placebo-controlled phase Ib study designed to evaluate the safety, efficacy and PK of TRD205 tablets administered orally .",[157],"Postoperative Analgesia After Unilateral Hallux Valgus Correction Surgery",[159],"TRD205 、Postoperative analgesia、unilateral hallux valgus correction surgery",{"date":138,"type":33},{"date":162,"type":22},"2025-08-26",{"date":142,"type":22},{"name":39,"class":40},{"id":166,"slug":167,"hasResults":11,"nctId":168,"briefTitle":169,"officialTitle":170,"acronym":4,"eligibilityCriteria":171,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":172,"enrollmentInfo":173,"targetDuration":4,"studyType":23,"phases":175,"briefSummary":176,"conditions":177,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":179,"lastUpdatePostDateStruct":180,"startDateStruct":182,"completionDateStruct":184,"leadSponsor":186,"locationsCount":41},"100513787","phase-1-a-phase-iii-clinical-study-in-patients-with-advanced-solid-tumor-100513787","NCT05970016","A Phase I\u002FII Clinical Study in Patients with Advanced Solid Tumor.","A Phase I\u002FII Clinical Study to Evaluate the Tolerability, Safety, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of TCC1727 Tablets in Patients with Advanced Solid Tumor.","Inclusion Criteria:\n\n1. Male or female subjects who have provided voluntary informed consent for participation in the study and to follow the protocol requirements\n2. Male or female subjects 18-70 years of age\n3. Subjects with histologically or cytologically confirmed malignant advanced solid tumors who have progressed on (or have not been able to tolerate) standard therapy or for whom no suitable effective standard therapy exists\n\n   1. For Phase I, all tumor types will be enrolled\n   2. For Phase II, Patients with DDR defects detection at central laboratory will be enrolled\n4. Subject with at least one measurable lesion according to RECIST criteria (version 1.1) for solid tumors will be allowed to include in phase II (if there is no measurable lesion but there are assessable lesions then the subject will be allowed to be included after the judgment of the investigator in phase I only)\n5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n6. Subjects with life expectancy of ≥12 weeks\n7. Subjects 12-lead ECG evaluation of QT level using Fridericia formula (QTcF) \\\u003C 450 mse\n8. Subjects must have the following laboratory values:\n\n   1. Absolute neutrophil count (ANC) ≥ 1.5 × 109\u002FL;\n   2. Platelet count (PLT) ≥ 100 × 109\u002FL;\n   3. Hemoglobin (HB) ≥ 9.0 g\u002FL;\n   4. No blood transfusion or hematopoietic stimulating factor treatment within 14 days;\n   5. Bilirubin total ≤ 1.5 times the upper limit of normal (ULN);\n   6. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 × ULN (In case of liver metastasis, ALT and AST ≤ 5 × ULN);\n   7. 24-hour or calculated creatinine clearance (CrCl) ≥ 60 mL\u002Fmin (according to Cockcroft-Gault formula)\\*, or the 24-hour creatinine clearance measured in urine is ≥ 50 mL\u002Fmin, the patient will still be selected. \\*For CrCl value, the eligibility should be determined using the Cockcroft-Gault formula:\n\n      * Male CrCl (mL\u002Fmin) = body weight (kg) × (140 - age)\u002F\\[72 × serum creatinine (mg\u002FdL)\\]\n      * Female CrCl (mL\u002Fmin) = male CrCl × 0.85\n   8. International normalized ratio (INR) ≤ 1.5 × ULN, Activated partial thromboplastin time (APTT) ≤ 1.5 × ULN;\n9. Women of childbearing potential agreed to use effective contraceptives during the study treatment period and within 3 months after the end of the study treatment period.\n\nExclusion Criteria:\n\nSubjects will be excluded from the study based on the following criteria:\n\n1. Imaging examination suggests intracranial metastasis, which requires local treatment (in case of asymptomatic or symptomatic brain metastasis requiring no local treatment based on the investigator's judgement, the subject can still be included), or currently taking steroid hormone prior to inclusion, such as \\>10 mg prednisone (or equivalent) for intracerebral edema from brain metastases; subjects with meningeal carcinomatosis will be excluded regardless of their clinical stability\n2. History of previously received major surgery or surgical therapy for any cause within 4 weeks of the first dose; radiotherapy, chemotherapy, other clinical trial drugs or other anti-tumor treatment, within 5 half-lives or 3 weeks (whichever is shorter), prior administering the first dose of study drug on Day 1\n3. History of previous treatment with ATR inhibitors or other DDR related inhibitors (except poly ADP ribose polymerase enzyme (PARP) inhibitors)\n4. Subjects with a history of another primary malignancy other than:\n\n   1. carcinomas in situ, (e.g., breast, cervix, and prostate)\n   2. Locally excised non-melanoma skin cancer\n   3. No evidence of disease from another primary cancer for two or more years and has not taken any anti-cancer treatment in two years. Exceptions are gonadotropin-releasing hormone (GnRH) therapy for prostate cancer and hormonal maintenance therapy for breast cancer.\n5. Previously received treatment with strong CYP3A4, CYP2C8 and P-gp inhibitors or strong CYP3A4, CYP2C8 and P-gp inducers within 14 days prior to the first medication\n6. Patients with AE due to previous anti-tumor treatment that has not recovered to ≤ CTCAE grade 1 (except for alopecia, pigmentation and lymphopenia)\n7. Patients who are unable to swallow the tablets normally, or have abnormal gastrointestinal function that may affect the drug absorption, such as malabsorption syndrome or major resection of the stomach or bowels based on the judgment of the investigator\n8. Subjects with any severe and\u002For uncontrolled disease, including:\n\n   1. Poor blood pressure control (systolic blood pressure ≥ 150 mmHg or diastolic blood pressure ≥ 100 mmHg)\n   2. Myocardial infarction, arrhythmia (CTCAE grade 2 and above, also including ≥ Class II congestive heart failure (CHF) (New York Heart Association (NYHA) classification) (refer to Appendix-A)\n   3. Active infection or fever of unknown origin ≥ 38.5℃ within 7 days prior to the first medication\n   4. Active viral hepatitis; positive hepatitis B surface antigen and\u002For hepatitis B core antibody and measured HBV DNA value ≥ 500 IU\u002Fml; positive HCV antibody and measured HCV titer exceeding the upper limit of normal;\n   5. Positive Treponema pallidum antibody;\n   6. History of immunodeficiency, including positive HIV antibody or other acquired or congenital immunodeficiency diseases, or history of organ transplant;\n   7. Poor control of diabetes (fasting blood glucose (FBG) \\> 10 mmol\u002FL);\n   8. Liver disease such as decompensated liver disease\n9. Uncontrolled pleural effusion, pericardial effusion, or peritoneal effusion as per the investigator opinion\n10. Patients with clinically significant hemorrhage symptoms or bleeding tendency within 3 months prior to the first study medication\n11. Known hypersensitivity or contraindication to any drug or any of the components of investigational product\n12. Any other clinically significant acute or chronic medical or psychiatric or any laboratory abnormality that may increase the risk associated with study drug administration or may interfere with the interpretation of study results","70 Years",{"count":174,"type":22},56,[75,25],"This is a 2-part, phase I\u002FII, open-label, multicenter study designed to evaluate the safety, PK, PD and preliminary efficacy of TCC1727 tablets administered orally QD.",[178],"Patients with Advanced Solid Tumors","2025-03-18",{"date":181,"type":33},"2025-03-21",{"date":183,"type":33},"2023-08-07",{"date":185,"type":22},"2025-12-30",{"name":39,"class":40},""]