[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"locally-advanced-or-metastatic-solid-tumor\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:locally-advanced-or-metastatic-solid-tumor":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,42,70],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100474735","phase-1-a-study-of-bl-m07d1-in-patients-with-locally-advanced-or-metastatic-her2-positivelow-expression-breast-cancer-and-other-solid-tumors-100474735",false,"NCT05461768","A Study of BL-M07D1 in Patients With Locally Advanced or Metastatic HER2-Positive\u002FNegative Breast Cancer and Other Solid Tumors","A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Preliminary Efficacy of BL-M07D1 for Injection in Patients With Locally Advanced or Metastatic HER2-Positive\u002FNegative Breast Cancer and Other Solid Tumors","Inclusion Criteria:\n\n* 1\\. Sign the informed consent voluntarily and follow the program requirements\n* 2\\. No gender limitation;\n* 3\\. Age: ≥18 years old and ≤75 years old (Stage Ia);≥18 years old (Ib);\n* 4\\. Expected survival time ≥3 months;\n* 5\\. Inoperable locally advanced or metastatic HER2-positive\u002Flow-expression breast cancer and other solid tumors that have been histopathologically and\u002For cytologically confirmed and have failed standard therapy, or are not available for standard therapy, or are not currently eligible for standard therapy; HER2 positive: IHC3+, or IHC2+ and ISH positive; HER2 low expression: IHC2+ and ISH negative, or IHC1+;\n* 6\\. Agree to provide archived tumor tissue samples or fresh tissue samples from the primary tumor or metastatic tumor within 2 years (to detect the expression of HER2 protein in tumor pathological tissue and explore the correlation between HER2 protein and bl-M07D1 validity index); If subjects are unable to provide tumor tissue samples, they will be admitted after evaluation by the investigator if other admission criteria are met.\n* 7\\. Must have at least one measurable lesion as defined by RECIST V1.1;\n* 8\\. ECOG score of 0 or 1;\n* 9\\. Toxicity of previous antitumor therapy has returned to level ≤1 as defined by NCI-CTCAE V5.0 (the investigator considered asymptomatic laboratory abnormalities, such as elevated ALP, hyperuricemia, and elevated blood glucose, etc.); Except for toxicity that the investigator judged to have no safety risk, such as alopecia, pigmentation, grade 2 peripheral neurotoxicity, etc.);\n* 10\\. No serious cardiac dysfunction, left ventricular ejection fraction ≥50%;\n* 11\\. Organ function level must meet the following requirements and meet the following standards: A) Bone marrow function: absolute neutrophil count (ANC) ≥1.5×10\\^9\u002FL, platelet count ≥90×10\\^9\u002FL, hemoglobin ≥90 g\u002FL; B) Liver function: total bilirubin (TBIL≤1.5 ULN), AST and ALT ≤2.5 ULN in patients without liver metastasis, AST and ALT ≤5.0 ULN in patients with liver metastasis; C) Renal function: creatinine (Cr) ≤1.5 ULN, or creatinine clearance (Ccr) ≥50 mL\u002Fmin (according to the Cockcroft and Gault formula).\n* 12\\. Coagulation function: International standardized ratio (INR) ≤1.5, and activated partial thrombin time (APTT) ≤1.5ULN;\n* 13\\. Urinary protein ≤2+ or ≤1000mg\u002F24h;\n* 14\\. For premenopausal women at risk of fertility, pregnancy tests must be performed within 7 days prior to the start of treatment. Serum\u002Furine pregnancy must be negative and must be non-lactation; All enrolled patients (male and female) should use adequate barrier contraception throughout the treatment cycle and 6 months after the end of treatment\n\nExclusion Criteria:\n\n* 1\\. Prior use of chemotherapy, biotherapy, immunotherapy, radical radiotherapy, major surgery (as defined by the investigator), targeted therapy (including small molecule tyrosine kinase inhibitors) and other antitumor therapies within 4 weeks or 5 half-lives (whichever is less) prior to initial dosing; Mitomycin and nitrosourea were administered within 6 weeks prior to initial administration; For oral fluorouracil drugs such as gio, capecitabine, or palliative radiotherapy within 2 weeks before initial administration; The Chinese medicine with anti-tumor indication was given within 2 weeks before the first administration.\n* 2\\. Prior ADC treatment (phase Ib only) with the toxin of camptothecin derivatives (topoisomerase I inhibitors);\n* 3\\. History of severe heart disease, such as symptomatic congestive heart failure (CHF) grade 2 or greater (CTCAE 5.0), NYHA grade 2 or greater heart failure, history of transmural myocardial infarction, unstable angina, etc.;\n* 4\\. QT prolongation (male QTc \\> 450 msec or female QTc \\> 470 msec), complete left bundle branch block, III atrioventricular block;\n* 5\\. Active autoimmune diseases and inflammatory diseases, such as: systemic lupus erythematosus, systemic treatment of psoriasis, rheumatoid arthritis, inflammatory bowel disease, and hashimoto's thyroiditis, etc., with the exception of type I diabetes, only replacement therapy can control the hypothyroidism, no systemic treatment of skin disease (e.g., vitiligo, psoriasis);\n* 6\\. Other malignancies diagnosed within 5 years prior to first administration, except for radical basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and\u002For radical resected carcinoma in situ;\n* 7\\. Screening for unstable thrombotic events such as deep vein thrombosis, arterial thrombosis and pulmonary embolism requiring therapeutic intervention within the first 6 months; Infusion device-related thrombosis is excluded;\n* 8\\. Patients with poorly controlled pleural effusion with clinical symptoms were judged by researchers to be unsuitable for inclusion;\n* 9\\. Hypertension poorly controlled by medications (systolic \\& GT; 150 mmHg or diastolic pressure \\& GT; 100 mmHg);\n* 10\\. According to CTCAE V5.0, patients were defined as ≥3 grade of lung disease, ≥2 grade of radioactive lung disease, existing or with a history of ILD;\n* 11\\. Symptoms of active CNS metastasis. But the researchers concluded that patients with stable parenchymal metastases could be included. The definition of stability must meet the following four requirements: A. Seizureless state lasting \\> 12 weeks with or without antiepileptic drugs; B. Glucocorticoids are not required; C. Two consecutive MRI scans (at least 4 weeks between scans) showed stable imaging state; D. Asymptomatic patients have been stable for more than 1 month after treatment;\n* 12\\. Patients with a history of allergy to recombinant humanized antibody or human-mouse chimeric antibody or to any excipient component of BL-M07D1;\n* 13\\. Prior organ transplantation or allogeneic hematopoietic stem cell transplantation (ALLO-HSCT);\n* 14\\. Equivalent cumulative dose of doxorubicin in anthracycline adjuvant therapy was \\> 360 mg\u002Fm\\^2;\n* 15\\. Positive human immunodeficiency virus antibody (HIVAb), active tuberculosis, active hepatitis B virus infection (HBV-DNA copy number \\> lower limit) or active hepatitis C virus infection (HCV antibody positive and HCV-RNA \\> lower limit);\n* 16\\. Active infections requiring systemic treatment, such as severe pneumonia, bacteremia, sepsis, etc.\n* 17\\. Participated in another clinical trial within 4 weeks prior to initial administration (starting from the time of last administration);\n* 18\\. Pregnant or nursing women;\n* 19\\. Other conditions considered inappropriate for participation in this clinical trial by the investigator","ALL","18 Years","75 Years",{"count":20,"type":21},348,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","In phase Ia study, the safety and tolerability of BL-B07D1 in patients with locally advanced or metastatic HER2-positive\u002Flow-expression breast cancer and other solid tumors will be investigated to determine the dose-limiting toxicity (DLT), maximum tolerated dose (MTD) of BL-M07D1.\n\nIn phase Ib study, the safety and tolerability of BL-M07D1 at the phase Ia recommended dose will be further investigated, and recommended phase II dose (RP2D) for phase II clinical studies will be determined.\n\nIn addition, the preliminary efficacy, pharmacokinetic characteristics, and immunogenicity of BL-M07D1 in patients",[27,28],"Breast Cancer","Locally Advanced or Metastatic Solid Tumor","RECRUITING","2026-08-14",{"date":32,"type":33},"2026-08-17","ACTUAL",{"date":35,"type":33},"2022-08-09",{"date":37,"type":21},"2027-12",{"name":39,"class":40},"Sichuan Baili Pharmaceutical Co., Ltd.","INDUSTRY",7,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":22,"phases":52,"briefSummary":53,"conditions":54,"keywords":55,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":69},"100570909","phase-1-azd5305-hadme-in-patients-with-advanced-solid-malignancies-100570909","NCT06713369","AZD5305 hADME in Patients With Advanced Solid Malignancies","A Phase I, Open-label Study to Assess the Absolute Bioavailability of Saruparib (AZD5305) and Absorption, Distribution, Metabolism, and Excretion (ADME) of [14C]-Saruparib ([14C]-AZD5305) in Patients With Advanced Solid Malignancies","AZD5305","Inclusion Criteria:\n\n1. Male or female ≥ 18 years of age (or the legal age of consent in the jurisdiction in which the study is taking place), at the time of signing the ICF.\n2. Histologically or cytologically documented, locally advanced or metastatic solid tumour, excluding lymphoma, for which standard therapy does not exist or has proven ineffective or intolerable.\n3. ECOG performance status of 0 or 1 with no deterioration over the 2 weeks prior to dosing.\n4. Predicted life expectancy ≥ 12 weeks.\n5. Adequate organ and marrow function as defined in the protocol\n6. Willingness and ability to comply with study and follow-up procedures.\n7. Able and willing to stay in hospital for specified residential periods following administration of Saruparib\u002F\\[14C\\]-Saruparib\n8. Regular bowel movements\n9. Body weight within normal range specified in protocol\n10. Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies Reproduction\n11. Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the ICF and in the protocol\n\nExclusion Criteria:\n\n1. Participants with a history of MDS\u002FAML or with features suggestive of MDS\u002FAML (as determined by prior diagnostic investigation). Specific screening for MDS\u002FAML is not required.\n2. Participants with any known predisposition to bleeding\n3. Any history of persisting severe cytopenia due to any cause\n4. Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product or previous significant bowel resection that would preclude adequate absorption, distribution, metabolism, or excretion of Saruparib.\n5. History of another primary malignancy, with some exceptions\n6. Persistent toxicities (CTCAE Grade ≥ 2), excluding alopecia, caused by previous anticancer therapy.\n7. Spinal cord compression or brain metastases for at least 4 weeks prior to start of study intervention unless asymptomatic and stable\n8. Abnormal cardiac function exclusions or cardiovascular disease\n9. History of arrhythmia\n10. Active HBV (positive HBsAg result) or HCV.\n11. Evidence of active and uncontrolled HIV infection.\n12. Active tuberculosis infection\n13. Major surgical procedure (excluding placement of vascular access) or significant traumatic injury within 4 weeks of the first dose of study intervention or an anticipated need for major surgery during the study.\n14. As judged by the investigator, any other evidence of diseases (such as severe or uncontrolled systemic diseases or active uncontrolled infections which, in the investigator's opinion, makes it undesirable for the participant to participate in the study or would jeopardise compliance with the protocol.\n15. Any prior treatment with a PARP inhibitor or platinum chemotherapy.\n16. Other anticancer therapy (chemotherapy, immunotherapy, hormonal anticancer therapy, radiotherapy \\[except for palliative local radiotherapy\\]), biological therapy or other novel agent is not permitted until the last PK sampling is completed.\n17. Palliative radiotherapy with a limited field of radiation within 2 weeks or with wide field of radiation or to more than 30% of the bone marrow within 4 weeks before the first dose of study intervention\n18. Concomitant use of medications or herbal supplements known to be CYP3A4 strong and moderate inhibitors or inducers\n19. Concomitant use of drugs that are known to prolong or shorten QT and have a known risk of Torsades de Pointes\n20. Participants who have participated in another absorption, distribution, metabolism, and excretion study within 1 year prior to screening.\n21. Participation in another clinical study with a study intervention administered in the last 3 months or 5 half-lives prior to dosing, whichever is longer.\n22. Participants with a known hypersensitivity to Saruparib or any of the excipients of the product.\n23. Participants who have been administered any amount of a \\[14C\\]-labelled compound within the last 12 months.\n24. Use of tobacco- or nicotine-containing products or alcohol may be exclusionary\n25. Poor peripheral venous access (venous access via a port will be permitted).\n26. Involvement in the planning and\u002For conduct of the study (applies to both AstraZeneca staff and\u002For staff at the study site).\n27. Judgment by the investigator that the participant should not participate in the study if the participant is unlikely to comply with study procedures, restrictions, and requirements.\n28. Previous enrolment in the present study.\n29. For female participants only: currently pregnant (confirmed with positive pregnancy test) or planning to become pregnant, breast-feeding, or intending to donate\u002Fretrieve ova before 6 months after the last dose of Saruparib.",{"count":51,"type":21},8,[24],"This Phase I, open-label study aims to study to absolute bioavailability of Saruparib (AZD5305) and the absorption, distribution, metabolism and excretion (ADME) of \\[14C\\]-Saruparib in patients with advanced solid malignancies.\n\nThis will be done on an inpatient basis in 2 parts (single-dose oral administration with radiolabeled microtracer in Part A, single-dose IV radiolabeled administration in Part B) during which samples will be obtained of plasma, urine, feces and vomitus (where applicable).",[28],[56,57,48,58,59],"hADME","saruparib","advanced solid tumour \u002F tumor","neoplasm","2026-06-23",{"date":62,"type":33},"2026-06-24",{"date":64,"type":33},"2025-04-02",{"date":66,"type":21},"2026-10-02",{"name":68,"class":40},"AstraZeneca",2,{"id":71,"slug":72,"hasResults":11,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":4,"eligibilityCriteria":76,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":77,"targetDuration":4,"studyType":22,"phases":79,"briefSummary":80,"conditions":81,"keywords":82,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":93,"locationsCount":51},"100454241","phase-1-a-study-of-bl-b01d1-in-patients-with-locally-advanced-or-metastatic-solid-tumor-100454241","NCT05194982","A Study of BL-B01D1 in Patients With Locally Advanced or Metastatic Solid Tumor","A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Preliminary Efficacy of BL-B01D1 in Patients With Locally Advanced or Metastatic Solid Tumor","Inclusion Criteria:\n\n1. Participants must sign the informed consent form voluntarily and follow the plan requirements.\n2. No gender limit.\n3. Age: ≥18 years old and ≤75 years old (stage Ia); ≥18 years old (stage Ib).\n4. Expected survival time ≥ 3 months.\n5. Locally advanced or metastatic solid tumor confirmed by histopathology and\u002For cytology, which are incurable or currently without standard treatment.\n6. Agrees to provide archived tumor tissue specimens or fresh tissue samples from the primary lesion or metastasis within 2 years; If a subject is unable to provide a tumor tissue sample, he\u002Fshe may be enrolled after being evaluated by the investigator if other inclusion criteria are met.\n7. Participants must have at least one measurable lesion that meets the definition of RECIST v1.1.\n8. Physical fitness score ECOG 0 or 1 point\n9. Toxicity of previous antitumor therapy has returned to ≤ level 1 as defined by NCI-CTCAE v5.0 (except for asymptomatic laboratory abnormalities considered by the investigators, such as elevated ALP, hyperuricemia, and elevated blood glucose; Toxicities with no safety risk, such as hair loss and grade 2 peripheral neurotoxicity, were excluded. Or decreased hemoglobin except ≥90 g\u002FL).\n10. No serious cardiac dysfunction, left ventricular ejection fraction (LVEF) ≥50%\n11. The organ function level must meet the following requirements: a) bone marrow function: absolute neutrophilic granulocyte count (ANC) ≥1.5×109\u002FL, platelet count ≥90×109\u002FL, hemoglobin ≥90 g\u002FL; b) Liver function: total bilirubin (TBIL≤1.5 ULN), AST and ALT ≤2.5 ULN in patients without liver metastasis, AST and ALT ≤5.0 ULN in patients with liver metastasis; c) Kidney function: creatinine (Cr) ≤1.5 ULN, or creatinine clearance (Ccr) ≥50 mL\u002Fmin (according to Cockcroft and Gault formula).\n12. Coagulation function: International normalized ratio (INR)≤1.5×ULN, and activated partial thromboplastin time (APTT)≤1.5ULN.\n13. Urinary protein ≤2+ or ≤1000mg\u002F24h.\n14. For premenopausal women with childbearing potential, a pregnancy test must be taken within 7 days prior to the start of treatment. Serum or urine pregnancy must be negative and must be non-lactating; all participants (regardless of male or female) in the group should be treated throughout the treatment. Adequate barrier contraceptive measures should be taken during the treatment and 6 months after the treatment.\n\nExclusion Criteria:\n\n1. Chemotherapy, biological therapy, immunotherapy, radical radiotherapy, major surgery, targeted therapy (including small molecule inhibitor of tyrosine kinase), and other anti-tumor therapy within 4 weeks or 5 half-lives (whichever is shorter) prior to the first administration; mitomycin and nitrosoureas treatment within 6 weeks prior to the first administration; oral fluorouracil-like drugs such as S-1, capecitabine, or palliative radiotherapy within 2weeks prior to the first administration.\n2. Participants with history of severe heart disease, such as: symptomatic congestive heart failure (CHF) ≥ grade 2 (CTCAE 5.0), New York Heart Association (NYHA) ≥ grade 2 heart failure, history of transmural myocardial infarction, unstable angina pectoris etc.\n3. Participants with prolonged QT interval (male QTc\\> 450 msec or female QTc\\> 470 msec), complete left bundle branch block, III grade atrioventricular block.\n4. Active autoimmune diseases and inflammatory diseases, such as: systemic lupus erythematosus, psoriasis requiring systemic treatment, rheumatoid arthritis, inflammatory bowel disease and Hashimoto's thyroiditis, etc., except for type I diabetes, hypothyroidism that can be controlled only by alternative treatment, and skin diseases that do not require systemic treatment (such as vitiligo, psoriasis).\n5. Other malignant tumors were diagnosed within 5 years prior to the first administration with the following exceptions: basal cell carcinoma of the skin, squamous cell carcinoma of the skin and\u002For carcinoma in situ after radical resection.\n6. Participants with poorly controlled hypertension by two kinds of antihypertensive drugs (systolic blood pressure\\>150 mmHg or diastolic blood pressure\\>100 mmHg).\n7. Participants have grade 3 lung disease defined according to NCI-CTCAE v5.0, or a history of interstitial lung disease (ILD).\n8. Unstable thrombotic events such as deep vein thrombosis, arterial thrombosis and pulmonary embolism requiring therapeutic intervention within 6 months prior to screening; Thrombus formation associated with infusion set is excluded.\n9. Symptoms of active central nervous system metastasis. However, patients with stable brain parenchymal metastases can be enrolled. Stable was defined as: a. The seizure-free state lasted for \\> 12 weeks with or without the use of antiepileptic drugs; b. Glucocorticoid use is not required; c. Consecutive MRI scans (at least 8 weeks between scans) showed stable imaging status.\n10. Patients with a history of allergy to recombinant humanized antibody or mouse chimeric antibody or to any excipients of BL-B01D1.\n11. Previous recipients of organ transplantation or allogeneic hematopoietic stem cell transplantation (Allo-HSCT).\n12. In previous adjuvant therapy with anthracyclines, the cumulative dose of anthracyclines was \\> 360 mg\u002Fm2.\n13. Positive human immunodeficiency virus antibody (HIVAb), active tuberculosis, active hepatitis B virus infection (HBV-DNA copy number \\> 103 IU\u002Fml) or active hepatitis C virus infection (HCV antibody positive and HCV-RNA \\> lower limit of detection).\n14. Active infections requiring systemic treatment, such as severe pneumonia, bacteremia, septicemia, etc.\n15. Participated in another clinical trial (calculated from the time of the last dose) within 4 weeks prior to the first dose.\n16. The other conditions of participation in this clinical trial were not considered appropriate by the investigators.",{"count":78,"type":21},570,[24],"In phase Ia study, the safety and tolerability of BL-B01D1 in patients with locally advanced or metastatic solid tumor will be investigated to determine the dose-limiting toxicity (DLT), maximum tolerated dose (MTD) of BL-B01D1.\n\nIn phase Ib study, the safety and tolerability of BL-B01D1 at the phase Ia recommended dose will be further investigated, and recommended phase II dose (RP2D) for phase II clinical studies will be determined.\n\nIn addition, the preliminary efficacy, pharmacokinetic characteristics, and immunogenicity of BL-B01D1 in patients with locally advanced or metastatic solid tumor will be evaluated.",[28],[83,84,85,86],"Non-Small Cell Lung Cancer (NSCLC)","Small cell lung cancer (SCLC)","Nasopharyngeal cacinoma (NPC)","Head and Neck Cancer (HNC)","2025-09-25",{"date":89,"type":33},"2025-09-26",{"date":91,"type":33},"2021-11-29",{"date":37,"type":21},{"name":39,"class":40}]