[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Conjupro Biotherapeutics, Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":107},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,51,78],{"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":33,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"100625585","phase-1-phase-i-study-of-sys6043-in-patients-with-advancedmetastatic-solid-tumors-100625585",false,"NCT07424547","Phase I Study of SYS6043 in Patients With Advanced\u002FMetastatic Solid Tumors","Phase I Dose Escalation and Cohort Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of SYS6043 in Patients With Advanced\u002FMetastatic Solid Tumors","Inclusion Criteria:\n\nMajor:\n\n* Aged ≥18 years old (on the date of signing the ICF).\n* Advanced\u002Funresectable or metastatic solid tumors confirmed by histology or cytology, disease recurrence or progression during or after systemic standard of care, and should be intolerant of or have no available standard of care therapy.\n* Have at least one measurable lesion, according to the Response Evaluation Criteria in Solid Tumors (RECIST V1.1). Participants with metastatic castration-resistant prostate cancer (mCRPC) who have only metastases to bone will be evaluated through discussion with the sponsor's medical monitor, before determining whether they can be enrolled.\n* Expected life expectancy of ≥ 3 months.\n* ECOG performance status of 0-1 and no worsening of the score within 28 days prior to enrollment.\n* LVEF ≥ 50% as shown by ECHO or MUGA within 28 days prior to enrollment.\n\nExclusion Criteria:\n\nMajor:\n\n* Prior B7-H3 targeted therapy.\n* Previously received drug therapy with topoisomerase inhibitor antibody-drug conjugate (e.g., trastuzumab deruxtecan).\n* Symptomatic congestive heart failure (CHF) (New York Heart Association \\[NYHA\\] Class II-IV) or a history of severe arrhythmia requiring treatment.\n* History of myocardial infarction or unstable angina within 6 months prior to enrollment.\n* Based on the results of three 12-lead electrocardiogram (ECG) examinations, the mean QT interval (QTcF) corrected by the Fridericia formula for both males and females is prolonged to \\>470 ms.\n* Unable or unwilling to discontinue concomitant medications known to prolong the QT interval.\n* History of interstitial lung disease (e.g., ILD\u002Fnon-infectious pneumonia requiring glucocorticoid treatment in the past), or currently have interstitial lung disease, or are suspected to have such diseases through imaging examinations during screening.\n* History of underlying lung disorders, including but not limited to pulmonary embolism within 3 months prior to the start of study treatment, severe asthma, severe COPD, restrictive pulmonary disease, and other clinically significant lung injuries or requiring supplemental oxygen.\n* Any autoimmune diseases, connective tissue disorders, or inflammatory diseases involving the lungs recorded or suspected during screening (e.g., rheumatoid arthritis, Sjögren's syndrome, sarcoidosis, etc.).\n* Presence of uncontrolled infection requiring intravenous injection of antibiotics, antiviral drugs, or antifungal drugs.\n* Active and clinically significant bacterial, fungal, viral infection, or Hepatitis C infection at screening (HCV antibodies test positive and HCV-RNA levels higher than the lower limit of quantification or 1000 copies\u002FmL (whichever is lower); HIV antibody positive or syphilis antibody positive (with confirmation)..\n* HBsAg positive and HBV-DNA above the lower limit of quantification or 1,000 copies\u002FmL (500 IU\u002FmL) (whichever is lower). Liver tumor: For participants with liver metastases and HBV infection, HBV DNA must be \\\u003C2000 IU\u002FmL before the first dose. Participants who are HBsAg-positive and\u002For HBV DNA-positive should receive at least 2 weeks of anti-Hepatitis B virus treatment prior to the first dose and be willing to continue treatment during the study.\n* Lactating women (women who are willing to temporarily discontinue breastfeeding will also be excluded), or women confirmed to be pregnant by pregnancy test within 7 days prior to enrollment.\n* Presence of spinal cord compression or clinically active brain metastasis, and\u002For meningeal metastases, defined as untreated, symptomatic, or requiring corticosteroids or anticonvulsants.","ALL","18 Years",{"count":19,"type":20},386,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","The goal of this clinical trial is to learn if investigational drug called SYS6043 works in adults with advanced or metastatic solid tumors that have spread or cannot be treated with standard therapies. The main goals of the study are to understand how safe SYS6043 is, what side effects it may cause, and what dose can be given safely. Researchers will also study how the drug moves through the body and whether the immune system reacts to it. In addition, the study will look for early signs that SYS6043 may help slow or shrink tumors and explore whether the amount of a tumor protein called B7-H3 is related to how well the treatment works.\n\nParticipants will:\n\n* Provide written informed consent\n* Undergo screening tests to ensure they are eligible for study treatment\n* Attend all required study visits and receive SYS6043 by intravenous infusion once every 3 weeks (Q3W), with 21 days as one treatment cycle until the study doctor determines that study treatment should be stopped based on how well a participant is doing on treatment.\n* Have safety follow-up (SFU), and long-term follow-up.\n* Be followed until progression.",[26,27,28,29,30,31,32],"Cancer","Solid Tumor Cancer","Advanced Metastatic Cancer","Prostate","Small Cell Lung Cancer","Ovarian Cancer","Breast Cancer",[34,35,36,37],"ovarian cancer","breast cancer","small cell lung cancer","prostate cancer","RECRUITING","2026-04-06",{"date":41,"type":42},"2026-04-07","ACTUAL",{"date":44,"type":42},"2026-03-03",{"date":46,"type":20},"2030-04",{"name":48,"class":49},"Conjupro Biotherapeutics, Inc.","INDUSTRY",5,{"id":52,"slug":53,"hasResults":11,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":4,"eligibilityCriteria":57,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":58,"targetDuration":4,"studyType":21,"phases":60,"briefSummary":61,"conditions":62,"keywords":64,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":77},"100512162","phase-1-a-phase-1-study-of-cpo301-in-adult-patients-with-advanced-or-metastatic-solid-tumors-100512162","NCT05948865","A Phase 1 Study of CPO301 in Adult Patients With Advanced or Metastatic Solid Tumors","A Phase 1, Multicenter, Single Agent Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Evidence of Antitumor Activity of CPO301, an EGFR-Targeting Antibody-Drug Conjugate, in Adult Patients With Advanced or Metastatic Solid Tumors","Major Inclusion Criteria:\n\n* Age ≥18 years\n* Patients with histologically confirmed locally advanced or metastatic solid tumors who have disease progression, intolerance to prior therapy, are ineligible for available therapies, or refuse standard of care therapy in the metastatic setting.\n* In Part A, patients with solid tumors including but not limited to NSCLC (adenocarcinoma and squamous cell carcinoma), breast cancer, KRAS-wild type colorectal cancer, and head \\& neck cancer based on previous biopsy result.\n* In Part B, Cohort 1 will exclusively include NSCLC patients with documented EGFR mutations based on previous biopsy result and Cohort 2 will be patients with other cancer(s) suggested to have sensitivity to CPO301 in Part A.\n* At least 1 measurable target lesion present and documented by CT or MRI according to RECIST v1.1\n* ECOG performance status 0 or 1 at screening\n* Life expectancy \\>12 weeks\n\nMajor Exclusion Criteria:\n\n* Known, active, or uncontrolled central nervous system (CNS) metastasis or carcinomatous meningitis.\n* Has AEs due to previous anti-tumor treatments not recovered to ≤Grade 1 (except for alopecia; some tolerable chronic toxicities of Grade 2 may be excluded after consultation with the sponsor, as judged by the investigator) according to NCI-CTCAE v5.0.\n* Any serious and\u002For uncontrolled concurrent illness that may interfere with study participation\n\nPrior therapy\n\n* Received other investigational drugs or treatments within 4 weeks before the first dose of the investigational drug in the study\n* The time interval between the latest anti-tumor treatment and the first dose of the investigational drug meets the following requirements: Have received anti-tumor treatments such as chemotherapy, radiotherapy, targeted therapy, immunotherapy and other clinical investigational drugs within 4 weeks before the first dose of the investigational drug; have received oral fluoropyrimidines, small molecule targeted drugs within 2 weeks before the first dose of the investigational drug; have received palliative radiotherapy or local therapy within 2 weeks before the first dose of investigational drug.\n* Had major surgery within 4 weeks before the first dose of the investigational drug in the study.",{"count":59,"type":20},132,[23],"The goal of this clinical trial is to test CPO301, a type of drug called an antibody drug conjugate in adult patients with advanced or metastatic solid tumors.\n\nThe main questions it aims to answer are:\n\n* To assess the safety and tolerability of CPO301 at increasing doses and determine the dose to be used in the second part of the study (Part A)\n* To assess the safety and tolerability of CPO301 at the dose determined to be safe and tolerable in Part A in patients with Non-Small Cell Lung Cancer and potentially other tumor types (Part B)\n* To evaluate how quickly CPO301 is metabolized by the body (pharmacokinetics or PK)\n* To evaluate if antibodies to the study drug develop (immunogenicity)\n* To evaluate preliminary efficacy to the drug\n* To correlate preliminary efficacy with mutations in a biomarker called EGFR\n\nParticipants will:\n\n* Provide written informed consent\n* Undergo screening tests to ensure they are eligible for study treatment\n* Attend all required study visits and receive CPO301 by intravenous injection every 3 weeks until the study doctor determines study treatment should be stopped, based on how well a participant is doing on treatment\n* Be followed for progression every 3 months for up to 2 years",[26,63],"Cancer, Lung",[26,65,66,67,68],"Non-Small Cell Lung Cancer","Solid Tumors","Metastatic","Advanced","2026-03-18",{"date":71,"type":42},"2026-03-20",{"date":73,"type":42},"2023-06-06",{"date":75,"type":20},"2027-08",{"name":48,"class":49},14,{"id":79,"slug":80,"hasResults":11,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":4,"eligibilityCriteria":84,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":85,"targetDuration":4,"studyType":21,"phases":87,"briefSummary":88,"conditions":89,"keywords":91,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":5},"100617352","phase-1-a-phase-1-study-of-jmt108-in-participants-with-advanced-solid-tumors-100617352","NCT07317505","A Phase 1 Study of JMT108 in Participants With Advanced Solid Tumors","A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Anti-tumor Activity of JMT108 Injection in Participants With Advanced Malignant Tumors","Major Inclusion Criteria:\n\n* Age ≥18 years\n* Participants with histologically or cytologically confirmed locally advanced or metastatic solid tumors who are unresponsive or intolerant to all standard of care or have no standard of care available\n* At least one evaluable tumor lesion according to RECIST v1.1.\n* ECOG performance status score ≤2.\n* Expected survival ≥ 3 months\n\nMajor Exclusion Criteria:\n\n* Active central nervous system metastases and\u002For leptomeningeal metastases\n* AEs from prior therapy which have not recovered to Grade ≤1 or baseline as per NCI CTCAE v5.0\n\nPrior therapy\n\n* Any other unapproved investigational drugs or treatments within 4 weeks prior to the first dose of the investigational drug (C1D1).\n* Chemotherapy, radiotherapy, biological therapy, endocrine therapy, targeted therapy, immunotherapy, or other anti-tumor therapies within 4 weeks prior to the first dose of the investigational drug, except in the following situations:\n\n  1. Nitrosoureas or mitomycin C within 6 weeks prior to the first dose of the investigational drug;\n  2. Use of oral fluoropyrimidines and small-molecule targeted drugs within 2 weeks or 5 half-lives of the drug (whichever is longer) prior to the first dose of the investigational drug;\n  3. Use of herbal medicine\u002Fproducts with anti-tumor indications within 2 weeks prior to the first dose of the investigational drug.",{"count":86,"type":20},270,[23],"The goal of this clinical trial is to test JMT108, a type of drug called a bispecific antibody in adult patients with locally advanced or metastatic solid tumors.\n\nThe main questions it aims to answer are:\n\n* To assess the safety and tolerability of JMT108 at increasing doses and determine the dose and schedule to be used in the second part of the study (Phase 1a)\n* To assess effectiveness of JMT108 in participants with locally advanced or metastatic tumors (Phase 1b)\n* To evaluate how quickly JMT108 is metabolized by the body (pharmacokinetics or PK)\n* To evaluate if antibodies to the study drug develop (immunogenicity)\n* To evaluate preliminary efficacy to the drug\n* To explore the pharmacodynamic (PD) characteristics of JMT108\n* To explore the correlation between biomarker levels and preliminary efficacy\n\nParticipants will:\n\n* Provide written informed consent\n* Undergo screening tests to ensure they are eligible for study treatment\n* Attend all required study visits and receive JMT108 by intravenous injection every 2 weeks until the study doctor determines study treatment should be stopped, based on how well a participant is doing on treatment\n* Be followed for progression every 3 months for up to 2 years",[26,90],"Cancer (Solid Tumors)",[92,93,94,95,96,97,98],"cancer","solid tumors","advanced malignant","colorectal cancer","hepatocellular cancer","gastric cancer","melanoma","2026-01-19",{"date":101,"type":42},"2026-01-21",{"date":103,"type":42},"2025-12-02",{"date":105,"type":20},"2029-09",{"name":48,"class":49},""]