[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"advanced-solid-tumours\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:advanced-solid-tumours":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,44,82,111,140,161],{"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":29,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100578767","phase-1-a-safety-and-pharmacokinetics-study-of-rc220-combined-with-doxorubicin-in-adult-participants-with-solid-tumours-100578767",false,"NCT06815575","A Safety and Pharmacokinetics Study of RC220 Combined With Doxorubicin in Adult Participants With Solid Tumours.","A Two-part Phase 1 Open-label Safety and Pharmacokinetic Study of Intravenous RC220 in Combination With Doxorubicin in Adult Patients With Solid Tumours.","Inclusion Criteria (For Part 1 and Part 2):\n\n1. Able to give voluntary informed consent and understand the study and are willing to follow and complete all the study required procedures.\n2. Aged between 18 years to ≤ 80 years at the time of informed consent. Note: In Korea, only participants aged ≥19 years at the time of informed consent will be enrolled\n3. Life expectancy ≥ 3 months.\n4. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.\n5. Have measurable or evaluable disease per RECIST v1.1. The target lesions must not have prior radiation or other locally treated area unless imaging-based progression has been clearly documented following radiation or other local therapy.\n6. Adequate haematological, liver, and kidney function as follows:\n\n   a. Bone marrow reserve:\n\n   • Absolute neutrophil count (ANC) ≥ 1.5 × 109\u002FL without growth factor support in the 2 weeks prior to study entry.\n   * Haemoglobin ≥ 90 g\u002FL without transfusion and\u002For without growth factor support in 2 weeks prior to study entry.\n   * Platelet count ≥ 100 × 109\u002FL without transfusion in 2 weeks prior to study entry.\n\n     b. Hepatic function:\n   * Aspartate aminotransferase (AST), alanine aminotransferase (ALT) \\\u003C 3 × upper limit of normal (ULN) (≤5 × ULN if liver metastases or hepatic cell carcinoma (HCC)).\n\n     c. Renal function:\n   * Serum creatinine \\\u003C 1.5 × ULN or Serum creatinine clearance (CrCL) \\> 50 mL\u002Fmin, as per the Cockcroft-Gault Equation Glomerular Filtration Rate: \\[(140-age in years) × weight in kg\\] \u002F (7.2 × serum creatinine in mg\u002FdL) (× 0.85 for females).\n7. International normalised ratio (INR) \u002Fprothrombin time (PT) \\\u003C 2 x ULN, activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN.\n8. Practice adequate contraceptive measures as per below:\n\n   Female patients must:\n\n   • Be of nonchildbearing potential i.e., surgically sterilised or postmenopausal, or;\n\n   • If of childbearing potential, must have a negative serum pregnancy test at Screening and a negative urine pregnancy test before the first study treatment administration and on Day 1 of each Cycle. They must agree not to attempt to become pregnant, must not donate ova, and must agree to use 2 forms of highly effective contraceptive method between signing consent, during the study, and at least 180 days after the last dose of study drug, OR use 1 form of highly effective contraceptive method, plus an additional barrier method of contraception between signing consent, during the study, and at least 180 days after the last dose of study drug.\n\n   • Women of childbearing potential with same sex partners (abstinence from penile vaginal intercourse) are eligible when this is their preferred and usual lifestyle.\n\n   Male patients must:\n\n   • be willing not to donate sperm and if engaging in sexual intercourse with a female partner who could become pregnant, a willingness to use a condom in addition to having the female partner use a highly effective contraceptive method between signing consent, during the study, and at least 90 days after the last dose of the study treatment.\n\n   PART 1 only - Dose Escalation Specific Inclusion Criteria\n9. Histologically\u002Fcytologically confirmed, locally advanced unresectable or metastatic solid tumours for whom prior treatments have failed, and where an anthracycline may be considered as a treatment option or is indicated.\n10. Adequate Hepatic function as per below:\n\n    * Serum Total bilirubin (TBIL) as per below:\n\n      1. Patients with documented Gilbert's syndrome - baseline TBIL \\\u003C 3 × ULN,\n      2. Patient with either HCC or liver metastases - baseline TBIL \\\u003C 2 × ULN\n      3. All other patients baseline TBIL \\\u003C 2 × ULN.\n\nPART 2 only - Exploratory Dose Expansion Specific Inclusion Criteria 8. Histologically\u002Fcytologically confirmed solid tumours of any stage for which the patient has not received prior treatment with an anthracycline and for whom treatment with doxorubicin is indicated.\n\n9\\. Adequate Hepatic function as per below:\n\n• Serum TBIL as per below:\n\n1. Patients with documented Gilbert's syndrome - baseline TBIL \\\u003C 3 × ULN,\n2. Patient with either HCC or liver metastases - baseline TBIL \\\u003C 3 × ULN\n3. All other patients baseline TBIL \\\u003C 2 × ULN.\n\nExclusion Criteria (for Part 1 and Part 2):\n\n1. Females who are pregnant or nursing.\n2. Received cancer-directed therapy within the following timeframes:\n\n   1. Antitumour therapy (chemotherapy, antibody therapy, molecular targeted therapy, hormonal therapy or investigational agent) within 28 days prior to the first dose of study treatment (or 5 times the half-life if shorter than 28 days, there can be exceptions on a case-by-case as approved by Study Medical Monitor based on pharmacology). Note: concurrent use of hormone deprivation therapy for hormone-refractory prostate cancer, bisphosphonate or denosumab for skeletal related events per institution guideline is permitted.\n   2. Wide-field radiation therapy within 28 days (or palliative radiation therapy within 7 days) prior to the first dose of study treatment or has not recovered from the side effects of radiation therapy in the opinion of the Investigator.\n   3. Any other concurrent investigational device(s) or conventional agent(s) within 28 days (unless 5 times the half-life is shorter than 28 days) prior to the first dose of study treatment.\n   4. Therapeutic radiopharmaceuticals must be stopped 8 weeks prior to the first dose of the study treatment.\n3. Persisting Grade 2 or higher severity AEs from prior antitumour treatment as per CTCAE v5.0. Patients with pre-existing non-treatable Grade 2 toxicities may be eligible per discretion of the Investigator and with approval from Study Medical Monitor (e.g., Grade 2 chemotherapy induced neuropathy).\n4. Patients with primary central nervous system (CNS) malignancy, symptomatic CNS metastases, meningeal metastases or leptomeningeal disease are not allowed.\n\n   Note: Patients with asymptomatic CNS metastases are eligible if clinically controlled, which is defined as 1) ≥ 4 weeks of stable neurologic function following CNS-directed therapy prior to the first dose of study treatment 2) no evidence of CNS disease progression as determined by radiographic imaging ≥ 4 weeks prior to the first dose of study treatment, 3) ≥ 2 weeks from discontinuation of anti-seizure and steroid therapies (receiving prednisone ≤ 10 mg or equivalent steroid therapies is allowed) prior to the first dose of study treatment.\n5. Had major surgery within 28-days of the Screening Visit. Note: Patients who have undergone a non-major surgical procedure within 28-days prior to Screening must have recovered adequately from the surgery before the administration of the first dose of study treatment. Exception: no waiting period applies following central venous catheter placement.\n6. History of tissue or organ transplantation.\n7. Treatment with systemic immunosuppressive medications within 4 weeks prior to the first dose of study treatment. Exceptions: Daily prednisone equivalent ≤10 mg\u002Fday; topical, inhaled, or intranasal corticosteroids.\n8. History of severe infection deemed clinically significant by the Investigator or designee within 4 weeks or signs and symptoms of any active infection within 2 weeks prior to the first dose of study treatment.\n9. Active hepatitis B or C. Note: Hepatitis B virus (HBV) carriers without active disease (HBV DNA titer \\\u003C 1000 copies\u002FmL or 200 IU\u002FmL) or cured hepatitis C (negative HCV RNA test) with confirmed viral clearance that are not receiving ongoing treatment and without residual chronic liver disease may be enrolled.\n10. Confirmed human immunodeficiency virus (HIV) infection and receiving anti-retroviral therapy (ART). Patients with well controlled HIV infection (i.e., CD4+ count \\>350 cells\u002FμL and viral copies less than 400\u002FmL after at least 4 weeks of ART) may be eligible per discretion of the Investigator and with approval from Study Medical Monitor.\n11. Patients with any inherited predisposition to bleeding or to thrombosis (von Willebrand disease, haemophilia, etc.). Patients with a history of nontraumatic haemorrhage (i.e., end stage liver disease, any haemorrhage requiring medical intervention), thromboembolic event or any condition which may increase bleeding risk including clotting disorders, thrombocytopenia during the last 3 months prior to the first dose of study treatment administration.\n12. Receiving immunosuppressive or myelosuppressive medications that would, in the opinion of the Investigator, increase the risk of serious neutropenic complications.\n13. Any other disease or clinically significant abnormality in laboratory parameters, including serious medical or psychiatric illness\u002Fcondition, which in the judgement of the Investigator might compromise the safety of the patient or integrity of the study, interfere with the patient's participation in the trial or compromise the trial objectives.\n14. Known allergies, hypersensitivity, or intolerance to the study drug or its excipients.\n15. Any known, documented, or suspected history of illicit substance abuse that would preclude patient from participation, unless clinically justified (i.e., will not interfere with study participation and\u002For will not compromise trial objectives) per judgement of the Investigator and with approval of Study Medical Monitor. Exception: Physician-prescribed medicinal opioids or cannabinoids are allowed for pain management.\n16. Vaccinated with any live vaccine within 4 weeks prior to the first dose of study treatment.\n17. Judgement by the Investigator that the patient is unlikely to comply with study procedures, restrictions and requirements.\n18. Use of prescription or non-prescription medications, including complementary medicines, within 14 days or 5 half-lives (whichever is longer) if the medication is a potential inhibitor of cytochrome P450 (CYP) isoform 3A4 or 2D6, and\u002For P-glycoprotein (P-gp), or if the medication is an inducer of CYP3A4 or P-gp, prior to dosing and throughout study participation.\n\n    PART 1 only - Dose Escalation Specific Criteria\n19. A ≥ 20% decrease in serum albumin from baseline, sustained over two consecutive measurements taken more than 14 days apart during screening prior to the first administration of study treatment.\n20. Severe or uncontrolled cardiac disease requiring treatment, CHF (New York Heart Association) NYHA III or IV, unstable angina pectoris even if medically controlled, history of myocardial infarction during the 6 months prior to screening, serious arrhythmias requiring medication (with exception of atrial fibrillation or paroxysmal supraventricular tachycardia).\n21. Treatment with prior anthracyclines exceeding the maximum equivalent cumulative lifetime dose.\n\nPART 2 only -Dose Expansion Specific Criteria 19. Uncontrolled or severe cardiac disease that in the opinion of the Investigator would prevent treatment with doxorubicin.","ALL","18 Years","80 Years",{"count":20,"type":21},53,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","This is a multi-centre, two-part, open-label, phase 1, first in human study of multiple ascending doses of RC220 bisantrene formulation alone and in combination with fixed dose doxorubicin to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) in adult patients with locally advanced unresectable or metastatic solid tumours where doxorubicin may be considered as a treatment option \u002F or is indicated.\n\nThe study will consist of two parts: Part 1 - This part involves a fixed-dose doxorubicin (60 mg\u002Fm2) tolerability lead-in period, followed by dose-escalating doses of IV RC220 alone, and in combination, with fixed dose doxorubicin, to determine the maximum tolerated combined dose (MTCD) of RC220 with doxorubicin to be evaluated in Part 2. This dose-expansion cohort will enrol patients with solid tumours that are anthracycline treatment naïve and for whom treatment with doxorubicin is indicated. The objective of Part 2 will be to confirm the safety and tolerability and evaluate the preliminary cardioprotective and anti-tumour efficacy of the maximum tolerated combined dose (MTCD) of RC220 with doxorubicin.",[27,28],"Solid Tumours","Advanced Solid Tumours",[27,28,30],"Phase 1","RECRUITING","2026-05-30",{"date":34,"type":35},"2026-06-02","ACTUAL",{"date":37,"type":35},"2025-04-02",{"date":39,"type":21},"2029-01-31",{"name":41,"class":42},"Racura Oncology Ltd","INDUSTRY",9,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":22,"phases":53,"briefSummary":55,"conditions":56,"keywords":67,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":81},"100545354","phase-1-a-phase-iii-trial-of-ucb4594-in-participants-with-advanced-cancer-100545354","NCT06380816","A Phase I\u002FII Trial of UCB4594 in Participants With Advanced Cancer","A Cancer Research UK Phase I\u002FII Trial to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumour Activity of UCB4594 Alone and in Combination With Anti-cancer Treatments in Participants With Advanced Malignancies","Inclusion Criteria:\n\n1. Written (signed and dated) informed consent and capable of co-operating with investigational medicinal product (IMP) administration and follow-up\n2. Participant population: Histologically or cytologically proven advanced solid tumours (as specified below), refractory to conventional treatment, or for which no conventional therapy is considered appropriate by the Investigator or is declined by the participant. Module A (dose escalation): Tumour types which have shown high levels of human HLA-G expression (as reported in the literature): head and neck squamous cell carcinoma, non-small cell lung cancer, colorectal cancer, triple-negative breast cancer, renal cell cancer (clear cell only), oesophago-gastric cancer (excluding gastrointestinal stromal tumour), cervical cancer, ovarian cancer, pancreatic cancer. N.B. Participants with small cell type cancers on histology\u002Fcytology are excluded. Pre-treatment biopsies are mandatory for all participants. Paired biopsies will be mandatory for participants from doses of 30 mg and higher. Participants must have disease amenable to biopsy (excluding bone metastases) as deemed safe by the Investigator\n3. Measurable disease, according to RECIST v1.1\n4. Life expectancy of at least 12 weeks\n5. Eastern Cooperative Oncology Group performance status of 0 or 1\n6. Haematological and biochemical indices within defined ranges. These measurements should be performed to confirm the patient's eligibility to participate in the trial\n7. Aged 18 years or over at the time consent is given. Participants aged 16-17 years may be eligible for recruitment to the backfill cohorts in dose escalation once adequate safety and toxicity data have been established in participants aged 18 years or over. All relevant data will be reviewed and a decision on the inclusion of participants aged 16-17 years will be made by the Trial Management Group\n\nExclusion Criteria:\n\n1. Radiotherapy (except palliative), endocrine therapy (unless for non-malignant disease), chemotherapy, targeted therapy or immunotherapy, or any other IMPs during the previous 4 weeks or 5 half-lives (whichever is shorter) before the first dose of IMP\n2. Ongoing toxicity of previous treatments \\>CTCAE Grade 1 (except alopecia of any grade, stable Grade 2 peripheral neuropathy or hormone-replacement therapy (HRT)-managed endocrine disorders)\n3. Patients with rapidly progressing \u002F symptomatically deteriorating brain\u002Fleptomeningeal metastases\u002Funtreated brain metastases are excluded. Patients with previously treated brain metastases are eligible if they haven't had a seizure or a clinically significant change in neurological status or required steroids in the last 2 weeks\n4. Pregnant or breastfeeding female patients (or planning to breastfeed)\n5. Women of childbearing potential. However, those not already pregnant or breastfeeding (or who discontinue breastfeeding) and meet the following are eligible:\n\n   5.1. Have a negative serum pregnancy test within 7 days before enrolment and either:\n\n   5.2.1. Agree to a form of highly effective contraception plus a barrier method, or\n\n   5.2.2. Agree to sexual abstinence\n\n   Effective from the negative pregnancy test, throughout the trial and for 10 months after the last dose of UCB4594\n6. Male patients with partners of childbearing potential. However, patients who meet the following are eligible:\n\n   6.1. Agree to a barrier method of contraception or sexual abstinence\n\n   6.2. Males with pregnant or breastfeeding partners must use barrier method contraception to prevent exposure of the foetus or neonate\n\n   6.3. Non-vasectomised males must also ensure any partner of childbearing potential uses highly effective contraception or agrees to sexual abstinence\n\n   Effective from the date of the first dose of UCB4594, throughout the trial and for 5 months after the last dose of UCB4594 N.B. Males must refrain from donating sperm for the same period\n7. Surgery from which the patient has not yet recovered\n8. High medical risk because of non-malignant systemic disease, including serious or uncontrolled infection (requiring intravenous antibiotics) or unexplained fever \\>38°C within 2 weeks prior to the first dose of UCB4594\n9. Known to be serologically positive for hepatitis B virus, hepatitis C virus or human immunodeficiency virus\n10. Active or suspected autoimmune disease, or any history of autoimmune condition that required systemic corticosteroids or immunosuppressive agents. Patients who have ever had a transplant are excluded. This does not apply to patients with: vitiligo, alopecia, or type I diabetes mellitus, psoriasis not requiring chronic systemic immunosuppressive treatment within the past 2 years, stable autoimmune-mediated hypothyroidism on HRT, and Raynaud's syndrome\n11. Are being treated with escalating or supraphysiologic doses of corticosteroids or immunosuppressive agents. Participants with immunotherapy-related hypophysitis adequately treated with physiologic doses of steroids are not excluded. Use of topical, ophthalmic, inhaled, intermittent steroid injections, and intranasal corticosteroids are permitted\n12. Hypersensitivity to the ingredients\u002Fexcipients (including polysorbate 80) in UCB4594\n13. History of significant toxicities from treatment of immune checkpoint inhibitors (CPIs) that necessitated permanent discontinuation (Patients who started on combination CPI \\[e.g., ipilimumab\u002Fnivolumab\\] and had toxicity requiring discontinuation of one CPI \\[e.g., continued with nivolumab single agent\\] are not excluded)\n14. History of Grade ≥3 infusion-related reaction to monoclonal antibodies or similar drugs\n15. Prior treatment with HLA-G, immunoglobulin-like transcript (ILT)2 or ILT4-targeting drug\n16. Live, attenuated vaccine within 28 days prior to the first dose of IMP\n17. Increased risk due to tumour flare (e.g., an initial increase in tumour size that may lead to obstruction of airways, etc)\n18. Significant active pulmonary disease or condition at screening, including:\n\n    18.1. Lymphangitis carcinomatosa\n\n    18.2. History of interstitial lung disease or pulmonary fibrosis\n\n    18.3. History of pulmonary inflammatory disease\n19. Evidence of bleeding diathesis\n20. Significant cardiovascular disease, defined as a history of: congestive heart failure requiring therapy or left ventricular ejection fraction \\\u003C40%, unstable angina pectoris or myocardial infarction within 6 months prior to entry, or current poorly controlled angina (symptoms weekly or more), clinically significant cardiac arrhythmia within 6 months prior to entry (asymptomatic atrial fibrillation or asymptomatic first-degree heart block permitted), or myocarditis. Presence of symptomatic or severe valvular heart disease. Baseline QT interval corrected by Fridericia \\>450 msec for males and \\>470 msec for females on triplicate electrocardiogram is ineligible\n21. Participant in or plans to join another interventional trial\n22. Other current malignancies. Cancer survivors who have undergone potentially curative therapy for prior malignancy with no evidence of disease for 3+ years are eligible\n23. Any other condition that, in the Investigator's opinion, means the trial is not in the patient's best interest",{"count":52,"type":21},167,[24,54],"PHASE2","This clinical trial is looking at UCB4594. This is the first time the drug is being tested in humans. UCB4594 is a type of drug called a monoclonal antibody. It has been designed to work by targeting a protein called human leucocyte antigen G (HLA-G) that is found in high levels on some cancer cells. By attaching itself to this protein it may help the immune system to attack and kill the cancer cells.\n\nThe four main aims of the clinical trial are to find out:\n\n1. The best dose of UCB4594 that can be given safely to participants in the trial.\n2. What the side effects of UCB4594 are and how they can be managed.\n3. What happens to UCB4594 inside the body and how it affects cancer cells.\n4. Whether UCB4594 can cause cancer to shrink.",[28,57,58,59,60,61,62,63,64,65,66],"Squamous Cell Carcinoma of Head and Neck","Carcinoma, Non-Small-Cell Lung","Colorectal Neoplasms","Triple Negative Breast Neoplasms","Carcinoma, Renal Cell (Clear Cell Only)","Esophageal Neoplasms","Stomach Neoplasms (Excluding Gastrointestinal Stromal Tumors)","Uterine Cervical Neoplasms","Ovarian Neoplasms","Pancreatic Neoplasms",[68,69,70],"HLA-G","Monoclonal Antibody","Cancer","2026-05-05",{"date":73,"type":35},"2026-05-08",{"date":75,"type":35},"2024-07-09",{"date":77,"type":21},"2029-11",{"name":79,"class":80},"Cancer Research UK","OTHER",4,{"id":83,"slug":84,"hasResults":11,"nctId":85,"briefTitle":86,"officialTitle":87,"acronym":4,"eligibilityCriteria":88,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":89,"targetDuration":4,"studyType":22,"phases":91,"briefSummary":92,"conditions":93,"keywords":94,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":110},"100493159","phase-1-a-study-of-ebc-129-in-advanced-solid-tumours-100493159","NCT05701527","A Study of EBC-129 in Advanced Solid Tumours","A Phase 1A\u002FB Study To Evaluate The Safety And Tolerability Of EBC-129 As A Single Agent And In Combination With Pembrolizumab In Advanced Solid Tumours","Inclusion Criteria:\n\n1. Male or female patients ≥18 years (US) or ≥21 years (Singapore) old\n2. Body weight within ≥40 kg - ≤100 kg during Parts A and B, and ≤120 kg during all other parts of the study\n3. Demonstrated progression of a locally advanced unresectable or metastatic solid tumour with no alternative standard-of-care therapeutic option with a proven clinical benefit, or are intolerant to these therapies\n4. Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 2 for Part A and 0-1 for Parts B, C and D\n5. Hepatic function and adequate renal function, as per protocol standard\n6. Adequate bone marrow function as per protocol standard\n\nExclusion Criteria:\n\n1. Unable or not willing to provide tumour tissue sample (from archival tissue or de-novo biopsy) unless if there is a significant risk for the patient to undergo biopsy\n2. Has received investigational or anti-cancer therapy within 4 weeks (28 days) prior to starting study drug\n3. Is receiving any concomitant anti-cancer therapy\n4. Known severe hypersensitivity to E coli-derived products or filgrastim or peg-filgrastim and have significant allergies to such biological products\n5. Has clinically active brain metastases\n6. Has received prior radiation therapy\n7. Has received prophylactic administration of haematopoietic colony stimulating factors within 4 weeks (28 days) prior to starting study drug\n8. Patients concurrently using any strong P-glycoprotein (P-gp) inducers\u002Finhibitors or strong cytochrome P3A (CYP3A) inhibitors within 14 days prior to the first dose of study drug or patients that use restricted or prohibited medications listed in the concomitant and other treatments section of the protocol\n9. Pregnancy or breast feeding\n10. For patients receiving pembrolizumab:\n\n    1. Has an active autoimmune disease that has required systemic treatment in the past 2 years\n    2. Patients who, according to the currently approved Keytruda (pembrolizumab) US package insert (USPI)\u002Fsummary of product characteristics, had an immune-related adverse event (irAE) for which permanent discontinuation is mandated (any Grade 4 event and Grade 3 events of pneumonitis, hepatitis, and nephritis). Also, patients without formal contraindication due to previous irAE with any immune checkpoint inhibitor (approved or investigational) are not eligible if the AE has not resolved to grade 1 or better and\u002For still requires steroids (\\>10 mg of prednisone equivalent per day) for ongoing management.\n    3. Patients with a history of pneumonitis\u002Finterstitial lung disease, patients who received live vaccines within 30 days of enrolment, and patients who discontinued prior immune checkpoint inhibitors due to Grade 2 myocarditis are excluded from enrolment into pembrolizumab-containing cohorts\n11. Has had a major surgical procedure within 4 weeks (28 days) from starting the study drug\n12. Patients with active or chronic corneal disorders, with other active ocular conditions requiring ongoing therapy or with any clinically significant corneal disease that prevents adequate monitoring of drug-induced keratopathy\n13. Active infection including HIV, Hepatitis B or Hepatitis C",{"count":90,"type":21},98,[24],"This study will assess the safety and tolerability of EBC-129 as a single agent and in combination with pembrolizumab in patients with advanced solid tumours",[28],[95,96,97,98,99],"Advanced solid tumours","Antibody drug conjugates (ADCs)","Recommended phase-2 dose (RP2D)","Monomethyl auristatin E (MMAE)","N-glycosylated CEACAM5\u002F6","2026-02-03",{"date":102,"type":35},"2026-02-05",{"date":104,"type":35},"2023-04-28",{"date":106,"type":21},"2026-12-24",{"name":108,"class":109},"EDDC (Experimental Drug Development Centre), A*STAR Research Entities","OTHER_GOV",5,{"id":112,"slug":113,"hasResults":11,"nctId":114,"briefTitle":115,"officialTitle":116,"acronym":117,"eligibilityCriteria":118,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":119,"targetDuration":4,"studyType":22,"phases":121,"briefSummary":122,"conditions":123,"keywords":128,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":130,"lastUpdatePostDateStruct":131,"startDateStruct":133,"completionDateStruct":135,"leadSponsor":137,"locationsCount":139},"100619714","phase-1-first-in-human-study-of-sim0610-in-solid-tumors-100619714","NCT07348211","First in Human Study of SIM0610 in Solid Tumors","An Open-Label, Multicenter, First-in-Human Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of SIM0610 in Adult Subjects With Locally Advanced\u002FMetastatic Solid Tumors","SIM0610-101","Inclusion Criteria:\n\n* Voluntarily participate and sign the informed consent form\n* At least 18 years old, male or female\n* Subjects with locally advanced\u002Fmetastatic solid tumors confirmed by histology and\u002For cytology;\n* Subjects in Part 1 should have at least one tumor lesion evaluable by RECIST v1.1 criteria, and subjects in Part 2 should have at least one measurable tumor lesion by RECIST v1.1 (lesions that have received radiotherapy or other local treatments cannot be used as target lesions unless there is clear progression of the lesion)\n* Subjects with locally advanced\u002Fmetastatic solid tumors who have failed standard treatment: Part 1: Subjects with solid tumors who have experienced disease progression during\u002Fafter at least one previous standard systemic anti-tumor regimen and are not suitable for standard treatment. Part 2: Non-small cell lung cancer, liver cancer, head and neck squamous cell carcinoma, colorectal cancer that have experienced disease progression during\u002Fafter at least one previous standard systemic anti-tumor regimen and are not suitable for standard treatment\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n* Expected survival period ≥ 12 weeks\n* Adequate organ and bone marrow function\n* Archived formalin-fixed, paraffin-embedded (FFPE) tumor tissue or fresh biopsy tissue within 5 years must be provided before the first administration\n\nExclusion Criteria:\n\n* A history of active second primary malignancy within the past 2 years, except for localized tumors that are considered cured and have a low risk of recurrence as assessed by the investigator.\n* Symptomatic central nervous system (CNS) metastases occurring within 2 weeks prior to the first dose of study treatment; or requirement for local therapy (e.g., radiotherapy or surgery) for CNS metastases; or requirement for corticosteroid therapy for CNS metastases.\n* A history of non-infectious interstitial lung disease (ILD)\u002Fpulmonary inflammation requiring corticosteroid treatment; current ILD\u002Fpulmonary inflammation; or suspected ILD\u002Fpulmonary inflammation that cannot be ruled out by screening imaging.\n* Uncontrolled pleural effusion, pericardial effusion, or ascites, or occurrence of such effusions requiring drainage or medical intervention within 4 weeks prior to the first dose of study treatment.\n* Failure to recover from adverse events (AEs) induced by prior anti-tumor therapy (i.e., recovery to Grade 1 or baseline level).\n* Current participation in a study involving investigational drugs or medical devices, or participation in such a study within 4 weeks prior to the first dose of study treatment.\n* Receipt of the following therapies prior to the first dose of study treatment:\n\n  1. Cytotoxic therapy within 3 weeks; or anti-tumor targeted small-molecule drugs (e.g., tyrosine kinase inhibitors) within 2 weeks.\n  2. Anti-tumor antibody-based immune checkpoint inhibitors, antibody-drug conjugates (ADCs), or other anti-tumor biologics within the shorter of 5 half-lives or 4 weeks.\n  3. Traditional Chinese medicines (TCMs)\u002Fherbal preparations with anti-tumor indications within 2 weeks.\n  4. Radiotherapy within 4 weeks.\n* Received antibody-drug conjugate (ADC) with topoisomerase I inhibitor (TOP1i) or other ADC targeting EGFR\u002FcMET.\n* Received any live vaccine within 4 weeks prior to the first dose of study treatment.\n* Received the following medications ≤ 14 days prior to the first dose of study treatment:\n\n  1. Strong or moderate CYP3A4 induction\u002Finhibitor;\n  2. Drugs known to be at risk for torsade de pointes (TdP);\n  3. Drugs associated with QTcF interval prolongation (TdP risk equivocal).\n* Known human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS).\n* A history of clinically significant cardiovascular diseases within 6 months prior to the first dose of study treatment, including but not limited to myocardial infarction, severe\u002Funstable angina pectoris, primary cardiomyopathy, cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction) or congestive heart failure (New York Heart Association \\[NYHA\\] Functional Classification \\> Class II); symptomatic coronary artery disease requiring pharmacotherapy.\n* A history of allogeneic organ transplantation or graft-versus-host disease (GVHD).\n* A history of hypersensitivity to the active ingredients, inactive excipients of SIM0610, or drugs with similar chemical structures or classifications to SIM0610.\n* Pregnant or lactating women. For women of childbearing potential (WOCBP), they are also excluded unless:\n\n  1. The result of serum pregnancy test within 72 hours prior to the first dose of study treatment is negative;\n  2. They use highly effective contraceptive methods from the time of signing the informed consent form (ICF) until 180 days after the last dose of study treatment.\n* Male subjects with female partners of childbearing potential are excluded unless they use highly effective contraceptive methods from the time of signing the ICF until 180 days after the last dose of study treatment.\n* Any other conditions that may increase subject-related risks or interfere with the interpretation of study results, and that, in the investigator's judgment, render the subject unsuitable for study enrollment.",{"count":120,"type":21},260,[24],"This is a multicenter, open-label, first-in-human (FIH) study to evaluate the safety, tolerability, pharmacokinetic\u002Fpharmacodynamic profile, and preliminary antitumor activity of SIM0610 in subjects with locally advanced\u002Fmetastatic solid tumors. Accelerated titration (ATD) and Bayesian optimal interval design (BOIN) will be used to guide dose escalation in part1, the preliminary anti-tumor effect of SIM0610 will to be further evaluated in part 2.",[28,124,125,126,127],"Non-Small Cell Lung Cancer","Colorectal Cancer","Head and Neck Squamous Cell Carcinoma","Hepatocellular Carcinoma",[129],"Locally Advanced\u002FMetastatic Solid Tumors","2026-01-21",{"date":132,"type":35},"2026-01-23",{"date":134,"type":35},"2026-01-19",{"date":136,"type":21},"2029-07",{"name":138,"class":42},"Jiangsu Simcere Pharmaceutical Co., Ltd.",7,{"id":141,"slug":142,"hasResults":11,"nctId":143,"briefTitle":144,"officialTitle":145,"acronym":4,"eligibilityCriteria":146,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":147,"targetDuration":4,"studyType":22,"phases":149,"briefSummary":150,"conditions":151,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":152,"lastUpdatePostDateStruct":153,"startDateStruct":155,"completionDateStruct":157,"leadSponsor":159,"locationsCount":5},"100582814","phase-1-a-study-of-lm-168-as-a-single-agent-or-in-combination-with-toripalimab-in-subjects-with-advanced-solid-tumours-100582814","NCT06868199","A Study of LM-168 as a Single Agent or in Combination With Toripalimab in Subjects With Advanced Solid Tumours","A Phase I\u002FII, First-in-Human (FIH), Open-Label, Dose Escalation and Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of LM-168 as a Single Agent or in Combination With Toripalimab in Subjects With Advanced Solid Tumours","Inclusion Criteria:\n\n1. Subjects who are willing to participate in the study and sign the informed consent form (ICF) prior to any procedure.\n2. Aged ≥18 years old (including boundary values) , male or female.\n3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.\n4. Life expectancy ≥ 3 months.\n5. In dose escalation stage, subjects must have histological or cytological confirmation of recurrent or refractory advanced solid tumours, and have progressed on standard therapy, or are intolerable for available standard therapy, or there is no available standard therapy.\n6. In dose expansion stage, subjects must have histological or cytological confirmation of selected advanced solid tumors.\n7. Pre-treatment archived tumour tissue or on-treatment tumour biopsy could be provided for biomarker analysis optionally.\n8. At least one measurable disease.\n9. Subjects must show appropriate organ and marrow function in laboratory examinations within 7 days prior to the first dose.\n10. Subjects who are able to communicate well with investigators and understand and adhere to the requirements of this study.\n\nExclusion Criteria:\n\n1. Participate in any other clinical trial within 28 days prior to 1st dosing of LM-168.\n2. Having received prior anti-CTLA-4 or any other immunotherapy or immune-oncology (IO) agent within 28 days of commencing treatment with LM-168 or experienced a toxicity that led to permanent discontinuation of prior immunotherapy.\n3. Subjects who have received the anti-tumor treatments within the specified time periods prior to the first dosing of LM-168.\n4. Any adverse event from prior anti-tumour therapy has not yet recovered to ≤ grade 1 of CTCAE v5.0.\n5. Subjects with uncontrolled tumour-related pain.\n6. Subjects with known central nervous system (CNS) or meningeal metastasis.\n7. Subjects who have uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures.\n8. Subjects with esophageal or gastric varices requiring immediate intervention, or those with a history of variceal bleeding.\n9. Hepatic encephalopathy, hepatorenal syndrome, Child-Pugh class B or more severe liver cirrhosis.\n10. Tumor invasion of surrounding vital organs or a risk of developing esophagotracheal fistula or esophagopleural fistula.\n11. Patients with a history of active or previously confirmed inflammatory bowel disease.\n12. Subjects who experienced grade 3 or higher hypersensitivity to the treatment that contains monoclonal antibody.\n13. Subjects who previously experienced grade ≥ 3 immune-related adverse events during immunotherapy, as well as subjects who discontinued prior immunotherapy due to severe or life-threatening immune-related adverse events.\n14. Subjects who take systemic corticosteroids (\\> 10 mg daily prednisone equivalents) or other systemic immunosuppressive medications within 2 weeks prior to the first dosing of LM-168.\n15. Subjects with the known history of autoimmune disease.\n16. Subjects with the history of idiopathic pulmonary fibrosis, organizing pneumonia , drug-induced pneumonitis, idiopathic pneumonitis, interstitial lung disease, severe radiation pneumonitis or evidence of active pneumonitis on screening chest CT scan.\n17. Use of any live attenuated vaccines within 28 days prior to 1st dosing of LM-168.\n18. Current or recent use of aspirin (\\> 325 mg\u002Fday) or treatment with dipyramidole, ticlopidine, clopidogrel, and cilostazol.\n19. Current unstable of full-dose oral or parenteral anticoagulants or thrombolytic agents for \\> 2 weeks prior to the first dose of LM-168.\n20. Subjects who received major surgery or interventional treatment within 28 days prior to 1st dosing of LM-168 (excluding tumour biopsy, puncture, etc.).\n21. Subjects who have severe cardiovascular disease.\n22. Subjects who have uncontrolled or severe illness.\n23. Subjects who have a history of immunodeficiency disease.\n24. HIV infection, active infection including tuberculosis, HBV and HCV infection.\n25. Subjects with a history of other malignancies within 5 years prior to the first administration of the study drug.\n26. Child-bearing potential female who have positive results in pregnancy test or are lactating.\n27. Subjects who have psychiatric illness or disorders that may preclude study compliance.\n28. Subject who is judged as not eligible to participate in this study by the investigator.",{"count":148,"type":21},87,[24,54],"For phase I ,this study is to assess the safety and tolerability, obtain the recommended phase 2 dose (RP2D) and\u002For Maximum Tolerated Dose (MTD) for LM-168 as a single agent or in combination with toripalimab in subjects with advanced solid tumours.\n\nFor phase II ,this study is to assess the preliminary anti-tumour activity of LM-168 as a single agent or in combination with toripalimab measured by objective response rate (ORR) in subjects with advanced solid tumours.",[28],"2025-09-06",{"date":154,"type":35},"2025-09-12",{"date":156,"type":35},"2025-05-06",{"date":158,"type":21},"2028-02-01",{"name":160,"class":42},"LaNova Medicines Limited",{"id":162,"slug":163,"hasResults":11,"nctId":164,"briefTitle":165,"officialTitle":166,"acronym":4,"eligibilityCriteria":167,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":168,"enrollmentInfo":169,"targetDuration":4,"studyType":22,"phases":171,"briefSummary":172,"conditions":173,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":174,"lastUpdatePostDateStruct":175,"startDateStruct":177,"completionDateStruct":179,"leadSponsor":181,"locationsCount":183},"100587358","phase-1-a-trial-to-evaluate-safety-tolerability-pharmacokinetics-and-preliminary-efficacy-of-ba1301-in-advanced-solid-tumors-100587358","NCT06927349","A Trial to Evaluate Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of BA1301 in Advanced Solid Tumors.","An Non-randomized Open-label, Multicenter Phase 1 Study to Evaluate Safety, Tolerability, Pharmacokinetics, Preliminary Efficacy of BA1301in Participants With Advanced Solid Tumors.","Inclusion Criteria:\n\n1. Voluntarily signed informed consent and able to follow the trial treatment protocol and visit plan;\n2. Age ≥ 18 years old and ≤ 75 years old, male or female;\n3. Patients with locally advanced or metastatic malignant solid tumours that cannot be surgically resected as histologically or cytologically confirmed by standard therapy failure or refusal or inability to tolerate standard treatment regimens.\n4. Agree to provide archival or fresh tumour tissue for immunohistochemical evaluation for immunohistochemical detection of CLDN18.2 expression.\n5. Eastern Cooperative Oncology Group (ECOG) Strength Status Score of 0 or 1.\n6. At least one evaluable lesion according to the efficacy evaluation criteria for solid tumours (RECIST1.1).\n7. Adequate organ function.\n8. Estimated survival ≥ 3 months;\n9. Negative blood pregnancy test result for females of childbearing potential at screening.\n\nExclusion Criteria:\n\n1. Poorly controlled hypertension as judged by the investigator\n2. Received any chemotherapy, radiotherapy, targeted therapy, cell therapy, immunotherapy, ADC drug therapy, major surgery, or other anti-cancer therapy within 28 days prior to the first dose of trial drug.\n3. Known hypersensitivity to any ingredient of the therapeutic drug used in the study protocol;\n4. Positive hepatitis B virus surface antigen (HBsAg) test; Positive hepatitis C virus (HCV) antibody, treponema pallidum antibody, human immunodeficiency virus (HIV) antibody;\n5. Pregnant or lactating females, those who have recently planned to become pregnant;\n6. Those who have participated in and received any clinical trial drugs (excluding vitamins and minerals) or clinical trial device intervention within 28 days before signing informed consent;\n7. Other serious physical or psychiatric illness or laboratory test abnormalities at screening that may increase the risk of participating in the study, or interfere with the results of the study, and patients who, in the opinion of the investigator, are not suitable to participate in this study.","75 Years",{"count":170,"type":21},70,[24],"This is an open label Phase 1, First in Human trial designed to evaluate the safety, tolerability pharmacokinetics, preliminary efficacy of BA1301 in participants with advanced solid tumors.",[28],"2025-04-07",{"date":176,"type":35},"2025-04-15",{"date":178,"type":35},"2023-01-11",{"date":180,"type":21},"2026-12-31",{"name":182,"class":42},"Shandong Boan Biotechnology Co., Ltd",1]