[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"solid-tumors-refractory-to-standard-therapy\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:solid-tumors-refractory-to-standard-therapy":115},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,46,76],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100588357","phase-1-interventional-study-to-evaluate-the-combination-of-palbociclib--sunitinib-as-a-treatment-for-advanced-solid-tumors-100588357",false,"NCT06940349","Interventional Study to Evaluate the Combination of Palbociclib + Sunitinib as a Treatment for Advanced Solid Tumors","A Phase 1b\u002F2 Open Label, Dose Escalating, Single Center Study to Evaluate the Safety, Tolerability and Initial Efficacy of Palbociclib + Sunitinib Oral Kinase Inhibitor Combination as a Treatment for Advanced Solid Tumors","COPS-01","Inclusion Criteria:\n\n* Age ≥18 years\n* Patients with Stage IV incurable\u002Frefractory metastatic solid tumors or locally advanced incurable\u002Frefractory tumor, who have one of the following tumor types:\n\n  (1) Gastric adenocarcinoma, (2) Ovarian Epithelial, Fallopian Tube, and Primary Peritoneal cancer (FIGO classification), (3) Breast cancer, (4) NSCLC, (5) Colorectal cancer, (6) Cholangiocarcinoma, (7) Pancreatic cancer, (8) Carcinosarcoma (any tissue origin), (9) High grade Neuroendocrine Carcinoma, from any tissue origin, (10) Sarcoma, all histological types, (11) Any other solid tumor.\n* Patients who have failed all other appropriate lines of therapy or who have refused treatment(s) of choice\n* Life expectancy of greater than 8 weeks\n* Clinical performance status of ECOG 0-2\n* Able to understand and sign the Informed Consent Form\n* Must be able to adhere to the study visit schedule and other protocol requirements.\n\nHematology criteria:\n\nAbsolute neutrophils count greater than 1000\u002Fmm3 without support of filgrastim Normal WBC (\\>3000\u002Fmm3). Hemoglobin greater than 8.0 g\u002FdL Platelet count greater than 80,000\u002Fmm3\n\n* Serology:\n* Seronegative for HIV antibody\n* Documented virology status of hepatitis, as confirmed by screening HBV and HCV serology test\n* Patients with active HBV must have:\n* HBV DNA \\\u003C 500 IU\u002FmL obtained within 28 days prior to initiation of study treatment\n* received anti-HBV treatment (per local standard of care; e.g., entecavir) for a minimum of 14 days prior to study entry and willingness to continue treatment for the length of the study\n* Patients with a history of HCV infection but who are negative for HCV RNA by PCR will be considered non-infected with HCV\n* Chemistry:\n* Serum ALT\u002FAST less than three times the upper limit of normal (ULN)\u002F less than five times ULN if liver metastasis present\n* Serum creatinine less than or equal to 1.6 mg\u002FdL\n* Total bilirubin no more than x1.5 times the ULN, except in patients with Gilbert's Syndrome who must have a total bilirubin less than 3 mg\u002FdL.\n* Non-pregnant (via negative pregnancy test)\u002Fnon-breast-feeding women and women with no intention to become pregnant\u002Fto breast-feed during the term of the trial and for at least three months after cessation of the P+S treatment\n* More than 14 days must have elapsed since any prior systemic therapy before day 1, and patients' toxicities must have recovered to a Grade 1 or less (except for toxicities such as alopecia or vitiligo). Patients may have undergone minor surgical procedures, local radiotherapy with the past two weeks, as long as all toxicities have recovered to Grade 1 or less.\n\nExclusion Criteria:\n\n* Inclusion Criteria:\n\n  * Age ≥18 years\n  * Patients with Stage IV incurable\u002Frefractory metastatic solid tumors or locally advanced incurable\u002Frefractory tumor, who have one of the following tumor types:\n\n    (1) Gastric adenocarcinoma, (2) Ovarian Epithelial, Fallopian Tube, and Primary Peritoneal cancer (FIGO classification), (3) Breast cancer, (4) NSCLC, (5) Colorectal cancer, (6) Cholangiocarcinoma, (7) Pancreatic cancer, (8) Carcinosarcoma (any tissue origin), (9) High grade Neuroendocrine Carcinoma, from any tissue origin, (10) Sarcoma, all histological types, (11) Any other solid tumor.\n  * Patients who have failed all other appropriate lines of therapy or who have refused treatment(s) of choice\n  * Life expectancy of greater than 8 weeks\n  * Clinical performance status of ECOG 0-2\n  * Able to understand and sign the Informed Consent Form\n  * Must be able to adhere to the study visit schedule and other protocol requirements\n  * Hematology:\n* Absolute neutrophils count greater than 1000\u002Fmm3 without support of filgrastim\n* Normal WBC (\\>3000\u002Fmm3).\n* Hemoglobin greater than 8.0 g\u002FdL\n* Platelet count greater than 80,000\u002Fmm3\n\n  • Serology:\n* Seronegative for HIV antibody\n* Documented virology status of hepatitis, as confirmed by screening HBV and HCV serology test\n* Patients with active HBV must have:\n* HBV DNA \\\u003C 500 IU\u002FmL obtained within 28 days prior to initiation of study treatment\n* received anti-HBV treatment (per local standard of care; e.g., entecavir) for a minimum of 14 days prior to study entry and willingness to continue treatment for the length of the study\n* Patients with a history of HCV infection but who are negative for HCV RNA by PCR will be considered non-infected with HCV\n\n  • Chemistry:\n* Serum ALT\u002FAST less than three times the upper limit of normal (ULN)\u002F less than five times ULN if liver metastasis present\n* Serum creatinine less than or equal to 1.6 mg\u002FdL\n* Total bilirubin no more than x1.5 times the ULN, except in patients with Gilbert's Syndrome who must have a total bilirubin less than 3 mg\u002FdL.\n\n  * Non-pregnant (via negative pregnancy test)\u002Fnon-breast-feeding women and women with no intention to become pregnant\u002Fto breast-feed during the term of the trial and for at least three months after cessation of the P+S treatment\n  * More than 14 days must have elapsed since any prior systemic therapy before day 1, and patients' toxicities must have recovered to a Grade 1 or less (except for toxicities such as alopecia or vitiligo). Patients may have undergone minor surgical procedures, local radiotherapy with the past two weeks, as long as all toxicities have recovered to Grade 1 or less.\n\nExclusion Criteria:\n\n* Known active current or history of recurrent bacterial, viral, fungal, mycobacterial, or other infections (including but not limited to tuberculosis, atypical mycobacterial disease, and herpes zoster), human immunodeficiency virus (HIV), or any major episode of infection requiring hospitalization or treatment with intravenous (IV) or oral antibiotics within 1 week of day 1\n* History of severe immediate hypersensitivity reaction to any of the agents used in this study\n* Uncontrolled hypertension\n* Proteinuria \\>3 grams per day\n* Subjects who have received any investigational drug or used investigational device within two weeks preceding screening\n* Active consumption of illicit drugs within one month preceding screening\n* Serious psychiatric or psychological disorders\n* Patients with significant cardiac, respiratory or active malignancy disease comorbidities.\n* Women of child-bearing potential who intend to become pregnant or breast-feed or who are pregnant or breastfeeding","ALL","18 Years",{"count":20,"type":21},100,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE1","PHASE2","The goal of this clinical trial is to learn if a combination of Palbociclib and Sunitinib is safe and effective in various solid tumors.\n\nThe main questions it aims to answer are:\n\n* Is the drugs combination safe for the participants?\n* Is the drug combination effective in all solid malignancies? It is a single arm study, phase 1b\u002F2, dose escalation and expansion, to determine the safety, tolerability and initial efficacy of this combination.\n\nParticipants will:\n\n* Take the drugs combination every day for 5 executive days, and 2 days of, in a 28 days cycle, for up to a year.\n* Visit the clinic once every 2 weeks for checkups and tests",[28],"Solid Tumors Refractory to Standard Therapy",[30,31,32],"COPS study","phase 1\u002Fphase 2 study","combination Palbociclib and Sutent","RECRUITING","2025-04-15",{"date":36,"type":37},"2025-04-23","ACTUAL",{"date":39,"type":37},"2021-10-21",{"date":41,"type":21},"2028-01-01",{"name":43,"class":44},"Rabin Medical Center","OTHER",1,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":17,"minAge":54,"maxAge":4,"enrollmentInfo":55,"targetDuration":4,"studyType":22,"phases":57,"briefSummary":58,"conditions":59,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":5},"100586127","phase-1-ad1208-in-subjects-with-any-progressive-locally-advanced-or-metastatic-solid-tumors-100586127","NCT06911333","AD1208 in Subjects With Any Progressive, Locally Advanced or Metastatic Solid Tumors","A Phase I\u002FIIa Trial of AD1208, a Cell Cycle Inhibitor\u002FMASTL Inhibitor, as a Single Agent or a Combination in Subjects With Any Progressive, Locally Advanced(Unresectable) or Metastatic Solid Tumors","AD1208","Inclusion Criteria:\n\n* Male or female subjects ≥19 years of age\n* Willing to consent to participate in study and ability to comply with scheduled visits, treatment plan, laboratory tests and other study procedures\n* Histologically and\u002For cytologically confirmed any progressive, locally advanced (unresectable), or metastatic solid tumors that have relapsed or are refractory following the last line of treatment and for which prior standard therapy has been ineffective, standard therapy does not exist or is not considered appropriate.\n* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1\n* Life expectancy of at least 12 weeks\n* Subjects with adequate hematologic, hepatic, and renal functions confirmed based on the screening laboratory test within 2 weeks prior to the first administration of IP.\n* Female subject who is surgically sterile, is postmenopausal, or agrees to use a highly effective method of birth control (2 methods strongly recommended) during the study and for 6 months following the last dose of IP.\n* Male subject with a pregnant or breastfeeding partner(s) must agree to remain abstinent or use a condom for the duration of the pregnancy or for the time the partner is breastfeeding throughout the study period and for 6 months after the final administration of IP.\n\nExclusion Criteria:\n\n* Untreated active brain metastases.\n* has leptomeningeal disease.\n* unrecovered \\> Grade 1 from the adverse event of prior therapy except for alopecia.\n* has an active autoimmune disease requiring systemic treatment within the past 2 years.\n* Active interstitial lung disease (ILD) or pneumonitis or a history of ILD.\n* Subject has received the following treatment;\n\n  * prior anticancer monoclonal antibody treatment or investigational therapy\n  * prior any chemotherapy\n  * prior radiotherapy\n  * Major surgery\n* Clinically significant (i.e., active) cardiovascular disease\n* known positive of human immunodeficiency virus (HIV) infection.\n* Active hepatitis B or C subjects.\n* known allergic reaction for active ingredients or inactive ingredients such as excipients of Investigational product.\n* Live vaccine administered against infectious disease.\n* Gastrointestinal (GI) track disease causing the inability to take oral medication, malabsorption syndrome or uncontrolled inflammatory GI disease.\n* having psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n* women with a positive pregnancy test at screening test.\n* women who are breast feeding.\n* subject has any condition because of which, in the opinion of the investigator, the participation would not be in the best interest of the subject.","19 Years",{"count":56,"type":21},36,[24,25],"The goal of this clinical trial is to evaluate the safety and tolerability of AD1208 to determine the maximum tolerated dose(MTD) or maximumly administered dose(MAD) in any progressive, locally advanced (unresectable) or metastatic solid tumors. The main questions it aims to answer are:\n\n* Which dosage of AD1208 is safe and tolerable for participants?\n* What medical problems do participants have when taking AD1208?\n\nParticipants will:\n\n* Take drug AD1208 every day up to 1 cycle at the least.\n* Visit the site once every 1 weeks for checkups and tests during cycle 1 and every 3 weeks from cycle 2 onwards.\n* Keep a diary of any adverse events and administrated drug",[60,61,62,63,64,28,65],"Solid Tumor, Adult","Tumor, Solid","Solid Tumor","Solid Tumor, Unspecified, Adult","Solid Tumor Cancer","Solid Tumor in Advanced Stage","2025-03-28",{"date":68,"type":37},"2025-04-04",{"date":70,"type":37},"2025-03-11",{"date":72,"type":21},"2030-02-20",{"name":74,"class":75},"Avelos Therapeutics Inc.","INDUSTRY",{"id":77,"slug":78,"hasResults":11,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":4,"eligibilityCriteria":82,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":83,"targetDuration":4,"studyType":22,"phases":85,"briefSummary":86,"conditions":87,"keywords":94,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":114},"100583992","phase-1-a-phase-i-study-of-lxp1788-injection-with-advanced-solid-tumors-100583992","NCT06883539","A Phase I Study of LXP1788 Injection with Advanced Solid Tumors.","A Phase I Open-label Dose-finding Study to Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of LXP1788 Injection in Patients with Advanced Solid Tumors.","Inclusion Criteria:\n\n1. Written (signed) Informed Consent.\n2. Male or female ≥ 18 years old.\n3. Life expectancy \\> 8 weeks.\n4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n5. A histologically or cytologically confirmed, advanced solid tumor that is refractory to currently available therapies or for which no effective treatment is available.\n6. Measurable disease per RECIST 1.1.\n7. Willing to have a tumor biopsy or having tissue sample from a previous biopsy available in the tissue bank for analysis that had been collected in the past 3 years.\n\nExclusion Criteria:\n\n1. Significant concurrent medical diseases, such as congestive heart failure, unstable angina, acute or recent myocardial infarction (\\\u003C 6 months before enrollment), COPD with frequent exacerbations, uncontrolled hypertension (systemic blood pressure \\>= 160 mmHg and\u002For diastolic blood pressure \\>= 100 mmHg with or without anti-hypertensive medication), recent CVA (\\\u003C 6 months before enrollment), or active infection which requires treatment withintravenous antibiotics.\n2. Patients with symptomatic CNS metastases who are neurologically unstable, receiving radiotherapy for the CNS lesion, or requiring increasing dose of steroids to control their CNS disease.\n\n   Asymptomatic patients with metastatic brain disease who have been on a stable dose of steroids for less than 14 days prior to screening.\n3. Inadequate bone marrow reserve or organ function as demonstrated by any of the following laboratory values:\n\n   Bone marrow:\n   * Absolute neutrophil count (ANC) \\\u003C 1.5 x 10\\^9\u002FL\n   * Platelet count \\\u003C 100 x 10\\^9\u002FL\n   * Hemoglobin \\\u003C 9 g\u002FdL\n   * Having had a blood transfusion within 2 weeks of screening date is also not allowed.\n\n   Hepatic:\n   * Total bilirubin \\> 1.5 x ULN\n   * AST and ALT \\> 3 x ULN if no liver metastases\n   * AST and ALT \\> 5 x ULN in the presence of liver metastases\n\n   Renal:\n\n   ⚫ Estimated creatinine clearance (CrCL) \\\u003C 60 mL\u002Fmin per the Cockcroft and Gault formula\n4. Known history of human immunodeficiency virus (HIV)-1 or -2 infection.\n5. Psychiatric disorders that would compromise the patient's compliance or ability to give consent.\n6. Major surgical intervention within 4 weeks of the first dose of LXP1788 Injection or with ongoing postoperative complications.\n7. Toxicities from any prior therapy, surgery, or radiotherapy that did not resolve to grade 0 or 1 as per the National Cancer Institute (NCI) - Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0, with the exception of alopecia, skin hyperpigmentation or hypopigmentation.\n8. Underlying medical conditions that, in the investigator's opinion, will make the administration of LXP1788 Injection hazardous or obscure the interpretation of toxicities or adverse events.\n9. Exposure to any other investigational or commercial anti-cancer agents or curative therapies within 28 days or 5 half-lives (whichever is shorter), before the first dose of LXP1788 Injection. Exposure to radiation therapy for non-curative purposes or pain control may be permitted under the judgement of the investigator.\n10. Judgment by the investigator that the patient should not participate in the study because the patient is unlikely to comply with study procedures, restrictions, or requirements.\n11. Pregnancy or breast feeding.\n12. Women or men of childbearing potential not willing to use effective means of contraception.\n13. Positive test for hepatitis B (HBsAg) or hepatitis C (positive HCV antibody with detectable HCV RNA).\n14. History of allergic reactions to any component of LXP1788 Injection.",{"count":84,"type":21},24,[24],"A Phase I, open-label, first-in-human study to determine the MTD, recommended phase 2 dose (RP2D), assess the safety, tolerability, pharmacokinetics and preliminary anti-tumor activity of LXP1788 Injection in patients with advanced solid tumor.\n\nPatients with advanced solid tumors that are refractory to currently available therapies or for whom no effective treatment is available will be selected.\n\nThe main questions it aims to answer are:\n\n1. To determine the maximum tolerated dose (MTD) and the recommended phase 2 dose (RP2D) of LXP1788 Injection\n2. To evaluate the pharmacokinetics (PK) of LXP1788 Injection",[88,89,64,63,90,28,91,92,93],"Solid Tumor Malignancies, Cancer","Solid Cancers","Solid Tumour","HCC - Hepatocellular Carcinoma","RCC, Renal Cell Cancer","Pancreas Cancer",[95,96,97,98,99,100,101,102,103,104],"Phase 1","LXP1788","LAUNXP","DBPR114-101","solid tumor","cancer","Hepatocellular carcinoma","Pancrease Cancer","Renal Cell Carcinoma","Tyrosine kinase inhibitor","2025-03-12",{"date":107,"type":37},"2025-03-19",{"date":109,"type":37},"2024-12-31",{"date":111,"type":21},"2028-06-30",{"name":113,"class":75},"LaunXP Biomedical Co., Ltd.",2,"Solid Tumors Refractory To Standard Therapy"]