[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"advanced-malignancies\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:advanced-malignancies":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,13,0,[8,45,69,91,116,146,172,194,214,237,258,279,303],{"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":27,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100619097","phase-1-a-drug-drug-interaction-study-to-evaluate-the-effects-of-pelabresib-on-the-pharmacokinetics-of-repaglinide-midazolam-and-combined-oral-contraceptive-in-patients-with-advanced-malignancies-100619097",false,"NCT07340190","A Drug-drug Interaction Study to Evaluate the Effects of Pelabresib on the Pharmacokinetics of Repaglinide, Midazolam, and Combined Oral Contraceptive in Patients With Advanced Malignancies","A Phase 1b, Open Label, 2-Part Study to Evaluate the Effect of Pelabresib (DAK539\u002FCPI-0610) on the Pharmacokinetics of Repaglinide, Midazolam, and Combined Drospirenone\u002FEthinyl Estradiol Oral Contraceptive in Patients With Advanced Malignancies","Key Inclusion Criteria:\n\nKey inclusion criteria for all participants (Arm A and Arm B)\n\n* Is at least 18 years of age at the time of signing the informed consent.\n* Has a confirmed documented diagnosis of an advanced malignancy for which no standard and\u002For curative treatment options are available\n* Has the following acceptable laboratory assessments prior to the first dose of study treatment:\n\n  1. Platelet count ≥ 150 × 109 \u002FL in the absence of thrombopoietic factors or transfusions within 2 weeks of the screening assessment\n  2. Absolute neutrophil count (ANC) ≥ 1 × 109 \u002FL in the absence of granulocyte growth factors\n  3. Peripheral blood blast count \\\u003C 5%. Assessment of blasts in bone marrow is not mandatory at screening; however, blasts must be \\\u003C5% if the bone marrow assessment is performed.\n  4. Serum total bilirubin ≤ 1.5 × upper limit of normal (ULN)\n  5. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 × ULN (≤5 × ULN if the elevation can be ascribed to liver involvement)\n  6. Calculated or measured creatinine clearance of ≥30 mL\u002Fmin\\*\n* Has fully recovered from major surgery and from the acute toxic effects of prior chemotherapy and radiotherapy (residual Grade 1 toxicities and residual alopecia of any grade are allowed).\n\nAdditional inclusion criterion for Arm B\n\n• Is a female participant.\n\nKey Exclusion Criteria:\n\nKey exclusion criteria for Arm A\n\n* Has a history of hypersensitivity to any of the study treatments or its excipients or to drugs of similar chemical class.\n* Is pregnant (confirmed by a pregnancy test at screening) or is breastfeeding.\n* Has current known active or chronic infection with HIV, hepatitis B, or hepatitis C.\n* Has impaired cardiac function or clinically significant cardiac disease.\n* Has a gastrointestinal tumor, impaired GI function, GI disease, or significant resection of stomach or other portion of the gastrointestinal tract that could alter the absorption of pelabresib, midazolam, or repaglinide, including any unresolved nausea, vomiting, or diarrhea.\n\nKey exclusion criteria for Arm B\n\n* Has renal impairment (CrCl less than 50 mL\u002Fmin).\n* Has a gastrointestinal tumor, impaired GI function, GI disease, or significant resection of stomach or other portion of the gastrointestinal tract that could alter the absorption of pelabresib, drospirenone and ethinyl estradiol, including any unresolved nausea, vomiting, or diarrhea.\n* Has breast cancer or other estrogen- or progestin-sensitive cancer.\n* Has undiagnosed abnormal uterine bleeding.\n\nOther protocol-defined inclusion\u002Fexclusion criteria may apply.","ALL","18 Years",{"count":19,"type":20},24,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","This drug-drug interaction (DDI) study aims to evaluate the impact of pelabresib at steady-state plasma concentrations on the pharmacokinetic (PK) profile of A) a single dose of repaglinide and a single dose of midazolam, and B) a single dose of combined drospirenone and ethinyl estradiol. The study will be conducted in adult participants with advanced malignancies for whom no standard or curative treatment options are available.",[26],"Advanced Malignancies",[28,29,26,30,31],"Drug-drug interaction (DDI)","Cytochrome P450 (CYP)","oral contraceptive","Pharmacokinetics (PK)","RECRUITING","2026-06-19",{"date":35,"type":36},"2026-06-23","ACTUAL",{"date":38,"type":36},"2026-06-12",{"date":40,"type":20},"2028-04-07",{"name":42,"class":43},"Novartis Pharmaceuticals","INDUSTRY",5,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":21,"phases":54,"briefSummary":56,"conditions":57,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":68},"100546929","phase-3-an-extension-study-for-patients-previously-enrolled-in-studies-with-pelabresib-100546929","NCT06401356","An Extension Study for Patients Previously Enrolled in Studies With Pelabresib","An Open-Label, Multicenter, Extension Study for Patients Previously Enrolled in Studies With Pelabresib","Inclusion Criteria:\n\n1. Eligibility for Ongoing Pelabresib Treatment\n\n   * Able to provide signed informed consent, agreeing to all protocol and ICF requirements.\n   * At least 18 years old and legally able to consent in the study's jurisdiction.\n   * Previously enrolled and currently receiving pelabresib in a parent study.\n   * Demonstrating clinical benefit from pelabresib, as judged by the investigator.\n   * Willing and able to follow all study visits, treatments, and procedures.\n   * Agree to avoid pregnancy or fathering children:\n\n     * Men: Must use highly effective contraception (≥99% effective) and avoid sperm donation from eligibility check through 94 days post-treatment.\n     * Women of childbearing potential (WOCBP): Must test negative for pregnancy at eligibility, use highly effective contraception through 184 days post-treatment, undergo regular pregnancy testing, and avoid breastfeeding and oocyte donation during this period.\n     * Women not of childbearing potential (surgically sterile or postmenopausal ≥12 months without other cause) are eligible.\n\n   Note: Women with amenorrhea due to chemo\u002Fradiotherapy are considered WOCBP and must use contraception.\n2. Eligibility for Survival Follow-up\n\n   * Provide signed informed consent, agreeing to all protocol and ICF requirements.\n   * Are at least 18 years old and legally able to consent.\n   * Were previously enrolled in a pelabresib clinical study.\n   * Are willing and able to comply with follow-up procedures.\n\nExclusion Criteria:\n\n1. Eligibility for Ongoing Pelabresib Treatment\n\n   * Legally institutionalized or under judicial protection.\n   * Enrolled in another interventional clinical trial (excluding the parent study).\n   * History of hypersensitivity to pelabresib, its excipients, or similar drugs.\n   * Significant gastrointestinal issues (e.g., active IBD, unresolved nausea\u002Fvomiting\u002Fdiarrhea \\> Grade 1) that may affect drug absorption.\n   * Any medical condition deemed unsuitable by the investigator.\n   * Uncontrolled illness or condition that may compromise safety or protocol compliance.\n   * Received systemic anticancer or investigational treatment (excluding parent study drug or hormonal therapy) within 2 weeks or 5 half-lives before first dose. (Hydroxyurea\u002Fanagrelide allowed up to 24 hours prior.)\n   * Received hematopoietic growth factors or androgenic steroids within 4 weeks before first dose.\n   * Used strong CYP3A4 inhibitors\u002Finducers (e.g., St. John's wort) within 2 weeks before first dose. Use during treatment is prohibited.\n   * Female participants who are pregnant, breastfeeding, or not using required contraception.\n   * Male participants who do not agree to use contraception or refrain from sperm donation as specified.\n   * Unwilling or unable to comply with the study protocol.\n2. Eligibility for Survival Follow-up • They are legally institutionalized or under judicial protection.",{"count":53,"type":20},50,[55],"PHASE3","The purpose of this study is to evaluate the long-term safety and the clinical benefit of pelabresib in patients with hematological and\u002For solid tumor indications or advanced malignancies. Additionally, participants previously enrolled in studies with pelabresib who received placebo or participants who discontinued pelabresib (for any other reason than participating in this extension study), may be enrolled in this extension study to evaluate the survival and leukemia-free survival (for patients with hematological malignancies) or only the Survival Follow-up (for all the other patients).",[58,59,26],"Hematologic Malignancy","Solid Tumor","2026-06-10",{"date":62,"type":36},"2026-06-11",{"date":64,"type":36},"2024-08-13",{"date":66,"type":20},"2027-06-30",{"name":42,"class":43},15,{"id":70,"slug":71,"hasResults":11,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":4,"eligibilityCriteria":75,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":76,"targetDuration":4,"studyType":21,"phases":78,"briefSummary":80,"conditions":81,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":90},"100642344","phase-1-study-of-pm54-in-combination-with-immunotherapy-in-adult-participants-with-advanced-malignancies-100642344","NCT07644039","Study of PM54 in Combination With Immunotherapy in Adult Participants With Advanced Malignancies","A Multicenter, Open-label, Phase 1\u002F2 Safety Run-in and Expansion Study of PM54 in Combination With Immunotherapy Evaluating Safety and Efficacy in Adult Participants Who Were Previously Treated for Advanced Malignancies","Inclusion Criteria:\n\n1. Voluntarily signed and dated written informed consent, obtained before the start of any study-specific procedures.\n2. Adults (greater than or equal to \\[\\>=\\]18 years or legal consenting age, per local regulations), and able to provide free and informed consent for study participation.\n3. Have a pathologically confirmed diagnosis of advanced malignancy.\n4. Have advanced disease, as defined by progressive, relapsed, or metastatic disease that is not amenable to multimodal ablative or excisional treatments with curative intent, according to international guidelines.\n5. Have measurable disease according to RECIST1.1 (or mRECIST v1.1 where applicable).\n6. Have experienced objective disease progression on or following the prior line(s) of systemic therapy, as determined either by (1) RECIST v1.1 or equivalent, or (2) by investigator's assessment of clinical progression of disease together with objective evidence of increased tumor burden even if not meeting criteria for progressive disease per RECIST v1.1 or equivalent.\n7. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1 at screening.\n8. Individuals with central nervous system (CNS) metastases are eligible, as long as all of the following are met:\n\n   1. Asymptomatic or minimally symptomatic and stable, with no worsening symptoms in the 4 weeks prior to start of study intervention.\n   2. Does not require systemic corticosteroids in excess of an equivalent prednisone dose of 5 milligrams per day (mg\u002Fday).\n   3. Has undergone surgery or radiation and recovered of the effects thereof or are undergoing active surveillance for small-volume CNS metastases with no immediate risk of worsening. A minimum of 2 weeks must have elapsed between the end of whole-brain radiation treatment and study intervention.\n   4. Have not had an epileptic seizure within the 4 weeks prior to start of anticancer treatment and are either free of antiepileptics or on a stable dose prescribed as prophylaxis.\n9. Adequate laboratory parameters, as specified below, within 7 days of start of study intervention:\n\n   1. Absolute neutrophil count (ANC) \\>=1.5\\*10\\^9 per liter, platelet count \\>=100\\*10\\^9 per liter, and hemoglobin \\>=9 gram per deciliter (g\u002FdL).\n   2. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than or equal to \\[\\\u003C=\\] 3.0\\*the upper limit of normal (ULN).\n   3. Total bilirubin \\\u003C=1.0\\*ULN; up to 1.5\\*ULN for participants with Gilbert's syndrome.\n   4. Creatinine clearance \\>=30 milliliter per minute (mL\u002Fmin), calculated using the Cockcroft and Gault's formula.\n   5. Serum albumin \\>=3 g\u002FdL. Albumin infusion to increase the blood level in order to fulfill this inclusion criterion is strictly forbidden.\n   6. Creatine kinase \\\u003C=2.5\\*ULN.\n10. Recovered from the effects of any prior surgery or radiation.\n11. No ongoing toxicities from prior anticancer treatment of Grade \\>1 (per National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) verison6.0), except for alopecia and other Grade 2 toxicities that are considered by the investigator to have stabilized\u002Fresolved with sequelae and are not at risk of worsening with study intervention. Residual Grade 1 to 2 toxicities from prior immunotherapy -which may include hypo- or hyperthyroidism, type 1 diabetes, hyperglycemia, and adrenal insufficiency - are allowed, if stable and on a stable dose of replacement therapy as applicable.\n12. Is willing to undergo trial procedures as specified in the protocol, including provision of biologic samples, as well as any study restrictions.\n13. Evidence of non-childbearing status for women of childbearing potential (WOCBP). WOCBP must agree to use a highly effective contraceptive measure during the course of the trial and up to 7 months after the last study intervention infusion. Fertile male participants with WOCBP partners should use condoms during treatment and for 4 months following the last study intervention infusion.\n\nExclusion Criteria:\n\n1. Prior treatment with PM54 or any other ecteinascidin agent, including ecubectedin, trabectedin, and lurbinectedin.\n2. History of hypersensitivity to PM54, pembrolizumab, or any of the inactive ingredients.\n3. History of other malignancies within 3 years prior to start of study intervention, except adequately resected non-melanoma skin cancer or other in-situ disease at neglectable risk of relapse.\n4. Presence of carcinomatous meningitis.\n5. Presence of any of these medical conditions\n\n   Cardiovascular:\n   1. History of myocardial, CNS, or other arterial infarction within 6 months before the start of study intervention.\n   2. Heart failure Class II or higher according to the New York Heart Association or left ventricular ejection fraction \\\u003C45 percent (%) per echocardiogram or multigated acquisition scan.\n   3. Symptomatic arrhythmia or other significant electrocardiogram (ECG) abnormalities that in the opinion of the investigator pose an increased risk of complications.\n   4. Corrected QT interval (QTc) \\>470 milliseconds (ms) on the screening ECG or history of a long QT syndrome.\n\n      Respiratory\n   5. History of interstitial lung disease (ILD) or pneumonitis that have required steroids or other forms of immunosuppression, or any ongoing or suspicion of ILD.\n   6. Severe underlying lung disorder, as per investigator's assessment that can include but not restricted to chronic obstructive pulmonary disease, asthma, restrictive lung disease, or significant pleural effusions not related to the study condition.\n   7. New onset or worsening of pulmonary embolism or deep vein thrombosis within the previous 2 months, or any history thereof if no stable dose of anticoagulant regimen has been achieved.\n\n      Other\n   8. History of autoimmune or connective tissue disease that (a) in the opinion of the investigator may have a significant risk of worsening with study intervention or (b) has a history or risk of significant mg\u002Fday of prednisone equivalent or other systemic immunosuppressants in the previous 1 year to control a disease flare.\n   9. Uncontrolled infection requiring antimicrobial agents or unexplained fever within 3 days of the first scheduled day of dosing. Participants with tumor fever may be enrolled if infectious etiology has been adequately ruled out. j. Prior bone marrow or stem cell transplantation.\n6. Has any other medical, behavioral, or social condition that, in the opinion of the investigator, makes the participant ineligible to receive PM54, pembrolizumab, or undergo key trial procedures.\n7. Exposure to the anticancer products\u002Ftreatments below, without adequate washout period prior to first dose of study intervention. Note that hormonal therapy received for the adjuvant treatment of tumors at a low risk of relapse is allowed.\n\n   Products\u002Ftreatments and washout periods:\n   1. Traditional Chinese or herbal medicine with the intent to treat cancer or with known effects on drug metabolism: 28 days.\n   2. Live, attenuated vaccines: 30 days.\n   3. Chemotherapy: 21 days.\n   4. Antibodies and antidrug conjugates: 28 days.\n   5. Targeted agents and small molecules: 2 weeks or 5 half-lives, whichever is longer.\n   6. Major surgery: 4 weeks. Note: Surgeries typically performed in an outpatient setting are not considered major, even if light sedation or an inpatient stay for oversight was needed.\n   7. Whole-brain radiation therapy, stereotactic therapy, palliative radiation for symptom control and minor impact on bone marrow: 2 weeks.\n   8. Other radiation therapy: 4 weeks.\n   9. Any medication associated with increased risk of torsade de pointes, except if considered indicated by the investigator, ideally for short duration, under medical monitoring and if no other risk factors for torsade de pointes are present such as prolonged QTc or significant electrolyte abnormalities.: 5 half-lives.\n   10. Strong or moderate inhibitors or inducers of cytochrome (CYP) 3A4: 2 weeks.\n   11. Corticosteroids: must be \\\u003C= 10 mg\u002Fday of prednisone equivalent within 3 days of start of study intervention. The investigator is encouraged to review indication for ongoing use of corticosteroids and consider de-escalation or interruption if appropriate.\n8. Active HIV infection. Inclusion is allowed if:\n\n   1. Undergoing adequate anti-viral treatment and regular clinical oversight with good compliance.\n   2. Undetectable human immunodeficiency virus (HIV) viral load.\n   3. CD4+ lymphocyte count over 350 per millimeter cube.\n   4. No evidence or suspicion of opportunistic infection. Note: The investigator should obtain and provide the sponsor with written documentation of the above, assessed by a medical doctor experienced in the management of individuals with HIV.\n9. Individuals with detectable hepatitis C virus (HCV) ribonucleic acid (RNA), which should be tested in case of positive anti-HCV antibody test.\n10. Positive serology test of hepatitis B surface antigen (HBsAg) with hepatitis B virus (HBV) DNA \\>= 1000 International Units per milliliter (IU\u002FmL). Hepatitis B virus (HBV) DNA test is mandatory in case of HBsAg+. Individuals with detectable HBV DNA \\\u003C1000 IU\u002FmL or suspected occult HBV infection must undergo prophylaxis of HBV reactivation in order to be eligible.\n11. Individuals with a short-term risk of anatomic complications from involvement of critical structures such as major vessels, large airways, and vertebral spine.\n12. Women who are pregnant or breastfeeding and fertile participants (men and women) who are not using a highly effective method of contraception (see inclusion criterion No. 13).",{"count":77,"type":20},119,[23,79],"PHASE2","The main purpose of the study is to evaluate the safety, tolerability and recommended dose of PM54 in combination with pembrolizumab. To assess the antitumor activity of PM54 in combination with pembrolizumab in terms of clinical benefit rate (CBR) and objective response rate (ORR) based on investigator's assessment in participants in other cohorts.",[26],"2026-06-08",{"date":38,"type":36},{"date":85,"type":36},"2026-05-21",{"date":87,"type":20},"2029-04-02",{"name":89,"class":43},"PharmaMar",6,{"id":92,"slug":93,"hasResults":11,"nctId":94,"briefTitle":95,"officialTitle":96,"acronym":4,"eligibilityCriteria":97,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":98,"targetDuration":4,"studyType":21,"phases":100,"briefSummary":101,"conditions":102,"keywords":104,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":115},"100625755","phase-1-an-open-label-study-to-evaluate-pf-07994525-in-participants-with-advanced-cancers-100625755","NCT07426757","An Open-Label Study to Evaluate PF-07994525 in Participants With Advanced Cancers","AN OPEN-LABEL PHASE 1 STUDY TO EVALUATE PF-07994525 IN PARTICIPANTS WITH ADVANCED MALIGNANCIES","Inclusion Criteria:\n\n* Participants aged 18 years or older (or the minimum age of consent in accordance with local regulations) at the time of informed consent.\n* Prior diagnosis of MM as defined according to IMWG criteria (Rajkumar et al. 2014)\n\nMeasurable disease based on IMWG criteria as defined by at least 1 of the following:\n\n1. Serum M-protein \\>0.5 g\u002FdL by serum protein electrophoresis (SPEP)\n2. Urinary M-protein excretion \\>200 mg\u002F24 hours by urine protein electrophoresis (UPEP)\n3. Serum immunoglobulin Free Light Chain (FLC) ≥10 mg\u002FdL (≥100 mg\u002FL) AND abnormal serum immunoglobulin kappa to lambda FLC ratio (\\\u003C0.26 or \\>1.65)\n\n   * Participants must be refractory to, or intolerant to, all established therapies known to provide clinical benefit in multiple myeloma that are an appropriate therapeutic option, in the judgement of the investigator. A minimum of 3 prior lines of therapy are required.\n   * Eastern Cooperative Oncology Group (ECOG) performance status 0-1.\n\nExclusion Criteria:\n\n* Active plasma cell leukemia, Smoldering MM, Waldenströms macroglobulinemia, Amyloidosis, POEMS Syndrome.\n* Autologous stem cell transplant within 12 weeks prior to enrollment or active Graft-versus-host disease (GVHD).\n* Active or suspected cerebral\u002Fmeningeal disease related to the underlying malignancy.\n* Any active, uncontrolled bacterial, fungal, or viral infection, including (but not limited to) COVID-19, Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), known HIV or AIDS related illness, unless deemed not clinically significant by the investigator (eg, onychomycosis).",{"count":99,"type":20},120,[23],"This is an open-label, dose escalation and dose expansion study evaluating the safety, tolerability, Pharmacokinetic (PK), Pharmacodynamic (PD), and antitumor activity of PF-07994525 in participants with R\u002FR MM.\n\nThe study will consist of 2 parts: Part 1 (Dose Escalation) will consist of PF-07994525 dose escalation to assess the safety, tolerability, and preliminary antitumor activity in participants with R\u002FR MM. In Part 2 (Dose expansion), PF-07994525 may be evaluated in additional participants with R\u002FR MM to further assess safety, PK, PD, and preliminary anti-tumor activity.",[26,103],"Advanced Cancer",[26,105,103],"Advanced Cancers","2026-05-28",{"date":108,"type":36},"2026-06-01",{"date":110,"type":20},"2026-05-15",{"date":112,"type":20},"2030-07-10",{"name":114,"class":43},"Pfizer",4,{"id":117,"slug":118,"hasResults":11,"nctId":119,"briefTitle":120,"officialTitle":121,"acronym":4,"eligibilityCriteria":122,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":123,"targetDuration":4,"studyType":21,"phases":125,"briefSummary":126,"conditions":127,"keywords":132,"overallStatus":136,"whyStopped":4,"lastUpdateSubmitDate":137,"lastUpdatePostDateStruct":138,"startDateStruct":140,"completionDateStruct":142,"leadSponsor":144,"locationsCount":4},"100631713","phase-1-phase-12a-study-of-rp-001-in-participants-with-advanced-malignancies-100631713","NCT07504263","Phase 1\u002F2a Study of RP-001 in Participants With Advanced Malignancies","An Open-label, Multicenter, Phase 1\u002F2a Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of RP-001 in Participants With Advanced Malignancies","Inclusion Criteria:\n\n* Male or female participants aged 18 years or older with advanced or metastatic cancer, which must be measurable per RECIST v1.1 and satisfy the following criteria:\n\n  * Phase 1: Participants with solid tumors who are candidates for treatment with a taxane\n  * Phase 2a: Participants with relapsed or refractory PDAC, or CRC.\n\nExclusion Criteria:\n\n* 1\\. Active infection requiring systemic anti-infective therapy within 28 days prior to first dose of RP-001.\n\n  2\\. Cardiovascular disease, including:\n\n  a. Unstable angina; b. symptomatic peripheral arterial vascular disease; c. Myocardial infarction within 6 months prior to RP-001 administration; d. New York Heart Association Class III or IV heart failure; e. Uncontrolled arrythmia; f. ECG abnormality that, in the opinion of the Investigator, increases the risks associated with participating in the trial.\n\n  3\\. Concurrent systemic anti-cancer therapy other than luteinizing hormone-releasing hormone (LH-RH) agonists.\n\n  4\\. Pregnancy, or breastfeeding. 5. Untreated central nervous system metastasis, or carcinomatous meningitis. 6. Any concurrent severe and\u002For uncontrolled medical or surgical condition which, in the opinion of the Investigator, may compromise the participant's involvement in the trial due to safety, compliance concerns or ability to evaluate response.",{"count":124,"type":20},66,[23,79],"Phase 1\u002F2a Study of RP-001 in participants with Advanced Malignancies",[26,128,129,130,131],"Oncology","Colorectal Cancer","Pancreatic Cancer","Cancer",[133,134,135],"advanced malignancies","colorectal cancer","pancreatic ductal adenocarcinoma","NOT_YET_RECRUITING","2026-03-25",{"date":139,"type":36},"2026-03-31",{"date":141,"type":20},"2026-04-23",{"date":143,"type":20},"2028-04-01",{"name":145,"class":43},"Recurv Pharma Inc",{"id":147,"slug":148,"hasResults":11,"nctId":149,"briefTitle":150,"officialTitle":151,"acronym":4,"eligibilityCriteria":152,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":153,"targetDuration":4,"studyType":21,"phases":155,"briefSummary":156,"conditions":157,"keywords":161,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":162,"lastUpdatePostDateStruct":163,"startDateStruct":165,"completionDateStruct":167,"leadSponsor":169,"locationsCount":171},"100420291","phase-1-bi-1808-as-a-single-agent-and-with-pembrolizumab-keytruda--in-treatment-of-advanced-malignancieskeynote-d20-100420291","NCT04752826","BI-1808 as a Single Agent and With Pembrolizumab (KEYTRUDA® ) in Treatment of Advanced Malignancies(Keynote-D20)","Phase 1\u002F2a Open-Label, Dose-Escalation, Multicenter, FIH, Consecutive-Cohort, Clinical Trial of BI-1808, a Monoclonal Antibody to TNFR 2 as a Single Agent and in Combination With Pembrolizumab (MK-3475-D20) in Subjects With Advanced Malignancies","Inclusion Criteria:\n\n1. Is willing and able to provide written informed consent for the trial.\n2. Is ≥18 years of age on the day of signing informed consent.\n3. Has a histologically confirmed advanced malignancy. Subjects with CTCL \\[MF or SS\\] who satisfy the Phase 2a, Cohort 3-specific eligibility criteria may be enrolled into the Phase 1 part of the study.\n4. Is intolerant of, refuses, or is not eligible for standard antineoplastic therapy.\n5. Has at least 1 measurable disease lesion as defined by RECIST.\n6. Is able to safely undergo a baseline tumor tissue biopsy prior to first dose of BI-1808 (on non previously irradiated lesions only). The biopsy must be performed at least 4 weeks following the last dose of tumor directed therapy.\n7. Has a life expectancy of ≥12 weeks.\n8. Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.\n9. Has adequate organ function as confirmed by laboratory values.\n\nPhase 2a Expansion Cohort-Specific Inclusion Criteria:\n\nOvarian Cancer:\n\nHistologically confirmed and documented recurrent ovarian, fallopian tube, and peritoneal cancer.\n\nTCL:\n\n1. histologically confirmed diagnosis\n2. Stable doses of systemic steroids (≤20 mg prednisone equivalent) and of low-to-medium potency topical steroids permitted (no change in preceding 4 weeks).\n3. Stage IB-IV with failure of at least 1 systemic therapy.\n4. No current large cell transformation for subjects with CTCL.\n5. Prior therapy - No prior allo hematopoietic stem cell transplantation (HSCT); \\>90 days since auto HSCT; \\>4 weeks since systemic therapy and \\>2 weeks since skin-directed therapy.\n6. Stable doses of systemic steroids (≤20 mg prednisone equivalent) and of low-to-medium potency topical steroids permitted (no change in preceding 4 weeks).\n7. Previous systemic therapies include brentuximab vedotin, bexarotene, extracorporeal photopheresis (ECP), methotrexate, mogamulizumab, romidepsin, vorinostat, or systemic therapy with localized radiation treatment or skin-directed therapy.\n\nMelanoma:\n\n1. Histologically confirmed diagnosis of unresectable or metastatic melanoma.\n\n   Subjects in Part A:\n2. Required prior therapies will include anti-programmed death-ligand 1 (PD-1) therapy either as monotherapy or as part of a combination regimen.\n3. For subjects with a known BRAF V600-activating mutation combination targeted therapy will be required in addition to anti-PD-1\u002Fprogrammed death-ligand 1 (PD-L1) therapy.\n\n   Subjects in part B:\n4. Subjects with prior lines of treatment are not eligible.\n\nAll Tumor Types:\n\nLocally advanced unresectable, recurrent or metastatic immune checkpoint inhibitor-naïve solid tumors, likely to benefit from immune checkpoint inhibitor treatment, based on Investigator opinion.\n\nb. Subjects must have received prior standard therapy appropriate for their tumor type and stage of disease, or in the opinion of the Investigator, would be unlikely to tolerate or derive clinical benefit from appropriate standard of care therapy.\n\nc. Subjects with known activation mutations must have prior target therapy.\n\nExclusion Criteria:\n\n1. Needs doses of prednisolone \\>10 mg daily (or equipotent doses of other corticosteroids) while on the trial other than as premedication.\n2. Has known active central nervous system (CNS) metastases and\u002For carcinomatous meningitis.\n3. Has known or suspected hypersensitivity to BI-1808 or pembrolizumab\n4. Has cardiac or renal amyloid light-chain amyloidosis.\n5. Has received the following:\n\n   1. Chemotherapy or small molecule products within 4 weeks of first dose of BI-1808.\n   2. Radiotherapy within 2 weeks of first dose of BI-1808. A 1-week washout is permitted for palliative radiation (≤2 weeks of radiotherapy) for non-CNS disease. Subjects who have previously had radiation pneumonitis are not allowed.\n   3. Immunotherapy within 4 weeks prior to the first dose of BI-1808.\n6. Has not recovered from AEs to at least Grade 1 by NCI CTCAE\n7. Has had Grade ≥3 autoimmune manifestations of previous immune checkpoint inhibitor treatments (eg, anti-PD-1, anti-PD-L1, or anti-CTLA-4).\n8. Has a history of (noninfectious) pneumonitis that required steroids or has current pneumonitis.\n9. Has an active, known, or suspected autoimmune disease.\n10. Is a female subject and has the ability to become pregnant (or already pregnant or lactating\u002Fbreastfeeding). However, those female subjects who have a negative serum or urine pregnancy test before enrollment and agree to use a highly effective method of birth control for 4 weeks before entering the trial, during the trial, and for 12 months after last dose of BI-1808, are considered eligible.\n11. Is a male subject with partner(s) of childbearing potential (unless he agrees to take measures not to father children by using 1 form of highly effective contraception \\[condom plus spermicide gel\\] during the trial and for 12 months after completing treatment).\n12. Has had major surgery from which the subject has not yet recovered.\n13. Is at high medical risk because of nonmalignant systemic disease including severe active infections on treatment with antibiotics, antifungals, or antivirals.\n14. Has presence of chronic graft versus host disease.\n15. Has had an allogenic tissue\u002Fsolid organ transplant.\n16. Has known human immunodeficiency (HIV) and\u002For history of hepatitis B or C infections, or has a positive test for HIV antibody, hepatitis B antigen\u002Fhepatitis B virus DNA or hepatitis C antibody or RNA.\n17. Has a history of active tuberculosis (Bacillus tuberculosis).\n18. Has received a live vaccine within 30 days before the first dose of study treatment.\n19. Has uncontrolled or significant cardiovascular disease.\n20. Has a known psychiatric or substance abuse disorder that would interfere with the subject's ability to cooperate with the requirements of the trial.\n21. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating Investigator.\n22. Is participating or planning to participate in another interventional clinical trial, or has participated in a trial of an investigational agent or has used an investigational device within 4 weeks prior to first dose of study drug.\n23. Has a known additional malignancy of another type, with the exception of adequately treated cone biopsied carcinoma in situ (eg, breast carcinoma, cervical cancer in situ) and basal or squamous cell carcinoma of the skin. Male subjects with asymptomatic prostate cancer without known metastatic disease and with no requirement for therapy or requiring only hormonal therapy and with normal prostate-specific antigen for \\>1 year prior to start of trial therapy are eligible.\n24. Has a diagnosis of primary or acquired immunodeficiency disorder or taking any other form of immunosuppressive therapy within 7 days prior the first dose of study drug.\n25. Has symptomatic ascites or pleural effusion, requires surgical intervention of additional medication",{"count":154,"type":20},176,[23,79],"The goal of this first in human clinical trial is to test BI-1808 administered as single agent and in combination with pembrolizumab in subjects with advanced malignancies whose disease has progressed after standard therapy.\n\nThe main questions it aims to answer are:\n\n* how safe and tolerable is BI-1808\n* what is maximum tolerated or administrated dose\n* to determine recommended dose for further clinical trials. Participants will receive infusions of BI-1808 alone or combination with pembrolizumab every 3 weeks.\n\nFor the purpose of this study, subjects with advanced malignancies includes subjects with advanced solid tumors and subjects with T-cell lymphoma (TCL),",[26,158,159,160],"Ovarian Cancer","T-cell Lymphoma","Melanoma",[26,159],"2026-02-16",{"date":164,"type":36},"2026-02-18",{"date":166,"type":36},"2021-01-25",{"date":168,"type":20},"2028-01-15",{"name":170,"class":43},"BioInvent International AB",25,{"id":173,"slug":174,"hasResults":11,"nctId":175,"briefTitle":176,"officialTitle":177,"acronym":4,"eligibilityCriteria":178,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":179,"targetDuration":4,"studyType":21,"phases":181,"briefSummary":182,"conditions":183,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":184,"lastUpdatePostDateStruct":185,"startDateStruct":187,"completionDateStruct":189,"leadSponsor":191,"locationsCount":193},"100519016","phase-1-a-study-of-bry812-for-injection-alone-in-subjects-with-advanced-malignancies-100519016","NCT06038058","A Study of BRY812 for Injection Alone in Subjects With Advanced Malignancies","A Phase I Clinical Study of the Safety, Tolerability and Efficacy of BRY812 for Injection in Patients With Advanced Malignancies","Inclusion Criteria:\n\n* (1) Subjects who voluntarily sign the informed consent form, understand the nature, objectives, and procedure of the study and are able to complete the study according to the protocol;\n* (2) Male or female patients, ≥ 18 years of age (based on the date of signing the informed consent form);\n* (3) In Phase Ia: patients must have advanced solid tumors confirmed by histopathology and\u002For cytology, who have failed to respond to standard-of-care (disease progression after treatment) or who could not tolerate standard-of-care, or who could not obtain effective standard-of-care or for whom there was no effective standard-of-care available; (Note: the patient population and inclusion criteria in phase Ib will be determined according to the data of phase Ia);\n* (4) According to RECIST v1.1 (Response Evaluation Criteria in Solid Tumors), there is at least 1 measurable lesion;\n* (5) Eastern Cooperative Oncology Group (ECOG) Status 0 to 1;\n* (6) Adequate organ and bone marrow function (no treatment with cells, growth factors, or transfusions within 14 days prior to the first administration), as defined below:\n\n  1. Hematology: absolute neutrophil count (ANC) ≥ 1.5 × 109\u002FL, platelet count (PLT) ≥ 100 × 109\u002FL, hemoglobin (HGB) ≥ 90 g\u002FL;\n  2. Liver function: serum total bilirubin (TBIL) ≤ 1.5 × upper limit of normal (ULN) (except for subjects with Gilbert syndrome, TBIL ≤ 2 × ULN in patients with liver cancer or liver metastases), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN (in patients with liver cancer or liver metastases, ALT or AST ≤ 5 × ULN);\n  3. Renal function: creatinine (Cr) ≤ 1.5 × ULN or creatinine clearance (CrCL) (based on Cockcroft-Gault equation) ≥ 60 mL\u002Fmin;\n* (7) Expected survival ≥ 12 weeks;\n* (8) Female subjects with fertility potential must test negative for serum human chorionic gonadotropin (HCG) before they are enrolled in the study. Female subjects with fertility potential or male subjects who have a female partner must agree to maintain no pregnancy plan and take effective contraceptive measures such as condoms from the signing of ICF to 6 months after the last dose of study drug (see Annex 1 for details); females are considered fertile from menarche to menopause (at least 12 months without menstruation) unless they are permanently infertile (through hysterectomy, bilateral salpingectomy, or bilateral oophorectomy).\n\nExclusion Criteria:\n\n* (1) Subjects who have previous severe hypersensitivity to BRY812 or known hypersensitivity to any component or excipient of the study drug;\n* (2) Subjects who have previously received drugs which target LIV-1;\n* (3) Subjects who have any active infection requiring systemic therapy by intravenous infusion within 2 weeks prior to the first dose of study drug;\n* (4) Subjects who have previous or current presence of two or more primary tumors (excluding cured cervical carcinoma in situ, basal cell carcinoma, or squamous cell carcinoma of the skin, and other tumors that have been stable for more than 5 years after treatment);\n* (5) Subjects who have symptoms of active central nervous system metastases, except those with brain parenchymal metastases assessed as stable by the investigator based on the following conditions:\n\n  1. No seizures within \\> 12 consecutive weeks with or without the treatment of antiepileptic drugs;\n  2. Glucocorticoids are not required;\n  3. Two consecutive MRI scans (at least 4 weeks apart) show a stable state on imaging;\n  4. Asymptomatic inactive brain metastases are newly identified where two consecutive MRI scans (at least 4 weeks apart) show a stable state on imaging;\n  5. The conditions remain stable and asymptomatic for more than 1 month after treatment;\n* (6) Subjects with serious cardiovascular and cerebrovascular diseases and lung diseases, including but not limited to:\n\n  1. Stroke, intracranial hemorrhage, unstable angina pectoris, congestive heart failure (NYHA class III-IV), myocardial infarction, severe arrhythmias (such as sustained ventricular tachycardia and ventricular fibrillation), congenital long QT syndrome, torsade de pointes, and symptomatic pulmonary embolism within 6 months before enrollment;\n  2. Uncontrolled hypertension (at least 2 consecutive measurements of systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg);\n  3. Echocardiogram (ECHO) or multigated acquisition scan (MUGA) shows left ventricular ejection fraction (LVEF) \\\u003C 50%;\n  4. During the screening period, the mean corrected (by Fridercia's formula) QT interval on three consecutive electrocardiograms is prolonged (\\> 450 ms in males and \\> 470 ms in females);\n  5. Subjects who have interstitial lung diseases, severe impaired lung function, severe pulmonary fibrosis, radiation pneumonitis, and other lung diseases assessed by the investigator as clinically significant;\n* (7) Subjects who have active gastrointestinal bleeding or severe intestinal obstruction;\n* (8) Subjects who have undergone major surgery within 4 weeks prior to the first dose of study drug or are expected to be performed during the study;\n* (9) Subjects who have a history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;\n* (10) Subjects who have bleeding tendency or are receiving thrombolytic or anticoagulant therapy;\n* (11) Subjects who have used strong inhibitors or substrates of CYP3A4 and\u002For Pgp within 4 weeks before the first dosing or within 5 half-lives of the used drug (whichever is shorter), or who have received anti-tumor therapy or participated in other clinical studies and used other study drugs, including chemotherapy, targeted therapy, immunotherapy, biotherapy (tumor vaccines, cytokines, or growth factors for cancer control), etc.; or who have received prepared slices of Chinese crude drugs or Chinese patent medicines as anti-tumor treatment within 1 week before the first dose of study drug;\n* (12) Subjects who have received radiation therapy, including abdominal palliative stereotactic radiotherapy, within 4 weeks prior to the first dose of study drug (non-abdominal palliative stereotactic radiotherapy within 2 weeks prior to the first dose);\n* (13) Toxicity of previous antineoplastic therapy does not resolve to grade ≤ 1 as defined by NCI-CTCAE v5.0 (except for asymptomatic abnormal laboratory findings considered by the investigator, such as elevated ALP, hyperuricemia, elevated blood glucose, etc.; except for toxicity with no safety risk determined by the investigator , such as alopecia, pigmentation, etc.);\n* (14) Subjects who have been vaccinated with a live vaccine within 4 weeks before the first dose, or who intend to be vaccinated with a live vaccine during the study;\n* (15) Subjects who have received more than 1 week of treatment with systemic corticosteroids (methylprednisolone \\> 10 mg\u002Fday or an equivalent dose of other similar drug) within 2 weeks prior to the first dose of study drug;\n* (16) Subjects who have used immunosuppressants within 2 weeks prior to the first dose or once had active autoimmune diseases or had a prior history of autoimmune diseases;\n* (17) Subjects who test positive for Hepatitis B surface antigen (HBsAg) with HBV DNA beyond the normal range; or subjects who test positive for hepatitis B core antibody with HBV DNA beyond the upper limit of normal, but do not agree to regular DNA testing during treatment and follow-up, or do not agree to receive antiviral therapy; subjects who test positive for hepatitis C virus (HCV) antibody and HCV RNA; subjects who are seropositive for human immunodeficiency virus (HIV); subjects who have syphilis and need to receive systemic treatment;\n* (18) Subjects who have any mental or cognitive disorders that may limit their understanding and execution of the informed consent form;\n* (19) Subjects who are pregnant or breastfeeding;\n* (20) Subjects who plan to donate sperm after signing the informed consent form and throughout the study period, or within 6 months after the last dose of the study drug;\n* (21) Subjects who are not eligible for enrollment or may not be able to complete the study due to other reasons by the investigator's assessment.",{"count":180,"type":20},164,[23],"This is a Phase I, multicenter, open-label, single-arm and first-in-human clinical study of BRY812 for injection. The study objectives are to evaluate the safety, tolerability, pharmacokinetic profile, anti-tumor activity and immunogenicity of BRY812 for injection in patients with advanced malignancies.\n\nPatients will receive treatment every 3 weeks until intolerable toxicity, disease progression, pregnancy, withdrawal of informed consent, death, study discontinuation, or withdrawal from the study.",[26],"2025-12-23",{"date":186,"type":36},"2025-12-30",{"date":188,"type":36},"2023-10-10",{"date":190,"type":20},"2028-12",{"name":192,"class":43},"BioRay Pharmaceutical Co., Ltd.",1,{"id":195,"slug":196,"hasResults":11,"nctId":197,"briefTitle":198,"officialTitle":199,"acronym":4,"eligibilityCriteria":200,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":201,"targetDuration":4,"studyType":21,"phases":203,"briefSummary":204,"conditions":205,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":206,"lastUpdatePostDateStruct":207,"startDateStruct":209,"completionDateStruct":211,"leadSponsor":213,"locationsCount":193},"100588174","phase-1-a-study-of-br111-in-patients-with-advanced-malignancies-100588174","NCT06937957","A Study of BR111 in Patients With Advanced Malignancies","A Phase I Study to Investigate the Safety, Pharmacokinetics, Immunogenicity and Efficacy of BR111 for Injection in Patients With Advanced Malignancies","Inclusion Criteria:\n\n1. Willingness to provide written informed consent for the study;\n2. Age ≥ 18 years, male or female; Patients with solid tumors: Patients with histopathologically confirmed advanced solid tumors who are not amenable to surgical resection who have failed standard therapy (i.e., existing therapies with known clinical benefit) (disease progression during or after treatment) or who cannot tolerate standard therapy and are unable to obtain or refuse or have no standard therapy.\n\n   Patients with lymphoma: Patients with histopathologically confirmed relapsed\u002Frefractory B-cell lymphoma who meet the 2016 WHO classification criteria and are indicated for treatment and currently have no other standard treatment as judged by the investigator.\n3. All patients are required to provide tumor samples for biomarker analysis at screening.\n4. ECOG score 0 to 1 .\n5. Life expectancy ≥ 3 months.\n6. Phase Ia dose Escalation: Patients with solid tumors or lymphoma have at least one evaluable lesion at baseline (ie, no measurable lesions) according to RECIST v1.1 or Lugano 2014 criteria; Phase Ia Safety Expansion and Phase Ib: Patients with at least 1 measurable lesion at baseline according to RECISTv1.1 and Lugano 2014 criteria. Lesions previously treated with radiotherapy or intervention should not be considered target lesions unless there is unequivocal progression.\n7. Adequate organ and bone marrow function ；\n8. Female patients of childbearing potential (defined as those who are not surgically sterile with hysterectomy and\u002For bilateral oophorectomy and are not postmenopausal, defined as having amenorrhea ≥ 12 months) must have a negative pregnancy test at entry into this study and must be non-lactating; female patients of childbearing potential or male patients with sexual partners of childbearing potential are willing to use appropriate effective contraceptive measures such as abstinence and double-barrier methods (e.g., condom plus diaphragm), oral contraceptives, and placement of an intrauterine device during the study and for 6 months after the last investigational product.\n9. Able to understand trial requirements and willing and able to comply with trial and follow-up procedures.\n\nExclusion Criteria:\n\nPatients will not be eligible to participate in the study if they meet any of the following exclusion criteria:\n\n1. Has unresolved toxicities from previous anticancer therapy, defined as toxicities not yet resolved to NCI CTCAE 5.0, Grade ≤1 or baseline（except for alopecia, pigmentation, or other toxicities judged by the investigator to have no safety risk）；\n2. Known history of allergy or delayed allergic reactions to BR111 for Injection and its components and considered severe by the investigator;\n3. Prior use of eribulin, or the treatments or clinical trials based on eribulin , or prior use of drugs or clinical trials targeting ROR1;\n4. Primary central nervous system malignancy or invasion of the central nervous system (Patients with CNS invasion may be considered for enrollment if they are untreated but asymptomatic, or with CNS metastases that have been radiologically documented to be progression-free for at least 4 weeks and require no treatment for at least 4 weeks). ;\n5. Patients with bacterial, viral, fungal, mycobacterial, parasitic or other infections within 14 days before the first dose and requiring intravenous infusion therapy (except for neoplastic fever);\n6. Patients with a history of (non-infectious) interstitial lung disease\u002Fpneumonia requiring steroid therapy, or current interstitial lung disease\u002Fnon-infectious pneumonia, or suspected interstitial lung disease\u002Fnon-infectious pneumonia that cannot be excluded by imaging at screening; radiation pneumonitis patients without clinical symptoms after 3 months of radiotherapy can be enrolled;\n7. Advanced malignant tumor complications resulting in quiescent dyspnea or current need for continuous oxygen therapy;\n8. Patients with moderate to severe lung diseases that have clinically significant impact on lung function, including but not limited to pulmonary embolism, severe asthma, severe chronic obstructive pulmonary disease, idiopathic pulmonary fibrosis, or previous pneumonectomy within 3 months before enrollment;\n9. Peripheral neuropathy of Grade ≥ 2 (refer to NCI CTCAE 5.0) ;\n10. Accompanied by severe cardiovascular and cerebrovascular diseases or other serious organic diseases, including but not limited to:\n\n    * Stroke, intracranial hemorrhage, unstable angina pectoris, congestive heart failure (NYHA Class III-IV), myocardial infarction, severe arrhythmia (such as sustained ventricular tachycardia, ventricular fibrillation), congenital long QT syndrome, torsades de pointes, etc. within 6 months prior to the first dose;\n    * Left ventricular ejection fraction LVEF \\\u003C 50% by echocardiography (ECHO) or multiple-gated acquisition (MUGA) scan;\n    * Mean corrected QT interval prolongation \\> 470 ms in 3 consecutive ECGs during the screening period, and QT interval correction (QTcF) is performed using the F ridercia formula;\n    * Grade ≥3 hypertension that cannot be stably controlled (refer to NCI CTCAE 5.0);\n    * Known inherited or acquired bleeding disorders or significant coagulation abnormalities (e.g., disseminated intravascular coagulation (DIC), autoimmune anemia, etc.)\n11. Complete intestinal obstruction before the first dose, or pericardial effusion with clinical symptoms requiring drainage, or pleural and peritoneal effusion, or skin lesions that are difficult to heal, recurrent episodes of any cause, and\u002For nonhealing ulcers (except for cancerous ulceration);\n12. Patients with previous or suspected serious skin conditions prior to first dose, including but not limited to bullous or exfoliative dermatitis, erythema multiforme, toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome (SJS), and drug reaction with eosinophilia and systemic symptoms (DRESS);\n13. Patients with immunodeficiency or active autoimmune diseases (except those with immune-related adverse reactions caused by previous application of immune checkpoint inhibitors that are relieved or stabilized at grade 1 after treatment) or requiring systemic steroid therapy. For patients with solid tumors: systemic corticosteroids at doses \\> 10 mg\u002Fday prednisone or equivalent hormone for more than 1 week within 14 days prior to first dose; for patients with lymphoma: systemic corticosteroids at doses \\> 20 mg\u002Fday prednisone or equivalent hormone for more than 1 week within 14 days prior to first dose ;\n14. Any other malignancy within 3 years (except basal cell carcinoma of the skin that has been radically treated and has not recurred, squamous cell carcinoma of the skin, superficial bladder cancer, localized prostate cancer, cervical cancer in situ, ductal carcinoma in situ of the breast, and malignancies that have been cured (CR) within 2 years prior to the first dose and judged by the investigator to be in stable disease status with minimal risk of recurrence);\n15. HIV virus test positive; syphilis infection requiring systemic treatment; HCVAb positive with HCV RNA titer above the upper limit of normal detected at the same time; Patients with solid tumors: HBsAg positive with HBV DNA ≥ 500 IU\u002FmL at the same time; Patients with lymphoma: HBsAg positive or HBcAb positive, simultaneous HBV DNA ≥ 500 IU\u002FmL;\n16. Participated in other clinical trial treatment within 4 weeks prior to the first dose (i.e., within 4 weeks from the last clinical trial drug\u002Fdevice treatment); Note: If the human half-life of the investigational product is clearly known, there should be an interval of at least 4 weeks or 5 half-lives (whichever is shorter) between the patient's previous clinical trial medication and the first dose of BR111;\n17. Major surgery or serious trauma within 4 weeks prior to the first dose that has not fully recovered or surgery is expected during the trial ;\n18. Received anti-tumor therapy such as radiotherapy and targeted therapy within 4 weeks prior to the first dose of study drug, as well as the following:\n\n    Received nitrosoureas (e.g., carmustine, romosustine, etc.) or mitomycin C within 6 weeks before the first dose; palliative radiotherapy for bone metastases or local radiotherapy for pain relief within 2 weeks before the first dose; chemotherapy, small molecule targeted drugs, endocrine therapy, or fluorouracil within 2 weeks before the first dose, but patients with prostate cancer are allowed to continue luteinizing hormone-releasing hormone (LHRH) agonist\u002Fantagonist therapy during the study; and traditional Chinese medicines or modern traditional Chinese medicine preparations with anti-tumor indications within 2 weeks before the first dose;\n19. Previous allogeneic hematopoietic stem cell transplantation or solid organ transplantation or autologous hematopoietic stem cell transplantation less than 3 months before the first dose or CAR-T cell therapy less than 3 months before the first dose;\n20. Any mental or cognitive impairment that may limit their understanding and execution of the informed consent form;\n21. Other serious, uncontrolled concomitant diseases that may affect protocol compliance or interfere with the results or other serious or uncontrollable disease conditions that, in the opinion of the investigator, may pose a risk to the patient by participating in this study.",{"count":202,"type":20},166,[23],"This is a Phase I, multicenter, open-label, single-arm and first-in-human clinical study of BR111-101 for injection. The study objectives are to evaluate the safety, tolerability, pharmacokinetic profile, anti-tumor activity and immunogenicity of BR111-101 for injection in patients with advanced malignancies.",[26],"2025-11-18",{"date":208,"type":36},"2025-11-21",{"date":210,"type":36},"2025-04-24",{"date":212,"type":20},"2027-12-31",{"name":192,"class":43},{"id":215,"slug":216,"hasResults":11,"nctId":217,"briefTitle":218,"officialTitle":219,"acronym":4,"eligibilityCriteria":220,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":221,"enrollmentInfo":222,"targetDuration":4,"studyType":21,"phases":224,"briefSummary":225,"conditions":226,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":227,"lastUpdatePostDateStruct":228,"startDateStruct":230,"completionDateStruct":232,"leadSponsor":234,"locationsCount":193},"100571256","phase-1-a-study-of-ibi363-in-combination-with-bevacizumab-or-furuitinib-in-subjects-with-advanced-colorectal-cancer-100571256","NCT06717880","A Study of IBI363 in Combination With Bevacizumab or Furuitinib in Subjects With Advanced Colorectal Cancer","Phase I Study to Evaluate the Safety, Tolerability and Efficacy of IBI363 in Combination With Bevacizumab or Furuitinib in Subjects With Advanced Colorectal Cancer","Inclusion Criteria:\n\n1. Sign written informed consent and be able to comply with the program's visit schedule and related procedures.\n2. Male or female subjects, age 18\\~75 years.\n3. Histologically or cytologically confirmed advanced colorectal cancer.\n4. Subjects who have progressed on standard therapy, who are unsuitable for standard therapy, who do not have standard therapy, or who have refused standard therapy.\n5. Adequate organ function.\n6. At least one measurable lesion (target lesion) per RECIST v1.1.\n7. Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1.\n8. Life expectancy of 3 months or more.\n9. Female subjects of childbearing age or male subjects whose partners are female subjects of childbearing age agree to strictly adopt effective contraceptive measures throughout the entire treatment period and 6 months after the treatment period.\n\nExclusion Criteria:\n\n1. Women who are pregnant or lactating, or intending to become pregnant before, during, or within 6 months after the last dose of study drug.\n2. Active epileptic seizures or active central nervous system (CNS ) metastases and so on.\n3. Clinically significant cardiovascular or cerebrovascular disease.\n4. Interstitial pneumonia, pulmonary fibrosis, pneumoconiosis, drug-associated pneumonia, and radiation pneumonitis requiring steroid hormone or other therapy, as well as history of severe abnormal lung function or other forms of restrictive lung disease.\n5. History of allergies, asthma, atopic dermatitis.\n6. Subjects with large amounts of pleural effusion or ascites.\n7. Active autoimmune disease requiring systemic therapy within 2 years prior to first dose.\n8. Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation.\n9. Subjects with known or suspected hypersensitivity to the study drug and any excipients.\n10. Subject has a prior history of significant toxicity associated with immune checkpoint inhibitor administration or Bevacizumab that requires permanent discontinuation.\n11. Subjects with unresolved \\> Grade 1 toxicity associated with any prior antineoplastic therapy, with the exception of persistent Grade 2 alopecia, peripheral neuropathy and so on.\n12. Active uncontrolled bleeding or known bleeding tendency.\n13. Any major surgery within 4 weeks prior to the first dose of study drug.\n14. Known positive Human Immunodeficiency Virus (HIV) test, active hepatitis B, hepatitis C (HCV), tuberculosis.\n15. Severe\u002Factive\u002Funcontrolled infection, infection requiring systemic intravenous antibiotic therapy, or unexplained fever within 2 weeks prior to the first dose of study drug.\n16. Diagnosis of another malignancy within 5 years prior to the first dose, exceptions include radically treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and\u002For radically resected carcinoma in situ, as well as post-radical localized prostate cancer, and papillary thyroid cancer.\n17. Presence of any disease, treatment or laboratory test abnormality, or history or current evidence of substance abuse that, in the judgment of the investigator, may compromise the safety of the subject, interfere with obtaining informed consent, affect subject compliance, or compromise the safety evaluation of the study drug.","75 Years",{"count":223,"type":20},260,[23],"A Phase 1 study of IBI363 in combination with Bevacizumab or Furuitinib in Subjects with Advanced Colorectal Cancer",[26],"2025-02-08",{"date":229,"type":36},"2025-02-12",{"date":231,"type":36},"2023-07-28",{"date":233,"type":20},"2026-07-31",{"name":235,"class":236},"Union Hospital, Tongji Medical College, Huazhong University of Science and Technology","OTHER",{"id":238,"slug":239,"hasResults":11,"nctId":240,"briefTitle":241,"officialTitle":242,"acronym":4,"eligibilityCriteria":243,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":244,"targetDuration":4,"studyType":21,"phases":246,"briefSummary":247,"conditions":248,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":249,"lastUpdatePostDateStruct":250,"startDateStruct":252,"completionDateStruct":254,"leadSponsor":256,"locationsCount":193},"100412499","phase-1-a-clinical-study-of-mil95-in-advanced-malignancies-100412499","NCT04651348","A Clinical Study of MIL95 in Advanced Malignancies.","A Phase I Clinical Study of Recombinant Humanized Monoclonal Antibody MIL95 Injection in the Treatment of Lymphomas and Advanced Malignant Solid Tumors","Inclusion Criteria:\n\n1. Adult patients, \\>=18 years of age;\n2. Diagnosis of Refractory\u002Frelapsed lymphomas or solid tumor;\n3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;\n4. Life expectancy \\>=3 months;\n5. Sufficient organ and bone marrow function;\n6. At least one measurable lesion or evaluable lesion (recist v1.1 or Lugano 2014);\n7. Able and willing to provide written informed consent and to comply with the study protocol.\n\nExclusion Criteria:\n\n1. Prior use of any anti-cancer therapy(including chemotherapy, radiotherapy, targeted therapy, immunotherapy, etc) within 4 weeks of study start;\n2. Previous exposure to any drug targeting CD47 or SIRPα;\n3. Major surgery within 4 weeks prior to the first administration or expected to undergo major surgery during the study treatment;\n4. Live attenuated vaccine administrated within 4 weeks before the first administration or during the study period;\n5. Central nervous system metastasis;\n6. History of other primary malignant tumors in 5 years;\n7. Evidence of significant, uncontrolled concomitant disease;\n8. Infection with human immunodeficiency virus (HIV), hepatitis B or hepatitis C(including HBsAg,HBcAb positive with abnormal HBV DNA or HCV RNA );\n9. Active or suspected autoimmune diseases;\n10. Females of childbearing potential (FCBP) must agree to use two reliable forms of contraception simultaneously or to practice complete abstinence from heterosexual contact during the following time periods related to this study: 1) while participating in the study; 2) for at least 12 months after discontinuation of all study treatments;\n11. Known history of hemolytic anemia;\n12. Known severe allergic reaction or\u002Fand infusion reaction to monoclonal antibody.",{"count":245,"type":20},58,[23],"This study is composed of two stages: Part A initial dose escalation and Part B maintenance dose escalation. Both parts will adopt the classical 3+3 dose escalation design.\n\nThe starting dose for phase Ia part A is 0.1 mg\u002Fkg QW, followed by 3 dose cohorts (0.3mg\u002Fkg QW, 0.8mg\u002Fkg QW and 1mg\u002Fkg QW). Duration of dose limiting toxicity (DLT) observation is 14 days.\n\nPart B will have 5 dose cohorts(3mg\u002Fkg QW, 10mg\u002Fkg QW, 20mg\u002Fkg QW 30mg\u002Fkg QW and 45mg\u002Fkg QW). DLT observation period is 28 days. The subject number for each cohort in Part B will be increased to 6 if the subject number enrolled in each cohort is less than 6.",[26],"2024-11-19",{"date":251,"type":36},"2024-11-20",{"date":253,"type":36},"2021-01-04",{"date":255,"type":20},"2024-11",{"name":257,"class":43},"Beijing Mabworks Biotech Co., Ltd.",{"id":259,"slug":260,"hasResults":11,"nctId":261,"briefTitle":262,"officialTitle":263,"acronym":4,"eligibilityCriteria":264,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":221,"enrollmentInfo":265,"targetDuration":4,"studyType":21,"phases":267,"briefSummary":268,"conditions":269,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":270,"lastUpdatePostDateStruct":271,"startDateStruct":273,"completionDateStruct":275,"leadSponsor":277,"locationsCount":193},"100552054","phase-1-a-study-of-ibi363-in-subjects-with-advanced-malignancies-100552054","NCT06468098","A Study of IBI363 in Subjects With Advanced Malignancies","Phase Ib Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of IBI363 Combination Therapy in Subjects With Advanced Malignancies","Inclusion Criteria:\n\n1. Sign written informed consent and be able to comply with the program's visit schedule and related procedures.\n2. Male or female subjects, age 18\\~75 years.\n3. Histologically or cytologically confirmed advanced malignancy.\n4. Subjects who have progressed on standard therapy, who are unsuitable for standard therapy, who do not have standard therapy, or who have refused standard therapy. For particular cohort, subjects who have not received prior systemic therapy for advanced disease.\n5. At least one measurable lesion (target lesion) per RECIST v1.1.\n6. Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1.\n7. Life expectancy of 3 months or more.\n8. Female subjects of childbearing age or male subjects whose partners are female subjects of childbearing age agree to strictly adopt effective contraceptive measures throughout the entire treatment period and 6 months after the treatment period.\n\nExclusion Criteria:\n\n1. Women who are pregnant or lactating, or intending to become pregnant before, during, or within 6 months after the last dose of study drug.\n2. Active or untreated CNS metastases confirmed by imaging evaluation during screening or previous imaging evaluation. Patients with asymptomatic brain metastases may participate in this study.\n3. History of active thrombosis or deep vein thrombosis or pulmonary embolism within 4 weeks prior to the first dose of study drug.\n4. Clinically significant cardiovascular or cerebrovascular disease.\n5. Interstitial pneumonia, pulmonary fibrosis, pneumoconiosis, drug-associated pneumonia, and radiation pneumonitis requiring steroid hormone or other therapy, as well as history of severe abnormal lung function or other forms of restrictive lung disease.\n6. History of allergies, asthma, atopic dermatitis.\n7. Concomitant pleural or pericardial effusion requiring repeated drainage or with significant symptoms.\n8. Active autoimmune disease requiring systemic therapy within 2 years prior to first dose.\n9. Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation.\n10. Subjects with known or suspected hypersensitivity to the study drug and any excipients.\n11. Subject has a prior history of significant toxicity associated with immune checkpoint inhibitor administration that requires permanent discontinuation.\n12. Subjects with unresolved \\> Grade 1 toxicity associated with any prior antineoplastic therapy, with the exception of persistent Grade 2 alopecia, peripheral neuropathy, hypomagnesemia, and toxicities that are not expected to be reversible but are stably controlled by medications (e.g., hypothyroidism stably controlled by substitution therapy, hypertension stably controlled by antihypertensive medications with a BP of less than 160\u002F100 mmHg).\n13. Inadequate recovery from previous surgery or any major surgery within 4 weeks prior to the first dose of study drug.\n14. Active uncontrolled bleeding or known bleeding tendency.\n15. Subject has a current or recent (within 6 months) major gastrointestinal disease or condition.\n16. Subjects with uncontrolled tumor-related pain or symptomatic hypercalcemia.\n17. Known positive HIV test, active hepatitis B, hepatitis C (HCV), tuberculosis.\n18. Severe\u002Factive\u002Funcontrolled infection, infection requiring systemic intravenous antibiotic therapy, or unexplained fever within 2 weeks prior to the first dose of study drug.\n19. Diagnosis of another malignancy within 5 years prior to the first dose, exceptions include radically treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and\u002For radically resected carcinoma in situ, as well as post-radical localized prostate cancer, and papillary thyroid cancer.\n20. Exclusion of contraindications to combination medications including, but not limited to: known contraindications to irinotecan therapy for the combination irinotecan or liposomal irinotecan cohort including, but not limited to: having the UGTA1\\*6\u002F\\*6, UGT1A1\\*28\u002F\\*28, or UGT1A1\\*6\u002F\\*28 genotypes; history of prior pelvic and abdominal radiotherapy.\n21. Presence of any disease, treatment or laboratory test abnormality, or history or current evidence of substance abuse that, in the judgment of the investigator, may compromise the safety of the subject, interfere with obtaining informed consent, affect subject compliance, or compromise the safety evaluation of the study drug.\n22. Mental illness, presence of altered mental status, or substance abuse that prevents understanding of the informed consent process and\u002For completion of necessary study-related evaluations.\n23. For known or foreseeable reasons, the Investigator believes that the subject is unable to fulfill the requirements of the protocol.",{"count":266,"type":20},556,[23],"This is an open-label, multicenter Phase Ib study to evaluate the safety, tolerability, and efficacy of IBI363 in advanced malignancies patients",[26],"2024-07-16",{"date":272,"type":36},"2024-07-18",{"date":274,"type":36},"2024-06-15",{"date":276,"type":20},"2026-12-31",{"name":278,"class":43},"Innovent Biologics (Suzhou) Co. Ltd.",{"id":280,"slug":281,"hasResults":11,"nctId":282,"briefTitle":283,"officialTitle":284,"acronym":4,"eligibilityCriteria":285,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":221,"enrollmentInfo":286,"targetDuration":4,"studyType":21,"phases":288,"briefSummary":289,"conditions":290,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":293,"lastUpdatePostDateStruct":294,"startDateStruct":296,"completionDateStruct":298,"leadSponsor":300,"locationsCount":302},"100531627","phase-1-a-study-of-tqb2930-for-injection-monotherapy-or-combination-therapy-in-patients-with-recurrentmetastatic-breast-cancer-100531627","NCT06202261","A Study of TQB2930 for Injection Monotherapy or Combination Therapy in Patients With Recurrent\u002FMetastatic Breast Cancer","A Phase Ib\u002FII Clinical Trial to Evaluate the Safety and Efficacy of TQB2930 for Injection Monotherapy or in Combination for the Treatment of Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Recurrent \u002F Metastatic Breast Cancer","Inclusion Criteria:\n\n* Age: 18-75 years old; Eastern Cooperative Oncology Group Performance Status (ECOG PS) score: 0\\~1; The expected survival is over 3 months.\n* Phase Ib\n\n  1. Advanced malignancies confirmed by cytology \u002F histopathology, priority given to subjects with HER2 expression or amplification;\n  2. Subjects with malignant tumors who have failed standard treatment or lack effective treatment;\n  3. Confirmed presence of at least one evaluable lesion according to RECIST 1.1 criteria\n* Phase II\n\n  1. Hormone receptor (HR)-negative, HER2-positive breast cancer confirmed by cytology \u002F histopathology, with evidence of local recurrence or distant metastasis, unsuitable for surgery or radiotherapy for curative purposes:\n  2. Have not received systemic antitumor therapy for metastatic stage; Systemic use of endocrine therapy is permitted, but not exceed 2 lines;\n  3. at least one measurable lesion that meets the RECIST 1.1 criteria.\n* Major organs are functioning normally.\n* Female subjects of reproductive age should agree to use contraceptive methods during the study period and until 6 months after the end of the study; Negative serum pregnancy \u002F urine pregnancy test within 7 days prior to study enrollment and must be non-lactating subjects; Male subjects should agree to use contraception during the study and until six months after the end of the study.\n\nExclusion Criteria:\n\n* Have occured other malignant tumors within 3 years prior to first dose.\n* Unalleviated toxicity above Common Terminology Criteria for Adverse Events (CTCAE) grade 1 due to any prior treatment;\n* Received major surgical treatment, open biopsy, or significant traumatic injury within 28 days prior to the first dose;\n* Long-term unhealed wounds or fractures;\n* Arterial\u002Fvenous thrombosis events occurred within 6 months before the first dose;\n* Have a history of psychotropic drug abuse and can't get rid of it or have mental disorders;\n* Subject with any severe and\u002For uncontrolled disease;\n* Subjects who have been treated with other antitumor agents such as chemotherapy, radiotherapy, or immunotherapy within 4 weeks prior to the first dose, within 5 half-lives of the drug;\n* Have used traditional chinese medicine with anti-tumor indications approved by National Medical Products Administration (NMPA) within 2 weeks before the first dose;\n* Severe bone injury due to bone metastasis;\n* Subjects with untreated active brain metastases or meningeal metastases or cancerous meningitis;\n* In the course of previous HER2-targeted therapy, Left Ventricular Ejection Fractions (LVEF) decreased to \\\u003C50% or absolute LVEF decreased \\>15%;\n* Cumulative doses of anthracyclines exceeded doxorubicin or doxorubicin liposomes \\>360 mg\u002Fm2;\n* Uncontrolled hypercalcemia or symptomatic hypercalcemia requires continued bisphosphonate therapy\n* Patients with severe hypersensitivity after the use of monoclonal antibodies;\n* Has participated in other antitumor clinical trials within 4 weeks prior to the first dose.",{"count":287,"type":20},154,[23,79],"This is a phase Ib\u002FII exploratory study. Phase Ib includes the dose escalation and expansion study of monotherapy, as well as the dose escalation study of combination therapy. After determining the maximum tolerated dose (MTD), a dose expansion study is conducted to observe the safety and efficacy in monotherapy. Phase II study is to further observe the safety and efficacy of TQB2930 combined with albumin-paclitaxel (cohort 3), or chemotherapy selected by investigators (cohort 4).",[291,292,26],"Metastatic Breast Cancer","Recurrent Breast Cancer","2024-03-10",{"date":295,"type":36},"2024-03-12",{"date":297,"type":36},"2023-04-13",{"date":299,"type":20},"2027-10",{"name":301,"class":43},"Chia Tai Tianqing Pharmaceutical Group Co., Ltd.",2,{"id":304,"slug":305,"hasResults":11,"nctId":306,"briefTitle":307,"officialTitle":308,"acronym":4,"eligibilityCriteria":309,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":310,"targetDuration":4,"studyType":21,"phases":312,"briefSummary":313,"conditions":314,"keywords":4,"overallStatus":136,"whyStopped":4,"lastUpdateSubmitDate":315,"lastUpdatePostDateStruct":316,"startDateStruct":318,"completionDateStruct":320,"leadSponsor":322,"locationsCount":4},"100531985","phase-1-phase-i-study-of-xz120-in-malignant-tumors-100531985","NCT06206915","Phase I Study of XZ120 in Malignant Tumors","To Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of XZ120 in Patients With Malignant Tumors in a Phase Ⅰ Clinical Trial","Inclusion Criteria:\n\n1. male or female aged ≥18 years old;\n2. The enrolled population was divided into the first part of monotherapy and the second part of combination therapy:\n\n   The first part of the monotherapy study was as follows:\n\n   A: single drug dose escalation is confirmed by histology and cytology and received a standard after treatment failure or intolerance to standard treatment or for other reasons can not accept standard or the lack of effective treatment of patients with late malignant tumor; B:Single-agent dose expansion: patients with histologically or cytologically confirmed advanced breast cancer who are eligible for standard anthracycline monotherapy;\n\n   The second part of the combination therapy dose expansion phase consists of the following cohorts:\n\n   Cohort 1: the pathology diagnosed patients with DLBCL treated first; Cohort 2: Histologically or cytologically confirmed advanced breast cancer patients eligible for anthracycline-based standard therapy;\n\n   Note: The patients with advanced breast cancer met any of the following criteria: ① Initially diagnosed as inoperable locally advanced or metastatic breast cancer; (2) did not receive chemotherapy after the eradicative resection of recurrent or metastatic breast cancer; ③ Recurrent or metastatic breast cancer after receiving anthracyclines for more than 12 months;\n3. subjects with at least one measurable and evaluable target lesion were enrolled in the dose-expansion phase;\n4. patients with ECOG performance status score of 0-1;\n5. dose extension stage lymphoma patients international prognostic index (IPI) score of 0 \\~ 2 points;\n6. the researchers determine subjects were expected to survive a period of 3 months or more;\n7. heart echocardiography measured LVEF 50% or higher;\n8. important organ function meet the following requirement (first dose not allowed within 2 weeks before blood transfusion treatment, and use the growth factors of drug) : Blood routine: absolute neutrophil count (ANC) ≥1.5×109\u002FL; The platelet count 75 x 109 \u002F L or higher; Hemoglobin (Hb) ≥90g\u002FL; Liver function: aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≤2.5×ULN, total bilirubin (TBIL) ≤1.5×ULN; If there is liver metastasis, AST and ALT≤5×ULN, TBIL≤3×ULN; Renal function: serum creatinine (Cr) \\\u003C1.5×ULN or creatinine clearance ≥50mL\u002Fmin (Cr≥1.5×ULN); coagulation function: international standardization ratio (INR) 1.5 x ULN or less and part activated clotting time (APTT) live enzymes acuities were 1.5 x ULN;\n9. understand the procedure and content of the trial and sign the informed consent form voluntarily.\n\nExclusion Criteria:\n\n1. always use too much Doxorubicin (or pirarubicin) \\> total cumulative dose of 360 mg\u002Fm2, or epirubicin total cumulative quantity \\> 600 mg\u002Fm2;\n2. patients received antineoplastic therapy 4 weeks before the first dose or within 5 half-lives of the drug, whichever was less; Patients who received a modern traditional Chinese medicine preparation with anti-tumor effect approved by NMPA within 2 weeks before the first medication;\n3. Prednisone acetate tablets at a maximum dose of \\>100mg or equivalent cortisol for more than 5 days for the purpose of controlling lymphoma symptoms in patients with lymphoma; For other purposes, use of prednisone acetate tablets at a dose of \\>30mg per day or a cortisol equivalent for more than 10 days (for patients receiving ≤30mg per day of prednisone acetate tablets or a cortisol equivalent, there was a written record of stable use of the dose for at least 4 weeks before randomization);\n4. patients with high-grade B-cell lymphoma;\n5. the toxicity of previous antineoplastic therapy has not recovered to ≤ grade 1 according to CTCAE version 5.0 definition (except alopecia);\n6. patients with other malignant tumors within 5 years before enrollment, except for the following: (1) radical cervical carcinoma in situ or non-melanoma skin cancer; (2) second primary cancer after radical resection without recurrence within 5 years; (3) The investigators thought that both patients with double primary cancers might benefit from this study; (4) if the metastatic lesion was clearly excluded from the primary tumor;\n7. primary central nervous system (CNS) malignant tumor, CNS metastasis failed by local treatment, and carcinomatous meningitis; Patients with asymptomatic brain metastases or clinically stable neurological symptoms and no need for steroids and other treatments for brain metastases for more than 4 weeks were eligible for enrollment.\n8. patients with a history of organ or allogeneic bone marrow transplantation or autologous stem cell transplantation within 3 months before the first dose;\n9. patients who underwent major surgery within 4 weeks before the first dose or minor surgery within 2 weeks before the first dose or who have not recovered from surgery (excluding diagnostic surgery);\n10. hepatitis b: HBsAg positive and\u002For HBcAb positive, and HBV DNA drop degree is higher than 2000 iu\u002FmL or 104 copies\u002FmL (hepatitis b virus infection should receive antiviral treatment according to local standard treatment guidelines and willing to accept the antiviral treatment) during the whole research; C: HCV antibody positive, and HCV RNA upper limit of normal value is higher than research center;\n11. human immunodeficiency virus antibody (Anti-HIV) positive and active syphilis infection;\n12. patients with uncontrolled or severe cardiovascular disease, congestive heart failure (NYHA class Ⅱ or above), unstable angina pectoris, myocardial infarction and other cardiovascular diseases within 6 months before the first drug administration; Patients with uncontrolled hypertension (systolic blood pressure ≥180mmHg and\u002For diastolic blood pressure ≥100mmHg);\n13. has the following patients medical history, including but not limited to active autoimmune diseases, active infection (such as active tuberculosis), severe mental illness, serious endocrine diseases such as serious abnormal thyroid function;\n14. for the first time to give medicine have received within 4 weeks before any other clinical trial drug\u002Finstruments treatment;\n15. with a history of drug abuse or alcohol abuse within 6 months before the first drug administration;\n16. patients with a history of severe allergy or known previous allergy to anthracyclines or anthradiones, or to any component of the investigational drug;\n17. planning to receive live or live attenuated vaccine within 4 weeks before the first dose or during the study;\n18. pregnancy or lactation women, women of childbearing age subjects or partner for women of child-bearing age male subjects to study period, and at the end of the study medication use medical certification within six months after effective contraceptive measures (such as intrauterine device or a condom);\n19. the researchers determine doesn't fit into the group.",{"count":311,"type":20},123,[23],"This research includes two parts: the first part of the patients with late malignant tumor monotherapy study, at the beginning of the second part in treat DLBCL and research on combination therapy in patients with advanced breast cancer.\n\nResearch purpose: to evaluate XZ120 safety, tolerability, for the treatment of malignant tumor patients pharmacokinetic characteristics and preliminary effectiveness.",[26],"2024-01-04",{"date":317,"type":36},"2024-01-16",{"date":319,"type":20},"2024-02-01",{"date":321,"type":20},"2027-02-01",{"name":323,"class":43},"Shandong New Time Pharmaceutical Co., LTD"]