[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"PharmaMar\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":84},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,41,63],{"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":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100642344","phase-1-study-of-pm54-in-combination-with-immunotherapy-in-adult-participants-with-advanced-malignancies-100642344",false,"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).","ALL","18 Years",{"count":19,"type":20},119,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE1","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.",[27],"Advanced Malignancies","RECRUITING","2026-06-08",{"date":31,"type":32},"2026-06-12","ACTUAL",{"date":34,"type":32},"2026-05-21",{"date":36,"type":20},"2029-04-02",{"name":38,"class":39},"PharmaMar","INDUSTRY",6,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":48,"targetDuration":4,"studyType":21,"phases":50,"briefSummary":51,"conditions":52,"keywords":54,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":55,"lastUpdatePostDateStruct":56,"startDateStruct":58,"completionDateStruct":60,"leadSponsor":62,"locationsCount":5},"100503922","phase-1-clinical-trial-of-pm54-in-advanced-solid-tumors-patients-100503922","NCT05841563","Clinical Trial of PM54 in Advanced Solid Tumors Patients.","Phase I\u002FIb, Open-label, Dose-escalating, Clinical and Pharmacokinetic Study of PM54 Administered Intravenously to Patients With Selected Advanced Solid Tumors.","Inclusion Criteria:\n\n1. Voluntarily signed and dated written informed consent, obtained prior to any specific study procedure.\n2. Age ≥18 years.\n3. Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤1.\n4. Phase Ia (dose escalation) stage: patients must have:\n\n   1. Pathologically confirmed diagnosis of advanced solid tumors for whom no standard therapy exists:\n\n      * Genitourinary tract tumors: urothelial carcinoma, clear cell renal carcinoma and prostate adenocarcinoma.\n      * Cutaneous melanoma.\n      * Gastrointestinal: esophageal adenocarcinoma, gastric adenocarcinoma, pancreatic adenocarcinoma, and poorly differentiated (grade 3) gastroenteropancreatic Neuroendocrine Carcinoma (NEC )with Ki67 index \\>55%.\n      * Lung: non-small cell lung cancer (NSCLC) and Small Cell Lung Cancer (SCLC).\n      * Gynecological tumors: epithelial ovarian carcinoma (including primary peritoneal disease and\u002For fallopian tube carcinomas), endometrial adenocarcinoma and carcinoma of cervix.\n      * Breast: ductal or lobular.\n      * Sarcoma: liposarcoma, leiomyosarcoma, synovial sarcoma and Ewing sarcoma.\n      * Deleterious germline BRCA1\u002F2 mutation tumors.\n      * Other: MPM, extrapulmonary small cell carcinoma, adrenocortical carcinoma.\n\n      Note: patients with measurable or non-measurable disease according to the Response Evaluation Criteria In Solid Tumors (RECIST) v.1.1 (or mRECIST v.1.1 in case of MPM) are eligible during this stage.\n   2. No more than three prior lines of chemotherapy.\n5. Phase Ib (safety run-in and expansion) stage: patients must have:\n\n   1. Pathologically confirmed diagnosis of one of the following:\n\n      * Extrapulmonary small cell carcinoma) or poorly differentiated grade 3 gastroenteropancreatic NEC with Ki67 index ≥55%.\n      * Cutaneous melanoma.\n      * Malignant pleural mesothelioma (MPM).\n      * Endometrial adenocarcinoma (Note: carcinosarcomas are not allowed).\n      * Synovial sarcoma\n   2. Measurable disease according to the RECIST v.1.1 (or mRECIST v.1.1 in case of MPM) and\u002For evaluable disease byserum markers in case of prostate and ovarian cancer (according to the Prostate-Specific Antigen Working Group Recommendations (PSAWGR) and the Gynecologic Cancer Intergroup (GCIG) specific criteria, respectively).\n   3. Progressive disease after last therapy at study entry.\n   4. Patients must have received standard treatments:\n\n      * Extrapulomnary small cell carcinoma\u002F gastroenteropancreatic NEC: no more than two prior lines of chemotherapy.\n      * Cutaneous melanoma:\n\n        1. BRAF wild-type (WT) melanoma: at least one prior line of immunotherapy for advanced disease. The patient may have received this therapy in the adjuvant setting. No more than two prior lines of systemic therapy for advanced disease. Note: patients with disease progression during adjuvant therapy or within the first six months after the last dose of adjuvant therapy will be considered as having been treated with one prior line of treatment.\n        2. BRAF-mutated melanoma: at least one prior line of target therapy for advanced disease with BRAF inhibitor with or without MEK-inhibitor, and at least one prior line of immunotherapy for advanced disease. The patient may have received any of these therapies in the adjuvant setting. No more than three prior lines of systemic therapy for advanced disease.\n      * Malignant pleural mesothelioma (MPM): no more than two prior lines of therapy; one of them should be a platinum containing line. Patients with non-epithelioid MPM should have received a prior immunotherapy line.\n      * Endometrial adenocarcinoma: no more than two prior lines of chemotherapy for metastatic disease. In addition, regardless of setting, patients must have received one prior platinum-containing regimen.\n      * Synovial sarcoma: at least one but no more than two prior lines of chemotherapy.\n6. Recovery to grade ≤1 from drug-related AEs of previous treatments, excluding grade 2 alopecia, according to the NCI-CTCAE v.5.\n7. Laboratory values within seven days prior to first infusion:\n\n   1. Absolute Neutrophil Count (ANC) ≥1.5 x 10\\^9\u002FL, platelet count ≥100 x 10\\^9\u002FL and hemoglobin ≥9 g\u002FdL (patients may be transfused for anemia as clinically indicated prior to study entry).\n   2. Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) ≤3.0 x ULN.\n   3. Total bilirubin ≤upper limit of normal (ULN) (up to 1.5 x ULN for patients with Gilbert's syndrome).\n   4. Creatinine clearance ≥30 mL\u002Fmin (calculated using the Cockcroft and Gault's formula).\n   5. Serum albumin ≥3 g\u002FdL. \\*\n   6. Creatine phosphokinase (CPK) ≤ 2.5 x ULN.\n8. Washout periods:\n\n   1. At least three weeks since the last chemotherapy.\n   2. At least four weeks since the last monoclonal antibody (MAb)-containing therapy.\n   3. At least two weeks since the last biological\u002Finvestigational single-agent therapy (excluding MAbs) and\u002For palliative radiotherapy (RT).\n   4. In patients with hormone-sensitive breast cancer progressing while on hormone therapy (except for luteinizing hormone-releasing hormone \\[LHRH\\] analogues in pre-menopausal women or megestrol acetate), all other hormonal therapies must be stopped at least one week before study treatment start.\n   5. Castrate-resistant prostate cancer (CRPC) patients may continue receiving hormone therapy prior to and during study treatment. Note: washout periods will be referred to the day of first cycle administration (Day 1), not to the day of registration.\n9. 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 seven months after the last study drug infusion. Fertile male patients with WOCBP partners should use condoms during treatment and for four months following the last study drug infusion.\n\n   * Albumin infusion to increase the blood level in order to fulfill the inclusion criterion is strictly forbidden.\n\nExclusion Criteria:\n\nFor both stages:\n\n1. Concomitant diseases\u002Fconditions:\n\n   1. Increased cardiac risk:\n\n      * Uncontrolled arterial hypertension despite optimal management (≥160\u002F100 mmHg).\n      * Presence of clinically relevant valvular disease.\n      * History of long QT syndrome.\n      * Corrected QT interval (QTcF, Fridericia correction) ≥450 ms on screening ECG.\n      * History of ischemic heart disease, including myocardial infarction, unstable angina, coronary arteriography or cardiac stress testing with findings consistent with coronary occlusion or infarction ≤6 months prior to study entry.\n      * History of heart failure or left ventricular dysfunction (left ventricular ejection fraction \\[LVEF\\] ≤50%) by multiple-gated acquisition scan (MUGA) or echocardiography (ECHO).\n      * Clinically relevant ECG abnormalities, including any of the following: right bundle branch block with left anterior hemiblock, second (Mobitz II) or third degree atrioventricular block.\n      * Symptomatic arrhythmia.\n      * Concomitant medication with risk of inducing torsades de pointes, which cannot be discontinued or switched to an alternative drug prior to start PM54 dosing.\n      * Use of a cardiac pacemaker.\n   2. Active infection requiring systemic treatment.\n   3. Known human immunodeficiency virus (HIV) or known chronic active hepatitis. For Hepatitis B, this includes positive tests for both Hepatitis B surface antigen and quantitative Hepatitis B polymerase chain reaction (PCR). For Hepatitis C, this includes positive tests for both Hepatitis C antibody and quantitative Hepatitis C PCR.\n   4. Any other major illness that, in the Investigator's judgment, will substantially increase the risk associated with the patient's participation in this study (e.g., COVID-19).\n2. Symptomatic, steroid-requiring, and progressing central nervous system (CNS) disease. Exceptions will be made for patients who have completed radiotherapy at least four weeks prior to inclusion (asymptomatic patients taking steroids in the process of already being tapered within two weeks prior to inclusion).\n3. Patients with carcinomatous meningitis.\n4. Prior bone marrow or stem cell transplantation.\n5. Prior treatment with trabectedin, lurbinectedin, or ecubectedin (PM14).\n6. Use of (strong or moderate) inhibitors or strong inducers of CYP3A4 activity within two weeks prior to the first infusion of PM54.\n7. Known hypersensitivity to any of the components of the drug product.\n8. Limitation of the patient's ability to comply with the treatment or to follow the protocol procedures.\n9. Women who are pregnant or breast feeding and fertile patients (men and women) who are not using a highly effective method of contraception (see inclusion criterion No. 9).",{"count":49,"type":20},125,[23],"The first part of the study (phase Ia - dose escalation) will evaluate the safety and tolerability and identify the dose-limiting toxicities (DLTs) of PM54.\n\nThe second part of the study (phase Ib - safety run-in and expansion) will be to reassess the maximum tolerated dose (MTD) defined in the Phase Ia stage in a framework of more extensive premedication, and to evaluate the antitumor activity of PM54 according to the RECIST v.1.1 (or mRECIST v.1.1 in case of MPM) and\u002For serum markers as appropriate, in patients with selected advanced solid tumors.",[53],"Advanced Solid Tumor",[53],"2025-09-19",{"date":57,"type":32},"2025-09-24",{"date":59,"type":32},"2023-04-28",{"date":61,"type":20},"2027-04-30",{"name":38,"class":39},{"id":64,"slug":65,"hasResults":11,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":4,"eligibilityCriteria":69,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":70,"targetDuration":4,"studyType":21,"phases":72,"briefSummary":73,"conditions":74,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":5},"100503465","phase-1-pm534-administered-intravenously-to-patients-with-advanced-solid-tumors-100503465","NCT05835609","PM534 Administered Intravenously to Patients With Advanced Solid Tumors","Phase I, Open-label, Dose-escalating, Clinical and Pharmacokinetic Study of PM534 Administered Intravenously to Patients With Advanced Solid Tumors","Inclusion Criteria:\n\n1. Voluntarily signed and dated written informed consent, obtained prior to any specific study procedure.\n2. Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤1\n3. Patients must have:\n\n   3.1 Pathologically confirmed diagnosis of advanced solid tumors 3.2 No more than three prior chemotherapy lines.\n4. Patients with measurable or non-measurable disease according to the RECIST v.1.1.\n5. Recovery to grade ≤1 from drug-related adverse events (AEs) of previous disease treatments, excluding grade 2 alopecia.\n6. Laboratory values within seven days prior to first infusion:\n\n   1. Absolute neutrophil count (ANC) ≥1.5 x 10⁹\u002FL, platelet count ≥100 x 10⁹\u002FL and hemoglobin ≥9 g\u002FdL\n   2. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3.0 x upper limit of normal (ULN).\n   3. Total bilirubin ≤ULN (up to 1.5 x ULN for patients with Gilbert's syndrome).\n   4. Creatinine clearance ≥30 mL\u002Fmin or serum creatinine ≤1.5 x ULN.\n   5. Serum albumin ≥3 g\u002FdL.\n   6. Serum potassium ≥3.5 mmol\u002FL.\n   7. Serum magnesium ≥1.6 mg\u002FdL.\n7. Wash-out periods:\n\n   1. At least three weeks since the last chemotherapy.\n   2. At least four weeks since the last monoclonal antibody (MAb)-containing therapy.\n   3. At least two weeks since the last biological\u002Finvestigational single-agent therapy (excluding MAbs) and\u002For palliative radiotherapy (RT).\n   4. In patients with hormone-sensitive breast cancer progressing while on hormone therapy (except for luteinizing hormone-releasing hormone \\[LHRH\\] analogues in pre-menopausal women or megestrol acetate), all other hormonal therapies must be stopped at least one week before study treatment start.\n   5. Castrate-resistant prostate cancer (CRPC) patients may continue receiving hormone therapy prior to and during study treatment.\n8. Life expectancy ≥3 months\n\nExclusion Criteria:\n\n1. Concomitant diseases\u002Fconditions:\n\n   1. Increased cardiac risk:\n\n      * History of long QT syndrome.\n      * Corrected QT interval (QTcF, Fridericia correction) ≥450 msec on screening electrocardiogram (ECG).\n      * History of or current ischemic heart disease, including myocardial infarction, stable\u002Funstable angina, coronary arteriography or cardiac stress testing with findings consistent with coronary occlusion or infarction or symptomatic arrhythmia.\n      * History of heart failure or left ventricular dysfunction (left ventricular ejection fraction \\[LVEF\\] ≤50%) by multiple-gated acquisition scan (MUGA) or echocardiography (ECHO).\n      * Clinically significant ECG abnormalities, including any of the following: right bundle branch block with left anterior hemiblock, second (Mobitz II) or third degree atrioventricular block and findings suggestive of ischemic heart disease.\n      * Symptomatic arrhythmia.\n      * Use of a cardiac pacemaker.\n      * History of or current peripheral vascular disease or cerebrovascular disease.\n   2. Presence of:\n\n      * Any grade of peripheral neuropathy (any etiology) at study entry.\n      * Prior history of grade ≥ 2 peripheral neuropathy due to any chemotherapeutic or investigational agent.\n      * Clinical or radiological signs of subocclusion\u002Fbowel obstruction.\n   3. Active infection requiring systemic treatment.\n   4. Known human immunodeficiency virus (HIV) or known hepatitis C virus (HCV) infection or active hepatitis B.\n   5. Any other major illness that, in the Investigator's judgment, will substantially increase the risk associated with the patient's participation in this study\n2. Symptomatic, steroid-requiring, central nervous system (CNS) disease.\n3. Patients with carcinomatous meningitis.\n4. Prior bone marrow or stem cell transplantation.\n5. Current treatment with colchicine.\n6. Use of (strong or moderate) inhibitors or strong inducers of CYP3A4 activity within two weeks prior to the first infusion of PM534\n7. Known hypersensitivity to any of the components of the drug product.\n8. Limitation of the patient's ability to comply with the treatment or to follow the protocol procedures.\n9. Women who are pregnant or breast feeding and fertile patients (men and women) who are not using an effective method of contraception\n10. Patients with pulmonary lymphangitis.\n11. Use of medications with known risk of inducing torsades de pointes (TdP) within five half-lives prior to the first infusion of PM534",{"count":71,"type":20},30,[23],"The goals of this trial are to identify the dose limiting toxicities, to determine the maximum tolerated dose and the recommended dose of PM534 in patients with advanced solid tumors. All Patients will receive PM534 via intravenous.",[75],"Patients With Advanced Solid Tumors","2025-08-18",{"date":78,"type":32},"2025-08-22",{"date":80,"type":32},"2022-12-23",{"date":82,"type":20},"2026-10",{"name":38,"class":39},""]