[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Lantern Pharma Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":89},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,50],{"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":28,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100526266","phase-1-safety-pharmacokinetics-and-clinical-activity-of-lp-284-in-adult-patients-with-relapsed-or-refractory-lymphomas-and-solid-tumors-100526266",false,"NCT06132503","Safety, Pharmacokinetics, and Clinical Activity of LP-284 in Adult Patients With Relapsed or Refractory Lymphomas and Solid Tumors","A Phase 1, Multicenter, Open-Label, Dose Escalation and Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Clinical Activity of Intravenously Administered LP-284 in Adult Patients With Relapsed or Refractory Lymphomas and Solid Tumors","Inclusion Criteria All Patients: Phase 1a and Phase 1b\n\n1. Male or female aged ≥ 18 years on the day of signing informed consent.\n2. Patient is capable of giving signed informed consent as described in Section 11.3 which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.\n3. Eastern Cooperative Oncology Group (ECOG) performance status: 0-2 at screening.\n4. For Lymphoma patients. At least one bi-dimensionally measurable disease site. The lesion must have a greatest transverse diameter of at least 1.5 cm and greatest perpendicular diameter of at least 1.0 cm at baseline. The lesion must be positive on positron emission tomography (PET) scan.\n\n   Note: Patients without measurable disease per Lugano Classification \\[9\\] may be eligible for Part 1a, following discussion with the Investigator and the Sponsor, if the patient presents with non-measurable but assessable disease of any size unequivocally attributable to advanced lymphoma.\n5. Adequate organ function at Screening and on C1D1 (pre-dose) defined as:\n\n   Liver Function i Aspartate aminotransferase (AST), alanine transaminase (ALT) ≤ 3x upper limit of normal (ULN) or \\\u003C 5x ULN in cases of documented lymphoma involvement of liver.\n\n   ii Total serum bilirubin ≤ 1.5 x ULN or \\\u003C 5x ULN if secondary to Gilbert's syndrome or documented lymphoma involvement of liver.\n\n   Renal Function iii Serum creatinine clearance ≥60 mL\u002Fmin, either measured or calculated using standard Cockcroft-Gault formula.\n\n   iv Serum electrolyte (potassium, calcium, and magnesium) levels within the normal reference range (may be supplemented according to institutional standards).\n\n   Bone Marrow Function:\n\n   v Absolute neutrophil count (ANC) ≥ 1500\u002FμL. (Phase 1b: ANC ≥ 1000\u002FμL if documented by investigator as the normal baseline for the patient) vi Hemoglobin ≥ 8 g\u002FdL (for those patients undergoing red blood cell \\[RBC\\] transfusion, hemoglobin must be evaluated after at least 14 days after the last RBC transfusion).\n\n   vii Platelet count ≥ 100,000\u002FμL (assessed ≥ 7 days following last platelet transfusion in patients with thrombocytopenia requiring platelets). (Phase 1b: ≥ 75,000\u002FμL may be acceptable after discussion with the Sponsor)\n6. Women of child-bearing potential (WOCBP) must agree to use highly effective contraceptive methods and avoid egg donation for the duration of study treatment and for 6 months after the last dose of study drug.\n7. Women of child-bearing potential must have a negative serum pregnancy test at Screening and within 72 hours prior to the first dose of study drug.\n8. Men must agree to use highly effective contraceptive methods and avoid sperm donation during the study treatment and for 3 months after the last dose of study drug if the partner is a WOCBP.\n\n   Phase 1a ONLY:\n9. Histologically confirmed diagnosis of B-cell NHL according to the 2016 World Health Organization (WHO) classification that has relapsed from or is refractory to at least two prior standard of care treatments or tumors for whom standard therapies are not available. Diffuse large B-cell lymphoma (DLBCL) includes: DLBCL not otherwise specified (NOS) with or without MYC and BCL2 and\u002For BCL6 rearrangements; Epstein-Barr virus (EBV) positive DLBCL, NOS; human herpesvirus 8 (HHV8) positive DLBCL, NOS; DLBCL associated with chronic inflammation; and Primary cutaneous DLBCL, leg type. Patients with indolent lymphoma are eligible if they meet criteria for systemic treatment.\n\n   OR Histologically or pathologically confirmed advanced solid tumor that has relapsed from or is refractory to standard treatment, or for which no standard treatment is available.\n\n   Notes: Archival formalin fixed paraffin embedded (FFPE) tumor tissue is preferred but optional.\n\n   Patients with small lymphocytic lymphoma (SLL) are only eligible if they do not require immediate cytoreductive therapy or if they do not have available treatments with potential benefit.\n\n   Patients with solid tumors Only: Non-measurable or Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (Eisenhauer, 2009) for solid tumors at Screening.\n\n   Phase 1b ONLY\n10. Histologically confirmed diagnosis of DLBCL or MCL according to the 2016 WHO classification. DLBCL includes: DLBCL not otherwise specified (NOS) with or without MYC and BCL2 and\u002For BCL6 rearrangements; Epstein-Barr virus (EBV) positive DLBCL, NOS; HHV8+ DLBCL, NOS; DLBCL associated with chronic inflammation; and Primary cutaneous DLBCL, leg type\n11. Relapsed and\u002For refractory disease to at least two prior standard of care treatments or tumors for which no standard therapies are available.\n12. Documented tumor alteration status. Archival (preferably collected within 6 months prior to first dose \\[C1D1\\]) FFPE tumor sample must be submitted for determination of genomic signature by Lantern Pharma's validated laboratory developed test regardless of whether a local test has been performed for enrollment. The FFPE testing results are not required for study entry.\n\nExclusion Criteria All Patients: Phase 1a and Phase 1b\n\nPatients are excluded from the study if any of the following criteria apply:\n\n1. History or suspicion of central nervous system (CNS) lymphoma or meningeal involvement or central nervous system (CNS) metastases.\n2. History of or active concurrent malignancy other than NHL (Phase 1a and Phase 1b) or solid tumor (Phase 1a only) unless the patient has been disease-free for ≥ 2 years. Exceptions to the ≥ 2-year time limit include treated basal cell or localized squamous cell skin carcinoma, localized prostate cancer, or other localized carcinomas such as carcinoma in situ of cervix, breast, or bladder.\n3. Clinically significant AEs that have not returned to baseline or ≤Grade 1 based on NCI-CTCAE prior to first dose of study drug, unless approved by the Sponsor. Patients with chronic Grade 2 toxicities may be eligible per the discretion of the investigator and Sponsor (e.g., Grade 2 chemotherapy-induced neuropathy or hypothyroidism from prior immunotherapy treatment)\n4. Ongoing unstable cardiovascular function:\n\n   * Symptomatic ischemia, or\n   * Uncontrolled clinically significant conduction abnormalities (i.e., ventricular tachycardia on anti-arrhythmia is excluded; 1st degree atrioventricular block or asymptomatic left anterior fascicular block \u002Fright bundle branch block will not be excluded), or\n   * Congestive heart failure of New York Heart Association Class ≥ III, or\n   * Myocardial infarction within 3 months prior to Screening.\n5. Congenital long QT syndrome, or a QT interval corrected by Fridericia's formula (QTcF) ≥ 470 ms (average of triplicate ECGs) at Screening and\u002For on C1D1 (pre-dose) except for a documented bundle branch block or unless secondary to pacemaker. In the case of a documented bundle branch block or a pacemaker, discussion with the Medical Monitor is required prior to enrollment.\n6. Thromboembolic or cerebrovascular event (i.e., transient ischemic attacks, cerebrovascular accidents, pulmonary emboli, or clinically significant deep vein thrombosis) ≤ 6 months prior to first dose of study drug.\n7. Infection requiring antibiotics, antivirals, or antifungals within 1 week prior to first dose of study drug, unless such infection is adequately controlled (defined as exhibiting no ongoing signs\u002Fsymptoms related to the infection and with clinical improvement). In the case of prophylactic use of these agents, discussion with the Medical Monitor is required prior to enrollment.\n8. Hepatitis B and\u002For hepatitis C infection (as detected by positive testing for hepatitis B surface antigen \\[HbsAg\\] or antibody to hepatitis C virus with confirmatory testing) or known seropositivity for or history of active viral infection with human immunodeficiency virus (HIV).\n9. Concurrent medical conditions including psychiatric disorders that in the judgment of the Investigator will interfere with the patient's ability to participate or with achieving the objectives of the study or pose a safety risk.\n10. The patient is pregnant or breastfeeding.\n11. Prior allogeneic hematopoietic stem cell transplant.\n12. Autologous hematopoietic stem cell transplant within 6 months prior to first dose of study drug or patient has progressed within 6 months from the day of stem cell infusion.\n13. Radiation treatment within 4 weeks prior to the first dose of study drug, unless the tumor site continues to increase in size after the patient has completed radiotherapy treatment.\n14. Major surgery requiring general anesthesia within 4 weeks prior to the first dose of study drug. If a patient required general anesthesia within the prior 4 weeks, consultation with the Medical Monitor is required prior to enrollment.\n15. Received live vaccine within 1 month prior to the first dose of study drug.\n16. Exposure to investigational or non-investigational anti-cancer therapy within 2 weeks or within at least 5 half-lives (up to a maximum of 4 weeks from any biologics\u002Fimmunotherapies) prior to the first dose of study drug, whichever is shorter.\n\n    Note: Low dose steroids (oral prednisone or equivalent ≤ 20 mg\u002Fday), localized non-CNS radiotherapy, are not criteria for exclusion.\n17. Patient has completed a course of SARS-CoV-2 vaccine within 14 days prior to first dose of study drug.\n18. Patient is unable or unwilling to comply with all requirements of the study.\n19. Patient with dependency on the Sponsor, Investigator or study site.\n20. A person that is committed to an institution by official or judicial order.\n21. Male patients with partners currently pregnant or male patients able to father children and female patients of childbearing potential who are unwilling or unable to use highly effective methods of contraception as outlined in this protocol for the duration of the study and for at least 3 months (male) or 6 months (female) after last dose of study drug.","ALL","18 Years",{"count":19,"type":20},110,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","The goal of this clinical trial is to evaluate the safety and tolerability of escalating doses of LP-284 and to determine the maximum tolerated dose (MTD) and the recommended Phase 2 dose (RP2D) in patients with relapsed or refractory (R\u002FR) lymphomas and solid tumors. The secondary objectives are to characterize the pharmacokinetics (PK) of LP-284 and to assess clinical activity of LP-284.",[26,27],"Relapsed or Refractory Lymphomas","Advanced Solid Tumor",[29,30,31,32,33,34,35,36],"LP-284","Phase 1a\u002F1b","Lantern Pharma","Cancer","lymphoma","DLBCL","MCL","Sarcoma","RECRUITING","2026-04-28",{"date":40,"type":41},"2026-05-04","ACTUAL",{"date":43,"type":41},"2023-01-03",{"date":45,"type":20},"2028-11-30",{"name":47,"class":48},"Lantern Pharma Inc.","INDUSTRY",1,{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":56,"eligibilityCriteria":57,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":58,"targetDuration":4,"studyType":21,"phases":60,"briefSummary":62,"conditions":63,"keywords":66,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":82,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":88},"100474311","phase-2-a-study-of-lp-300-with-carboplatin-and-pemetrexed-in-never-smokers-with-advanced-lung-adenocarcinoma-100474311","NCT05456256","A Study of LP-300 With Carboplatin and Pemetrexed in Never Smokers With Advanced Lung Adenocarcinoma","Phase II Trial of LP-300 in Combination With Carboplatin and Pemetrexed in Never Smoker Patients With Relapsed Advanced Primary Adenocarcinoma of the Lung After Treatment With Tyrosine Kinase Inhibitors (The HARMONIC Study)","HARMONIC","Inclusion Criteria:\n\n1. Patients with confirmed histopathological diagnosis of inoperable advanced (Stage III or IV) primary adenocarcinoma (including bronchioalveolar cell carcinoma) of the lung with specific actionable genomic alterations (e.g., mesenchymal epithelial transition (MET) exon14 skipping mutations, anaplastic lymphoma kinase (ALK), epidermal growth factor receptor (EGFR), neurotrophic tyrosine receptor kinase (NTRK) fusions, etc.). If pathological or radiological findings are inconclusive for a diagnosis of primary adenocarcinoma of the lung, additional studies must be performed to confirm primary lung versus metastatic adenocarcinoma. Patients with no known actionable genomic alterations are ineligible to enroll in the study.\n2. Locally advanced inoperable or metastatic lung cancer.\n3. Patients must be never smokers: a never smoker is an adult who has never smoked, or who has smoked less than 100 cigarettes (or equivalent in other products such as vapes, cigars, pipes, hookahs, and marijuana use) in his or her lifetime. Note: a patient with actionable genomic alteration(s) who is a former smoker may be enrolled if such a patient would ordinarily be treated with pemetrexed and carboplatin combination based on institutional standard clinical practice; consultation with the sponsor's Medical monitor would be required\n4. Patients who have received systemic treatment with tyrosine kinase inhibitors (TKIs) for non-small cell lung cancer but have experienced disease progression, unacceptable TKI-related toxicities, or are unable to tolerate the further use of TKIs.\n5. Prior radiation therapy is allowed, provided (1) that at least one area of measurable tumor (by computed tomography (CT) scan with at least one target lesion) per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 that has not been subject to prior irradiation, and (2) that any such therapy is completed and any radiation-induced sequelae are recovered at least 21 days before randomization.\n6. Patients with an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n7. Patients who are at least 18 years of age.\n8. Patients with documented stable central nervous system (CNS) metastases with no cognitive deficits, or progressive sensory or motor deficits, or seizures during the last 21 days prior to enrollment are eligible. Patients must have discontinued anti-seizure medications and steroids at least 14 days prior to patient enrollment.\n9. Patients must have fully recovered from any prior major surgical or diagnostic staging procedure (e.g., thoracotomy, mediastinoscopy), and have a post-operative status of at least 30 days before enrollment.\n10. Patients must have adequate bone marrow, adequate hepatic function, and baseline creatinine levels documented by specific laboratory criteria within 21 days prior to enrollment, including the following:\n\n    * White blood cell count ≥ 2 x 10\\*9\u002FL\n    * Absolute neutrophil count (ANC) ≥ 1.5 x 10\\*9\u002FL\n    * Hemoglobin ≥ 10 g\u002FdL\n    * Platelet count ≥ 100 x 10\\*9\u002FL\n    * Total bilirubin \\\u003C 1.5 x the upper limit of normal (ULN). For patients with Gilbert's syndrome, total bilirubin \\\u003C 2.5 x ULN\n    * Aspartate aminotransferase\u002F serum glutamic oxaloacetic transaminase (AST\u002FSGOT) ≤ 2.5 x ULN\n    * Alanine aminotransferase\u002F serum glutamic pyruvic transaminase (ALT\u002FSGPT) ≤ 2.5 x ULN\n    * Alkaline phosphatase ≤ 2.5 x ULN\n    * Baseline serum creatinine level no greater than 1.5 mg\u002FdL or 133 μmol\u002FL.\n    * Creatinine clearance ≥ 45 mL\u002Fmin as calculated using the Cockcroft-Gault methodology (Cockcroft 1976)\n    * Magnesium ≥ 1.7 mg\u002FdL\n11. Female patients of child-bearing potential must have a negative pregnancy test and must agree to use an acceptable contraceptive method during the study and for 12 weeks after their last dose of study treatment. Male patients with partners of child-bearing potential must also agree to use an adequate method of contraception for the duration of the study and for 12 weeks after their last dose of study treatment.\n\n    Note: a) A patient is considered of childbearing potential if she is biologically capable of having children and is sexually active. Medically acceptable contraceptives include: (1) surgical sterilization (such as a tubal ligation, hysterectomy, or vasectomy), (2) approved hormonal contraceptives (such as birth control pills, patches, implants or injections), (3) barrier methods (such as a condom or diaphragm) used with a spermicide (only if used in combination with another mentioned method), or (4) an intrauterine device (IUD). Contraceptive measures and other medications sold for emergency use after unprotected sex, are not acceptable methods for routine use. If a female patient becomes pregnant, study therapy must be discontinued immediately. Lastly, b) the period for use of contraception after last dose of pemetrexed or carboplatin should be determined by the domestic drug labels and\u002For institutional standard clinical practice. For S Korea, contraception is to be used for 6 months after the last dose.\n12. Patients must have been disease-free at least two years for other malignancies, excluding:\n\n    * Curatively-treated basal cell carcinoma,\n    * Ductal carcinoma in situ (DCIS) of the breast\n    * Non-melanomatous carcinoma of the skin, or\n    * Carcinoma in situ of the cervix.\n13. Be willing to provide an archival tumor tissue sample, if available. The archival sample must be from a tumor lesion that was not previously irradiated. Formalin-fixed, paraffin embedded (FFPE) tissue blocks are preferred to slides. The sample must have been obtained less than 36 months prior to consent.\n14. Provide signed, written, Institutional Review Board (IRB) approved informed consent prior to any screening procedures.\n\nExclusion Criteria:\n\n1. Patients with small cell, squamous cell, large cell, undifferentiated, mesothelioma, or any form of mixed (e.g., small cell and adenocarcinoma or squamous and adenocarcinoma) histopathological diagnosis of primary lung cancer.\n2. Patients with metastatic adenocarcinoma arising from any primary site other than the lung.\n3. Patients who have received any prior investigational agents except for investigational TKI drugs. The minimum drug washout period for all TKIs, including approved and investigational, is ≥ 5 half-lives or 2 weeks, whichever is shorter.\n4. Patients who have received chemotherapy and\u002For immunotherapy but transitioned to a TKI with no evidence of disease progression will be allowed to enroll. Patients who experienced disease progression while on chemotherapy and\u002For immunotherapy will be ineligible for the trial.\n5. Patients taking medications that are sensitive substrates of CYP2C19 or P-gp transporters\n6. Patients with recent onset (within 6 months of randomization) of congestive heart failure (New York Heart Association Classification Class II or greater), angina pectoris, unstable angina pectoris, serious uncontrolled cardiac arrhythmias, myocardial infarction, stroke, or transient ischemic attacks.\n7. Have a corrected QT interval (using Fridericia's correction formula) (QTcF) of \\> 470 msec. (average of triplicate ECGs) at Screening and\u002For on C1D1 (pre- dose) except for a documented bundle branch block or unless secondary to pacemaker. In the case of a documented bundle branch block or a pacemaker, discussion with the Medical Monitor is required prior to enrollment.\n8. Patients with unstable CNS metastases (characterized by progressive sensory\u002Fmotor impairment, cognitive\u002Fspeech impairment, or seizure activity) within 21 days before enrollment.\n9. Patients who do not have at least one (1) measurable disease site that has not been previously irradiated.\n10. Patients who are known to be positive for human immunodeficiency virus (HIV), hepatitis B virus surface antigen (HbsAg) or hepatitis C virus (HCV).\n11. Patients with active infections, active interstitial lung disease, uncontrolled high blood pressure, uncontrolled diabetes mellitus, uncontrolled seizures (not due to CNS metastases) within the last 3 months, or other serious underlying medical condition.\n12. Patients with documented hypersensitivity to any of the study medications (LP-300, pemetrexed, carboplatin and\u002For excipients) or supportive agents that may be used.\n13. Patients who are pregnant or are breastfeeding.\n14. Patients who have undergone blood transfusions within 10 days before randomization.\n15. Any other medical intervention or other condition which, in the opinion of the Principal Investigator, could compromise adherence to study requirements or confound the interpretation of study results.\n16. Patients who have a life expectancy of less than 3 months.",{"count":59,"type":20},90,[61],"PHASE2","The goal of this clinical trial is to determine clinical advantages for LP-300 in combination with carboplatin and pemetrexed in the never smoker patient population. The primary objectives of this study are to determine progression-free survival (PFS) and overall survival (OS) in the study-defined patient population when LP-300 is co-administered with the standard of care chemotherapy drugs carboplatin and pemetrexed compared to carboplatin and pemetrexed alone. This has been designed as a multicenter, open label, phase II trial with 90 patients to be enrolled in the United States.",[64,65],"Adenocarcinoma of Lung","Carcinoma, Non-Small-Cell Lung",[67,68,69,70,71,72,73,74,75,76,77,78,79,80,81],"never smoker","non smoker","EGFR","ALK","ROS","MET","tyrosine kinase inhibitor","TKI","pemetrexed","carboplatin","NSCLC","never-smoker","non-smoker","TK inhibitor","lung cancer",{"date":40,"type":41},{"date":84,"type":41},"2023-03-01",{"date":86,"type":20},"2027-06",{"name":47,"class":48},16,""]