[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Oncotelic Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":64},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,41],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":5},"100522186","phase-2-a-study-of-ot-101-with-mfolfirinox-in-patients-with-advanced-and-unresectable-or-metastatic-pancreatic-cancer-100522186",false,"NCT06079346","A Study of OT-101 With mFOLFIRINOX in Patients With Advanced and Unresectable or Metastatic Pancreatic Cancer","A Randomized Phase 2b\u002FPhase 3 Study of the TGF-β2 Targeting Antisense Oligonucleotide OT-101 in Combination With mFOLFIRINOX Compared With mFOLFIRINOX Alone in Patients With Advanced and Unresectable or Metastatic Pancreatic Cancer","STOP-PC","Inclusion Criteria:\n\n1. A diagnosis of advanced and unresectable or metastatic pancreatic adenocarcinoma confirmed by:\n\n   1. Histopathology from primary tumor in pancreas, OR\n   2. Histopathology from a non-pancreatic lesion in the presence of a mass in the pancreas consistent with pancreatic adenocarcinoma or a medically documented history of pancreatic adenocarcinoma.\n2. Measurable disease per RECIST v.1.1\n3. Male or non-pregnant, non-lactating female, ≥18 years or age\n\n   1. If a female patient is of child-bearing potential, as evidenced by menstrual periods, she must have a negative serum pregnancy test (beta-human chorionic gonadotropin \\[β- hCG\\]) documented prior to the first administration of stud drugs\n   2. Female patients of childbearing age and women \\\u003C 12 months since the onset of menopause must agree to use acceptable contraceptive methods for the duration of the study and 9 months following the last injection of OT-101.\n   3. Male patients must use effective contraception for a duration of 6 months after the final dose, as per the prescribing information for oxaliplatin.\n4. Provide signed written informed consent\n5. Eastern Cooperative Group (ECOG) Performance Status (PS) score of 0-1\n6. Willingness and ability to comply with study requirements\n7. Patient has adequate organ function by the following laboratory assessments at baseline(obtained ≤28 days prior to Randomization):\n\n   Hematologic\n   * Platelets ≥100×109\u002FL\n   * Hemoglobin ≥9.0 g\u002FdL\n   * Absolute Neutrophil Count (ANC) ≥1.5×109\u002FL\n   * Patient has acceptable coagulation values obtained ≤28 days prior to Randomization as demonstrated by prothrombin time (PT) or international normalized ratio (INR) and partial thromboplastin time (PTT) ≤1.5× upper limit of normal (ULN) (if on Coumadin, patient must be changed to LMWH or on Factor II or Xa anticoagulant with a t½ of less than 24 hours\n\n   Hepatic\n   * Aspartate transaminase (AST)\u002Falanine transaminase (ALT) ≤3×ULN (if liver metastases are present, ≤5×ULN)\n   * Alkaline phosphatase ≤2.0×ULN (if liver metastases are present, ≤5×ULN)\n   * Total bilirubin ≤2.0×ULN (in patients with Gilbert's Syndrome total bilirubin \\\u003C or = 2.5xULN)\n\n   Renal\n   * Calculated creatinine clearance ≥50 mL\u002Fmin. Actual body weight should be used for calculating creatinine clearance (e.g., using the Modification of Diet in Renal Disease \\[MDRD\\] formula. For patients with a body mass index (BMI) \\>30 kg\u002Fm2, lean body weight should be used instead\n8. Patient must have a life expectancy of ≥3 months in the opinion of the Investigator\n\nExclusion Criteria:\n\n1. Diagnosis of pancreatic islet neoplasm, acinar cell carcinoma, non-adenocarcinoma (ie,lymphoma, sarcoma), adenocarcinoma originating from the biliary tree, or cystadenocarcinoma\n2. Patient has experienced a decrease in ECOG PS between Screening visit and within 72 hours prior to Randomization\n3. Patient on Coumadin and not willing to change to LMWH or oral Factor II or Xa inhibitor with t½ of less than 24 hours\n4. History of prior malignancy, except for adequately treated in situ cancer, basal cell, squamous cell skin cancer, or other cancers (eg, breast and prostate) for which the patient has been disease-free for at least 3 years. Patients with prior cancer that is adequately controlled per the judgement of the Investigator will not be excluded from the study\n5. Any serious medical condition, laboratory abnormality, psychiatric illness, or comorbidity that, in the judgment of the Investigator, would make the patient inappropriate for the study\n6. Patients with abnormal electrocardiogram (ECG) at baseline (QT or QTc interval \\>470 ms) will be excluded from this study. The eligibility of patients with ventricular pacemakers for whom the QT interval may not be accurately measurable will be determined on a case-by-case basis by the Sponsor's medical representative in consultation with the principal investigator.\n7. Serious systemic fungal, bacterial, viral, or other infection that is not controlled or requires intravenous antibiotics\n8. Known history of positivity (regardless of immune status) for human immunodeficiency virus(HIV)\n9. Known history of chronic active or active viral hepatitis A, B, or C infection\n10. Clinically significant bleeding within 2 weeks prior to Randomization (eg, gastrointestinal\\[GI\\] bleeding or intracranial hemorrhage)\n11. Pregnant or lactating women\n12. Myocardial infarction, coronary bypass surgery, or arterial thromboembolic events within the last 6 months prior to Randomization, symptomatic congestive heart failure (New York Heart Association Classification \\>Class II, unstable angina, or unstable cardiac arrhythmia requiring medication\n13. Clinically significant ascites defined as requiring ≥1 paracentesis every 2 weeks\n14. Major surgery, defined as any surgical procedure that involves general anesthesia and a significant incision (ie, larger than what is required for placement of central venous access, percutaneous feeding tube, or biopsy) within 28 days prior to Randomization or anticipated surgery during the study period\n15. Prior history of receiving immune checkpoint inhibitors (anti-CTLA4, anti-PD1, anti-PD-L1)\n16. Peripheral neuropathy (\\>Grade 1)\n17. Known history of dihydropyrimidine dehydrogenase deficiency (DPD) - Dihydropyrimidine dehydrogenase (DPD) is the initial and rate-limiting enzyme in the catabolism of 5-fluorouracil (5-FU). Thus, patients with a DPD deficiency are at risk of developing severe 5-FU-associated toxicity\n18. History or risk of autoimmune disease, including but not limited to systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegner´s granulomatosis, Sjogren´s syndrome, Bell´s palsy, Guillain-Barre syndrome, multiple sclerosis, vasculitis, or glomerulonephritis, except for psoriasis not requiring systemic therapy, vitiligo or alopecia areata, or hypothyroidism\n19. Patients receiving any of the following medications are not eligible for study:\n\n    1. Investigational agents other than the protocol drugs\n    2. Anti-coagulants (except for heparin to maintain the patency of central venous catheters)\n    3. Non-steroidal anti-inflammatory drugs\n    4. Clopidogrel (Plavix), dipyridamole (Persantine), or any other drug that inhibits platelet functions\n    5. Patients on greater than 2 mg dexamethasone, 10 mg Prednisone or or equivalent dose in alternate corticosteroid daily or actively undergoing corticosteroid dose escalation are NOT eligible\n20. History of allergic reactions or known hypersensitivity to compounds of similar chemical or biologic composition to OT-101 such as anti-sense oligonucleotides or siRNA\n21. Patients who are unable to return for follow-up visits or obtain follow-up studies required to assess toxicity to therapy. Telemedicine visits are acceptable\n22. Not willing and able to comply with study requirements including protocol mandated procedures and visits\n23. Other contraindications as defined in the product label of the components of the mFOLFIRINOX treatment regimen\n24. Participation in another investigational clinical trial within 30 days of receiving the last dose of investigational study drug\n25. Clinically significant psychiatric disorders, legal incapacity or limited legal capacity\n26. Patients with a primary immunodeficiency\n27. Patients with active central nervous system (CNS) metastases. (Patients with adequately treated CNS metastases who are clinically stable for at least 6 weeks after discontinuation of corticosteroids may be eligible for enrollment with the approval of the Sponsor's medical representative and the principal investigator)","ALL","18 Years",{"count":20,"type":21},455,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE2","PHASE3","The goal of this clinical study is to compare the efficacy and safety of OT-101 in combination with mFOLFIRINOX (folinic acid, 5-FU, irinotecan, oxaliplatin) to mFOLFIRINOX alone in patients with advanced and unresectable or metastatic pancreatic cancer.",[28],"Pancreatic Ductal Adenocarcinoma","RECRUITING","2024-08-10",{"date":32,"type":33},"2024-08-13","ACTUAL",{"date":35,"type":33},"2024-05-01",{"date":37,"type":21},"2027-06-01",{"name":39,"class":40},"Oncotelic Inc.","INDUSTRY",{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":48,"targetDuration":4,"studyType":22,"phases":50,"briefSummary":51,"conditions":52,"keywords":4,"overallStatus":54,"whyStopped":4,"lastUpdateSubmitDate":55,"lastUpdatePostDateStruct":56,"startDateStruct":58,"completionDateStruct":60,"leadSponsor":62,"locationsCount":63},"100471953","phase-2-ot-101-in-combination-with-pembrolizumab-in-subjects-with-malignant-pleural-mesothelioma-failing-to-respond-to-checkpoint-inhibition-100471953","NCT05425576","OT-101 in Combination With Pembrolizumab in Subjects With Malignant Pleural Mesothelioma Failing to Respond to Checkpoint Inhibition","Phase 2 Trial of TGF-β Inhibition (OT-101) With Anti-PD-1 (Pembrolizumab) in Patients With Malignant Pleural Mesothelioma (MPM) Failing to Achieve or Maintain Response to Checkpoint Inhibition","Inclusion Criteria:\n\n1. Participants must have progressed on treatment with an anti-PD-1 or anti-PD-L1 mAb or anti-CTLA-4 mAb administered either as monotherapy or in combination with other therapies including platinum-based chemotherapy. PD-1 treatment progression is defined by meeting all of the following criteria:\n\n   a. Has demonstrated disease progression after anti-PD-1 or anti-PD-L1 or anti-CTLA-4 mAb as defined by the investigator.\n2. Male\u002Ffemale participants who are at least 18 years of age on the day of signing informed consent with histologically confirmed diagnosis of Malignant Pleural Mesothelioma will be enrolled in this study.\n3. Male participants: A male participant must agree to use contraception as detailed in Appendix 4 of this protocol during the treatment period and for at least 90 days, corresponding to time needed to eliminate any study treatment(s) (e.g. 5 terminal half-lives for pembrolizumab) plus an additional 90 days (a spermatogenesis cycle) for study treatments with evidence of genotoxicity at any dose after the last dose of study treatment and refrain from donating sperm during this period.\n4. Female participants: A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:\n\n   1. Not a woman of childbearing potential (WOCBP) OR\n   2. A WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 90 days\u002Fweeks corresponding to time needed to eliminate any study treatment(s) plus 30 days (a menstruation cycle) for study treatments with risk of genotoxicity after the last dose of study treatment.\n5. The participant (or legally acceptable representative if applicable) provides written informed consent for the trial.\n6. Have measurable disease by Revised mRECIST\n7. Provide a baseline biopsy prior to the start of therapy. Archival biopsy is acceptable.\n8. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.\n9. Have adequate organ function. Specimens must be collected within 10 days prior to the start of study intervention.\n\nExclusion Criteria:\n\n1. A WOCBP who has a positive urine pregnancy test within 72 hours prior to agent administration. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.\n2. Has received prior systemic anti-cancer therapy including investigational agents within 28 days prior to study therapy.\n3. Has received prior radiotherapy within 2 weeks of start of study intervention. Participants must have recovered from all radiation-related toxicities and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (≤2 weeks of radiotherapy) to non-CNS disease.\n4. Has received a live vaccine within 30 days prior to the first dose of study drug. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella\u002Fzoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (eg, FluMist®) are live attenuated vaccines and are not allowed.\n5. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug. The following are exceptions to this criterion:\n\n   * Intranasal, inhaled, topical steroids, or local steroid injections (e.g., intra articular injection)\n   * Systemic corticosteroids at physiologic doses not to exceed 10 mg\u002Fday of prednisone or its equivalent\n   * Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication)\n6. Has a history of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 2 years.\n7. Has known active CNS metastases and\u002For carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable, i.e. without evidence of progression for at least 4 weeks by repeat imaging (note that the repeat imaging should be performed during study screening), clinically stable and without requirement of steroid treatment for at least 10 days prior to first dose of study intervention.\n8. Has severe hypersensitivity (≥Grade 3) to pembrolizumab and\u002For any of its excipients.\n9. Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment and is allowed.\n10. Has a history of (non-infectious) pneumonitis\u002Finterstitial lung disease that required steroids or has current pneumonitis\u002Finterstitial lung disease.\n11. Has an active infection requiring systemic therapy.\n12. Has a known history of Hepatitis B (defined as Hepatitis B surface antigen \\[HBsAg\\] reactive) or known active Hepatitis C virus (defined as HCV RNA \\[qualitative\\] is detected) infection.\n13. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator.\n14. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.\n15. Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of trial treatment.\n16. Has had an allogenic tissue\u002Fsolid organ transplant.",{"count":49,"type":21},63,[24],"This is a study of OT-101, a TGF-b2 inhibitor in combination of pembrolizumab in patients with malignant pleural mesothelioma. Both efficacy assessment, and safety and tolerability of various dose of OT-101 in combination of pembrolizumab are evaluated.",[53],"Malignant Pleural Mesothelioma","NOT_YET_RECRUITING","2024-03-13",{"date":57,"type":33},"2024-03-15",{"date":59,"type":21},"2025-06",{"date":61,"type":21},"2029-12",{"name":39,"class":40},1,""]