[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Xenothera SAS\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":70},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,44],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100554179","phase-1-polyspecific-antibodies-in-lymphoproliferative-t-cell-disorders-100554179",false,"NCT06495723","Polyspecific Antibodies in Lymphoproliferative T-cell Disorders","Phase I\u002FII, Open-label, Multi-center Study to Evaluate the Safety and Efficacy of Glyco-humanized Polyclonal Antibody Directed Against Tumoral T Cells, in Patients With Relapsed\u002FRefractory Peripheral T Cells Lymphoma (PTCL)","PALT1","Inclusion Criteria:\n\n1. Provide signed, written informed consent.\n2. Is male or female, age ≥18 years old (at the time consent is obtained)\n3. For Part 1: Has a histological diagnosis of the following relapsed or refractory PTCL based on WHO 2022 classification of lymphoid neoplasms\n\n   * Intestinal T-cell and NK cell lymphoid proliferations and lymphomas (without NK cell neoplasms)\n   * Hepatosplenic T-cell lymphoma\n   * Anaplastic large cell lymphoma\n   * Nodal TFH cell lymphoma\n   * Other peripheral t-cell lymphomas For Part 2: The type of PTCL will be defined based on SC review after completion of Part 1 and will be documented in the protocol amendment\n4. Had previously received 1 or more appropriate systemic therapies, including an alkylating agent and\u002For anthracycline, for treatment of the current disease (radiation therapy alone would not be acceptable as previous therapy). Participants with ALCL must have received prior brentuximab vedotin or be unable to receive it due to allergy or intolerance.\n5. Experienced disease progression during or after completion of most recent therapy or refractory disease.\n6. Has a measurable lesion by imaging: the longest diameter should be ≥1.5 cm for nodal lesions and \\>1 cm for extra-nodal lesions.\n7. Experienced a toxicity of prior therapy: Participants must have recovered to less than Grade 1 or to baseline from toxicity of prior chemotherapy or biologic therapy and must not have had major surgery, chemotherapy, radiation, or biologic therapy within 2 weeks prior to beginning treatment.\n\n   Note: Exceptions to this include events not considered to place the participant at unacceptable risk of participation in the opinion of the Investigator (e.g., alopecia).\n8. Has either unstained tissues (block or unstained slides) or stained slides and pathology report available for central review. If stained slides or unstained tissue are not available or insufficient, a fresh tumor tissue sample is mandatory for central pathology. Central pathology confirmation is not required prior to enrollment.\n9. Is able to provide a bone marrow aspirate and\u002For a biopsy no older than 3 months at screening and agrees to undergo post-treatment bone marrow aspirate or biopsy when required to confirm response.\n10. Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n11. Has life expectancy of \\>3 months.\n12. Has an adequate hematological and organ function at screening, including:\n\n    * Hemoglobin ≥8.0 g\u002FdL (prior transfusion is acceptable)\n    * Absolute neutrophil count (ANC) ≥1000 cells\u002Fmm3 (without growth factor support within 7 days of ANC measurement)\n    * Platelet count ≥50,000 cells\u002Fmm3 (without growth factor support or transfusion within 7 days of platelets measurement)\n    * Creatinine clearance ≥30 mL\u002Fmin\n    * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \\\u003C3 × the upper limit of normal (ULN)\n    * Serum total bilirubin \\\u003C2 × ULN OR \\\u003C3 × ULN (for participants with Gilbert's Syndrome)\n13. Participants must be able to understand and sign an informed consent form.\n14. All participants must use adequate contraception during participation in this study and for 6 months following completing therapy.\n\nExclusion Criteria:\n\n1. Is diagnosed with a bulky disease (≥10 cm).\n2. Has known history or presence of central nervous system involvement by leukemia or lymphoma.\n3. Has Mature T-cell and NK-cell leukemias (WHO 2022 criteria)\n4. Has T-lymphoblastic leukemia\u002Flymphoma (WHO 2022 criteria)\n5. Has tumor-like lesions with T-cell predominance (WHO 2022 criteria)\n6. Has Primary cutaneous T-cell lymphomas (WHO 2022 criteria)\n7. Has any other active cancers, or history of treatment for invasive cancer ≤3 years.\n\n   Note: Participants with stage I cancer who have received definitive local treatment at least 3 years previously and are considered unlikely to recur are eligible. All participants with previously treated in situ carcinoma (i.e., non-invasive) are eligible.\n8. Received any of the following treatments prior to the first dose of study medication:\n\n   * Systemic chemotherapy, targeted small molecule therapy, or radiation therapy within 4 weeks (or 5 half-lives, whichever is shorter) before Cycle 1 Day 1. Participants that received local radiation therapy are eligible.\n   * Therapeutic anti-cancer antibodies \\\u003C4 weeks\n   * Any investigational drug in the last 4 weeks prior\n   * Any major surgery or immunotherapy within 28 days\n   * Toxin immunoconjugates \\\u003C4 weeks\n   * Nitrosoureas \\\u003C6 weeks\n   * Allogeneic hematologic stem cell transplant within 3 months\n   * Adaptive cellular therapy such as autologous or donor natural killer cell or T lymphocyte infusions within 90 days\n   * Systemic corticosteroids (prednisone or equivalent \\>10 mg daily) within 2 weeks prior to the start of therapy, or 12 weeks if given to treat graft versus host disease (GVHD), except for physiological replacement doses of cortisone acetate or equivalent\n   * Systemic treatment for GVHD (including but not limited to oral or parenteral corticosteroids, ibrutinib, and extracorporeal phototherapy) within the last 12 weeks\n9. Is experiencing a toxicity (or AE) from prior anti-cancer treatment that has not resolved to Grade ≤1 or baseline.\n10. Has a known infection with human immunodeficiency virus (HIV) or serologic status reflecting active hepatitis B or C infection as follows:\n\n    * Presence of hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb). Participants with presence of HBcAb, but absence of HBsAg, are eligible only if hepatitis B virus (HBV) DNA is undetectable by an assay with sensitivity \\\u003C20 IU\u002FmL. If so, participants may either undergo regularly scheduled monitoring of HBV DNA or less frequent monitoring of HBV DNA while on prophylactic antiviral medication as defined by regional standard of care.\n    * Presence of hepatitis C virus (HCV) antibody. Participants with presence of HCV antibody are eligible only if HCV RNA is undetectable.\n11. Has a known active tuberculosis infection.\n12. Has an active fungal, bacterial, and\u002For viral infection requiring systemic therapy.\n13. Had a vaccination with a live vaccine within 35 days prior to the first dose of LIS1.\n14. If woman, is pregnant or nursing a child.\n15. Has an active autoimmune disease or history of autoimmune disease that may relapse except for type I diabetes under control, hypothyroidism managed with hormone replacement therapy, controlled celiac disease, and skin disease (vitiligo, psoriasis, etc.) not requiring systemic treatment.\n16. Has a known history of interstitial lung disease, non-infectious pneumonitis, pulmonary fibrosis, acute lung disease, or dyspnea at rest or pulse oxymetrie \\\u003C 92% at room air.\n17. Has a clinically significant cardiovascular disease including the following:\n\n    * Myocardial infarction or unstable angina within 3 months before screening\n    * Congestive heart failure (New York Heart Association functional classification III-IV)\n    * History of clinically significant arrythmias\n    * QTcF \\> 470 msec\n    * History of Mobitz II second degree or third-degree heart block without a permanent pacemaker in place\n    * Uncontrolled hypertension as indicated by a minimum of 2 consecutive blood pressure measurements showing systolic blood pressure \\>170 mm Hg and diastolic blood pressure \\>105 mmHg at screening\n18. Has a cognitive impairment, active substance abuse, or psychiatric illness or social situations that, in the view of the Investigator, would preclude safe treatment or the ability to give informed consent and limit compliance with study requirements.\n19. Has a known history of drug-induced liver injury, alcoholic liver disease, non- alcoholic steatohepatitis, primary biliary cirrhosis, ongoing extrahepatic obstruction caused by stones, cirrhosis of the liver or portal hypertension.\n20. Has a hemophilia or von Willebrand's disease.\n21. Has any psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol.\n22. Has a concurrent condition that, in the Investigator's opinion, would jeopardize compliance with the protocol.\n23. Are unable or unwilling to comply with study and\u002For follow-up procedures outlined in the protocol.\n24. For France, participants under legal protection (safeguard, guardianship, curatorship).\n25. Is currently participating in another therapeutic clinical study.\n26. Has a known hypersensitivity to polyclonal antibody.","ALL","18 Years",{"count":20,"type":21},54,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE1","PHASE2","This is a 2-part study consisting of a Part 1, dose escalation and dose-finding component to establish the Maximal Tolerated Dose (MTD), or Recommended Part 2 Dose (RP2D) of LIS1 as a single agent; followed by a Part 2, to investigate anti-tumors efficacy of LIS1 in selected subtypes of Peripheral TCell Lymphoma (PTCL) and to further evaluate its safety and tolerability at RP2D.",[28],"Peripheral T Cells Lymphoma (PTCL)",[30],"Relapsed Refractory PTCL","RECRUITING","2025-07-21",{"date":34,"type":35},"2025-07-22","ACTUAL",{"date":37,"type":35},"2024-07-09",{"date":39,"type":21},"2027-07-31",{"name":41,"class":42},"Xenothera SAS","INDUSTRY",8,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":22,"phases":54,"briefSummary":55,"conditions":56,"keywords":59,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":69},"100527940","phase-1-fih-xon7-in-advancedmetastatic-solid-tumors-100527940","NCT06154291","FIH XON7 in Advanced\u002FMetastatic Solid Tumors","Phase I\u002FII, Multi Center, Open Label, First-in-human, Dose Escalation and Expansion Study to Investigate the Safety, Pharmacokinetics, and Anti-tumors Efficacy of the Glyco-humanized Polyclonal Antibody XON7 in Patients With Advanced or Metastatic Solid Tumors","FIPO23","Inclusion Criteria:\n\n1. Provide signed, written informed consent.\n2. Male and female participant, age ≥ 18 years old (at the time consent is obtained)\n3. Solid tumors indications:\n\n   * Participant in phase I, must have a histologically or cytologically confirmed advanced or metastatic solid tumors for which no effective standard therapy is available. All tumor types except glioblastoma, could be included.\n   * Participant in phase II, must have histologically or cytologically confirmed advanced or metastatic solid tumors of the following: NSCLC, gastro-esophageal adenocarcinoma, CRC, pancreatic cancer, Sarcoma, TNBC, or ovarian cancer.\n4. Line of treatment: Participant must have solid tumors progressing after ≤ 4 lines of standard appropriate anticancer therapies for the specific tumor type, or for which the patient is ineligible. Participants whose cancers harbor molecular alterations for which targeted therapy is standard of care should have received health authority-approved appropriate targeted therapy for their tumor types before enrollment.\n5. Measurable disease per RECIST version 1.1 - v5\n6. (ECOG) performance status (PS) 0-1\n7. Life expectancy of at least 12 weeks.\n8. Adequate organ function\n9. QT duration corrected for heart rate by Fridericia's formula (QTcF) \\\u003C450 msec or QTcF \\\u003C480 msec for participants with bundle branch block.\n10. In France, a participant will be eligible for inclusion in this trial only if either affiliated to or a beneficiary of a social security category.\n11. Female participant who are not of child-bearing potential, and female participants of child-bearing potential who have a negative serum pregnancy test within 7 days prior to initial trial treatment. Female participants of child-bearing potential, and all male partners must consent to use a medically acceptable method of contraception throughout the trial period and for at least 60 days after the last dose of XON7. A barrier method of contraception must be included.\n12. Male participant willing to use adequate contraceptive measures throughout the trial period and for at least 60 days after the last dose of trial intervention.\n13. For phase II, participant in pharmacodynamics cohort must provide biopsy of a tumor lesion not previously irradiated during the screening period and must agree to provide at least one additional on-treatment biopsy between day 36 and 42 after trial intervention administration.\n14. For phase II, participant in pharmacodynamics cohort must have accessible tumor tissue available for fresh biopsy except for ovarian cancer and sarcoma.\n\nExclusion Criteria:\n\n1. A participant who has received more than 4 prior lines of therapy for advanced or metastatic disease.\n2. A participant who has had a prior anti-cancer mAb within 3 weeks prior to trial Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier prior to trial Day 1.\n3. A participant who has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to trial Day 1 or who have not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to a previously administered agent (Except alopecia, hearing loss, grade 2 neuropathy or endocrinopathy managed with replacement therapy).\n4. A participant with ≥Grade 3 toxicity related to prior immunotherapy leading to treatment discontinuation.\n5. A participant whose toxicity related to prior treatment has not resolved to Grade 1 (except alopecia, hearing loss, grade 2 neuropathy or endocrinopathy managed with replacement therapy).\n6. A participant who has received major surgery 2 weeks before the first dose of trial treatment or has not recovered adequately from the toxicity and\u002For complications from any surgery (major or minor) before initiating trial treatment.\n7. Concomitant use of another experimental drug, or wash-out period of at least 5 half-lives for a previous experimental drug not completed before start of trial intervention\n8. Participant treated with drugs known to prolong the QT interval\n9. Participant with carcinomatous meningitis.\n10. Central nervous system (CNS) metastases, with the exception of individuals who have been previously treated CNS metastases, are asymptomatic, and have had no requirement for steroids for 3 weeks prior to first dose of trial drug.\n11. Malignancies other than disease under trial within 3 years prior to first dose of trial intervention.\n12. History of autoimmune disease\n13. Active or uncontrolled infections requiring systemic treatment (known human immunodeficiency virus infection, or positive test for hepatitis B surface antigen or hepatitis C).\n14. Any severe and\u002For uncontrolled medical conditions or other conditions that could affect their participation in the trial such as history or evidence of cardiovascular risk including any of the following:\n\n    * Recent (within the past 6 months) history of serious uncontrolled cardiac arrhythmia or clinically significant ECG abnormalities including second degree (Type II) or third-degree atrioventricular block.\n    * Documented cardiomyopathy, myocardial infarction, acute coronary syndromes (including unstable angina pectoris), coronary angioplasty, stenting, or bypass grafting within the past 6 months before enrollment.\n    * Documented congestive heart failure (Class II, III, or IV) as defined by the New York Heart Association functional classification system (NYHA, 1994).\n15. Prior allogeneic or autologous bone marrow transplantation or other solid organ transplantation.\n16. Current active liver or biliary disease (Except for Gilbert's syndrome or asymptomatic gallstones, liver metastases, or otherwise stable chronic liver disease per investigator assessment).\n17. Concurrent medical condition requiring the use of systemic immunosuppressive medications within 28 days before the first dose of trial treatment.\n18. Recent history (within the past 6 months) of acute diverticulitis, inflammatory bowel disease, intra-abdominal abscess, or gastrointestinal obstruction.\n19. Current or history of idiopathic pulmonary fibrosis, interstitial lung disease, or organizing pneumonia. Note: post-radiation changes in the lung related to prior radiotherapy and\u002For asymptomatic radiation-induced pneumonitis not requiring treatment may be permitted if agreed by the investigator and Medical Monitor.\n20. History of (non-infectious) pneumonitis that required steroids or current pneumonitis.\n21. Recent history (within 6 months) of uncontrolled symptomatic ascites or pleural effusions.\n22. Participant who has received transfusion of blood products (including platelets or red blood cells) or administration of colony stimulating factors (including granulocyte colony- stimulating factor \\[G-CSF\\], granulocyte-macrophage colony-stimulating factor \\[GM- CSF\\], recombinant erythropoietin) within 2 weeks before the first dose of trial intervention.\n23. Known, current drug or alcohol abuse.\n24. Female participant who is pregnant or lactating.\n25. Psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol.\n26. Inability or unwillingness to comply with trial and\u002For follow-up procedures outlined in the protocol.\n27. For France, patients under legal protection (safeguard, guardianship, curatorship)",{"count":53,"type":21},255,[24,25],"This is a two-stage trial consisting of a Part I, dose escalation and dose-finding component to establish the Maximal Tolerated Dose (MTD), if any, and Recommended Part 2 Dose (RP2D) of XON7, followed by a Part II component to investigate anti-tumors efficacy in selected solid tumor types and to further evaluate safety and tolerability of XON7 at RP2D.",[57,58],"Advanced Solid Tumor","Metastatic Cancer",[60],"Advanced or metastatic solid tumors","2025-06-20",{"date":63,"type":35},"2025-06-22",{"date":65,"type":35},"2023-11-14",{"date":67,"type":21},"2027-11",{"name":41,"class":42},5,""]