[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Corvus Pharmaceuticals, Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":80},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,53],{"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":33,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":42,"startDateStruct":45,"completionDateStruct":47,"leadSponsor":49,"locationsCount":52},"100559201","phase-3-soquelitinib-vs-standard-of-care-in-participants-with-relapsedrefractory-peripheral-t-cell-lymphoma-not-otherwise-specified-follicular-helper-t-cell-lymphomas-or-systemic-anaplastic-large-cell-lymphoma-100559201",false,"NCT06561048","Soquelitinib vs Standard of Care in Participants With Relapsed\u002FRefractory Peripheral T-cell Lymphoma Not Otherwise Specified, Follicular Helper T-cell Lymphomas, or Systemic Anaplastic Large-cell Lymphoma","A Phase 3, Randomized, Open-Label Study to Investigate the Efficacy and Safety of ITK Inhibitor Soquelitinib Versus Physician's Choice Standard of Care Treatment (Selected Single Agent) in Participants With Relapsed\u002FRefractory Peripheral T-cell Lymphoma Not Otherwise Specified, Follicular Helper T-cell Lymphomas, or Systemic Anaplastic Large-cell Lymphoma","Inclusion Criteria:\n\n1. Adult participants ≥18 years of age on the day of signing the informed consent form.\n2. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2.\n3. Histologically confirmed PTCL-NOS, FHTCLs or sALCL per The International Consensus Classification of Mature Lymphoid Neoplasms.\n4. Progressed on, be refractory to, relapsed, or intolerant to standard therapy for their cancer. At least 1 but not more than 3 prior systemic therapies.\n5. Fluorodeoxyglucose-avid disease by positron emission tomography and measurable disease of at least 1.5 cm by computed tomography, as assessed by the site radiologist.\n6. Life expectancy \\>12 weeks.\n7. Adequate organ function as determined by:\n\n   * Absolute neutrophil count ≥ 1.0×10\\^9\u002FL (1000\u002Fmm3) (without receiving granulocyte-colony stimulating factor)\n   * Platelet count ≥ 100×10\\^9\u002FL (without transfusion)\n   * Hemoglobin ≥ 9.0 g\u002FdL, without packed red blood cell transfusion within the last 1 week of starting study drug\n   * Prothrombin time international normalized ratio and partial thromboplastin time ≤1.5 × upper limit of normal (ULN), unless participant is receiving anticoagulant therapy and prothrombin time or activated partial thromboplastin time is within therapeutic range of intended use of anticoagulants\n   * Calculated creatinine clearance (CrCl) according to Cockcroft-Gault formula and based on ideal body weight or 24-hour urine CrCl ≥ 50 mL\u002Fminute\n   * Total bilirubin ≤ 1.5 × ULN or direct bilirubin ≤ ULN for participants with total bilirubin levels \\> 1.5 × ULN. For participants with Gilbert's disease: ≤ 3.0 mg\u002FdL or discussion with the Medical Monitor\n   * Aspartate aminotransferase and alanine transaminase ≤ 2.5 × ULN (≤ 5 × ULN for participants with liver metastases)\n   * Serum albumin \\> 2.5 g\u002FdL\n   * Serum calcium \\\u003C 12 mg\u002FdL or corrected serum calcium \\\u003C ULN\n8. Must have recovered from all AEs due to previous therapies to Grade ≤ 1 or baseline except for the following:\n\n   * Grade ≤ 2 neuropathy\n   * Alopecia and non-acute toxicities\n   * If major received major surgery, then must have recovered adequately per the investigator from the toxicity and\u002For complications from the intervention prior to starting study treatment\n9. Female participants of childbearing potential who are sexually active with a non-sterilized male partner must agree to use at least 1 highly effective method of contraception from the time of screening and must agree to continue using such precautions for 120 days after the last dose of study drug for participants who receive soquelitinib, or 6 months after the last dose for participants who receive either belinostat or pralatrexate.\n10. Non-sterilized males who are sexually active with a female partner of childbearing potential must use a condom plus spermicide from Day 1 through 120 days after the last dose of study drug.\n\nExclusion Criteria:\n\n1. Participants who have T-cell lymphoma with active central nervous system involvement.\n2. Any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the participant from participating in the study.\n3. History of primary immunodeficiency or sold organ transplantation.\n4. History of opportunistic infection within 30days of screening requiring active systemic treatment or active infection requiring IV therapy.\n5. Any active infection requiring IV therapy.\n6. History of invasive prior malignancy that required systemic therapy within last 3 years.\n7. Any condition that confounds the ability to interpret data from the study.\n8. Known to be positive for HIV, or positive test for chronic hepatitis B virus (HBV) infection (defined as positive hepatitis B surface antigen \\[HBsAg\\]) or positive test for hepatitis C antibody.\n9. Monoclonal antibody therapy for cancer, radiotherapy, or chemotherapy within 3 weeks and targeted therapy within 2 weeks prior to the first dose of study treatment.\n10. Prior administration of an ITK inhibitor.\n11. Participants who need immediate cytoreductive therapy.\n12. Participants requiring the concomitant use of strong inhibitors or inducers of CYP3A or who have received these within 5 half-lives or 14 days prior to the start of study treatment.\n13. History of allogeneic hematopoietic stem cell transplantation.\n14. Candidate for hematopoietic stem cell transplantation at screening.\n15. History of progressive disease within 6 months of autologous hematopoietic stem cell transplantation.\n16. Concurrent enrollment in another clinical study\n17. Females who are pregnant, lactating, or intend to become pregnant during their participation in the study, starting with the screening visit through 6 months after the last dose of study treatment.\n18. Participants who cannot ingest medications orally or who have malabsorption.","ALL","18 Years",{"count":19,"type":20},150,"ESTIMATED","INTERVENTIONAL",[23],"PHASE3","A Phase 3, randomized, 2-arm, open-label, multicenter, stratified study of soquelitinib versus physician's choice standard of care (SOC) treatment (selected single agents) in participants with relapsed\u002Frefractory (R\u002FR) peripheral T-cell lymphoma not otherwise specified (PTCL-NOS), follicular helper T-cell lymphomas (FHTCLs), or systemic anaplastic large-cell lymphoma (sALCL).",[26,27,28,29,30,31,32],"Peripheral T-Cell Lymphoma, Not Otherwise Specified","Angioimmunoblastic T-cell Lymphoma","Follicular T-Cell Lymphoma","Nodal Peripheral T-Cell Lymphoma With TFH Phenotype","Systemic Anaplastic Large Cell Lymphoma","Lymphoma, T-Cell, Peripheral","Lymphoma, T-Cell",[34,35,36,37,38,39],"Peripheral T-Cell Lymphoma, Not Otherwise Specified (PTCL-NOS)","Follicular Helper T-Cell Lymphoma (FHTCL)","Angioimmunoblastic T-cell Lymphoma (AITL)","Follicular T-Cell Lymphoma (FTCL)","Nodal Peripheral T-Cell Lymphoma with T Follicular Helper Phenotype (PTCL-Tfh)","Systemic Anaplastic Large Cell Lymphoma (sALCL)","RECRUITING","2026-04-02",{"date":43,"type":44},"2026-04-08","ACTUAL",{"date":46,"type":44},"2024-10-02",{"date":48,"type":20},"2028-12",{"name":50,"class":51},"Corvus Pharmaceuticals, Inc.","INDUSTRY",34,{"id":54,"slug":55,"hasResults":11,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":59,"eligibilityCriteria":60,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":61,"targetDuration":4,"studyType":21,"phases":63,"briefSummary":65,"conditions":66,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":79},"100626881","phase-2-study-to-evaluate-soquelitinib-in-participants-with-moderate-to-severe-ad-100626881","NCT07441395","Study to Evaluate Soquelitinib in Participants With Moderate to Severe AD","A Phase 2 Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of Soquelitinib in Moderate to Severe Atopic Dermatitis (SIERRA1)","SIERRA1","Inclusion Criteria:\n\n* Adult male or female, ≥18 years of age, as applicable according to local legislation, at Screening.\n* Diagnosis of AD with onset of symptoms at least 1 year prior to the Screening visit.\n* Moderate to severe disease at screening and pre-randomization on Day 1 defined by:\n* EASI ≥16\n* Body surface area ≥10%\n* vIGA ≥3\n* PP-NRS average score of ≥4 over a period of 7 days prior to randomization at Day 1.\n* Documented history of prior topical and\u002For systemic therapy for AD within 6 months of randomization.\n* A female participant is eligible if she is not pregnant or breastfeeding, and is either of non-childbearing potential, OR of childbearing potential and agrees to use highly effective birth control\n\nExclusion Criteria:\n\n* Other concomitant skin conditions that would interfere with evaluations of the effect of study medication on AD.\n* Other active skin diseases or skin infections (bacterial, fungal, or viral) requiring systemic treatment within 30 days of the Baseline visit or that could interfere with the appropriate assessment of AD lesions.\n* Known immunodeficiency syndrome, history of an invasive infection or active non skin-related infection requiring systemic anti-infective treatment within 30 days of Baseline.\n* History of immunosuppression not related to medication, history of clinically significant medical conditions, or any other reason which in the opinion of the investigator would interfere with the participant's participation in this study.\n* Have an unstable or uncontrolled illness, including but not limited to cerebrocardiovascular, respiratory, gastrointestinal, endocrine, hematologic, or neurologic disorders that would potentially affect participant safety within the study or confound efficacy and safety assessments.",{"count":62,"type":20},200,[64],"PHASE2","The main purpose of this study is to see how well different doses of soquelitinib work in participants with atopic dermatitis (AD) as compared to a placebo (pill with no medicine in it). To check this, the study doctors will examine participants' skin regularly to track how their AD changes during the study.\n\nThe study doctors will see how safe soquelitinib is by tracking side effects among participants. They will also check \"tolerability,\" which means how well the participants can handle soquelitinib and whether any potential side effects are manageable for them.\n\nTo understand how well soquelitinib works, it will be compared with a placebo. Placebo is a substance that looks like soquelitinib but contains no active medicine in it.\n\nParticipants will:\n\n* Take study treatment (soquelitinib or placebo) every day for 12 weeks\n* Visit the clinic for check-ups and tests every week for the first 2 weeks then every 2 weeks during the treatment period, and then return for follow-up visits 30, 60, and 90 days after the last dose of study treatment",[67,68,69,70],"Atopic Dermatitis","Atopic Dermatitis Eczema","Eczema","Eczema, Atopic","2026-03-03",{"date":73,"type":44},"2026-03-05",{"date":75,"type":20},"2026-02",{"date":77,"type":20},"2027-09",{"name":50,"class":51},1,""]