[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07732413":3,"trial-entities:NCT07732413":130,"trial-summary:NCT07732413":136},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":21,"primary_purpose":22,"phases":23,"enrollment_info":25,"interventions":28,"primary_outcomes":39,"secondary_outcomes":44,"sex":60,"minimum_age":61,"maximum_age":62,"healthy_volunteers":63,"eligibility_criteria":64,"std_ages":98,"locations":101,"central_contacts":123,"overall_officials":127,"references":128,"see_also_links":129},"NCT07732413","NLG8022","Trial of NLG802 Indoximod Prodrug Plus Temozolomide for Patients With Progressive Pediatric Brain Cancer","Phase 1b Trial of NLG802 Indoximod Prodrug Plus Temozolomide for Patients With Progressive Pediatric Brain Cancer","NOT_YET_RECRUITING","2030-10-08","2026-07","2026-07-28","2026-10-08","Lumos Pharma","INDUSTRY",null,"This is a open label Phase 1 study to evaluate the safety, tolerability, and pharmacokinetics of escalating oral doses of NLG802, an investigational agent intended to inhibit the indoleamine 2,3-dioxygenase 1 (IDO1) enzyme, in combination with temozolomide chemotherapy in children with primary brain tumors.","The study will enroll subjects 5 to 21 years of age with relapsed or refractory primary brain or spinal malignancy of any histology, who have exhausted available curative treatment options. A standard 3+3 dose-escalation design will be used to determine the pediatric maximum tolerated dose (MTD) for NLG802 indoximod prodrug in combination with temozolomide (Treatment Regimen). The MTD of NLG802 for the Treatment Regimen will be the highest dose level where no more than 1 of 6 subjects have (a) Regimen-Limiting Toxicity(\u002Fies) (RLT\\[s\\]) in Cycle 1, which will be 28 days duration plus any toxicity-related delay before starting Cycle 2. Toxicity will be defined and graded using the Common Terminology Criteria for Adverse Events (CTCAE), version 5.0. All subjects will have timed blood draws for NLG802 pharmacokinetic (PK) analysis in Cycle 1.",[19],"Progressive Pediatric Brain Cancer",[],"INTERVENTIONAL","TREATMENT",[24],"PHASE1",{"count":26,"type":27},30,"ESTIMATED",[29,35],{"type":30,"name":31,"description":32,"armGroupLabels":33},"DRUG","NLG802 (indoximod Prodrug)","NLG802 will be taken by mouth twice daily, throughout each treatment cycle.",[34],"NLG802 indoximod prodrug in combination with temozolomide",{"type":30,"name":36,"description":37,"armGroupLabels":38},"Temozolomide","Temozolomide will be taken by mouth once daily, on days 1-5 of each treatment cycle.",[34],[40],{"measure":41,"description":42,"timeFrame":43},"Maximum tolerated dose in pediatric participants for NLG802 in combination with temozolomide.","Determined by number of patients with dose limiting toxicities.","Cycle 1, which will be 28 days duration plus any toxicity-related delay before starting Cycle 2.",[45,48,51,54,57],{"measure":46,"description":47,"timeFrame":43},"Incidence of Regimen-limiting toxicities in in pediatric participants for NLG802 in combination with temozolomide.","Determined by number of patients with regimen limiting toxicities.",{"measure":49,"description":50,"timeFrame":43},"Pharmacokinetics in pediatric participants for NLG802 in combination with temozolomide","Serum concentrations (Cmax\u002FSteady State).",{"measure":52,"timeFrame":53},"Overall survival for NLG802 in combination with temozolomide.","Day 1 up to 12 months.",{"measure":55,"description":56,"timeFrame":53},"Evidence of efficacy for NLG802 in combination with temozolomide based on change to objective response rate.","Measured by subjects who achieve complete response, partial response or no response.",{"measure":58,"description":59,"timeFrame":53},"Percentage of patients with adverse events","Assessment of safety and tolerability of NLG802 in combination with temozolomide.","ALL","5 Years","21 Years",false,{"inclusion":65,"exclusion":88,"raw_text":97},[66,67,68,69,70,71,72,73,74,75,76,77,78,79,80,81,82,83,84,85,86,87],"Age must be ≥ 5 years and \\\u003C 22 years.","Subjects must have relapsed or treatment-refractory primary brain or spinal malignancy of any histology.","Subjects are allowed to have surgical debulking and\u002For radiation\u002Fproton therapy prior to enrollment in this trial.","Tumor tissue is required for central review of tissue diagnosis and biomarker correlate studies.","Collection of baseline blood samples for required biomarker correlate trials.","Performance score: Lansky or Karnofsky performance status score must be ≥ 70.","Life expectancy must be ≥ 3 months.","Hemoglobin ≥ 10 g\u002FdL","Platelets ≥ 100,000\u002FμL","ANC ≥ 1,000\u002FμL","ALT ≤ 3-times upper limit of normal.","Total bilirubin ≤ 1.5-times upper limit of normal.","Adequate renal function","Seizure disorders must be well controlled with antiepileptic medication.","Subjects must be able to swallow pills.","Corticosteroid therapy: When necessary for adrenal replacement, subjects may receive hydrocortisone ≤ 1.7 mg\u002Fkg\u002Fday, maximum dose 70 mg\u002Fday (or equivalent).","At the time of starting protocol therapy, subjects must be ≥ 21 days from the administration of any prior cytotoxic therapy (including chemotherapy).","At the time of starting protocol therapy, subjects must be ≥ 28 days from any radiation or proton therapy.","At the time of starting protocol therapy, subjects must be ≥ 28 days from administration of antibody-based immune checkpoint-inhibitor therapies, tumor-directed vaccines, or cellular immune therapies.","At the time of starting protocol therapy, subjects must be ≥ 56 days from administration of tumor-directed therapies using infectious agents.","At the time of starting protocol therapy, subjects must be ≥ 90 days from a stem cell transplant with growth-factor independent recovery of adequate bone marrow function.","Subjects, or their parent for subjects \\\u003C 18 years of age, must sign an Informed Consent Form (ICF) indicating that they understand the purpose of the trial and procedures required, including biomarkers, and are willing to participate in the trial.",[89,90,91,92,93,94,95,96],"Unable to swallow capsules.","Active therapy for radiation necrosis.","Baseline QTcB of \\> 470 msec at screening, and subjects with known congenital long QT syndrome.","Clinically significant cardiovascular disease.","Active systemic infection requiring treatment.","Active autoimmune disease that requires systemic therapy.","Any known bleeding diathesis.","Subjects who are breastfeeding or pregnant women.","Inclusion Criteria:\n\n* Age must be ≥ 5 years and \\\u003C 22 years.\n* Subjects must have relapsed or treatment-refractory primary brain or spinal malignancy of any histology.\n* Subjects are allowed to have surgical debulking and\u002For radiation\u002Fproton therapy prior to enrollment in this trial.\n* Tumor tissue is required for central review of tissue diagnosis and biomarker correlate studies.\n* Collection of baseline blood samples for required biomarker correlate trials.\n* Performance score: Lansky or Karnofsky performance status score must be ≥ 70.\n* Life expectancy must be ≥ 3 months.\n* Hemoglobin ≥ 10 g\u002FdL\n* Platelets ≥ 100,000\u002FμL\n* ANC ≥ 1,000\u002FμL\n* ALT ≤ 3-times upper limit of normal.\n* Total bilirubin ≤ 1.5-times upper limit of normal.\n* Adequate renal function\n* Seizure disorders must be well controlled with antiepileptic medication.\n* Subjects must be able to swallow pills.\n* Corticosteroid therapy: When necessary for adrenal replacement, subjects may receive hydrocortisone ≤ 1.7 mg\u002Fkg\u002Fday, maximum dose 70 mg\u002Fday (or equivalent).\n* At the time of starting protocol therapy, subjects must be ≥ 21 days from the administration of any prior cytotoxic therapy (including chemotherapy).\n* At the time of starting protocol therapy, subjects must be ≥ 28 days from any radiation or proton therapy.\n* At the time of starting protocol therapy, subjects must be ≥ 28 days from administration of antibody-based immune checkpoint-inhibitor therapies, tumor-directed vaccines, or cellular immune therapies.\n* At the time of starting protocol therapy, subjects must be ≥ 56 days from administration of tumor-directed therapies using infectious agents.\n* At the time of starting protocol therapy, subjects must be ≥ 90 days from a stem cell transplant with growth-factor independent recovery of adequate bone marrow function.\n* Subjects, or their parent for subjects \\\u003C 18 years of age, must sign an Informed Consent Form (ICF) indicating that they understand the purpose of the trial and procedures required, including biomarkers, and are willing to participate in the trial.\n\nExclusion Criteria:\n\n* Unable to swallow capsules.\n* Active therapy for radiation necrosis.\n* Baseline QTcB of \\> 470 msec at screening, and subjects with known congenital long QT syndrome.\n* Clinically significant cardiovascular disease.\n* Active systemic infection requiring treatment.\n* Active autoimmune disease that requires systemic therapy.\n* Any known bleeding diathesis.\n* Subjects who are breastfeeding or pregnant women.",[99,100],"CHILD","ADULT",[102],{"facility":103,"city":104,"state":105,"zip":106,"country":107,"contacts":108,"geoPoint":120},"Augusta University, Georgia Cancer Center","Augusta","Georgia","30912","United States",[109,114,118],{"name":110,"role":111,"phone":112,"email":113},"Theodore S. Johnson, MD, PhD","CONTACT","706-721-4962","thjohnson@augusta.edu",{"name":115,"role":111,"phone":116,"email":117},"Robin Dobbins, RN","706-721-2154","rdobbins@augusta.edu",{"name":110,"role":119},"PRINCIPAL_INVESTIGATOR",{"lat":121,"lon":122},33.47097,-81.97484,[124],{"name":13,"role":111,"phone":125,"email":126},"515-296-5555","clinical.trials@lumos-pharma.com",[],[],[],{"nct_id":4,"conditions":131,"biomarkers":134},[132,133],"Malignant Brain Neoplasm","Spinal Malignancy",[135],"IDO1 Gene",{"nct_id":4,"found":137,"summary":138,"prompt_version":148},true,{"design":139,"status":140,"heading":141,"summary":142,"follow_up":143,"word_count":144,"commitments":145,"compensation":146,"drugs_mentioned":147},"This is an open-label Phase 1 study, meaning everyone knows what treatments are being given. It will enroll about 30 participants to find the maximum tolerated dose of NLG802 in combination with temozolomide.","completed","NLG802 and Temozolomide for Pediatric Brain Cancer","This study is testing a new drug called NLG802 in combination with an existing chemotherapy, temozolomide, for children and young adults (ages 5-21) with progressive brain or spinal cancer. NLG802 is designed to block a protein called IDO1, which may help the body fight cancer. The main goal of this Phase 1 study is to find the highest safe dose of NLG802 when given with temozolomide. To join, you must have a brain or spinal tumor that has come back or isn't responding to other treatments, and tumor tissue is needed for review. The study is currently unclear on its recruitment status, but plans to enroll 30 participants.","The primary endpoint, maximum tolerated dose, is measured at the end of Cycle 1, which is 28 days plus any delay before starting Cycle 2.",108,"Participants will take NLG802 by mouth twice daily and temozolomide by mouth once daily for 5 days, throughout each treatment cycle. Blood draws will be taken in the first cycle to see how the body processes NLG802.","Not stated in the trial record.",[36],"v2"]