Ignite Creation Date:
2025-12-24 @ 7:35 PM
Ignite Modification Date:
2026-01-01 @ 6:07 AM
Study NCT ID:
NCT03164603
Status:
COMPLETED
Last Update Posted:
2020-06-04
First Post:
2017-05-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
NLG802 Indoleamine 2,3-Dioxygenase (IDO) Inhibitor in Advanced Solid Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 26}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-06-29', 'type': 'ACTUAL'}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2019-09-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-06-03', 'studyFirstSubmitDate': '2017-05-22', 'studyFirstSubmitQcDate': '2017-05-22', 'lastUpdatePostDateStruct': {'date': '2020-06-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-04-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of patients with dose-limiting toxicities', 'timeFrame': '28 Days'}, {'measure': 'Percentage of patients with adverse events', 'timeFrame': 'From Screening until 30 days after last dose (up to approximately 2 years)'}], 'secondaryOutcomes': [{'measure': 'Pharmacokinetics: Serum concentrations (Cmax/Steady State)', 'timeFrame': '21 Days'}, {'measure': 'Percentage of Participants With Objective Response According to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) as Determined by the Investigator', 'timeFrame': 'From Screening until disease progression, death, new anti-cancer therapy, or premature study withdrawal (up to approximately 3 years)'}, {'measure': 'Percentage of Participants With Progression Free Survival (PFS)', 'timeFrame': '18 months', 'description': 'equals date of progression/death - date of study enrollment'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Solid Tumor']}, 'descriptionModule': {'briefSummary': 'This is an open-label Phase I 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 and help the human immune system attack solid tumor cells more effectively.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically or cytologically confirmed solid tumor cancer (including glioblastoma)\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n* Adequate hematologic and organ function\n\nExclusion Criteria:\n\n* Active or history of medically significant autoimmune disease\n* Cytotoxic therapy or investigational agent use within 28 days\n* Human immunodeficiency virus (HIV), active hepatitis B or C\n* Untreated brain metastases\n* Known QT interval prolongation\n* Use of concomitant medications with high risk of causing Torsades des Pointes.\n* Use of immune suppressive agents within 30 days\n* More than one active malignancy at the time of enrollment'}, 'identificationModule': {'nctId': 'NCT03164603', 'briefTitle': 'NLG802 Indoleamine 2,3-Dioxygenase (IDO) Inhibitor in Advanced Solid Tumors', 'organization': {'class': 'INDUSTRY', 'fullName': 'Lumos Pharma'}, 'officialTitle': 'A Phase 1 Study of NLG802 for Adult Patients With Recurrent Advanced Solid Tumors', 'orgStudyIdInfo': {'id': 'NLG8021'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'NLG8021 Dose Escalation', 'description': 'Approximately 6 to 36 participants will be enrolled and treated at escalating doses of NLG802. Treatment may continue until unacceptable toxicity or disease progression. Successive groups of at least 3 participants will be evaluated during a 28-day window for DLTs, which will determine the enrollment and dosing for subsequent cohorts in the dose-escalation stage.', 'interventionNames': ['Drug: NLG802']}], 'interventions': [{'name': 'NLG802', 'type': 'DRUG', 'description': 'Indoleamine 2,3-Dioxygenase (IDO) Inhibitor', 'armGroupLabels': ['NLG8021 Dose Escalation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32610', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Florida', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University School of Medicine', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '87131', 'city': 'Albuquerque', 'state': 'New Mexico', 'country': 'United States', 'facility': 'University of New Mexico Comprehensive Cancer Center', 'geoPoint': {'lat': 35.08449, 'lon': -106.65114}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NewLink Genetics Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}