Ignite Creation Date:
2025-12-25 @ 2:39 AM
Ignite Modification Date:
2025-12-27 @ 11:30 PM
Study NCT ID:
NCT04272034
Status:
TERMINATED
Last Update Posted:
2025-10-16
First Post:
2020-02-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of INCB099318 in Participants With Advanced Solid Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002295', 'term': 'Carcinoma, Transitional Cell'}, {'id': 'D002583', 'term': 'Uterine Cervical Neoplasms'}, {'id': 'D000077277', 'term': 'Esophageal Squamous Cell Carcinoma'}, {'id': 'D015266', 'term': 'Carcinoma, Merkel Cell'}, {'id': 'D055752', 'term': 'Small Cell Lung Carcinoma'}, {'id': 'D008654', 'term': 'Mesothelioma'}, {'id': 'D000077274', 'term': 'Nasopharyngeal Carcinoma'}, {'id': 'D002280', 'term': 'Carcinoma, Basal Cell'}, {'id': 'D009362', 'term': 'Neoplasm Metastasis'}, {'id': 'D002292', 'term': 'Carcinoma, Renal Cell'}, {'id': 'D016889', 'term': 'Endometrial Neoplasms'}, {'id': 'D001005', 'term': 'Anus Neoplasms'}], 'ancestors': [{'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D014594', 'term': 'Uterine Neoplasms'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D002577', 'term': 'Uterine Cervical Diseases'}, {'id': 'D014591', 'term': 'Uterine Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D002294', 'term': 'Carcinoma, Squamous Cell'}, {'id': 'D018307', 'term': 'Neoplasms, Squamous Cell'}, {'id': 'D004938', 'term': 'Esophageal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D027601', 'term': 'Polyomavirus Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014412', 'term': 'Tumor Virus Infections'}, {'id': 'D018278', 'term': 'Carcinoma, Neuroendocrine'}, {'id': 'D018358', 'term': 'Neuroendocrine Tumors'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D000236', 'term': 'Adenoma'}, {'id': 'D018301', 'term': 'Neoplasms, Mesothelial'}, {'id': 'D009303', 'term': 'Nasopharyngeal Neoplasms'}, {'id': 'D010610', 'term': 'Pharyngeal Neoplasms'}, {'id': 'D010039', 'term': 'Otorhinolaryngologic Neoplasms'}, {'id': 'D009302', 'term': 'Nasopharyngeal Diseases'}, {'id': 'D010608', 'term': 'Pharyngeal Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D018295', 'term': 'Neoplasms, Basal Cell'}, {'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D007680', 'term': 'Kidney Neoplasms'}, {'id': 'D014571', 'term': 'Urologic Neoplasms'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D012004', 'term': 'Rectal Neoplasms'}, {'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D001004', 'term': 'Anus Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The study consists of 2 parts. Part 1 is a dose-escalation design to identify the maximum tolerated dose and/or pharmacologically active dose for INCB099318. Part 2 is an expansion at 1 or more dose levels to further explore safety, preliminary efficacy, pharmacoketics, and pharmacodynamic effects.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 105}}, 'statusModule': {'whyStopped': 'A business decision was made to discontinue further enrollment. There were no safety concerns that contributed to this decision.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2021-03-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2024-08-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-10-15', 'studyFirstSubmitDate': '2020-02-13', 'studyFirstSubmitQcDate': '2020-02-13', 'lastUpdatePostDateStruct': {'date': '2025-10-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2020-02-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of treatment-emergent adverse events', 'timeFrame': 'Up to approximately 25 months', 'description': 'Defined as any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study drug up to 30 days after last dose of study drug.'}], 'secondaryOutcomes': [{'measure': 'Cmax of INCB099318', 'timeFrame': 'Up to approximately 3 months', 'description': 'Maximum observed plasma concentration'}, {'measure': 'tmax of INCB099318', 'timeFrame': 'Up to approximately 3 months', 'description': 'Time to maximum plasma concentration'}, {'measure': 'Cmin of INCB099318', 'timeFrame': 'Up to approximately 3 months', 'description': 'Minimum observed plasma concentration over the dose interval'}, {'measure': 'AUC0-t of INCB099318', 'timeFrame': 'Up to approximately 3 months', 'description': 'Area under the plasma concentration-time curve from time = 0 to the last measurable concentration at time = t'}, {'measure': 't½ of INCB099318', 'timeFrame': 'Up to approximately 3 months', 'description': 'Apparent terminal-phase disposition half-life'}, {'measure': 'λz of INCB099318', 'timeFrame': 'Up to approximately 3 months', 'description': 'Terminal elimination rate constant'}, {'measure': 'CL/F of INCB099318', 'timeFrame': 'Up to approximately 3 months', 'description': 'Oral dose clearance'}, {'measure': 'Vz/F of INCB099318', 'timeFrame': 'Up to approximately 3 months', 'description': 'Apparent oral dose volume of distribution'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Advanced solid tumors'], 'conditions': ['Advanced Solid Tumors', 'MSI-H/dMMR Tumors', 'Cutaneous Squamous Cell Carcinoma', 'Urothelial Carcinoma, HCC', 'Cervical Cancer', 'Esophageal Squamous Cell Carcinoma', 'Merkel Cell Carcinoma', 'Small-cell Lung Cancer', 'Mesothelioma', 'PD-L1 Amplified Tumor (9p24.1)', 'Nasopharyngeal Carcinoma', 'Cyclin-dependent Kinase 12 Mutated Tumors', 'Basal Cell Carcinoma (Unresectable or Metastatic)', 'Sarcomatoid Renal Cell Carcinoma', 'Clear Cell Ovarian or Endometrial Carcinoma', 'Anal Carcinoma', 'Squamous Cell Penile Carcinoma', 'DNA Polymerase Epsilon Mutated Tumors (P286R and V411L)']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the safety and tolerability, pharmacokinetics, and pharmacodynamics of INCB099318 in select solid tumors.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Must have disease progression after treatment with available therapies that are known to confer clinical benefit or must be intolerant to or ineligible for standard treatment.\n* Histologically confirmed advanced solid tumors (protocol-defined select solid tumors) with measurable lesions per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST v1.1) that are considered nonamenable to surgery or other curative treatments or procedures.\n* ECOG performance status score of 0 or 1.\n* Life expectancy \\> 12 weeks.\n* Willingness to avoid pregnancy or fathering children.\n\nExclusion Criteria:\n\nExclusion Criteria:\n\n* Laboratory values outside the Protocol-defined ranges.\n* Clinically significant cardiac disease.\n* History or presence of an ECG that, in the investigator's opinion, is clinically meaningful.\n* Untreated brain or central nervous system (CNS) metastases or brain or CNS metastases that have progressed (eg, evidence of new or enlarging brain metastasis or new neurological symptoms attributable to brain or CNS metastases).\n* Known additional malignancy that is progressing or requires active treatment.\n* Has not recovered to ≤ Grade 1 or baseline from toxic effects of prior therapy (including prior IO) and/or complications from prior surgical intervention before starting study treatment.\n* Prior receipt of an anti-PD-L1 therapy.\n* Treatment with anticancer medications or investigational drugs within protocol-defined intervals before the first administration of study drug.\n* A 28-day washout for systemic antibiotics is required.\n* Probiotic usage while on study and during screening is prohibited.\n* Active infection requiring systemic therapy.\n* Known history of HIV\n* Evidence of hepatitis B virus or hepatitis C virus infection or risk of reactivation."}, 'identificationModule': {'nctId': 'NCT04272034', 'briefTitle': 'Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of INCB099318 in Participants With Advanced Solid Tumors', 'organization': {'class': 'INDUSTRY', 'fullName': 'Incyte Corporation'}, 'officialTitle': 'A Phase 1 Study Exploring the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of INCB099318 in Participants With Select Advanced Solid Tumors', 'orgStudyIdInfo': {'id': 'INCB 99318-122'}, 'secondaryIdInfos': [{'id': '2019-004990-21', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cohort 1', 'description': 'Participants with select solid tumors who are immunotherapy treatment-naive', 'interventionNames': ['Drug: INCB099318']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 2', 'description': 'Participants with high microsatellite instability (MSI-H) or deficient mismatch repair (dMMR) tumors who are immunotherapy treatment-naïve.', 'interventionNames': ['Drug: INCB099318']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 3', 'description': 'Participants with progression of any solid tumor treated with an approved anti-PD-1 monoclonal antibody therapy', 'interventionNames': ['Drug: INCB099318']}], 'interventions': [{'name': 'INCB099318', 'type': 'DRUG', 'description': 'INCB099318 administered orally in 20 mg or 100 mg tablets once daily or twice daily on each day of each 28-day cycle.', 'armGroupLabels': ['Cohort 1', 'Cohort 2', 'Cohort 3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '07601', 'city': 'Hackensack', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Hackensack University Medical Center', 'geoPoint': {'lat': 40.88593, 'lon': -74.04347}}, {'zip': '29605', 'city': 'Greenville', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Prisma Health Cancer Institute Faris', 'geoPoint': {'lat': 34.85262, 'lon': -82.39401}}, {'zip': '37232', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt-Ingram Cancer Center', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '01090', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'Universitair Ziekenhuis Brussel', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': 'B-1070', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'Institut Jules Bordet', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': '02650', 'city': 'Edegem', 'country': 'Belgium', 'facility': 'Universitair Ziekenhuis Antwerpen (Uza)', 'geoPoint': {'lat': 51.15662, 'lon': 4.44504}}, {'zip': '09000', 'city': 'Ghent', 'country': 'Belgium', 'facility': 'Ghent University Hospital', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}, {'zip': '03000', 'city': 'Leuven', 'country': 'Belgium', 'facility': 'Universitaire Ziekenhuis Leuven - Gasthuisberg', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}, {'zip': '02100', 'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'Rigshospitalet Uni of Hospital of Copenhagen', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}, {'zip': '00029', 'city': 'Helsinki', 'country': 'Finland', 'facility': 'Helsinki University Central Hospital', 'geoPoint': {'lat': 60.16952, 'lon': 24.93545}}, {'zip': '00180', 'city': 'Helsinki', 'country': 'Finland', 'facility': 'Docrates Cancer Center', 'geoPoint': {'lat': 60.16952, 'lon': 24.93545}}, {'zip': '33520', 'city': 'Tampere', 'country': 'Finland', 'facility': 'Tampere University Hospital', 'geoPoint': {'lat': 61.49911, 'lon': 23.78712}}, {'zip': '20520', 'city': 'Turku', 'country': 'Finland', 'facility': 'Turku University Hospital', 'geoPoint': {'lat': 60.45148, 'lon': 22.26869}}, {'zip': '05051', 'city': 'Bergen', 'country': 'Norway', 'facility': 'Haukeland University Hospital', 'geoPoint': {'lat': 60.39299, 'lon': 5.32415}}, {'zip': '00450', 'city': 'Oslo', 'country': 'Norway', 'facility': 'Oslo University Hospital', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}, {'zip': '41345', 'city': 'Gothenburg', 'country': 'Sweden', 'facility': 'Sahlgrenska University Hospital', 'geoPoint': {'lat': 57.70716, 'lon': 11.96679}}, {'zip': '17164', 'city': 'Solna', 'country': 'Sweden', 'facility': 'Karolinska University Hospital Solna', 'geoPoint': {'lat': 59.36004, 'lon': 18.00086}}, {'zip': '75185', 'city': 'Uppsala', 'country': 'Sweden', 'facility': 'Uppsala Universitet - Akademiska Sjukhuset', 'geoPoint': {'lat': 59.85882, 'lon': 17.63889}}, {'zip': 'EH4 2XU', 'city': 'Edinburgh', 'country': 'United Kingdom', 'facility': 'Western General Hospital', 'geoPoint': {'lat': 55.95206, 'lon': -3.19648}}, {'zip': 'LS9 7TF', 'city': 'Leeds', 'country': 'United Kingdom', 'facility': 'St James University Hospital', 'geoPoint': {'lat': 53.79648, 'lon': -1.54785}}, {'zip': 'SE1 9RT', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Guys and St Thomas Nhs Foundation Trust', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'SM2 5PT', 'city': 'London', 'country': 'United Kingdom', 'facility': 'The Royal Marsden Hospital Nhs Trust London', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'W12 0HS', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Imperial College Healthcare Nhs Trust - Hammersmith Hospital', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'NE7 7DN', 'city': 'Newcastle upon Tyne', 'country': 'United Kingdom', 'facility': 'Freeman Hospital Newcastle Upon Tyne Foundation Nhs Trust', 'geoPoint': {'lat': 54.97328, 'lon': -1.61396}}], 'overallOfficials': [{'name': 'Louis Viviers, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Incyte Corporation'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Access to patient level data is not available for this study'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Incyte Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}