Ignite Creation Date:
2025-12-24 @ 5:32 PM
Ignite Modification Date:
2025-12-28 @ 3:46 PM
Study NCT ID:
NCT05052268
Status:
COMPLETED
Last Update Posted:
2025-05-07
First Post:
2021-08-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
XTX202 in Patients With Advanced Solid Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 95}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-01-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2025-03-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-02', 'studyFirstSubmitDate': '2021-08-23', 'studyFirstSubmitQcDate': '2021-09-10', 'lastUpdatePostDateStruct': {'date': '2025-05-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-09-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of Dose Limiting Toxicities (DLTs) (Phase 1 Part 1A only)', 'timeFrame': 'Cycle 1 day 1 up to just prior to the second dose of study drug at Cycle 2 day 1 (each cycle is 21 days)'}, {'measure': 'Incidence of treatment-emergent adverse events (Phase 1 only)', 'timeFrame': 'Up to 24 months'}, {'measure': 'Incidence of changes in clinical laboratory values (Phase 1 only)', 'timeFrame': 'Up to 24 months'}, {'measure': 'Investigator-assessed objective response rate (ORR) per RECIST 1.1 (Phase 2 only)', 'timeFrame': 'Up to 24 months'}], 'secondaryOutcomes': [{'measure': 'Plasma concentrations of XTX202 (total and intact)', 'timeFrame': 'Up to Cycle 7 (21 days per cycle)'}, {'measure': 'Maximum observed plasma concentration (Cmax)', 'timeFrame': 'Up to Cycle 7 (21 days per cycle)'}, {'measure': 'Time of maximum observed concentration (Tmax)', 'timeFrame': 'Up to Cycle 7 (21 days per cycle)'}, {'measure': 'Trough concentrations (Ctrough)', 'timeFrame': 'Up to Cycle 7 (21 days per cycle)'}, {'measure': 'Area under the curve (AUC)', 'timeFrame': 'Up to Cycle 7 (21 days per cycle)'}, {'measure': 'Half-life (T1/2)', 'timeFrame': 'Up to Cycle 7 (21 days per cycle)'}, {'measure': 'Systemic clearance (CL)', 'timeFrame': 'Up to Cycle 7 (21 days per cycle)'}, {'measure': 'Volume of distribution (Vd)', 'timeFrame': 'Up to Cycle 7 (21 days per cycle)'}, {'measure': 'Antidrug antibody (ADA) occurrence and titer in serum (Phase 1 only)', 'timeFrame': 'Up to 24 months'}, {'measure': 'Investigator-assessed objective response rate (ORR) per RECIST 1.1 (Phase 1 only)', 'timeFrame': 'Up to 24 months'}, {'measure': 'Duration of response (DOR) (Phase 2 only)', 'timeFrame': 'Up to 24 months'}, {'measure': 'Disease control rate (Phase 2 only)', 'timeFrame': 'Up to 24 months'}, {'measure': 'Progression-free survival (PFS) (Phase 2 only)', 'timeFrame': 'Up to 24 months'}, {'measure': 'Overall survival (OS) (Phase 2 only)', 'timeFrame': 'Up to 24 months'}, {'measure': 'Incidence of treatment-emergent adverse events (Phase 2 only)', 'timeFrame': 'Up to 24 months'}, {'measure': 'Incidence of changes in clinical laboratory values (Phase 2 only)', 'timeFrame': 'Up to 24 months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Advanced Solid Tumor']}, 'descriptionModule': {'briefSummary': 'A First-in-Human, Multicenter, Phase 1/2, Open-Label Study of XTX202 in Patients with Advanced Solid Tumors', 'detailedDescription': 'This is a first-in-human, Phase 1/2, multicenter, open-label study designed to evaluate the safety, tolerability, and efficacy of XTX202, an engineered IL-2 prodrug with its activity masked, as monotherapy in patients with advanced solid tumors.\n\nPhase 1 Part 1a will examine XTX202 monotherapy in an accelerated and standard 3+3 dose-escalation design. Based on the results of Part 1a, Part 1b will be initiated to further examine XTX202 in patients with select advanced solid tumors and to further characterize XTX202.\n\nBased on results of Phase 1 patients with select advanced solid tumors will be enrolled in Phase 2.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Disease Criteria\n\n * Phase 1, Part 1a: Any histologically or cytologically confirmed solid tumor malignancy that is locally advanced or metastatic and has failed standard therapy, or standard therapy is not curative or available\n * Phase 1, Part 1b: Histologically or cytologically confirmed solid tumor malignancy with one of the following tumor histologies: RCC of clear cell histology only, melanoma, squamous cell skin carcinoma, ovarian cancer, non-small cell lung cancer. Those patients who previously received immunotherapy must have derived benefit from this treatment. Additionally, patients with any of the above histologies in an advanced setting who plan to undergo debulking surgery or oligometastasectomy may be eligible to receive 2 cycles of XTX202 treatment in a "window of opportunity" subcohort".\n * Phase 2, Part 2a: Patients with metastatic RCC who have previously been treated with an anti-PD-1 and a TKI, per local and institutional SOC. Patients must have progressed on treatment with an anti-PD-1 mAb administered either as monotherapy or in combination with other therapies\n * Phase 2, Part 2b: Patients with unresectable or metastatic melanoma who have previously been treated with at least 1 prior line of therapy in the recurrent or metastatic setting. Prior therapy must have included an anti-PD-1 alone or in combination per local and institutional standard of care, and patient must have progressed on checkpoint inhibitor therapy. Patients with BRAF V600-activating mutation must have previously received targeted therapy per local and institutional standard of care.\n2. ECOG performance status of 0 or 1\n3. Adequate organ function\n4. Part 1b only patients must be willing to provide fresh tumor biopsies before and after initiation of study treatment.\n\nExclusion Criteria:\n\n1. Received prior treatment with IL-2 therapy\n2. History of clinically significant pulmonary disease\n3. History of clinically significant cardiovascular disease\n4. Has a diagnosis of immunodeficiency\n5. Has an active autoimmune disease that has required systemic treatment in past 2 years, including the use of disease modifying agents, corticosteroids or immunosuppressive drugs\n6. Has an active infection requiring systemic therapy within 4 weeks prior to study treatment'}, 'identificationModule': {'nctId': 'NCT05052268', 'briefTitle': 'XTX202 in Patients With Advanced Solid Tumors', 'organization': {'class': 'INDUSTRY', 'fullName': 'Xilio Development, Inc.'}, 'officialTitle': 'A First-in-Human, Multicenter, Phase 1/2, Open-Label Study of XTX202 in Patients With Advanced Solid Tumors', 'orgStudyIdInfo': {'id': 'XTX202-01/02-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Phase 1 XTX202 Dose Escalation and Pharmacodynamics Expansion', 'description': 'Part 1A Dose Escalation of XTX202 administered in ascending doses to patients with advanced or metastatic solid tumors to find the recommended phase 2 doses (RP2Ds).\n\nPart 1B Evaluation of XTX202 in patients with selected advanced solid tumors to further characterize the pharmacodynamic profile of XTX202', 'interventionNames': ['Drug: XTX202']}, {'type': 'EXPERIMENTAL', 'label': 'Phase 2 XTX202 Dose Expansion', 'description': 'Part 2A will enroll patients with metastatic renal cell carcinoma who have progressed following standard-of-care treatment.\n\nPart 2B will enroll patients with melanoma who have progressed following standard-of-care treatment.', 'interventionNames': ['Drug: XTX202']}], 'interventions': [{'name': 'XTX202', 'type': 'DRUG', 'description': 'XTX202 Monotherapy', 'armGroupLabels': ['Phase 1 XTX202 Dose Escalation and Pharmacodynamics Expansion', 'Phase 2 XTX202 Dose Expansion']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92093', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'UC San Diego Moores Cancer Center', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '90033', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Norris Comprehensive Cancer Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'University of California Los Angeles', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '92663', 'city': 'Newport Beach', 'state': 'California', 'country': 'United States', 'facility': 'Hoag Memorial Hospital Presbyterian- Newport Beach', 'geoPoint': {'lat': 33.61891, 'lon': -117.92895}}, {'zip': '20007', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Georgetown University Medical Center', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '33612', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Moffitt Cancer Center', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '52242', 'city': 'Iowa City', 'state': 'Iowa', 'country': 'United States', 'facility': 'University of Iowa Hospitals and Clinics', 'geoPoint': {'lat': 41.66113, 'lon': -91.53017}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '55101', 'city': 'Saint Paul', 'state': 'Minnesota', 'country': 'United States', 'facility': 'HealthPartners Cancer Center at Regions Hospital', 'geoPoint': {'lat': 44.94441, 'lon': -93.09327}}, {'zip': '07960', 'city': 'Morristown', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Atlantic Health System/Morristown Medical Center', 'geoPoint': {'lat': 40.79677, 'lon': -74.48154}}, {'zip': '08903', 'city': 'New Brunswick', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Rutgers Cancer Institute of NJ', 'geoPoint': {'lat': 40.48622, 'lon': -74.45182}}, {'zip': '28078', 'city': 'Huntersville', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Carolina BioOncology Institute', 'geoPoint': {'lat': 35.41069, 'lon': -80.84285}}, {'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'The Ohio State University Wexner Medical Center James Cancer Hospital and Solove Research Institute', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'UPMC Hillman Cancer Center Pavilion', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '37203', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Sarah Cannon Research Institute', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Xilio Development, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}