Ignite Creation Date:
2025-12-24 @ 2:06 PM
Ignite Modification Date:
2025-12-31 @ 1:15 PM
Study NCT ID:
NCT06960395
Status:
RECRUITING
Last Update Posted:
2025-08-06
First Post:
2025-04-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Preliminary Efficacy of VIR-5525 and VIR-5525 + Pembrolizumab in Participants With Locally Advanced or Metastatic Solid Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C582435', 'term': 'pembrolizumab'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 450}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-07-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2029-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-31', 'studyFirstSubmitDate': '2025-04-21', 'studyFirstSubmitQcDate': '2025-04-28', 'lastUpdatePostDateStruct': {'date': '2025-08-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Primary Safety Objectives (Parts 1 and 3)', 'timeFrame': 'From Cycle 1, Day 1 (each cycle is 21 days), up to approximately 52 months.', 'description': 'Objective: To evaluate the safety and tolerability of escalating doses of VIR-5525 as monotherapy (Part 1) and in combination with pembrolizumab (Part 3).\n\nEndpoint: Incidence and severity of AEs, including DLTs, with severity determined according to NCI CTCAE v5.0, ASTCT CRS, or ASTCT ICANS Consensus Grading, as appropriate.'}, {'measure': 'Primary Safety Objectives (Parts 1 and 3)', 'timeFrame': 'From Cycle 1, Day 1 (each cycle is 21 days), up to approximately 52 months.', 'description': 'Objective: To determine the recommended dose(s) for expansion cohorts of VIR-5525 as monotherapy (Part 1) and in combination with pembrolizumab (Part 3).\n\nEndpoint: Incidence and severity of AEs, including DLTs, with severity determined according to NCI CTCAE v5.0, ASTCT CRS, or ASTCT ICANS Consensus Grading, as appropriate.'}, {'measure': 'Primary Efficacy Objectives (Parts 2 and 4)', 'timeFrame': 'From Cycle 1, Day 1 (each cycle is 21 days), up to approximately 52 months.', 'description': 'Objective: To evaluate the preliminary anti-tumor activity of VIR-5525 as monotherapy (Part 2) and in combination with pembrolizumab (Part 4) at the recommended dose(s) for expansion cohorts.\n\nEndpoint: Objective response, defined as a CR or PR per RECIST v1.1.'}], 'secondaryOutcomes': [{'measure': 'Secondary Safety Objectives (Parts 1 and 3)', 'timeFrame': 'From Cycle 1, Day 1 (each cycle is 21 days), up to approximately 52 months.', 'description': 'Objective: To further evaluate the safety and tolerability of VIR-5525 as a monotherapy (Part 2) and in combination with pembrolizumab (Part 4).\n\nEndpoint: Incidence and severity of AEs, with severity determined according to NCI CTCAE v5.0, ASTCT CRS, or ASTCT ICANS Consensus Grading, as appropriate.'}, {'measure': 'Secondary Efficacy Objectives (Parts 1 and 3)', 'timeFrame': 'From Cycle 1, Day 1 (each cycle is 21 days), up to approximately 52 months.', 'description': 'Objective: To evaluate the preliminary anti-tumor activity of VIR-5525 as monotherapy (Part 1) and in combination with pembrolizumab (Part 3).\n\nEndpoint: Objective response, defined as a CR or PR per RECIST v1.1.\n\nEndpoint: DOR, defined as the time from the first occurrence of a documented objective response to the time of the first documented disease progression or death from any cause, whichever occurs first, per RECIST v1.1.'}, {'measure': 'Secondary Efficacy Objectives (Parts 2 and 4)', 'timeFrame': 'From Cycle 1, Day 1 (each cycle is 21 days), up to approximately 52 months.', 'description': 'Objective: To further evaluate the preliminary anti-tumor activity of VIR-5525 as monotherapy (Part 2) and in combination with pembrolizumab (Part 4) at the recommended dose(s) for expansion cohorts and schedule.\n\nEndpoint: DOR, defined as the time from the first occurrence of a documented objective response to the time of the first documented disease progression or death from any cause, whichever occurs first, per RECIST v1.1.'}, {'measure': 'Secondary Efficacy Objectives (Parts 2 and 4)', 'timeFrame': 'From Cycle 1, Day 1 (each cycle is 21 days), up to approximately 52 months.', 'description': 'Objective: To further evaluate the preliminary anti-tumor activity of VIR-5525 as monotherapy (Part 2) and in combination with pembrolizumab (Part 4) at the recommended dose(s) for expansion cohorts and schedule.\n\nEndpoint: PFS (per investigator using RECIST v1.1), defined as the length of time from the start of treatment until first documented disease progression or death.'}, {'measure': 'Secondary PK Objectives (Parts 1 Through 4)', 'timeFrame': 'From Cycle 1, Day 1 (each cycle is 21 days), up to approximately 52 months.', 'description': 'Objective: To characterize the PK profile of VIR-5525 as monotherapy (Parts 1 and 2) and in combination with pembrolizumab (Parts 3 and 4).\n\nEndpoint: PK parameters of VIR-5525, including, but not limited to, area under the curve (AUC), calculated as data allow.'}, {'measure': 'Secondary PK Objectives (Parts 1 Through 4)', 'timeFrame': 'From Cycle 1, Day 1 (each cycle is 21 days), up to approximately 52 months.', 'description': 'Objective: To characterize the PK profile of VIR-5525 as monotherapy (Parts 1 and 2) and in combination with pembrolizumab (Parts 3 and 4).\n\nEndpoint: PK parameters of VIR-5525, including, but not limited to, maximum concentration of the drug (Cmax), calculated as data allow.'}, {'measure': 'Secondary PK Objectives (Parts 1 Through 4)', 'timeFrame': 'From Cycle 1, Day 1 (each cycle is 21 days), up to approximately 52 months.', 'description': 'Objective: To characterize the PK profile of VIR-5525 as monotherapy (Parts 1 and 2) and in combination with pembrolizumab (Parts 3 and 4).\n\nEndpoint: PK parameters of VIR-5525, including, but not limited to, time to peak drug concentration (tmax), calculated as data allow.'}, {'measure': 'Secondary PK Objectives (Parts 1 Through 4)', 'timeFrame': 'From Cycle 1, Day 1 (each cycle is 21 days), up to approximately 52 months.', 'description': 'Objective: To characterize the PK profile of VIR-5525 as monotherapy (Parts 1 and 2) and in combination with pembrolizumab (Parts 3 and 4).\n\nEndpoint: PK parameters of VIR-5525, including, but not limited to, drug accumulation ratio (Rac), calculated as data allow.'}, {'measure': 'Secondary Immunogenicity Objectives (Parts 1 Through 4)', 'timeFrame': 'From Cycle 1, Day 1 (each cycle is 21 days), up to approximately 52 months.', 'description': 'Objective: To evaluate the immunogenicity of VIR-5525 as monotherapy (Parts 1 and 2) and in combination with pembrolizumab (Parts 3 and 4).\n\nEndpoint: Incidence of ADAs to VIR-5525 at baseline and incidence of treatment-emergent ADAs to VIR-5525.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['VIR-5525'], 'conditions': ['Solid Tumor Malignancies', 'EGFR Positive Solid Tumors', 'EGFR']}, 'descriptionModule': {'briefSummary': 'This Phase 1, first-in-human (FIH), dose-escalation and dose-expansion study is designed to evaluate the safety, PK, and preliminary anti-tumor activity of VIR-5525 as a monotherapy and in combination with pembrolizumab in participants with solid tumors that are known to express EGFR.\n\nThe study will be conducted in the following 4 parts:\n\n* Part 1: VIR-5525 monotherapy dose escalation\n* Part 2: VIR-5525 monotherapy dose expansion\n* Part 3: VIR-5525 plus pembrolizumab dose escalation\n* Part 4: VIR-5525 plus pembrolizumab dose expansion'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\nI 01. Are ≥ 18 years of age, or at the country's legal age of majority of the legal adult age is \\>18 years, at the time of signing the ICF.\n\nI 02. Have an ECOG performance status of 0 to 1.\n\nI 03. Have a life expectancy of at least 12 weeks.\n\nI 04. Have histological, pathological, or cytological confirmation of disease type that is unresectable, locally advanced, or metastatic.\n\nI 05. Have measurable disease per RECIST v1.1 as assessed by the local site investigator/radiology. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.\n\nI 06. Have diseases under study, lines of therapy, and biomarker status, as follows:\n\nHave one of the following:\n\n• (Parts 1 and 3): NSCLC (nonsquamous or squamous histology), CRC, HNSCC, or CSCC.\n\nNote: Participants with nasopharyngeal tumors are eligible. Note: Participants with upper esophageal or salivary gland tumors are not eligible.\n\nOR\n\n• Have a solid tumor with EGFR amplification (as previously determined locally with an analytically validated assay in a certified testing laboratory).\n\nHave no available standard systemic therapy; or standard therapy is intolerable, not effective, or not accessible; or participant has refused standard therapy.\n\nExclusion Criteria:\n\nE 01. Are a WOCBP with a positive serum or urine pregnancy test within 72 hours prior to treatment.\n\nE 02. Have acute or chronic infections, including the following:\n\n* Acute or chronic active Epstein-Barr virus (EBV) infection (Exception: asymptomatic EBV-positive participants are still eligible)\n* Chronic active EBV disease defined as a chronic illness lasting at least 6 months, an increased EBV level in either the tissue or the blood, and lack of evidence of a known underlying immunodeficiency\n* History of hepatitis B infection (defined as hepatitis B surface antigen \\[HBsAg\\] reactive) or known active hepatitis C virus (HCV) infection (defined as HCV \\[HCV RNA; qualitative\\] is detected)\n* History of HIV infection. No HIV testing is required unless mandated by the local health authority.\n* Active infection requiring systemic therapy within 14 days of Cycle 1 Day 1\n* Known positive COVID-19 test result at screening (Exception: If follow-up test is negative, participants may be eligible if asymptomatic and upon consultation with medical monitor)\n\nE 03. Have a concomitant medical or inflammatory condition that may increase the risk of toxicity to VIR-5525 or pembrolizumab, per the investigator\n\nE 04. Have a QT interval corrected by Fridericia's method (QTcF) that is \\>480 ms\n\nE 05. Have received prior systemic anti-cancer therapy, including investigational agents, within 5 half-lives prior to first dose of study intervention. For drugs with a long t1/2, such as mAbs, or for drugs for which the t1/2 is not known, the last dose should not have been within 28 days prior to first dose of study intervention.\n\nNote: If the participant has had major surgery, the participant must have recovered adequately from the procedure and/or any complications from the surgery prior to starting study intervention.\n\nE 06. Have received prior radiotherapy within 2 weeks of start of study intervention Note: Participants must have recovered from all radiation-related toxicities to Grade ≤1 or baseline, must not require corticosteroids, and must not have had radiation pneumonitis.\n\nException: External beam radiotherapy, including palliative external radiation, is allowed.\n\nA 1-week washout is permitted for palliative radiation (≤2 weeks of radiotherapy) to non-CNS disease.\n\nThe above information is not intended to contain all considerations relevant to the potential participation in a clinical trial."}, 'identificationModule': {'nctId': 'NCT06960395', 'briefTitle': 'Safety and Preliminary Efficacy of VIR-5525 and VIR-5525 + Pembrolizumab in Participants With Locally Advanced or Metastatic Solid Tumors', 'organization': {'class': 'INDUSTRY', 'fullName': 'Vir Biotechnology, Inc.'}, 'officialTitle': 'A Phase 1, First-in-Human Study of the Safety, Pharmacokinetics, and Preliminary Efficacy of VIR-5525 Alone and in Combination With Pembrolizumab in Participants With Locally Advanced or Metastatic Solid Tumors', 'orgStudyIdInfo': {'id': 'VIR-5525-V101'}, 'secondaryIdInfos': [{'id': 'U1111-1294-8156', 'type': 'REGISTRY', 'domain': 'ICTRP'}, {'id': '2023-508555-39', 'type': 'REGISTRY', 'domain': 'CTIS'}, {'id': 'AMX-525', 'type': 'OTHER', 'domain': 'Amunix'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Part 1: VIR-5525 Monotherapy Dose Escalation', 'description': 'Screening Period: Up to 28 days\n\nTreatment Period: Once successfully screened, enrolled participants may receive study intervention of VIR-5525 in monotherapy.', 'interventionNames': ['Drug: VIR-5525']}, {'type': 'EXPERIMENTAL', 'label': 'Part 2: VIR-5525 Monotherapy Dose Expansion', 'description': 'Screening Period: Up to 28 days\n\nTreatment Period: Once successfully screened, enrolled participants may receive study intervention of VIR-5525 in monotherapy.', 'interventionNames': ['Drug: VIR-5525']}, {'type': 'EXPERIMENTAL', 'label': 'Part 3: VIR-5525 Combination Dose Escalation', 'description': 'Screening Period: Up to 28 days\n\nTreatment Period: Once successfully screened, enrolled participants may receive study intervention of VIR-5525 in combination with pembrolizumab.', 'interventionNames': ['Drug: VIR-5525', 'Drug: Pembrolizumab']}, {'type': 'EXPERIMENTAL', 'label': 'Part 4: VIR-5525 Combination Dose Expansion', 'description': 'Screening Period: Up to 28 days\n\nTreatment Period: Once successfully screened, enrolled participants may receive study intervention of VIR-5525 in combination with pembrolizumab.', 'interventionNames': ['Drug: VIR-5525', 'Drug: Pembrolizumab']}], 'interventions': [{'name': 'VIR-5525', 'type': 'DRUG', 'otherNames': ['AMX-525'], 'description': 'Pharmaceutical Form: Solution for Infusion Route of Administration: Intravenous (IV) infusion', 'armGroupLabels': ['Part 1: VIR-5525 Monotherapy Dose Escalation', 'Part 2: VIR-5525 Monotherapy Dose Expansion', 'Part 3: VIR-5525 Combination Dose Escalation', 'Part 4: VIR-5525 Combination Dose Expansion']}, {'name': 'Pembrolizumab', 'type': 'DRUG', 'description': 'Pharmaceutical Form: Solution for Infusion Route of Administration: Intravenous (IV) infusion', 'armGroupLabels': ['Part 3: VIR-5525 Combination Dose Escalation', 'Part 4: VIR-5525 Combination Dose Expansion']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85258-4566', 'city': 'Scottsdale', 'state': 'Arizona', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Honor Health Research Institute', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '2500', 'city': 'Wollongong', 'state': 'New South Wales', 'status': 'RECRUITING', 'country': 'Australia', 'facility': 'Wollongong Hospital', 'geoPoint': {'lat': -34.424, 'lon': 150.89345}}, {'zip': '4102', 'city': 'Woolloongabba', 'state': 'Queensland', 'status': 'NOT_YET_RECRUITING', 'country': 'Australia', 'facility': 'Princess Alexandra Hospital', 'geoPoint': {'lat': -27.48855, 'lon': 153.03655}}], 'centralContacts': [{'name': 'Study Inquiry', 'role': 'CONTACT', 'email': 'clinicaltrials@vir.bio', 'phone': '1-415-654-5281'}], 'overallOfficials': [{'name': 'Clinical Sciences & Operations', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Vir Biotechnology'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vir Biotechnology, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}