Ignite Creation Date:
2025-12-24 @ 2:23 PM
Ignite Modification Date:
2026-03-05 @ 11:18 PM
Study NCT ID:
NCT05846659
Status:
TERMINATED
Last Update Posted:
2024-12-09
First Post:
2023-04-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of PULSAR-ICI +/- IMSA101 in Patients with Oligoprogressive Solid Tumor Malignancies
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2025-11-19', 'mcpReleaseN': 16, 'releaseDate': '2025-11-11'}, {'resetDate': '2025-12-03', 'mcpReleaseN': 17, 'releaseDate': '2025-11-19'}, {'resetDate': '2025-12-22', 'mcpReleaseN': 18, 'releaseDate': '2025-12-05'}], 'estimatedResultsFirstSubmitDate': '2025-11-11'}}, 'interventionBrowseModule': {'meshes': [{'id': 'D000082082', 'term': 'Immune Checkpoint Inhibitors'}, {'id': 'C582435', 'term': 'pembrolizumab'}, {'id': 'D000077594', 'term': 'Nivolumab'}, {'id': 'D003637', 'term': 'DEAE-Dextran'}], 'ancestors': [{'id': 'D045504', 'term': 'Molecular Mechanisms of Pharmacological Action'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D000074322', 'term': 'Antineoplastic Agents, Immunological'}, {'id': 'D000970', 'term': 'Antineoplastic Agents'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}, {'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}, {'id': 'D003911', 'term': 'Dextrans'}, {'id': 'D005936', 'term': 'Glucans'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'whyStopped': 'Change in ImmuneSensor corporate strategy', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2023-07-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2024-11-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-04', 'studyFirstSubmitDate': '2023-04-27', 'studyFirstSubmitQcDate': '2023-04-27', 'lastUpdatePostDateStruct': {'date': '2024-12-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-11-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Anti-tumor effects', 'timeFrame': 'assessment at 12 months', 'description': 'Progression-free rate at 12 months'}], 'secondaryOutcomes': [{'measure': 'Safety and tolerability', 'timeFrame': 'upon enrolment through end of study period (2 years)', 'description': 'Occurrence of treatment-related adverse events and SAEs'}, {'measure': 'Anti-tumor effects', 'timeFrame': '6 to 22 months', 'description': 'Progression-free at 8-week intervals from 6 months to 22 months'}, {'measure': 'Anti-tumor effects', 'timeFrame': 'upon enrolment through end of study period (2 years)', 'description': 'Time-to-progression (TTP)'}, {'measure': 'Anti-tumor effects', 'timeFrame': 'upon enrolment through end of study period (2 years)', 'description': 'Overall response rate, duration of response, progression-free survival'}, {'measure': 'Quality of life (QoL)', 'timeFrame': 'upon enrolment through end of study period (2 years)', 'description': 'Patient-reported outcome using FACT-G'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Oligoprogressive solid tumor malignancies', 'Adult'], 'conditions': ['Oligoprogressive']}, 'descriptionModule': {'briefSummary': 'Phase 2, open-label, multicenter, randomized study comparing the safety and efficacy of personalized ultra-fractionated stereotactic adaptive radiotherapy (PULSAR) combined with immune checkpoint inhibitor (ICI) immunotherapy (PULSAR-ICI) + IMSA101 and PULSAR-ICI alone in patients with oligoprogressive solid tumor malignancies after prior anti-cancer therapy.', 'detailedDescription': 'Patients shall be enrolled in 2 treatment arms as follows:\n\n1. 15 patients in the control arm (PULSAR-ICI alone)\n2. 30 patients in the experimental arm (PULSAR-ICI + IMSA101)\n\nPULSAR-ICI with or without IMSA101 treatment will be administered to the patients in Cycles 1, 2, and 3, and thereafter only standard of care ICI monotherapy will be administered to all patients. Each treatment cycle will be 28 days in duration for Cycles 1, 2 and 3, then per standard of care monotherapy thereafter based on the product labels of the prescribed ICI.\n\nThe study will start with a safety run-in portion at 2 dose levels for the experimental arm, followed by a randomized portion for both treatment arms. The safety run-in shall employ a 3+3 safety run-in component.\n\nAll patients will be followed throughout the study for drug tolerability and safety by collecting clinical and laboratory data, including adverse events (AEs) using Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 criteria, SAEs, concomitant medications, and vital signs.\n\nAll patients will be assessed for anti-tumor efficacy at screening, prior to the end of Cycle 3, and at 8-week intervals thereafter based on radiographic assessments (all outcome measures per RECIST Version 1.1 and iRECIST).\n\nTumor types and the corresponding treatment combinations to be evaluated will be identified prior to the first patient enrolled.\n\nAll patients will continue to receive their assigned treatment throughout the study until the occurrence of disease progression (based on iRECIST), death, or other unacceptable treatment-related toxicity, or until the study is closed by the sponsor.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Male or female patients ≥ 18 years of age\n2. Signed informed consent and mental capability to understand the informed consent\n3. Histologically or cytologically documented solid tumor malignancies demonstrating new progression through prior anti-cancer therapy, with a prior 2 months of clinical stability (with at least Stable Disease), with radiographically documented presence of ≤ 6 metastatic lesions consistent with the diagnosis of "oligoprogressive" disease that are technically amenable to PULSAR\n4. Patient\'s disease must be evaluable per RECIST Version 1.1\n5. All metastatic lesions amenable to administration of radiotherapy, at the discretion of the investigator\n6. Must have at least one single pre-defined progressing lesion/lesion site (longest diameter ≥ 10 mm and ≤ 50 mm) suitable for intra-tumoral injection\n7. Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1\n8. Electrocardiogram (ECG) without evidence of clinically meaningful conduction abnormalities or active ischemia as determined by the investigator\n9. Acceptable organ and marrow function as defined below:\n\n * Absolute neutrophil count (ANC) \\> 1,500 cells/μL\n * Platelets \\> 50,000 cells/μL\n * Total bilirubin ≤ 1.5 times (×) the upper limit of normal (ULN)\n * Aspartate aminotransferase (AST)/alanine aminotransaminase (ALT) ≤ 2.5 × ULN. If liver metastases are present, AST/ALT \\< 5 × ULN\n * Serum creatinine \\< 1.5 mg/dL and a measured creatinine clearance ≥ 50 mL/min using the Cockcroft-Gault formula\n * Prothrombin time (PT)/partial thromboplastin time (PTT) ≤ 1.5 × ULN\n10. Women of child-bearing potential (defined as a female who has experienced menarche and who has not undergone successful surgical sterilization \\[hysterectomy, bilateral salpingectomy, or bilateral oophorectomy\\]) or is not postmenopausal (defined as amenorrhea for at least 12 consecutive months with an appropriate clinical profile at the appropriate age, eg, greater than 45 years) must have a negative serum pregnancy test prior to first dose of study treatment\n11. Male and female patients with reproductive potential must agree to use two forms of highly effective contraception throughout the study\n\nExclusion Criteria:\n\n1. Prior receipt of stimulator of interferon genes (STING) agonist\n2. Prior receipt of therapeutic radiotherapy to all progressive lesions intended for PULSAR treatment\n3. Anti-cancer therapy, except pembrolizumab and nivolumab, within 4 weeks or \\< 5 half-lives of the first dose of study treatment\n4. Existence of primary tumor that requires therapeutic treatment beyond the provided immune checkpoint inhibitor drug\n5. Failure to recover, to Grade 1 or less, from clinically significant AEs due to prior anti-cancer therapy, as judged by the investigator\n6. Previous life-threatening (Grade 4) immune-related adverse event (irAE)\n7. Known untreated brain metastases or treated brain metastases that have not been stable (scan showing no worsening of central nervous system \\[CNS\\] lesion\\[s\\] and no requirement of corticosteroids) ≥ 4 weeks prior to study enrollment\n8. Existence of actionable mutations that are eligible for a mutation-targeting drug that represents standard-of-care\n9. Baseline prolongation of QT/corrected QT (QTc) interval (QTc interval \\> 470)\n10. Uncontrolled intercurrent illness (including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations) that in the opinion of the investigator would limit compliance with study requirements\n11. Women who are pregnant or breastfeeding\n12. Sponsor reserves the right to exclude any patient from the study on the basis of pre-study medical histories, physical examination findings, clinical laboratory results, prior medications, or other entrance criteria'}, 'identificationModule': {'nctId': 'NCT05846659', 'briefTitle': 'Study of PULSAR-ICI +/- IMSA101 in Patients with Oligoprogressive Solid Tumor Malignancies', 'organization': {'class': 'INDUSTRY', 'fullName': 'ImmuneSensor Therapeutics Inc.'}, 'officialTitle': 'Phase 2 Randomized Clinical Trial Comparing the Safety and Efficacy of PULSAR-Integrated Radiotherapy + Pembrolizumab or Nivolumab Administered with or Without STING-Agonist IMSA101 in Patients with Oligoprogressive Solid Tumor Malignancies', 'orgStudyIdInfo': {'id': 'IMSA101-103'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental Arm', 'description': 'PULSAR-ICI + IMSA101', 'interventionNames': ['Drug: IMSA101', 'Drug: Immune checkpoint inhibitor', 'Radiation: PULSAR']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control Arm', 'description': 'PULSAR-ICI', 'interventionNames': ['Drug: Immune checkpoint inhibitor', 'Radiation: PULSAR']}], 'interventions': [{'name': 'IMSA101', 'type': 'DRUG', 'description': 'Intra-tumoral administration once weekly for the first three weeks of Cycle 1 (Days 1, 8 and 15) and then on Day 1 of Cycles 2 and 3.', 'armGroupLabels': ['Experimental Arm']}, {'name': 'Immune checkpoint inhibitor', 'type': 'DRUG', 'otherNames': ['pembrolizumab', 'nivolumab'], 'description': '1st infusion on Cycle 1 Day 2, and then thereafter as per product label.', 'armGroupLabels': ['Control Arm', 'Experimental Arm']}, {'name': 'PULSAR', 'type': 'RADIATION', 'description': '1st day of Cycles 1, 2 and 3.', 'armGroupLabels': ['Control Arm', 'Experimental Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92618', 'city': 'Irvine', 'state': 'California', 'country': 'United States', 'facility': 'City of Hope Orange County Lennar Foundation Cancer Center', 'geoPoint': {'lat': 33.66946, 'lon': -117.82311}}, {'zip': '90033', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'USC/Norris Comprehensive Cancer Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'UCLA', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwestern Memorial Hospital', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60637', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'University of Chicago Medical Center', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Brigham and Women's Hospital/Dana Farber Cancer Institute", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University School of Medicine', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '10016', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Laura & Isaac Perlmutter Cancer Center at NYU Langone Health', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10461', 'city': 'The Bronx', 'state': 'New York', 'country': 'United States', 'facility': 'Montefiore Medical Center', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}, {'zip': '44106', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Louis Stokes Cleveland VA Medical Center', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '44109', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'MetroHealth Medical Center', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '75390', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'UT Southwestern Medical Center', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Baylor College of Medicine Medical Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '53792', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'University of Wisconsin Hospital and Clinics', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}], 'overallOfficials': [{'name': 'Patrick Widhelm', 'role': 'STUDY_DIRECTOR', 'affiliation': 'ImmuneSensor Therapeutics'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ImmuneSensor Therapeutics Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}