Ignite Creation Date:
2025-12-25 @ 4:05 AM
Ignite Modification Date:
2025-12-26 @ 3:01 AM
Study NCT ID:
NCT05222802
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-08-17
First Post:
2022-01-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study to Evaluate ERAS-801 in Patients With Recurrent Glioblastoma (THUNDERBBOLT-1)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005909', 'term': 'Glioblastoma'}], 'ancestors': [{'id': 'D001254', 'term': 'Astrocytoma'}, {'id': 'D005910', 'term': 'Glioma'}, {'id': 'D018302', 'term': 'Neoplasms, Neuroepithelial'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 52}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-02-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2025-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-13', 'studyFirstSubmitDate': '2022-01-24', 'studyFirstSubmitQcDate': '2022-01-24', 'lastUpdatePostDateStruct': {'date': '2025-08-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dose Limiting Toxicities (DLT)', 'timeFrame': 'Study Day 1 up to Day 29', 'description': 'Based on adverse events observed during dose escalation'}, {'measure': 'Maximum Tolerated Dose (MTD)', 'timeFrame': 'Study Day 1 up to Day 29', 'description': 'Based on adverse events observed during dose escalation'}, {'measure': 'Recommended Dose (RD)', 'timeFrame': 'Study Day 1 up to Day 29', 'description': 'Based on adverse events observed during dose escalation'}, {'measure': 'Adverse Events', 'timeFrame': 'Assessed up to 24 months from time of first dose', 'description': 'Incidence and severity of treatment-emergent AEs and serious AEs'}], 'secondaryOutcomes': [{'measure': 'Plasma concentration (Cmax)', 'timeFrame': 'Study Day 1 up to Day 29', 'description': 'Maximum plasma or serum concentration of ERAS-801'}, {'measure': 'Time to achieve Cmax (Tmax)', 'timeFrame': 'Study Day 1 up to Day 29', 'description': 'Time to achieve maximum plasma or serum concentration of ERAS-801'}, {'measure': 'Area under the curve', 'timeFrame': 'Study Day 1 up to Day 29', 'description': 'Area under the plasma concentration-time curve of ERAS-801'}, {'measure': 'Half-life', 'timeFrame': 'Study Day 1 up to Day 29', 'description': 'Half-life of ERAS-801'}, {'measure': 'Objective Response Rate (ORR)', 'timeFrame': 'Assessed up to 24 months from time of first dose', 'description': 'Based on assessment of radiographic imaging per modified RANO response assessment'}, {'measure': 'Duration of Response (DOR)', 'timeFrame': 'Assessed up to 24 months from time of first dose', 'description': 'Based on assessment of radiographic imaging per modified RANO response assessment'}, {'measure': 'Time to Response (TTR)', 'timeFrame': 'Assessed up to 24 months from time of first dose', 'description': 'Based on assessment of radiographic imaging per modified RANO response assessment'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['GBM', 'EGFR', 'epidermal growth factor receptor', 'alteration', 'ERBB1'], 'conditions': ['Glioblastoma Multiforme']}, 'descriptionModule': {'briefSummary': '* To evaluate the safety and tolerability of escalating doses of ERAS-801 in study participants with recurrent glioblastoma multiforme (GBM).\n* To determine the Maximum Tolerated Dose (MTD) and/or Recommended Dose (RD) of ERAS-801.\n* To evaluate the antitumor activity of ERAS-801.\n* To evaluate the PK profile of ERAS-801.', 'detailedDescription': 'This is a Phase 1, open-label, multicenter clinical study evaluating ERAS-801 as a monotherapy. The study will initially commence with dose escalation of ERAS-801 in study participants with recurrent GBM. Once the MTD and/or RD has been determined from dose escalation, then dose expansion of ERAS-801 may commence in study participants with recurrent GBM harboring alterations in epidermal growth factor receptor (EGFR).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years\n* Willing and able to give written informed consent\n* Diagnosis of Glioblastoma, IDH WT as defined by the WHO 2021 criteria\n* Adequate organ function\n* Willing to comply with all protocol-required visits, assessments, and procedures\n* Able to swallow oral medication\n\nExclusion Criteria:\n\n* Prior treatment with an EGFR inhibitor for Glioblastoma\n* Currently enrolled in another therapeutic study\n* History of clinically significant cardiovascular disease\n* Gastrointestinal conditions that may affect administration/absorption of oral medications\n* Have an active infection (bacterial, fungal, or viral) requiring systemic therapy\n* Pregnant or breastfeeding women\n* Any serious underlying medical or psychiatric condition or evidence of any other significant clinical disorder or laboratory finding that renders the patient inappropriate to participate in the study\n* Known allergies, hypersensitivity, or intolerance to ERAS-801 or its excipients'}, 'identificationModule': {'nctId': 'NCT05222802', 'briefTitle': 'A Study to Evaluate ERAS-801 in Patients With Recurrent Glioblastoma (THUNDERBBOLT-1)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Katmai Pharmaceuticals Inc.'}, 'officialTitle': 'A Phase 1 Study to Evaluate the CNS-Penetrant EGFR/ERBB1 Inhibitor ERAS-801 in Patients With Recurrent Glioblastoma (THUNDERBBOLT-1)', 'orgStudyIdInfo': {'id': 'ERAS-801-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dose Escalation (Part 1)', 'description': 'ERAS-801 will be orally administered to study participants with recurrent GBM in sequential ascending doses until unacceptable toxicity, disease progression, or withdrawal of consent.', 'interventionNames': ['Drug: ERAS-801']}, {'type': 'EXPERIMENTAL', 'label': 'Dose Expansion (Part 2)', 'description': 'ERAS-801 will be orally administered at the recommended dose (as determined from Part 1) to study participants with recurrent GBM harboring alterations in EGFR.', 'interventionNames': ['Drug: ERAS-801']}], 'interventions': [{'name': 'ERAS-801', 'type': 'DRUG', 'description': 'Administered orally', 'armGroupLabels': ['Dose Escalation (Part 1)', 'Dose Expansion (Part 2)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'University of California, Los Angeles', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '33176', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Miami Cancer Institute-Baptist Heath South Florida', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Dana Farber Cancer Institute', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '48202', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Henry Ford Health System', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '10022', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Memorial Sloan Kettering Cancer Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Clinic Foundation', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '37203', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Sarah Cannon Research Institute (Tennessee Oncology)', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '84112', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'Huntsman Cancer Institute', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}], 'overallOfficials': [{'name': 'Les Brail', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Medical Director'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Katmai Pharmaceuticals Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Erasca, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}