protocolSection identificationModule nctId: NCT06265025, orgStudyIdInfo id: GM103-CT-101, briefTitle: GM103 Intratumoral Injection in Patients With Locally Advanced, Unresectable, Refractory and/or Metastatic Solid Tumors, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-20, primaryCompletionDateStruct date: 2025-05-30, completionDateStruct date: 2028-10-30, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-03-21, sponsorCollaboratorsModule leadSponsor name: GeneMedicine Co., Ltd., class: INDUSTRY, descriptionModule briefSummary: The purpose of this study is to measure safety, tolerability, and preliminary antitumor efficacy of GM103 administered alone and in combination with pembrolizumab in patients with locally advanced, unresectable, refractory and/or metastatic solid tumors (including but not limited to head and neck cancer, malignant melanoma, CRC, renal cell carcinoma, cervical cancer, and breast cancer). Study details include:, conditionsModule conditions: Head and Neck Cancer, conditions: Malignant Melanoma, conditions: Colorectal Cancer, conditions: Renal Cell Carcinoma, conditions: Cervical Cancer, conditions: Breast Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: NON_RANDOMIZED, interventionModel: SEQUENTIAL, interventionModelDescription: Dose escalation and dose expansion, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 125, type: ESTIMATED, armsInterventionsModule interventions name: GM103 (Part A), interventions name: GM103 (Part B), interventions name: GM103 and Pembrolizumab (Part C), outcomesModule primaryOutcomes measure: Percentage of patients with DLTs by cohorts, primaryOutcomes measure: Percentage of patients with DLTs, primaryOutcomes measure: Incidence of AEs, AESIs, SAEs, AEs leading to discontinuation, and AEs resulting in death, secondaryOutcomes measure: ORR, secondaryOutcomes measure: DCR defined as the proportion of patients whose BOR was CR, PR and SD, secondaryOutcomes measure: Median PFS defined as the time from the date of the first administration of study drug to the date of disease progression or death, secondaryOutcomes measure: Incidence of GM103 detection, secondaryOutcomes measure: Changes in the level of anti-adenovirus antibodies(ADA) in blood compared to baseline (ADA in genome copies/mL using qPCR), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: National Cancer Center, status: NOT_YET_RECRUITING, city: Goyang-si, state: Gyeonggi-do, zip: 10408, country: Korea, Republic of, contacts name: WY Choi, role: CONTACT, geoPoint lat: 37.65639, lon: 126.835, locations facility: Korea University Anam Hospital, status: NOT_YET_RECRUITING, city: Seoul, zip: 02841, country: Korea, Republic of, contacts name: SH Lee, role: CONTACT, geoPoint lat: 37.566, lon: 126.9784, locations facility: Hanyang University Seoul Hospital, status: NOT_YET_RECRUITING, city: Seoul, zip: 04763, country: Korea, Republic of, contacts name: MS Chung, role: CONTACT, geoPoint lat: 37.566, lon: 126.9784, locations facility: Severance Hospital, Yonsei University Health System, status: RECRUITING, city: Seoul, country: Korea, Republic of, contacts name: JY Lee, role: CONTACT, geoPoint lat: 37.566, lon: 126.9784, hasResults: False