protocolSection identificationModule nctId: NCT06380660, orgStudyIdInfo id: ACE-106-001, briefTitle: Study of ACE-86225106 to Treat Patients With Advanced Solid Tumors, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-22, primaryCompletionDateStruct date: 2028-12-21, completionDateStruct date: 2029-03-21, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: Acerand Therapeutics (Shanghai) Limited, class: INDUSTRY, descriptionModule briefSummary: The purpose of this study is to determine if the experimental treatment with poly-ADP ribose polymerase (PARP) inhibitor, ACE-86225106 is safe, tolerable and has anti-cancer activity in adult patients with advanced solid tumors., conditionsModule conditions: Solid Tumor, Adult, conditions: BRCA1 Mutation, conditions: BRCA2 Mutation, conditions: Ovarian Cancer, conditions: Breast Cancer, conditions: Prostate Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 298, type: ESTIMATED, armsInterventionsModule interventions name: ACE-86225106 tablet, outcomesModule primaryOutcomes measure: Number of participants experiencing adverse events (AEs)/serious adverse events (SAEs), primaryOutcomes measure: The number of patients experiencing dose limiting toxicity (DLT), as defined in the protocol, primaryOutcomes measure: Recommended Phase 2 dose (RP2D) and/or maximum tolerated dose (MTD), secondaryOutcomes measure: Objective Response Rate (ORR), secondaryOutcomes measure: Duration of Response (DoR) and Time to Response (TTR), secondaryOutcomes measure: Progression Free Survival (PFS), secondaryOutcomes measure: Overall Survival (OS), secondaryOutcomes measure: Pharmacokinetic (PK) parameters and Pharmacodynamic (PD) marker change, secondaryOutcomes measure: Serum tumor marker change: CA125, etc. (OC), prostatic specific antigen (PSA, prostate cancer) decreased, and specific tumor markers for other tumor types may also be included (to be assessed by clinical investigators), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Fujian Cancer Hospital, status: RECRUITING, city: Fuzhou, state: Fujian, country: China, geoPoint lat: 26.06139, lon: 119.30611, locations facility: Sun Yat-Sen University Cancer Center, status: NOT_YET_RECRUITING, city: Guangzhou, state: Guangdong, country: China, geoPoint lat: 23.11667, lon: 113.25, locations facility: Hubei Cancer Hospital, status: RECRUITING, city: Wuhan, state: Hubei, country: China, geoPoint lat: 30.58333, lon: 114.26667, locations facility: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, status: NOT_YET_RECRUITING, city: Wuhan, state: Hubei, country: China, geoPoint lat: 30.58333, lon: 114.26667, locations facility: Hunan Cancer Hospital, status: RECRUITING, city: Changsha, state: Hunan, country: China, geoPoint lat: 28.19874, lon: 112.97087, locations facility: Fudan University Shanghai Cancer Center, status: RECRUITING, city: Shanghai, state: Shanghai, country: China, geoPoint lat: 31.22222, lon: 121.45806, locations facility: Zhejiang Cancer Hospital, status: RECRUITING, city: Hangzhou, state: Zhejiang, country: China, geoPoint lat: 30.29365, lon: 120.16142, hasResults: False