protocolSection identificationModule nctId: NCT06308406, orgStudyIdInfo id: HRS-1167-201-Bev, briefTitle: A Phase Ib/II Clinical Study of HRS-1167 in Combination With Bevacizumab in Patients With Recurrent Ovarian Cancer, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-15, primaryCompletionDateStruct date: 2025-10, completionDateStruct date: 2025-10, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Jiangsu HengRui Medicine Co., Ltd., class: INDUSTRY, descriptionModule briefSummary: This study is a multicenter, open-label Phase Ib/II clinical trial to observe and evaluate the safety, tolerability and pharmacokinetics of HRS-1167 in combination with bevacizumab in patients with recurrent ovarian cancer mechanical characterization and preliminary evaluation of the efficacy of HRS-1167 in combination with bevacizumab in patients with recurrent ovarian cancer., conditionsModule conditions: Recurrent Ovarian Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 54, type: ESTIMATED, armsInterventionsModule interventions name: Bevacizumab； HRS-1167, outcomesModule primaryOutcomes measure: The number of subjects with dose-limiting toxicity (DLT), primaryOutcomes measure: Determination of Recommended Phase II dose (RP2D), secondaryOutcomes measure: Objective Response Rate (ORR), secondaryOutcomes measure: Disease Control Rate (DCR), secondaryOutcomes measure: Duration of Response (DoR), secondaryOutcomes measure: Progression free Survival (PFS), secondaryOutcomes measure: Overall Survival (OS), secondaryOutcomes measure: Time To Response(TTR), eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: First Affiliated Hospital of University of Science and Technology of China, status: NOT_YET_RECRUITING, city: Hefei, state: Anhui, zip: 230002, country: China, contacts name: Ying Zhou, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 31.86389, lon: 117.28083, locations facility: Cancer Hospital Chinese Academy of Medical Sciences, status: NOT_YET_RECRUITING, city: Beijing, state: Beijing, zip: 100021, country: China, contacts name: Lingying Wu, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.9075, lon: 116.39723, locations facility: Beijing Cancer Hospital, status: NOT_YET_RECRUITING, city: Beijing, state: Beijing, zip: 100142, country: China, contacts name: Hong Zheng, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.9075, lon: 116.39723, locations facility: Chongqing University Cancer Hospital, status: NOT_YET_RECRUITING, city: Chongqing, state: Chongqing, zip: 400000, country: China, contacts name: Yu Huang, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 29.56278, lon: 106.55278, locations facility: The First Affiliated Hospital of Chongqing Medical University, status: NOT_YET_RECRUITING, city: Chongqing, state: Chongqing, zip: 400016, country: China, contacts name: Junying Tang, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 29.56278, lon: 106.55278, locations facility: Guangxi Medical University Affiliated Tumor Hospital, status: NOT_YET_RECRUITING, city: Nanning, state: Guangxi, zip: 530022, country: China, contacts name: He Wang, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 22.81667, lon: 108.31667, locations facility: The Fourth Hospital of Hebei Medical University, status: NOT_YET_RECRUITING, city: Shijiazhuang, state: Hebei, zip: 050001, country: China, contacts name: Hui Zhang, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 38.04139, lon: 114.47861, locations facility: Harbin Medical University Cancer Hospital, status: NOT_YET_RECRUITING, city: Harbin, state: Heilongjiang, zip: 150001, country: China, contacts name: Ge Lou, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 45.75, lon: 126.65, locations facility: Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology, status: NOT_YET_RECRUITING, city: Wuhan, state: Hubei, zip: 430030, country: China, contacts name: Qinglei Gao, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 30.58333, lon: 114.26667, locations facility: Hunan Cancer Hospital, status: RECRUITING, city: Changsha, state: Hunan, zip: 410013, country: China, contacts name: Jing Wang, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 28.19874, lon: 112.97087, locations facility: Liaoning Cancer Hospital, status: NOT_YET_RECRUITING, city: Shenyang, state: Liaoning, zip: 110042, country: China, contacts name: Danbo Wang, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 41.79222, lon: 123.43278, locations facility: Qilu Hospital of Shandong University, status: NOT_YET_RECRUITING, city: Jinan, state: Shandong, zip: 250000, country: China, contacts name: Hualei Bu, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 36.66833, lon: 116.99722, locations facility: Shandong First Medical University Affiliated Cancer Hospital, status: NOT_YET_RECRUITING, city: Jinan, state: Shangdong, zip: 250117, country: China, contacts name: Liang Chen, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 36.66833, lon: 116.99722, locations facility: Shanxi Provincial Cancer Hospital, status: NOT_YET_RECRUITING, city: Taiyuan, state: Shanxi, zip: 030006, country: China, contacts name: Hongwei Zhao, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 37.86944, lon: 112.56028, locations facility: Sichuan Cancer Hospital, status: NOT_YET_RECRUITING, city: Chengdu, state: Sichuan, zip: 610042, country: China, contacts name: Guonan Zhang, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 30.66667, lon: 104.06667, locations facility: Tianjin Cancer Hospital, status: NOT_YET_RECRUITING, city: Tianjin, state: Tianjin, zip: 300000, country: China, contacts name: Ke Wang, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.14222, lon: 117.17667, locations facility: Yunnan Cancer Hospital, status: NOT_YET_RECRUITING, city: Kunming, state: Yunnan, zip: 650118, country: China, contacts name: Hongying Yang, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 25.03889, lon: 102.71833, locations facility: Zhejiang Cancer Hospital, status: NOT_YET_RECRUITING, city: Hangzhou, state: Zhejiang, zip: 310005, country: China, contacts name: Tao Zhu, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 30.29365, lon: 120.16142, hasResults: False