A Phase Ib/II Clinical Study of HRS-1167 in Combination With Bevacizumab in Patients With Recurrent Ovarian Cancer

Status: Recruiting
Location: See all (18) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY

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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• Voluntarily join this study, sign the informed consent form, have good compliance, and be able to cooperate with the follow-up.

• Age 18\

⁃ 75 years old.

• Cytologically or histologically confirmed diagnosis of recurrent epithelial ovarian, fallopian tube, or primary peritoneum cancer.

• Patient has been previously treated with a platinum-containing regimen and has been treated with a platinum-based regimen during the last dose of platinum-based therapy (self-treatment initiation to within 1 month after the last dose) efficacy is non-PD, 6 months after the end of treatment (183 disease progression or recurrence within calendar days, and the number of lines of systemic therapy after platinum resistance ≤1 line.

• At least one measurable lesion per RECIST v1.1 criteria.

• ECOG PS score: 0-1 points.

• Expected survival period ≥ 3 weeks.

• Good level of organ function.

• Subjects of childbearing potential who need to use highly effective contraception from the time of signing informed to 210 days after the last dose of trial drug; Subjects of childbearing potential must have a negative serum HCG within 7 days prior to the first dose and must be non-lactating.

Locations
Other Locations
China
Beijing Cancer Hospital
NOT_YET_RECRUITING
Beijing
Cancer Hospital Chinese Academy of Medical Sciences
NOT_YET_RECRUITING
Beijing
Hunan Cancer Hospital
RECRUITING
Changsha
Sichuan Cancer Hospital
NOT_YET_RECRUITING
Chengdu
Chongqing University Cancer Hospital
NOT_YET_RECRUITING
Chongqing
The First Affiliated Hospital of Chongqing Medical University
NOT_YET_RECRUITING
Chongqing
Zhejiang Cancer Hospital
NOT_YET_RECRUITING
Hangzhou
Harbin Medical University Cancer Hospital
NOT_YET_RECRUITING
Harbin
First Affiliated Hospital of University of Science and Technology of China
NOT_YET_RECRUITING
Hefei
Qilu Hospital of Shandong University
NOT_YET_RECRUITING
Jinan
Shandong First Medical University Affiliated Cancer Hospital
NOT_YET_RECRUITING
Jinan
Yunnan Cancer Hospital
NOT_YET_RECRUITING
Kunming
Guangxi Medical University Affiliated Tumor Hospital
NOT_YET_RECRUITING
Nanning
Liaoning Cancer Hospital
NOT_YET_RECRUITING
Shenyang
The Fourth Hospital of Hebei Medical University
NOT_YET_RECRUITING
Shijiazhuang
Shanxi Provincial Cancer Hospital
NOT_YET_RECRUITING
Taiyuan
Tianjin Cancer Hospital
NOT_YET_RECRUITING
Tianjin
Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology
NOT_YET_RECRUITING
Wuhan
Contact Information
Primary
Xin Xu
xin.xu@hengrui.com
0518-82342973
Backup
Yuting Wang
yuting.wang@hengrui.com
0518-82342973
Time Frame
Start Date: 2024-03-15
Estimated Completion Date: 2025-10
Participants
Target number of participants: 54
Treatments
Experimental: HRS-1167 in combination with bevacizumab in patients with recurrent ovarian cancer
Related Therapeutic Areas
Sponsors
Leads: Jiangsu HengRui Medicine Co., Ltd.

This content was sourced from clinicaltrials.gov

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