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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
54
Bevacizumab: injection, 100mg(4mL), intravenous infusion HRS-1167: Tablets, 25mg/tablet, oral
First Affiliated Hospital of University of Science and Technology of China
Hefei, Anhui, China
The number of subjects with dose-limiting toxicity (DLT)
Time frame: From first dose of study treatment until the end of Cycle 1(up to 21 days)
Determination of Recommended Phase II dose (RP2D)
Time frame: From first dose of study treatment until the end of Cycle 1(up to 21 days)
Objective Response Rate (ORR)
The percentage of participants with a confirmed CR or PR according to RECIST v1.1 criteria.
Time frame: From time of first dose of HRS-1167 or Bevacizumab until the date of objective disease progression or death (up to 24 months)]
Disease Control Rate (DCR)
The percentage of participants who have a best objective response of confirmed CR or PR or who have SD for at least 15 weeks after start of treatment
Time frame: From time of first dose of HRS-1167 or Bevacizumab until the date of objective disease progression or death (up to 24 months)
Duration of Response (DoR)
The time from the date of first response until date of disease progression or death in the absence of disease progression.
Time frame: From time of first dose of HRS-1167 or Bevacizumab until the date of objective disease progression or death (up to 24 months)
Progression free Survival (PFS)
Progression-free survival is defined as the time from the start of treatment until the date of objective disease progression or death
Time frame: From time of fist dose of HRS-1167 or Bevacizumab until the date of objective disease progression or death (up to 24 months)
Overall Survival (OS)
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Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
NOT_YET_RECRUITINGBeijing Cancer Hospital
Beijing, Beijing Municipality, China
NOT_YET_RECRUITINGChongqing University Cancer Hospital
Chongqing, Chongqing Municipality, China
NOT_YET_RECRUITINGThe First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
NOT_YET_RECRUITINGGuangxi Medical University Affiliated Tumor Hospital
Nanning, Guangxi, China
NOT_YET_RECRUITINGThe Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
NOT_YET_RECRUITINGHarbin Medical University Cancer Hospital
Harbin, Heilongjiang, China
NOT_YET_RECRUITINGTongji Hospital, Tongji Medical College, Huazhong University of Science & Technology
Wuhan, Hubei, China
NOT_YET_RECRUITINGHunan Cancer Hospital
Changsha, Hunan, China
RECRUITING...and 8 more locations
The time until death due to any cause.
Time frame: From time of first dose of HRS-1167 or Bevacizumab until the date of death (up to 24 months)
Time To Response(TTR)
Time from C1D1 to complete or partial response, according to RECIST v1.1 criteria.
Time frame: From time of first dose of HRS-1167 or Bevacizumab until the date of objective disease progression or death (up to 24 months)