A Phase Ib/II Clinical Study of HRS-1167 in Combination With Bevacizumab in Patients With Recurrent Ovarian Cancer
1 other identifier
interventional
54
1 country
18
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Mar 2024
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 26, 2024
CompletedFirst Posted
Study publicly available on registry
March 13, 2024
CompletedStudy Start
First participant enrolled
March 15, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2025
CompletedApril 11, 2024
February 1, 2024
1.5 years
February 26, 2024
April 9, 2024
Conditions
Outcome Measures
Primary Outcomes (2)
The number of subjects with dose-limiting toxicity (DLT)
From first dose of study treatment until the end of Cycle 1（up to 21 days）
Determination of Recommended Phase II dose (RP2D)
From first dose of study treatment until the end of Cycle 1（up to 21 days）
Secondary Outcomes (6)
Objective Response Rate (ORR)
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)
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)
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)
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)
From time of first dose of HRS-1167 or Bevacizumab until the date of death (up to 24 months)
- +1 more secondary outcomes
Study Arms (1)
HRS-1167 in combination with bevacizumab in patients with recurrent ovarian cancer
EXPERIMENTALInterventions
Bevacizumab: injection, 100mg(4mL), intravenous infusion HRS-1167: Tablets, 25mg/tablet, oral
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Those who have received chemotherapy, immune checkpoint inhibitors, major surgical operations, anti-tumor vaccines within 4 weeks before the first dose; Those who have received palliative radiotherapy within 2 weeks prior to the first dose; Oral molecularly targeted therapy (including other clinical trial targeted agents) 5 drug half-lives or 4 weeks (whichever is shorter) \< from the first study dose; Those who have received a live vaccine within 4 weeks prior to the first dose or possibly during the study.
- Toxicity due to prior antineoplastic therapy has not recovered according to NCI-CTCAE v5.0 grade≤ Level 1.
- Subject has previous or concurrent other malignancies.
- Subject has carcinomatous meningitis, or has untreated central nervous system metastases.
- Imaging shows tumor invasion of large blood vessels or unclear demarcation from blood vessels; or the investigator judges that the patient's tumor has a high possibility of invading important blood vessels and causing fatal hemorrhage during treatment.
- Cancerous ascites and pleural effusion with clinical symptoms, requiring puncture and drainage; or those who have received ascites, pleural effusion drainage within 14 days before the first dose of the drug.
- Severe bone injury due to tumor bone metastases, including severe bone pain with poor control, pathological fractures of important sites and spinal cord that have occurred within the last 6 months or are expected to occur in the near future oppression, etc.
- Previous or current interstitial pneumonitis/interstitial lung disease (except for those with radiographic changes only), pneumonia requiring systemic treatment with glucocorticoids (such as radiation pneumonitis, etc.); Current active pneumonitis or those with severe impairment of lung function confirmed by pulmonary function tests.
- People who are known to be allergic to bevacizumab or have had a severe allergic reaction to other monoclonal antibodies.
- Those with active tuberculosis; Those who have been adequately treated before the first dose and have discontinued anti-tuberculosis therapy for ≥ 3 months can be enrolled.
- Have hypertension that is not well controlled with antihypertensive medication (systolic blood pressure ≥ 150 mmHg or diastolic blood pressure ≥ 90 mmHg); Previous hypertensive crisis or hypertensive sex encephalopathy.
- Have clinical symptoms or disease of the heart that are not well controlled.
- Coagulation abnormalities, bleeding tendency, or those receiving thrombolytic or anticoagulant therapy are allowed to receive low-dose low-molecular-weight heparin or oral aspirin prophylactic anticoagulation therapy during the trial.
- NCI-CTCAE v5.0 grade ≥2 bleeding events within 4 weeks prior to the first dose, including but not limited to hemoptysis (hemoptysis in a single episode ≥2mL), vaginal bleeding, gastrointestinal bleeding, etc.
- Experienced arterior/venous thrombotic event within 6 months prior to the first dose.
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (18)
First Affiliated Hospital of University of Science and Technology of China
Hefei, Anhui, 230002, China
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100021, China
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142, China
Chongqing University Cancer Hospital
Chongqing, Chongqing Municipality, 400000, China
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400016, China
Guangxi Medical University Affiliated Tumor Hospital
Nanning, Guangxi, 530022, China
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050001, China
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, 150001, China
Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology
Wuhan, Hubei, 430030, China
Hunan Cancer Hospital
Changsha, Hunan, 410013, China
Liaoning Cancer Hospital
Shenyang, Liaoning, 110042, China
Qilu Hospital of Shandong University
Jinan, Shandong, 250000, China
Shandong First Medical University Affiliated Cancer Hospital
Jinan, Shangdong, 250117, China
Shanxi Provincial Cancer Hospital
Taiyuan, Shanxi, 030006, China
Sichuan Cancer Hospital
Chengdu, Sichuan, 610042, China
Tianjin Cancer Hospital
Tianjin, Tianjin Municipality, 300000, China
Yunnan Cancer Hospital
Kunming, Yunnan, 650118, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310005, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 26, 2024
First Posted
March 13, 2024
Study Start
March 15, 2024
Primary Completion
October 1, 2025
Study Completion
October 1, 2025
Last Updated
April 11, 2024
Record last verified: 2024-02