Trial Title:
A Phase Ib/II Clinical Study of HRS-1167 in Combination With Bevacizumab in Patients With Recurrent Ovarian Cancer
NCT ID:
NCT06308406
Condition:
Recurrent Ovarian Cancer
Conditions: Official terms:
Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Recurrence
Bevacizumab
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Bevacizumab; HRS-1167
Description:
Bevacizumab: injection, 100mg(4mL), intravenous infusion HRS-1167: Tablets, 25mg/tablet,
oral
Arm group label:
HRS-1167 in combination with bevacizumab in patients with recurrent ovarian cancer
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Voluntarily join this study, sign the informed consent form, have good compliance,
and be able to cooperate with the follow-up.
2. Age 18~75 years old.
3. Cytologically or histologically confirmed diagnosis of recurrent epithelial ovarian,
fallopian tube, or primary peritoneum cancer.
4. 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.
5. At least one measurable lesion per RECIST v1.1 criteria.
6. ECOG PS score: 0-1 points.
7. Expected survival period ≥ 3 weeks.
8. Good level of organ function.
9. 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.
Exclusion Criteria:
1. 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.
2. Toxicity due to prior antineoplastic therapy has not recovered according to
NCI-CTCAE v5.0 grade≤ Level 1.
3. Subject has previous or concurrent other malignancies.
4. Subject has carcinomatous meningitis, or has untreated central nervous system
metastases.
5. 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.
6. 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.
7. 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.
8. 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.
9. People who are known to be allergic to bevacizumab or have had a severe allergic
reaction to other monoclonal antibodies.
10. 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.
11. 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.
12. Have clinical symptoms or disease of the heart that are not well controlled.
13. 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.
14. 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.
15. Experienced arterior/venous thrombotic event within 6 months prior to the first
dose.
16. Patients with gastrointestinal perforation or fistula (except artificial fistula),
urethral fistula, intra-abdominal abscess, intestinal obstruction, or those
requiring parenteral nutrition within 3 months prior to the first dose.
17. Those who are unable to swallow tablets normally, or have abnormal gastrointestinal
function, which may affect drug absorption as judged by the investigator.
18. Subjects who have had a serious infection within 1 month before the first dose,
including but not limited to infectious complications requiring hospitalization,
bacteremia, severe pneumonia, etc.; Subjects with any active infection requiring
intravenous system therapy, or who have a progeny during the screening period, prior
to the first dose 38.5°C due to unknown fever>; Those who have used antibiotics
within 2 weeks before the first dose.
19. Known history of positive human immunodeficiency virus (HIV) test; Known active
hepatitis.
20. Treatment with a strong inhibitor of CYP3A4, CYP2D6, P-gp, or BCRP, <5 drug
half-lives or 14 days from the date of first dose; Treatment with the above enzyme
strong inducers was 28 days < the first dose.
21. As judged by the investigator, there are other factors that may affect the results
of the study or cause the study to be terminated halfway, such as alcoholism, drug
abuse, other serious diseases (such as severe diabetes, thyroid disease, spinal cord
compression, superior vena cava syndrome, psychiatric diseases) that require
concomitant treatment, serious laboratory test abnormalities, accompanied by family
or social factors, which will affect the safety of the subjects.
Gender:
Female
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
First Affiliated Hospital of University of Science and Technology of China
Address:
City:
Hefei
Zip:
230002
Country:
China
Status:
Not yet recruiting
Investigator:
Last name:
Ying Zhou
Email:
Principal Investigator
Facility:
Name:
Cancer Hospital Chinese Academy of Medical Sciences
Address:
City:
Beijing
Zip:
100021
Country:
China
Status:
Not yet recruiting
Investigator:
Last name:
Lingying Wu
Email:
Principal Investigator
Facility:
Name:
Beijing Cancer Hospital
Address:
City:
Beijing
Zip:
100142
Country:
China
Status:
Not yet recruiting
Investigator:
Last name:
Hong Zheng
Email:
Principal Investigator
Facility:
Name:
Chongqing University Cancer Hospital
Address:
City:
Chongqing
Zip:
400000
Country:
China
Status:
Not yet recruiting
Investigator:
Last name:
Yu Huang
Email:
Principal Investigator
Facility:
Name:
The First Affiliated Hospital of Chongqing Medical University
Address:
City:
Chongqing
Zip:
400016
Country:
China
Status:
Not yet recruiting
Investigator:
Last name:
Junying Tang
Email:
Principal Investigator
Facility:
Name:
Guangxi Medical University Affiliated Tumor Hospital
Address:
City:
Nanning
Zip:
530022
Country:
China
Status:
Not yet recruiting
Investigator:
Last name:
He Wang
Email:
Principal Investigator
Facility:
Name:
The Fourth Hospital of Hebei Medical University
Address:
City:
Shijiazhuang
Zip:
050001
Country:
China
Status:
Not yet recruiting
Investigator:
Last name:
Hui Zhang
Email:
Principal Investigator
Facility:
Name:
Harbin Medical University Cancer Hospital
Address:
City:
Harbin
Zip:
150001
Country:
China
Status:
Not yet recruiting
Investigator:
Last name:
Ge Lou
Email:
Principal Investigator
Facility:
Name:
Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology
Address:
City:
Wuhan
Zip:
430030
Country:
China
Status:
Not yet recruiting
Investigator:
Last name:
Qinglei Gao
Email:
Principal Investigator
Facility:
Name:
Hunan Cancer Hospital
Address:
City:
Changsha
Zip:
410013
Country:
China
Status:
Recruiting
Investigator:
Last name:
Jing Wang
Email:
Principal Investigator
Facility:
Name:
Liaoning Cancer Hospital
Address:
City:
Shenyang
Zip:
110042
Country:
China
Status:
Not yet recruiting
Investigator:
Last name:
Danbo Wang
Email:
Principal Investigator
Facility:
Name:
Qilu Hospital of Shandong University
Address:
City:
Jinan
Zip:
250000
Country:
China
Status:
Not yet recruiting
Investigator:
Last name:
Hualei Bu
Email:
Principal Investigator
Facility:
Name:
Shandong First Medical University Affiliated Cancer Hospital
Address:
City:
Jinan
Zip:
250117
Country:
China
Status:
Not yet recruiting
Investigator:
Last name:
Liang Chen
Email:
Principal Investigator
Facility:
Name:
Shanxi Provincial Cancer Hospital
Address:
City:
Taiyuan
Zip:
030006
Country:
China
Status:
Not yet recruiting
Investigator:
Last name:
Hongwei Zhao
Email:
Principal Investigator
Facility:
Name:
Sichuan Cancer Hospital
Address:
City:
Chengdu
Zip:
610042
Country:
China
Status:
Not yet recruiting
Investigator:
Last name:
Guonan Zhang
Email:
Principal Investigator
Facility:
Name:
Tianjin Cancer Hospital
Address:
City:
Tianjin
Zip:
300000
Country:
China
Status:
Not yet recruiting
Investigator:
Last name:
Ke Wang
Email:
Principal Investigator
Facility:
Name:
Yunnan Cancer Hospital
Address:
City:
Kunming
Zip:
650118
Country:
China
Status:
Not yet recruiting
Investigator:
Last name:
Hongying Yang
Email:
Principal Investigator
Facility:
Name:
Zhejiang Cancer Hospital
Address:
City:
Hangzhou
Zip:
310005
Country:
China
Status:
Not yet recruiting
Investigator:
Last name:
Tao Zhu
Email:
Principal Investigator
Start date:
March 15, 2024
Completion date:
October 2025
Lead sponsor:
Agency:
Jiangsu HengRui Medicine Co., Ltd.
Agency class:
Industry
Source:
Jiangsu HengRui Medicine Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06308406