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

Inclusion Criteria:

1. Voluntarily join this study, sign the informed consent form, have good compliance, andbe 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 beentreated 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 withincalendar 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 fromthe time of signing informed to 210 days after the last dose of trial drug; Subjectsof childbearing potential must have a negative serum HCG within 7 days prior to thefirst dose and must be non-lactating.

Exclusion Criteria:

1. Those who have received chemotherapy, immune checkpoint inhibitors, major surgicaloperations, anti-tumor vaccines within 4 weeks before the first dose; Those who havereceived palliative radiotherapy within 2 weeks prior to the first dose; Oralmolecularly targeted therapy (including other clinical trial targeted agents) 5 drughalf-lives or 4 weeks (whichever is shorter) < from the first study dose; Those whohave received a live vaccine within 4 weeks prior to the first dose or possibly duringthe study.
2. Toxicity due to prior antineoplastic therapy has not recovered according to NCI-CTCAEv5.0 grade≤ Level 1.
3. Subject has previous or concurrent other malignancies.
4. Subject has carcinomatous meningitis, or has untreated central nervous systemmetastases.
5. Imaging shows tumor invasion of large blood vessels or unclear demarcation from bloodvessels; or the investigator judges that the patient's tumor has a high possibility ofinvading important blood vessels and causing fatal hemorrhage during treatment.
6. Cancerous ascites and pleural effusion with clinical symptoms, requiring puncture anddrainage; or those who have received ascites, pleural effusion drainage within 14 daysbefore the first dose of the drug.
7. Severe bone injury due to tumor bone metastases, including severe bone pain with poorcontrol, pathological fractures of important sites and spinal cord that have occurredwithin 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 forthose with radiographic changes only), pneumonia requiring systemic treatment withglucocorticoids (such as radiation pneumonitis, etc.); Current active pneumonitis orthose 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 allergicreaction to other monoclonal antibodies.
10. Those with active tuberculosis; Those who have been adequately treated before thefirst dose and have discontinued anti-tuberculosis therapy for ≥ 3 months can beenrolled.
11. Have hypertension that is not well controlled with antihypertensive medication (systolic blood pressure ≥ 150 mmHg or diastolic blood pressure ≥ 90 mmHg); Previoushypertensive 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 oranticoagulant therapy are allowed to receive low-dose low-molecular-weight heparin ororal 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), vaginalbleeding, 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 requiringparenteral nutrition within 3 months prior to the first dose.
17. Those who are unable to swallow tablets normally, or have abnormal gastrointestinalfunction, 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 requiringintravenous system therapy, or who have a progeny during the screening period, priorto 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 activehepatitis.
20. Treatment with a strong inhibitor of CYP3A4, CYP2D6, P-gp, or BCRP, <5 drug half-livesor 14 days from the date of first dose; Treatment with the above enzyme stronginducers was 28 days < the first dose.
21. As judged by the investigator, there are other factors that may affect the results ofthe study or cause the study to be terminated halfway, such as alcoholism, drug abuse,other serious diseases (such as severe diabetes, thyroid disease, spinal cordcompression, superior vena cava syndrome, psychiatric diseases) that requireconcomitant treatment, serious laboratory test abnormalities, accompanied by family orsocial factors, which will affect the safety of the subjects.