Recurrent Ovarian Cancer Clinical Trial
Official title:
A Phase Ib/II Clinical Study of HRS-1167 in Combination With Bevacizumab in Patients With Recurrent Ovarian Cancer
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.
Status | Recruiting |
Enrollment | 54 |
Est. completion date | October 2025 |
Est. primary completion date | October 2025 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 75 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
China | Beijing Cancer Hospital | Beijing | Beijing |
China | Cancer Hospital Chinese Academy of Medical Sciences | Beijing | Beijing |
China | Hunan Cancer Hospital | Changsha | Hunan |
China | Sichuan Cancer Hospital | Chengdu | Sichuan |
China | Chongqing University Cancer Hospital | Chongqing | Chongqing |
China | The First Affiliated Hospital of Chongqing Medical University | Chongqing | Chongqing |
China | Zhejiang Cancer Hospital | Hangzhou | Zhejiang |
China | Harbin Medical University Cancer Hospital | Harbin | Heilongjiang |
China | First Affiliated Hospital of University of Science and Technology of China | Hefei | Anhui |
China | Qilu Hospital of Shandong University | Jinan | Shandong |
China | Shandong First Medical University Affiliated Cancer Hospital | Jinan | Shangdong |
China | Yunnan Cancer Hospital | Kunming | Yunnan |
China | Guangxi Medical University Affiliated Tumor Hospital | Nanning | Guangxi |
China | Liaoning Cancer Hospital | Shenyang | Liaoning |
China | The Fourth Hospital of Hebei Medical University | Shijiazhuang | Hebei |
China | Shanxi Provincial Cancer Hospital | Taiyuan | Shanxi |
China | Tianjin Cancer Hospital | Tianjin | Tianjin |
China | Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology | Wuhan | Hubei |
Lead Sponsor | Collaborator |
---|---|
Jiangsu HengRui Medicine Co., Ltd. |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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) | ||
Primary | Determination of Recommended Phase II dose (RP2D) | From first dose of study treatment until the end of Cycle 1(up to 21 days) | ||
Secondary | Objective Response Rate (ORR) | The percentage of participants with a confirmed CR or PR according to RECIST v1.1 criteria. | From time of first dose of HRS-1167 or Bevacizumab until the date of objective disease progression or death (up to 24 months)] | |
Secondary | 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 | From time of first dose of HRS-1167 or Bevacizumab until the date of objective disease progression or death (up to 24 months) | |
Secondary | 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. | From time of first dose of HRS-1167 or Bevacizumab until the date of objective disease progression or death (up to 24 months) | |
Secondary | 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 | From time of fist dose of HRS-1167 or Bevacizumab until the date of objective disease progression or death (up to 24 months) | |
Secondary | Overall Survival (OS) | The time until death due to any cause. | From time of first dose of HRS-1167 or Bevacizumab until the date of death (up to 24 months) | |
Secondary | Time To Response(TTR) | Time from C1D1 to complete or partial response, according to RECIST v1.1 criteria. | From time of first dose of HRS-1167 or Bevacizumab until the date of objective disease progression or death (up to 24 months) |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT02195973 -
Phase IB Trial of LDE225 and Paclitaxel in Recurrent Ovarian Cancer
|
Phase 1 | |
Not yet recruiting |
NCT05270720 -
Dendritic Cell Vaccination With Standard Postoperative Chemotherapy for the Treatment of Adult Ovarian Cancer
|
Phase 1 | |
Not yet recruiting |
NCT06070285 -
Investigating Participation Patterns Among Recurrent Ovarian Cancer Patients
|
||
Completed |
NCT02303912 -
Safety and Efficacy Study of Nuc-1031 and Carboplatin Combination to Treat Recurrent Ovarian Cancer
|
Phase 1 | |
Active, not recruiting |
NCT01802749 -
Bevacizumab Beyond Progression in Platinum Sensitive Ovarian Cancer
|
Phase 3 | |
Completed |
NCT02788708 -
Lenvatinib and Weekly Paclitaxel for Patients With Recurrent Endometrial or Ovarian Cancer
|
Phase 1 | |
Recruiting |
NCT03564340 -
Study of REGN4018 Administered Alone or in Combination With Cemiplimab in Adult Patients With Recurrent Ovarian Cancer or Other Recurrent Mucin-16 Expressing (MUC16+) Cancers
|
Phase 1/Phase 2 | |
Recruiting |
NCT05610735 -
Combination Therapy for Recurrent Ovarian Cancer
|
Phase 1/Phase 2 | |
Withdrawn |
NCT02083536 -
LDFWART With Docetaxel in Patients With Platinum-Resistant Recurrent Ovarian Carcinoma
|
Phase 1 | |
Completed |
NCT03430518 -
Durvalumab and Eribulin in Her2-negative Metastatic Breast Cancer and Recurrent Ovarian Cancer
|
Phase 1 | |
Recruiting |
NCT03618706 -
Standard of Care Therapy With Involved Field Radiation Therapy for Selective Recurrent Ovarian Cancer
|
Phase 2 | |
Recruiting |
NCT05311579 -
Niraparib Plus Anlotinib for Recurrent Ovarian Cancer
|
Phase 2 | |
Active, not recruiting |
NCT01851746 -
A Study of Docetaxel and Lobaplatin Versus Docetaxel and Carboplatin Combination Regimen in Patients With Platinum-sensitive (>6 Months) Relapsed Ovarian Cancer
|
N/A | |
Active, not recruiting |
NCT06107868 -
Phase 1 Study of RP-6306 With Carboplatin and Paclitaxel in TP53 Ovarian and Uterine Cancer
|
Phase 1 | |
Not yet recruiting |
NCT06365853 -
A Study of Ocular Toxicity Evaluation and Mitigation During Treatment With Mirvetuximab Soravtansine in Participants With Recurrent Ovarian Cancer With High Folate Receptor-Alpha Expression
|
Phase 2 | |
Completed |
NCT04718740 -
A Drug-drug Interaction Study Of Fluzoparib (SHR3162) on Patients With Recurrent Ovarian Cancer
|
Phase 1 | |
Active, not recruiting |
NCT05335993 -
A Clinical Study Evaluating a Combination of Oregovomab and Niraparib in Adult Women With Platinum Sensitive Recurrent Ovarian Cancer.
|
Phase 2 | |
Completed |
NCT01381861 -
Evaluation of TRC105 in the Treatment of Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Carcinoma
|
Phase 2 | |
Not yet recruiting |
NCT05126342 -
Study to Estimate Efficacy of Combining Dostarlimab and Niraparib in Relapsed EOC After Treatment With PARPi
|
Phase 2 | |
Completed |
NCT02849353 -
Combination of Cryosurgey and NK Immunotherapy for Recurrent Ovarian Cancer
|
Phase 1/Phase 2 |