LBL-024 for InjectionPaclitaxel injectionBevacizumab injection
LBL-024 for Injection: Intravenous infusion.
Paclitaxel injection: Intravenous infusion.
Bevacizumab injection: Intravenous infusion.
Study summary
This study is an open-label, multicenter Phase Ib/II clinical trial of LBL-024 in combination with other drugs for the treatment of patients with platinum-resistant ovarian cancer (OC), aiming to evaluate the efficacy and safety of LBL-024 in combination with other drugs in the treatment of advanced recurrent platinum-resistant ovarian cancer (OC).
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
1. Agree to follow the trial treatment regimen, visit schedule, laboratory test, and other requirements of the protocol, and voluntarily enroll in the study and sign the written informed consent.
2. At the time of signing the informed consent form, the age was ≥ 18 years old.
3. The Eastern Cooperative Oncology Group's physical status scoring standard (ECOG) is 0\~1.
4. The expected survival time is at least 12 weeks.
5. According to the evaluation of RECIST 1.1 (Response Evaluation Criteria in Solid Tumours),the Participants enrolled have at least one measurable lesion.
6. Females of childbearing age are willing to take highly effective contraceptive measures From the signing of the informed consent form to within 6 months after the last administration of the trial drug;Women of childbearing age include pre-menopausal women and women within 2 years after menopause. Women of childbearing age must have a negative pregnancy test within 7 days before the first trial drug is administered.
Exclusion Criteria:
1. The Participants is currently participating in any other clinical trial,Or has received or is receiving other investigational agents within 4 weeks prior to the first dose of study drug.
2. Use of immunomodulatory drugs within 2 weeks prior to the first use of study drug.
3. Participants with active infection and currently requiring systemic treatment. active pulmonary tuberculosis (TB), receiving anti-tuberculosis treatment or Received anti-tuberculosis treatment within 6 months before screening.
4. Participants with clinically uncontrollable pleural effusion, pericardial effusion or ascites, and those requiring repeated drainage or medical intervention.
5. The Participants has a Medical history of immunodeficiency, including HIV antibody positive.
6. Active hepatitis B or active hepatitis C.
7. Women during pregnancy or lactation.
8. History of mental and/or psychiatric illness (impairing understanding or giving informed consent), drug abuse, alcoholism, or drug addiction.
9. The investigator believes that the Participants has other conditions that may affect compliance or are not suitable for participating in this study.
Primary outcome measure(s)
Objective Response Rate (ORR) — From all subjects signed the informed consent form up to the completion of the follow-up period of drug withdrawal (28 days after drug withdrawal or before the start of new anti-tumor therapy) According to the evaluation criteria of RECIST V1.1 (solid tumour) ,Proportion of subjects achieving complete response (CR) or partial response (PR).It was used to evaluate the efficacy in Phase Ib.
Occurrence of adverse event (AE) and serious adverse event (SAE) — From all subjects signed the informed consent form up to the completion of the follow-up period of drug withdrawal (90 days after drug withdrawal or before the start of new anti-tumor therapy) Adverse event (AE) will be graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) 5.0.The safety profile of LBL-024 in combination with paclitaxel will be assessed by monitoring the adverse event (AE) and serious adverse event (SAE) in Phase Ib study.
Progression-free Survival(PFS) — From all subjects signed the informed consent form up to the completion of the follow-up period of drug withdrawal (28 days after drug withdrawal or before the start of new anti-tumor therapy) According to the evaluation criteria of RECIST V1.1 (solid tumour),Time from randomisation to disease progression or death from any cause.It was used to evaluate Time of disease no-progression or Drug resistance in Phase II.
Trial sites (13)
Facility
City
Region
Status
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijing
Beijing Municipality
Recruiting
Beijing Obstetrics and Gynecology Hospital Capital Medical University
Beijing
Beijing Municipality
Not Yet Recruiting
Fujian Cancer Hospital
Fuzhou
Fujian
Not Yet Recruiting
Sun Yat-sen University Cancer Center
Guangzhou
Guangdong
Not Yet Recruiting
Harbin Medical University Cancer Hospital
Harbin
Heilongjiang
Not Yet Recruiting
AnYang Tumor Hospital
Anyang
Henan
Recruiting
The First Affiliated Hospital of Zhengzhou University
Zhengzhou
Henan
Not Yet Recruiting
The Affiliated Hospital of Xuzhou Medical University
Xuzhou
Jiangsu
Recruiting
The First Hospital of China Medical University
Shenyang
Liaoning
Recruiting
Shandong Cancer Hospital
Jinan
Shandong
Recruiting
Tianjin Medical University Cancer Institute &Hospital
Tianjin
Tianjin Municipality
Recruiting
Yunnan Cancer Hospital
Kunming
Yunnan
Recruiting
Zhejiang Cancer Hospital
Hangzhou
Zhejiang
Recruiting
More Nanjing Leads Biolabs Co.,Ltd trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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