NCT07042802 A Phase Ib/Ⅱ Clinical Trial of LBL-024 Combined With Paclitaxel in Patients With Platinum-resistant Ovarian Cancer
| NCT ID | NCT07042802 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Nanjing Leads Biolabs Co.,Ltd |
| Condition | Ovarian Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 110 participants |
| Start Date | 2025-12-02 |
| Primary Completion | 2027-12-25 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 110 participants in total. It began in 2025-12-02 with a primary completion date of 2027-12-25.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This trial is an open-label, multicenter phase Ib/II clinical study of LBL-024 combination therapy in patients with platinum-resistant ovarian cancer (OC),To evaluate the efficacy and safety of LBL-024 combination therapy in the treatment of advanced recurrent platinum-resistant ovarian cancer (OC) patients.
Eligibility Criteria
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, and the gender was not limited. 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 subjects 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 subject 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. Patients 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. Patients with clinically uncontrollable pleural effusion, pericardial effusion or ascites, and those requiring repeated drainage or medical intervention. 5. The patient 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 subject has other conditions that may affect compliance or are not suitable for participating in this study.
Contact & Investigator
lingying wu
PRINCIPAL INVESTIGATOR
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Frequently Asked Questions
Who can join the NCT07042802 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Ovarian Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07042802 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07042802 currently recruiting?
Yes, NCT07042802 is actively recruiting participants. Contact the research team at mengdongtao@leadsbiolabs.com for enrollment information.
Where is the NCT07042802 trial being conducted?
This trial is being conducted at Beijing, China, Beijing, China, Fuzhou, China, Guangzhou, China and 9 additional locations.
Who is sponsoring the NCT07042802 clinical trial?
NCT07042802 is sponsored by Nanjing Leads Biolabs Co.,Ltd. The principal investigator is lingying wu at Cancer Institute and Hospital, Chinese Academy of Medical Sciences. The trial plans to enroll 110 participants.
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