A Phase Ib/Ⅱ Clinical Trial of LBL-024 Combined With Paclitaxel in Patients With Platinum-resistant Ovarian Cancer

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorNanjing Leads Biolabs Co.,Ltd

About this trial

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

Qualifiers

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.

At the time of signing the informed consent form, the age was ≥ 18 years old, and the gender was not limited.

The Eastern Cooperative Oncology Group's physical status scoring standard (ECOG) is 0~1.

The expected survival time is at least 12 weeks.

Disqualifiers

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.

Use of immunomodulatory drugs within 2 weeks prior to the first use of study drug.

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.

Patients with clinically uncontrollable pleural effusion, pericardial effusion or ascites, and those requiring repeated drainage or medical intervention.

Trial design

Treatments tested in this trial

  • LBL-024 for Injection
  • Paclitaxel Injection

Treatment groups

110 Participants
are divided into 2 treatment groups

Sponsors and collaborators