Health TrialsbyHealthPanel

A Study of LBL-024 in Combination With Paclitaxel ± Bevacizumab for the Treatment of Platinum-resistant Ovarian Cancer

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

About this trial

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 criteria

This trial does not accept healthy volunteers

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.

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 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.

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

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.

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • LBL-024 for Injection

    Drug

    Intravenous infusion.

  • Paclitaxel injection

    Drug

    Intravenous infusion.

  • Bevacizumab injection

    Drug

    Intravenous infusion.

Treatment groups

180 Participants
are divided into 4 treatment groups
Group A: LBL-024 + Paclitaxel injectionExperimental treatment 2 interventions
Group B: LBL-024 + Paclitaxel injection + bevacizumabExperimental treatment 3 interventions
Group C: LBL-024 in Combination With paclitaxel ± bevacizumabExperimental treatment 3 interventions
Group D: Paclitaxel ± bevacizumabActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

Objective Response Rate (ORR)

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.

Time frame
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)
2

Occurrence of adverse event (AE) and serious adverse event (SAE)

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.

Time frame
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)
3

Progression-free Survival(PFS)

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.

Time frame
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)

Secondary outcomes

1

Cmax

Maximum drug concentration in plasma after administration.

Time frame
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)
2

Tmax

After administration,Time to reach maximum drug concentration in plasma.

Time frame
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)
3

Immunogenicity

The immunogenicity is evaluated by the incidence of anti-drug antibodies (ADA) and neutralizing antibodies (if applicable) in subjects.Immunogenicity refers to the performance that can elicit an immune response.

Time frame
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)
4

Disease Control Rate(DCR)

Percentage of participants achieving CR, PR, iCR, iPR and stable disease (SD) after treatment.

Time frame
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)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Nanjing Leads Biolabs Co.,Ltd

Lead sponsor

Source ClinicalTrials.gov
Apply now