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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.
The trial was divided into two phases.
Stage I (Phase Ib): Single-Arm Safety Lead-In Period. In this stage, a small number of subjects were enrolled first and received LBL-024 combined with paclitaxel treatment, with 21 days as a cycle.Safety, tolerability and preliminary efficacy of combination drugs were assessed by the sponsor and investigators.LBL-024 Dose De-escalation Principle Based on Safety and Tolerability.
Stage II (Phase II) Randomized, Expansion Cohort Study. If safety and tolerability are good, the combined administration extension study will be continued. Subjects were continued to be enrolled in the study. The study was designed as a randomized, open-label, positive-controlled trial.Subjects who met the criteria were randomly assigned to the experimental group and the control group in a ratio of 2: 1.Experimental group (LBL-024 combined with paclitaxel) and Control group (paclitaxel monotherapy).
This study will enroll up to 110 subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LBL-024+paclitaxel | Experimental | Experimental group:LBL-024+Paclitaxel. LBL-024 and Paclitaxel Intravenous infusion. |
|
| Paclitaxel | Active Comparator | control group: Paclitaxel. Paclitaxel Intravenous infusion. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LBL-024 for Injection | Drug | LBL-024 Intravenous infusion. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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) |
| 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. | 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) |
| 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. | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax | Maximum drug concentration in plasma after administration. | 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) |
| Tmax |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| lingying wu | Contact | 025-83378099 | mengdongtao@leadsbiolabs.com |
| Name | Affiliation | Role |
|---|---|---|
| lingying wu | Cancer Institute and Hospital, Chinese Academy of Medical Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Institute and Hospital, Chinese Academy of Medical Sciences | Recruiting | Beijing | Beijing Municipality | 100021 | China |
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| Paclitaxel Injection | Drug | Paclitaxel Intravenous infusion. |
|
|
After administration,Time to reach maximum drug concentration in plasma. |
| 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) |
| 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. | 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) |
| Disease Control Rate(DCR) | Percentage of participants achieving CR, PR, iCR, iPR and stable disease (SD) after treatment. | 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) |
| Duration of Response(DOR) | DOR is defined as the duration from earliest date of disease response (CR、PR 、iCR or iPR) until earliest date of disease progression or death from any cause(if occurring sooner than progression). | 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) |
| Beijing Obstetrics and Gynecology Hospital Capital Medical University | Not yet recruiting | Beijing | Beijing Municipality | 100026 | China |
|
| Fujian Cancer Hospital | Not yet recruiting | Fuzhou | Fujian | 350014 | China |
|
| Sun Yat-sen University Cancer Center | Not yet recruiting | Guangzhou | Guangdong | 510060 | China |
|
| Harbin Medical University Cancer Hospital | Not yet recruiting | Harbin | Heilongjiang | 150081 | China |
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| AnYang Tumor Hospital | Recruiting | Anyang | Henan | 455000 | China |
|
| The First Affiliated Hospital of Zhengzhou University | Not yet recruiting | Zhengzhou | Henan | 450052 | China |
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| The Affiliated Hospital of Xuzhou Medical University | Recruiting | Xuzhou | Jiangsu | 221006 | China |
|
| The First Hospital of China Medical University | Recruiting | Shenyang | Liaoning | 110001 | China |
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| Shandong Cancer Hospital | Recruiting | Jinan | Shandong | 250117 | China |
|
| Tianjin Medical University Cancer Institute &Hospital | Recruiting | Tianjin | Tianjin Municipality | 300060 | China |
|
| Yunnan Cancer Hospital | Recruiting | Kunming | Yunnan | 650106 | China |
|
| Zhejiang Cancer Hospital | Recruiting | Hangzhou | Zhejiang | 310022 | China |
|
| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
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| ID | Term |
|---|---|
| D007267 | Injections |
| D017239 | Paclitaxel |
| ID | Term |
|---|---|
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
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