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This trial is an open and multicenter phase Ib/II clinical study, which aims to evaluate the safety, tolerability, PK characteristics, immunogenicity, and effectiveness.
This is an open, multicenter Phase Ib/II clinical trial of LBL-007 combined with Tislelizumab in the treatment of malignant tumors,which aims to evaluate the safety, tolerability, PK characteristics, immunogenicity, and effectiveness.
The study was divided into two phases: Phase Ib (Part A): Dose escalation and PK expansion; Phase II includes: Part B, Part C, Part D, Part E, Part F, Part G, Part H. Part B ~ Part H will be designed and conducted based on the safety , tolerability and PK analysis of the Part A Study Part, after RP2D is determined, will be used for Part B ~ Part H cohort. Approximately 250-490 subjects will be enrolled (Specific sample size shall be subject to actual occurrence)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LBL-007 & Tislelizumab | Experimental | LBL-007 Injection; dose A or dose B; Q3W |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LBL-007 Injection | Drug | Initial dose - MTD; Q3W; intravenous infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | ORR (complete response (CR) + partial response (PR)), as assessed by Response Evaluation Criteria in Solid Tumors (RECIST), refers to the percentage of study subjects who achieve a complete response or partial response | All subjects signed the informed consent form to the completion of the follow-up period of drug withdrawal (30+7 days after drug withdrawal or before the start of new anti-tumor therapy |
| Dose-limiting toxicities(DLT) | DLT is defined as toxicity during the DLT observation period (3 weeks after the first dose). | DLT is defined as toxicity during the DLT observation period. The duration of DLT observation period is from the first dose to 3 weeks after the first dose |
| Maximum tolerated dose (MTD) | MTD is defined as the hightest dose level at which no more than 1 out of 6 subjects experiences a DLT during the first cycles | At the end of Cycle 1 (each cycle is 21days) |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax | Maximum serum concentration | All subjects signed the informed consent form to the completion of the follow-up period of drug withdrawal (30+7 days after drug withdrawal or before the start of new anti-tumor therapy) |
| immunogenicity |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| li zhang | Sun Yat-Sen University Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anhui Cancer Hospital | Hefei | Anhui | 230031 | China | ||
| Fujian Cancer Hospital |
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| Tislelizumab Injection | Drug | Initial dose; Q3W; intravenous infusion |
|
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| Cisplatin Injection | Drug | Initial dose;Q3W; intravenous infusion |
|
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| Gemcitabine Hydrochloride for Injection | Drug | Initial dose;Q3W; intravenous infusion |
|
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| Docetaxel injection | Drug | Initial dose;Q3W; intravenous infusion |
|
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The immunogenicity is evaluated by the incidence of anti-drug antibodies (ADA) and neutralizing antibodies (if applicable) in subjects
| All subjects signed the informed consent form to the completion of the follow-up period of drug withdrawal (30+7 days after drug withdrawal or before the start of new anti-tumor therapy) |
| Disease Control Rate(DCR) | DCR per RECIST 1.1 is defined as the percentage of participants with a best overall response of Complete Response (CR), Partial Response (PR) or Stable Disease (SD). | All subjects signed the informed consent form to the completion of the follow-up period of drug withdrawal (30+7 days after drug withdrawal or before the start of new anti-tumor therapy) |
| Duration of Response(DOR) | To measure duration of response | All subjects signed the informed consent form to the completion of the follow-up period of drug withdrawal (30+7 days after drug withdrawal or before the start of new anti-tumor therapy) |
| Tmax | After taking a single dose, Time to reach maximum plasma concentration | All subjects signed the informed consent form to the completion of the follow-up period of drug withdrawal (30+7 days after drug withdrawal or before the start of new anti-tumor therapy) |
| Fuzhou |
| Fujian |
| 350001 |
| China |
| Sun Yat-sen University Cancer Center | Guangzhou | Guangdong | 510060 | China |
| Sun Yat-Sen Memorial Hospital,Sun Yat-Sen University | Guangzhou | Guangdong | 510120 | China |
| Huizhou Municipal Central Hospital | Huizhou | Guangdong | 516000 | China |
| Guangxi Medical University Cancer Hospital | Nanning | Guangxi | 530000 | China |
| The First Affiliated Hospital of Guangxi Medical University | Nanning | Guangxi | 530021 | China |
| The First People's Hospital of Yu Lin | Yulin | Guangxi | 537000 | China |
| The Second Affiliated Hospital of Hainan Medical University | Haikou | Hainan | 570000 | China |
| Zhejiang Cancer Hospital | Hangzhou | Hangzhou | 310000 | China |
| Hubei Cancer Hospital | Wuhan | Hubei | 430000 | China |
| Union Hospital Tongji Medical College Huazhong University of Science And Technology | Wuhan | Hubei | 430022 | China |
| Hunan Cancer Hospital | Changsha | Hunan | 410000 | China |
| Jiangxi Cancer Hospital | Nanchang | Jiangxi | 330029 | China |
| West China Hospital of Sichuan University | Chengdu | Sichuan | 610041 | China |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C000707970 | tislelizumab |
| D002945 | Cisplatin |
| D000093542 | Gemcitabine |
| D007267 | Injections |
| D000077143 | Docetaxel |
| ID | Term |
|---|---|
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| 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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