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TQB2223 is a recombinant, fully humanized antibody that binds lymphocyte activation gene-3 (LAG-3) and blocks the LAG-3/ major histocompatibility complex class II (MHC-II) interaction, thus allowing for increased T-cell proliferation and cytokine production. This is a phase I study to evaluate the safety, tolerability, pharmacokinetics (PK) and effectiveness of TQB2223 injection in combination with Penpulimab in subjects with advanced cancers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TQB2223 injection+ Penpulimab Injection | Experimental | intravenous injection of TQB2223 injection and Penpulimab injection for one times every three weeks, 21 days as a treatment cycle. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TQB2223 injection+ Penpulimab Injection | Drug | TQB2223 is an anti lymphocyte activation gene-3 (LAG-3) antibody. Penpulimab Injection is an anti-PD-1 antibody. |
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| Measure | Description | Time Frame |
|---|---|---|
| Dose Limiting Toxicity (DLT) | DLT is defined as toxicities that meet pre-defined severity criteria of Common Terminology Criteria for Adverse Events (CTCAE) v5.0, and assessed as having a suspected relationship to TQB2223 injection, and unrelated to disease, disease progression, inter-current illness, or concomitant medications that occurs within the first cycle (21 days) of treatment. | During the first treatment cycle (21 days). |
| Maximum tolerated dose (MTD) | MTD was defined as the highest dose at which dose-limiting toxicity (DLT) occurred in less than 33% of patients. | During the first treatment cycle (21 days). |
| Objective Response Rate (ORR) | Defined as the percentage of Complete Response (CR) plus partial response (PR) assessed by Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 criteria and Guidelines for Response Criteria for Use in Trials Testing Immunotherapeutics (iRECIST) for solid tumors, Lugano 2014 criteria and Lymphoma Response to Immunomodulatory therapy Criteria (LYRIC) for lymphoma. | From date of the first dose until the date of first documented progression or date of death from any cause, assessed up to 100 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of anti-drug antibody (ADA) positive patients | Percentage of ADA positive patients will be calculated to evaluate immunogenicity of TQB2223. | Pre-dose on Cycle 1, 2, 4, 8 . 30 days and 90 days after the last dose. Each cycle is 21 days. |
| The area under the curve (AUC) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Li Zhang, Doctor | Contact | 86-020-87343458 | zhangli@sysucc.org.cn | |
| Qingqing Cai, Doctor | Contact | +86 13798101121 | caiqq@sysucc.org.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fujian Cancer Hospital | Not yet recruiting | Fuzhou | Fujian | 350014 | China |
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The area under the curve (AUC) of serum concentration of TQB2223 |
| 5 minutes, 2 hour, 6 hours, 24 hours, 144 hours and 336 hours after dose on cycle 1 and cycle 3. Pre-dose on cycle 2, 4, 5, 6, 7, 8. Each cycle is 21 days. |
| Peak concentration (Cmax) | Maximum observed concentration (Cmax) of TQB2223 | 5 minutes, 2 hour, 6 hours, 24 hours, 144 hours and 336 hours after dose on cycle 1 and cycle 3. Pre-dose on cycle 2, 4, 5, 6, 7, 8. Each cycle is 21 days. |
| Terminal half-life (T1/2) | The terminal elimination half-life (t 1/2) is the time that takes for the elimination processes to reduce the plasma concentration of the drug in the body by 50 %. | 5 minutes, 2 hour, 6 hours, 24 hours, 144 hours and 336 hours after dose on cycle 1 and cycle 3. Pre-dose on cycle 2, 4, 5, 6, 7, 8. Each cycle is 21 days. |
| Receptor occupation (RO) | Receptor occupation (RO) of LAG-3 after administration. | 5 minutes, 2 hour, 6 hours, 24 hours, 144 hours and 336 hours after dose on cycle 1 and cycle 3. Pre-dose on cycle 2, 4, 5, 6, 7, 8. Each cycle is 21 days. |
| Objective Response Rate (ORR) | Defined as the percentage of Complete Response (CR) plus partial response (PR) assessed by Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 criteria and Guidelines for Response Criteria for Use in Trials Testing Immunotherapeutics (iRECIST) for solid tumors, Lugano 2014 criteria and Lymphoma Response to Immunomodulatory therapy Criteria (LYRIC) for lymphoma. | From date of the first dose until the date of first documented progression or date of death from any cause, assessed up to 100 weeks |
| Disease control rate (DCR) | Defined as the proportion of subjects with CR, PR, or Stable Disease (SD). | From date of the first dose until the date of first documented progression or date of death from any cause, assessed up to 100 weeks |
| Duration of Response (DOR) | Defined as the time from first documented response to documented disease progression or death. | From date of the first dose until the date of first documented progression or date of death from any cause, assessed up to 100 weeks |
| Progression-free survival (PFS) | Defined as the time from the first dose of TQB2223 to the first occurrence of disease progression or death from any cause. | From date of the first dose until the date of first documented progression or date of death from any cause, assessed up to 100 weeks |
| Overall survival (OS) | Overall survival refers to the time from the first treatment to death from any cause. | From date of the first dose until the date of first documented progression or date of death from any cause, assessed up to 100 weeks |
| Number of patients with adverse events (AEs) | Assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0 | From the time of informed consent signed to 28 days after the last dose |
| Number of patients with serious adverse events (SAEs) | Assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0 | From the time of informed consent signed to 28 days after the last dose |
| Cancer Hospital of Guizhou Medical University | Recruiting | Guiyang | Guizhou | 550001 | China |
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| Henan Cancer Hospital | Recruiting | Zhengzhou | Henan | 450003 | China |
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| The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University | Recruiting | Changsha | Hunan | 410006 | China |
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| Jiangxi Cancer Hospital | Recruiting | Nanchang | Jiangxi | 330029 | China |
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| The second hospital of Dalian medical university | Not yet recruiting | Dalian | Liaoning | 116027 | China |
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| Tongji Hospital of Tongji University | Recruiting | Shanghai | Shanghai Municipality | 200000 | China |
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| West China Hospital, Sichuan University | Recruiting | Chengdu | Sichuan | 610044 | China |
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| Yunnan Cancer Hospital | Recruiting | Kunming | Yunnan | 650118 | China |
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| Zhejiang Cancer Hospital | Recruiting | Hangzhou | Zhejiang | 310022 | China |
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| The First Affiliated Hospital of Ningbo University | Recruiting | Ningbo | Zhejiang | 315010 | China |
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