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This project is a clinical trial on the efficacy and safety of TQB2916 injection combined with chemotherapy or penpulimab injection in solid tumors. This project is divided into two cohorts. Cohort 1 aims to explore the safety and efficacy of specific subtypes of soft tissue sarcoma in subjects; Cohort 2 aims to explore safety and efficacy in subjects with undifferentiated pleomorphic sarcoma and melanoma. A total of 54 subjects are planned to be enrolled in this project.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TQB2916 injection + doxorubicin hydrochloride for injection | Experimental | TQB2916 injection + doxorubicin hydrochloride for injection, 21 days as a treatment cycle. |
|
| TQB2916 injection+penpulimab injection | Experimental | TQB2916 injection+penpulimab injection , 21 days as a treatment cycle. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TQB2916 injection + doxorubicin hydrochloride for injection | Drug | TQB2916 is a humanized immune gamma globulins 2 (IgG2) monoclonal antibody targeting CD40. The mechanism of action of doxorubicin is mainly to destroy the DNA structure of tumor cells, thereby killing malignant tumors. It interferes with the DNA synthesis process of cancer cells by targeting DNA and inhibiting enzymes in DNA replication and repair. In addition, doxorubicin can also trigger cross-link breaks in DNA, leading to apoptosis of cancer cells. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall response rate (ORR) | Objective response rate refers to the percentage of complete response (CR) or partial response (PR) subjects determined by the investigator based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 or modified RECIST 1.1 for immune based therapeutics(guidelines for response criteria for use in trials testing Immunotherapeutics(iRECIST)) (CR and PR) under iRECIST criteria can occur after imaging disease progression). | Up to 48 weeks |
| Progression-Free Survival (PFS) | PFS will be defined as median number of months from the date of randomization until the first documented sign of disease progression or death due to any causes, whichever occurs first. | Up to 48 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival (OS) | Overall survival defined as the time from enrollment to death from any cause. | Up to 2 years |
| Duration of Response (DOR) | DOR will be defined as median number of months from date of first documented objective response until first documented sign of disease progression or death due to any causes. |
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Inclusion Criteria:
Exclusion Criteria:
Concomitant diseases and medical history:
Has experienced or currently suffers from other malignant tumors within 5 years.
Unresolved toxic reactions above CommonTerminology Criteria for Adverse Events level 1 caused by any previous treatment;
The research treatment began with significant surgical treatment, open biopsy, or obvious traumatic injury;
Long term unhealed wounds or fractures;
Arterial/venous thrombotic events that have occurred within 6 months and affect current normal function;
Individuals with a history of psychiatric drug abuse who are unable to quit or have mental disorders;
Individuals who have previously undergone splenectomy or received splenic radiotherapy within 3 months prior to enrollment;
Currently present with congenital hemorrhagic or coagulation diseases, or currently undergoing treatment with warfarin;
Subjects with any severe and/or uncontrolled diseases, including:
Tumor related symptoms and treatment:
Research and treatment related:
Participated in clinical trials of other anti-tumor drugs within the first 4 weeks of grouping.
According to the researcher's judgment, there are individuals with accompanying diseases that seriously endanger the safety of the subjects or affect the completion of the study, or individuals who are deemed unsuitable for enrollment due to other reasons.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jilong Yang, Doctor | Contact | 18622221626 | yangjilong@tjmuch.com | |
| Yong Chen, Doctor | Contact | 18017317571 | chenyong@shca.org.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Hospital Chinese Academy of Medical Science | Beijing | Beijing Municipality | 100021 | China |
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|
| TQB2916 injection+penpulimab injection | Drug | TQB2916 is a humanized IgG2 monoclonal antibody targeting CD40. Penpulimab injection is a programmed cell death protein 1 (PD-1) immune checkpoint inhibitor. |
|
| Up to 48 weeks |
| Beijing Cancer Hospital | Beijing | Beijing Municipality | 100142 | China |
|
| Henan Cancer Hospital Affiliated Cancer Hospital of Zhengzhou University | Zhengzhou | Henan | 450000 | China |
|
| Hunan Cancer Hospital | Changsha | Hunan | 410000 | China |
|
| Jilin Cancer Hospital | Changchun | Jilin | 130012 | China |
|
| Cancer Hospital Affiliated to Shandong First Medical University | Jinan | Shandong | 250117 | China |
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| Fudan University Shanghai Cancer Center | Shanghai | Shanghai Municipality | 200032 | China |
|
| Shanxi Cancer Hospital | Taiyuan | Shanxi | 030000 | China |
|
| Tianjin Medical University Cancer Institute and Hospital | Tianjin | Tianjin Municipality | 300060 | China |
|
| Xinjiang Medical University Affiliated Cancer Hospital | Ürümqi | Xinjiang | 830000 | China |
|
| Zhe Jiang Cancer Hospital | Hangzhou | Zhejiang | 310022 | China |
|
| ID | Term |
|---|---|
| D012509 | Sarcoma |
| D008545 | Melanoma |
| ID | Term |
|---|---|
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D004317 | Doxorubicin |
| D007267 | Injections |
| ID | Term |
|---|---|
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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