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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
54
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.
TQB2916 is a humanized IgG2 monoclonal antibody targeting CD40. Penpulimab injection is a programmed cell death protein 1 (PD-1) immune checkpoint inhibitor.
Cancer Hospital Chinese Academy of Medical Science
Beijing, Beijing Municipality, China
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Henan Cancer Hospital Affiliated Cancer Hospital of Zhengzhou University
Zhengzhou, Henan, China
Hunan Cancer Hospital
Changsha, Hunan, China
Jilin Cancer Hospital
Changchun, Jilin, China
Cancer Hospital Affiliated to Shandong First Medical University
Jinan, Shandong, China
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
Shanxi Cancer Hospital
Taiyuan, Shanxi, China
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, China
Xinjiang Medical University Affiliated Cancer Hospital
Ürümqi, Xinjiang, China
...and 1 more locations
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).
Time frame: 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.
Time frame: Up to 48 weeks
Overall survival (OS)
Overall survival defined as the time from enrollment to death from any cause.
Time frame: 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.
Time frame: Up to 48 weeks
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