A Multicenter, Open-Label, Single-Arm, Multi-Cohort Phase II Clinical Trial Evaluating the Efficacy and Safety of TQB2916 Injection in Combination With Chemotherapy or in Combination With Penpulimab Injection for Solid Tumors
Overview
- Phase
- Phase 2
- Intervention
- TQB2916 injection + doxorubicin hydrochloride for injection
- Conditions
- Soft Tissue Sarcoma
- Sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Enrollment
- 54
- Locations
- 11
- Primary Endpoint
- Overall response rate (ORR)
- Status
- Not yet recruiting
- Last Updated
- last year
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •The subjects voluntarily joined this study, signed an informed consent form, and had good compliance.
- •Age: 18-75 years old; Eastern Cooperative Oncology Group Performance Status (ECOG PS) score: 0-1 points; The expected survival period exceeds 3 months.
- •Patients with locally advanced or unresponsive relapsed/metastatic soft tissue sarcoma and melanoma diagnosed by pathology and unable or refused surgery. Cohort 1contains the following subtypes: "dedifferentiated liposarcoma, highly differentiated liposarcoma with dedifferentiated components, leiomyosarcoma (excluding uterine leiomyosarcoma)", and cohort 2 contains undifferentiated pleomorphic sarcoma and melanoma.
- •Cohort 1: No previous history of failure of anthracycline-based chemotherapy. Cohort 2: Previously treated with standard of care.
- •Cohort 2: Previously treated.
- •According to RECIST 1.1 standard, it is confirmed that there is at least one measurable lesion.
- •The main organs are functioning well.
- •Female participants of childbearing age should agree to use contraceptive measures during the study period and within 6 months after the end of the study; Within 7 days prior to enrollment, the serum pregnancy test was negative and must be a non lactating subject; Male participants should agree to use contraceptive measures during the study period and within 6 months after the end of the study period.
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:
Arms & Interventions
TQB2916 injection + doxorubicin hydrochloride for injection
TQB2916 injection + doxorubicin hydrochloride for injection, 21 days as a treatment cycle.
Intervention: TQB2916 injection + doxorubicin hydrochloride for injection
TQB2916 injection+penpulimab injection
TQB2916 injection+penpulimab injection , 21 days as a treatment cycle.
Intervention: TQB2916 injection+penpulimab injection
Outcomes
Primary Outcomes
Overall response rate (ORR)
Time Frame: Up to 48 weeks
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).
Progression-Free Survival (PFS)
Time Frame: Up to 48 weeks
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.
Secondary Outcomes
- Overall survival (OS)(Up to 2 years)
- Duration of Response (DOR)(Up to 48 weeks)