TQB2916 Injection Combined With Chemotherapy or Penpulimab Injection in the Treatment of Solid Tumors

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 75 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. The subjects voluntarily joined this study, signed an informed consent form, and had good compliance. 2. Age: 18-75 years old; Eastern Cooperative Oncology Group Performance Status (ECOG PS) score: 0-1 points; The expected survival period exceeds 3 months. 3. 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. 4. Cohort 1: No previous history of failure of anthracycline-based chemotherapy. Cohort 2: Previously treated with standard of care. 5. Cohort 2: Previously treated. 6. According to RECIST 1.1 standard, it is confirmed that there is at least one measurable lesion. 7. The main organs are functioning well. 8. 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:

1. Concomitant diseases and medical history: 1. Has experienced or currently suffers from other malignant tumors within 5 years. 2. Unresolved toxic reactions above CommonTerminology Criteria for Adverse Events level 1 caused by any previous treatment; 3. The research treatment began with significant surgical treatment, open biopsy, or obvious traumatic injury; 4. Long term unhealed wounds or fractures; 5. Arterial/venous thrombotic events that have occurred within 6 months and affect current normal function; 6. Individuals with a history of psychiatric drug abuse who are unable to quit or have mental disorders; 7. Individuals who have previously undergone splenectomy or received splenic radiotherapy within 3 months prior to enrollment; 8. Currently present with congenital hemorrhagic or coagulation diseases, or currently undergoing treatment with warfarin; 9. Subjects with any severe and/or uncontrolled diseases, including:
  • - Blood pressure control is still not ideal after dual drug treatment; - Suffering from ≥ grade 2 myocardial ischemia or myocardial infarction, arrhythmia; ≥ Grade 2 unstable angina pectoris; - Active or uncontrolled severe infection or unexplained fever>38.5 °C; - Cirrhosis and active hepatitis *; - Active syphilis patients; - Renal failure requiring hemodialysis or peritoneal dialysis; - Have a history of immunodeficiency; - Poor control of diabetes; - Urinary routine indicates urine protein ≥++; - Individuals with epilepsy who require treatment; - Weight<40 kg and BMI<18.5 kg/m2, or weight loss of ≥ 10% within 3 months.
2. Tumor related symptoms and treatment: 1. Has received surgery, chemotherapy, radiation therapy, or other anti-cancer therapies before the start of the research treatment; 2. Before the start of the study treatment, he received the treatment of traditional Chinese patent medicines and simple preparations with anti-tumor indications specified in the National MedicalProducts Administration (NMPA) approved drug directions; 3. Cohort 1: Previously used doxorubicin exceeding 200mg/m2; 4. Cohort 2: Undifferentiated multidirectional sarcoma that has previously received more than 2 types of anti vascular tyrosine kinase inhibitors (TKIs), or has previously received relevant immunotherapy drugs; 5. Previously received antibodies or fusion proteins targeting CD40; 6. Imaging shows that the tumor invades large blood vessels or has unclear boundaries with large blood vessels, or the researcher determines that the tumor is highly likely to invade important blood vessels and cause fatal massive bleeding during subsequent studies; 7. Uncontrollable pleural effusion, pericardial effusion, or ascites that still require repeated drainage; 8. Severe bone damage caused by tumor bone metastasis may occur in the presence or after enrollment; 9. Uncontrollable pain related to tumor bone metastasis; 10. There was central nervous system metastasis before enrollment. 3. Research and treatment related: 1. History of live attenuated vaccine administration before the start of research treatment or planned live attenuated vaccine administration during the study period; 2. There is a clear bleeding tendency or clinically significant bleeding symptoms before the first use of medication; 3. Individuals who have experienced severe hypersensitivity reactions after using monoclonal antibodies, or who are allergic to known components of the investigational drug; 4. Active autoimmune diseases that require systemic treatment have occurred within 2 years prior to the start of the research treatment. 5. Diagnosed with immunodeficiency or undergoing systemic glucocorticoid therapy or any other form of immunosuppressive therapy. 4. Participated in clinical trials of other anti-tumor drugs within the first 4 weeks of grouping. 5. 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT06500091
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Not yet recruiting
Countries China
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Soft Tissue Sarcoma, Melanoma
Arms & Interventions

Arms

Experimental: TQB2916 injection + doxorubicin hydrochloride for injection

TQB2916 injection + doxorubicin hydrochloride for injection, 21 days as a treatment cycle.

Experimental: TQB2916 injection+penpulimab injection

TQB2916 injection+penpulimab injection , 21 days as a treatment cycle.

Interventions

Drug: - TQB2916 injection + doxorubicin hydrochloride for injection

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.

Drug: - TQB2916 injection+penpulimab injection

TQB2916 is a humanized IgG2 monoclonal antibody targeting CD40. Penpulimab injection is a programmed cell death protein 1 (PD-1) immune checkpoint inhibitor.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Beijing 1816670, Beijing Municipality 2038349, China

Status

Address

Cancer Hospital Chinese Academy of Medical Science

Beijing 1816670, Beijing Municipality 2038349, 100021

Site Contact

Helin Feng, Doctor

[email protected]

18900189633

Beijing Cancer Hospital, Beijing 1816670, Beijing Municipality 2038349, China

Status

Address

Beijing Cancer Hospital

Beijing 1816670, Beijing Municipality 2038349, 100142

Site Contact

Jiayong Liu, Doctor

[email protected]

13641103227

Zhengzhou 1784658, Henan 1808520, China

Status

Address

Henan Cancer Hospital Affiliated Cancer Hospital of Zhengzhou University

Zhengzhou 1784658, Henan 1808520, 450000

Site Contact

Weitao Yao, Doctor

[email protected]

13298189535

Hunan Cancer Hospital, Changsha 1815577, Hunan 1806691, China

Status

Address

Hunan Cancer Hospital

Changsha 1815577, Hunan 1806691, 410000

Site Contact

Xianan Li, Doctor

[email protected]

18874933879

Jilin Cancer Hospital, Changchun 2038180, Jilin 2036500, China

Status

Address

Jilin Cancer Hospital

Changchun 2038180, Jilin 2036500, 130012

Site Contact

Yanling Liu, Bachelor

[email protected]

13500891447

Jinan 1805753, Shandong 1796328, China

Status

Address

Cancer Hospital Affiliated to Shandong First Medical University

Jinan 1805753, Shandong 1796328, 250117

Site Contact

Dongyuan Zhu, Doctor

[email protected]

18954516655

Fudan University Shanghai Cancer Center, Shanghai 1796236, Shanghai Municipality 1796231, China

Status

Address

Fudan University Shanghai Cancer Center

Shanghai 1796236, Shanghai Municipality 1796231, 200032

Site Contact

Yong Chen, Doctor

[email protected]

18017317571

Shanxi Cancer Hospital, Taiyuan 1793511, Shanxi 1795912, China

Status

Address

Shanxi Cancer Hospital

Taiyuan 1793511, Shanxi 1795912, 030000

Site Contact

Yuxia Shi, Bachelor

[email protected]

15835108188

Tianjin 1792947, Tianjin Municipality 1792943, China

Status

Address

Tianjin Medical University Cancer Institute and Hospital

Tianjin 1792947, Tianjin Municipality 1792943, 300060

Site Contact

Jilong Yang, Doctor

[email protected]

18622221626

Ürümqi 1529102, Xinjiang 1529047, China

Status

Address

Xinjiang Medical University Affiliated Cancer Hospital

Ürümqi 1529102, Xinjiang 1529047, 830000

Site Contact

Renbing Jiang, Doctor

[email protected]

13999153829

Zhe Jiang Cancer Hospital, Hangzhou 1808926, Zhejiang 1784764, China

Status

Address

Zhe Jiang Cancer Hospital

Hangzhou 1808926, Zhejiang 1784764, 310022

Site Contact

Meiyu Fang, Doctor

[email protected]

13750851650

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