Trial Title:
TQB2916 Injection Combined With Chemotherapy or Penpulimab Injection in the Treatment of Solid Tumors
NCT ID:
NCT06500091
Condition:
Soft Tissue Sarcoma
Melanoma
Conditions: Official terms:
Sarcoma
Doxorubicin
Liposomal doxorubicin
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
TQB2916 injection + doxorubicin hydrochloride for injection
Description:
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.
Arm group label:
TQB2916 injection + doxorubicin hydrochloride for injection
Intervention type:
Drug
Intervention name:
TQB2916 injection+penpulimab injection
Description:
TQB2916 is a humanized IgG2 monoclonal antibody targeting CD40. Penpulimab injection is a
programmed cell death protein 1 (PD-1) immune checkpoint inhibitor.
Arm group label:
TQB2916 injection+penpulimab injection
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.
Criteria for eligibility:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Cancer Hospital Chinese Academy of Medical Science
Address:
City:
BeiJing
Zip:
100021
Country:
China
Contact:
Last name:
Helin Feng, Doctor
Phone:
18900189633
Email:
fenghelin0311@126.com
Facility:
Name:
Beijing Cancer Hospital
Address:
City:
Beijing
Zip:
100142
Country:
China
Contact:
Last name:
Jiayong Liu, Doctor
Phone:
13641103227
Email:
liujiayong@aliyun.com
Facility:
Name:
Henan Cancer Hospital Affiliated Cancer Hospital of Zhengzhou University
Address:
City:
Zhengzhou
Zip:
450000
Country:
China
Contact:
Last name:
Weitao Yao, Doctor
Phone:
13298189535
Email:
ywtwhm@163.com
Facility:
Name:
Hunan Cancer Hospital
Address:
City:
Changsha
Zip:
410000
Country:
China
Contact:
Last name:
Xianan Li, Doctor
Phone:
18874933879
Email:
Lixianan2001@163.com
Facility:
Name:
Jilin Cancer Hospital
Address:
City:
Changchun
Zip:
130012
Country:
China
Contact:
Last name:
Yanling Liu, Bachelor
Phone:
13500891447
Email:
1301878994@qq.com
Facility:
Name:
Cancer Hospital Affiliated to Shandong First Medical University
Address:
City:
Jinan
Zip:
250117
Country:
China
Contact:
Last name:
Dongyuan Zhu, Doctor
Phone:
18954516655
Email:
405683898@qq.com
Facility:
Name:
Fudan University Shanghai Cancer Center
Address:
City:
Shanghai
Zip:
200032
Country:
China
Contact:
Last name:
Yong Chen, Doctor
Phone:
18017317571
Email:
chenyong@shca.org.cn
Facility:
Name:
Shanxi Cancer Hospital
Address:
City:
Taiyuan
Zip:
030000
Country:
China
Contact:
Last name:
Yuxia Shi, Bachelor
Phone:
15835108188
Email:
1274174089@qq.com
Facility:
Name:
Tianjin Medical University Cancer Institute and Hospital
Address:
City:
Tianjin
Zip:
300060
Country:
China
Contact:
Last name:
Jilong Yang, Doctor
Phone:
18622221626
Email:
yangjilong@tjmuch.com
Facility:
Name:
Xinjiang Medical University Affiliated Cancer Hospital
Address:
City:
Ürümqi
Zip:
830000
Country:
China
Contact:
Last name:
Renbing Jiang, Doctor
Phone:
13999153829
Email:
1911452679@qq.com
Facility:
Name:
Zhe Jiang Cancer Hospital
Address:
City:
Hangzhou
Zip:
310022
Country:
China
Contact:
Last name:
Meiyu Fang, Doctor
Phone:
13750851650
Email:
fangmy@zjcc.org.cn
Start date:
July 2024
Completion date:
December 2026
Lead sponsor:
Agency:
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Agency class:
Industry
Source:
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06500091
