Trial Title:
A Clinical Study of TQB2618 Injection Monotherapy and Combination Regimen (With Penpulimab Injection ±Anlotinib Hydrochloride Capsules) in the Four or Later Lines of Treatment of Advanced Colorectal Cancer.
NCT ID:
NCT06010901
Condition:
Colorectal Cancer
Conditions: Official terms:
Colorectal Neoplasms
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
TQB2618 injection
Description:
TQB2618 is a monoclonal antibody targeting T cell immunoglobulin and mucin domain-3
(TIM-3) receptor.
Arm group label:
TQB2618 injection
Arm group label:
TQB2618 injection+Penpulimab injection
Arm group label:
TQB2618 injection+Penpulimab injection +Anlotinib hydrochloride capsules
Intervention type:
Drug
Intervention name:
Penpulimab injection
Description:
Penpulimab is a humanized Immunoglobulin G-1 (IgG1) monoclonal antibody that binds to
human programmed cell death 1 (PD-1), a cell membrane protein that is primarily expressed
on activated T cells and inhibits T cell activation.
Arm group label:
TQB2618 injection+Penpulimab injection
Arm group label:
TQB2618 injection+Penpulimab injection +Anlotinib hydrochloride capsules
Intervention type:
Drug
Intervention name:
Anlotinib hydrochloride capsules
Description:
Anlotinib hydrochloride is a muti-target tyrosine kinase inhibitor.
Arm group label:
TQB2618 injection+Penpulimab injection +Anlotinib hydrochloride capsules
Summary:
This is a Phase Ib clinical study to evaluate the efficacy and safety of TQB2618
injection as monotherapy and a combination regimen (with Penpulimab injection ± Anlotinib
hydrochloride capsules) in the treatment of advanced colorectal cancer. 75 participants
will be enrolled in the study. Objective response rate (ORR) as assessed by Response
Evaluation Criteria In Solid Tumors (RECIST) version 1.1 is the primary endpoint.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Age: 18-75 years old; Eastern Cooperative Oncology Group Performance Status (ECOG
PS) score: 0-1; Expected survival of more than 3 months;
- Histologically/cytologically confirmed metastatic colorectal cancer;
- The subjects should provide tumor tissues that meet the requirements for mismatch
repair protein detection and Programmed cell death-Ligand 1 (PD-L1) expression level
detection;
- Advanced colorectal cancer that progresses or is intolerant after receiving ≥3 lines
of standard therapy;
- Failure of treatment with at least one of these drugs (TAS-102, Regorafenib,
Fruquintinib);
- Confirmed presence of at least one measurable lesion according to Response
Evaluation Criteria In Solid Tumors 1.1 (RECIST 1.1) criteria;
- Body weight ≥40 kg and Body Mass Index (BMI) ≥18.5 kg/m^2.
- The function of the main organs is good, and the laboratory examination meets the
requirements;
- Female subjects of reproductive age should agree to use contraception during the
study period and for 6 months after the end of the study; Male subjects should agree
that contraception must be used during the study period and for 6 months after the
end of the study period.
Exclusion Criteria:
- Have had or are currently suffering from other malignant tumors within 3 years;
- Have any poorly controlled cardiovascular clinical symptoms or diseases;
- Patients with ulcerative colitis and Crohn's disease; Patients with active
inflammatory bowel disease within the first 4 weeks of enrollment;
- Symptoms of hematemesis and hematochezia occurred within 6 months before screening,
and the daily bleeding volume ≥ 2.5 mL;
- The presence of unmitigated toxic reactions of grade 1 or above as assessed per
Common Terminology Criteria for Adverse Events (CTC-AE) due to any treatment prior
to first administration, excluding hair loss;
- Patients who had received Programmed Death 1 (PD-1) or PD-L1 monoclonal antibody
treatment and experienced ≥ grade 3 immune-related adverse reactions or stopped
immune checkpoint inhibitor treatment due to immune-related adverse reactions;
- Active or uncontrolled severe infection (≥CTC AE grade 2 infection);
- Decompensated cirrhosis, active hepatitis;
- Poor diabetes control (fasting blood glucose > 10 mmol/L);
- Patients with renal failure requiring hemodialysis or peritoneal dialysis;
- Have a clear history of neurological or psychiatric disorders, including epilepsy or
dementia, and require treatment;
- Had undergone a major surgical, open biopsy or significant traumatic injury within 4
weeks prior to the first dose of the study or expected to require major surgery
during the study treatment.
- Patients with arterial/venous thrombosis events, such as cerebrovascular accident,
deep vein thrombosis and pulmonary embolism, occurred within 6 months before the
study treatment;
- Ascites with clinical significance, including any ascites that can be found by
physical examination, ascites that have been treated in the past or still need to be
treated, and only those who show a small amount of ascites but no symptoms on
imaging can be included; Patients with an equal or greater amount of fluid in both
pleural cavities, or a large amount of fluid in one pleural cavity, or have caused
respiratory dysfunction and need drainage;
- The presence of unhealed wounds, ulcers or fractures;
- Have active tuberculosis, or have a history of active tuberculosis infection within
1 year prior to enrollment, or have a history of active tuberculosis infection more
than 1 year prior to enrollment, but are not receiving treatment;
- There is a history of idiopathic pulmonary fibrosis, institutional pneumonia,
drug-induced pneumonia, radiation pneumonia requiring treatment or active pneumonia
with clinical symptoms, and interstitial lung disease requiring steroid hormone
therapy;
- Have a history of immunodeficiency, including Human Immunodeficiency Virus (HIV)
positive or other acquired or congenital immunodeficiency diseases, or have a
history of organ transplantation or hematopoietic stem cell transplantation;
- Imaging shows that the tumor has invaded large blood vessels or is not clearly
demarcated with blood vessels;
- Known central nervous system metastatic and/or cancerous meningitis;
- Have multiple factors that affect oral medication (such as inability to swallow,
chronic diarrhea, and intestinal obstruction);
- Allergic to the ingredients of the investigational pharmaceutical preparations or
excipients, or allergic to similar drugs;
- An active autoimmune disease requiring systemic treatment (e.g., disease-modifying
drugs, corticosteroids, or immunosuppressants) has occurred within 2 years prior to
initial medication;
- Have been diagnosed with immune deficiency or are receiving systemic glucocorticoid
therapy or any other form of immunosuppressive therapy (dose > 10 mg/day prednisone
or other therapeutic hormone) and continue to use within 2 weeks before the first
dose;
- History of live attenuated vaccine vaccination within 28 days before the first dose
or planned live attenuated vaccine vaccination during the study period;
- Have received systematic anti-tumor therapy and other interventional anti-tumor drug
clinical trials such as radical surgery, chemotherapy, radical radiotherapy or
immunotherapy, biotherapy, etc. within 4 weeks before the start of the study
treatment;
- Within 2 weeks prior to the first drug use, the treatment of Chinese patent drugs
with anti-tumor indications specified in the National Medical Products
Administration (NMPA) approved drug instructions.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Fuyang Cancer Hospital
Address:
City:
Fuyang
Zip:
236010
Country:
China
Status:
Recruiting
Contact:
Last name:
Hesheng Qian, Bachelor
Phone:
+86 13956814015
Email:
qianhesheng@soho.com
Facility:
Name:
Huai Nan First People's Hospital
Address:
City:
Huainan
Zip:
232007
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Yanshun Zhang, Bachelor
Phone:
+86 18155498761
Email:
zhangyanshun2006@163.com
Facility:
Name:
Fujian Cancer Hospital
Address:
City:
Fuzhou
Zip:
350001
Country:
China
Status:
Recruiting
Contact:
Last name:
Rongbo Lin, Bachelor
Phone:
+86 13705919382
Email:
rongbo_lin@163.com
Facility:
Name:
The First Affiliated Hospital of Xiamen University
Address:
City:
Xiamen
Zip:
361003
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Jiayi Li, Master
Phone:
+86 13799792820
Email:
ljy778848@qq.com
Facility:
Name:
Meizhou People's Hospital (Huangtang Hospital)
Address:
City:
Meizhou
Zip:
514031
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Xiwen Huang, Bachelor
Phone:
+86 13751952289
Email:
811253076@qq.com
Facility:
Name:
Guangxi Medical University Cancer Hospital
Address:
City:
Nanning
Zip:
530021
Country:
China
Status:
Recruiting
Contact:
Last name:
Yongqiang Li, Master
Phone:
+86 13457161928
Email:
lyq702702@126.com
Facility:
Name:
Hunan Cancer Hospital
Address:
City:
Changsha
Zip:
410000
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Zhenyang Liu, Doctor
Phone:
+86 18673181133
Email:
1323081926@qq.com
Facility:
Name:
Jilin Cancer Hospital
Address:
City:
Changchun
Zip:
130021
Country:
China
Status:
Recruiting
Contact:
Last name:
Ying Cheng, Doctor
Phone:
+86 0431-80596315
Email:
jl.cheng@163.com
Facility:
Name:
The First Hospital of China Medical University
Address:
City:
Shenyang
Zip:
110002
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Xiujuan Qu, Doctor
Phone:
+86 13604031355
Email:
qu_xiujuan@hotmail.com
Facility:
Name:
The First Affiliated Hospital of Air Force Medical University
Address:
City:
Xi'an
Zip:
710000
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Hai chuan Su, Doctor
Phone:
+86 18629190366
Email:
cntdgcp@163.com
Facility:
Name:
The First Affiliated Hospital of Xi'an Jiao Tong University
Address:
City:
Xi'an
Zip:
710000
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Aili Suo, Doctor
Phone:
+86 18991232561
Email:
ailisuo@mail.xjtu.edu.cn
Facility:
Name:
Affiliated Hospital of Jining Medical University
Address:
City:
Jining
Zip:
272007
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Junye Wang, Bachelor
Phone:
+86 18678766866
Email:
18678766866@163.com
Facility:
Name:
Shanxi Cancer Hospital
Address:
City:
Taiyuan
Zip:
030013
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Wenhui Yang, Doctor
Phone:
+86 15835133400
Email:
yangwenhui-10012@163.com
Facility:
Name:
The people's hospital of Leshan
Address:
City:
Leshan
Zip:
614003
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Jing Tian, Master
Phone:
+86 13981302204
Email:
5635452@qq.com
Facility:
Name:
Mianyang central hospital
Address:
City:
Mianyang
Zip:
621009
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Xiaobo Du, Doctor
Phone:
+86 13550822229
Email:
Duxiaobo2005@126.com
Start date:
January 13, 2024
Completion date:
July 2025
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/NCT06010901
