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.
A Phase Ib Clinical Study to Evaluate the Efficacy and Safety of 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.
1 other identifier
interventional
75
1 country
15
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 colorectal-cancer
Started Jan 2024
Shorter than P25 for phase_1 colorectal-cancer
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 21, 2023
CompletedFirst Posted
Study publicly available on registry
August 25, 2023
CompletedStudy Start
First participant enrolled
January 13, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2025
CompletedJanuary 23, 2024
August 1, 2023
1.1 years
August 21, 2023
January 22, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Objective response rate (ORR)
According to RECIST 1.1 or Modified RECIST 1.1 for immune based therapeutics, (iRECIST) criteria, the proportion of subjects whose confirmed tumor volume reduction reached the pre-specified value and maintained the minimum time-frame requirements, i.e., the proportion of subjects with complete response (CR) and partial response (PR).
From first administration until disease progression or withdrawal due to other reasons, estimated to not exceed 8 months.
Secondary Outcomes (7)
Overall survival (OS)
Baseline up to death, estimated to not exceed 12 months
Progress free survival (PFS)
From randomization to the time of disease progression or death from any cause, estimated to not exceed 12 months.
Disease control rate (DCR)
From first administration to the time of disease progression or withdrawal from any cause, estimated to not exceed 12 months.
Duration of response (DOR)
From first administration to the time of disease progression or death from any cause, estimated to not exceed 12 months.
The incidence of adverse event (AE)
From first administration to 28 days after withdrawal or the start time of the new anti-tumor treatment, whichever comes first.
- +2 more secondary outcomes
Study Arms (3)
TQB2618 injection+Penpulimab injection +Anlotinib hydrochloride capsules
EXPERIMENTALTQB2618 injection combined with Penpulimab injection and Anlotinib hydrochloride capsules, 3 weeks as a treatment cycle.
TQB2618 injection+Penpulimab injection
EXPERIMENTALTQB2618 injection combined with Penpulimab injection, 3 weeks as a treatment cycle.
TQB2618 injection
EXPERIMENTALTQB2618 injection, 3 weeks as a treatment cycle.
Interventions
TQB2618 is a monoclonal antibody targeting T cell immunoglobulin and mucin domain-3 (TIM-3) receptor.
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.
Anlotinib hydrochloride is a muti-target tyrosine kinase inhibitor.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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;
- +12 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (15)
Fuyang Cancer Hospital
Fuyang, Anhui, 236010, China
Huai Nan First People's Hospital
Huainan, Anhui, 232007, China
Fujian Cancer Hospital
Fuzhou, Fujian, 350001, China
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, 361003, China
Meizhou People's Hospital (Huangtang Hospital)
Meizhou, Guangdong, 514031, China
Guangxi Medical University Cancer Hospital
Nanning, Guangxi, 530021, China
Hunan Cancer Hospital
Changsha, Hunan, 410000, China
Jilin Cancer Hospital
Changchun, Jilin, 130021, China
The First Hospital of China Medical University
Shenyang, Liaoning, 110002, China
The First Affiliated Hospital of Air Force Medical University
Xi'an, Shaanxi, 710000, China
The First Affiliated Hospital of Xi'an Jiao Tong University
Xi'an, Shaanxi, 710000, China
Affiliated Hospital of Jining Medical University
Jining, Shandong, 272007, China
Shanxi Cancer Hospital
Taiyuan, Shanxi, 030013, China
The people's hospital of Leshan
Leshan, Sichuan, 614003, China
Mianyang central hospital
Mianyang, Sichuan, 621009, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 21, 2023
First Posted
August 25, 2023
Study Start
January 13, 2024
Primary Completion
March 1, 2025
Study Completion
July 1, 2025
Last Updated
January 23, 2024
Record last verified: 2023-08