Colorectal CancerPhase 1NCT06010901
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 1 study testing TQB2618 injection, Penpulimab injection and Anlotinib hydrochloride capsules in people with Colorectal Cancer, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 15 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- TQB2618 injection, Penpulimab injection and Anlotinib hydrochloride capsules
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 15 sitesChina
- Study dates
- 13 Jan 2024to Jul 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
China15 sites, 15 recruiting
- Recruiting
Jilin Cancer Hospital
Changchun, Jilin, 130021
Ying Cheng, Doctor, +86 0431-80596315, jl.cheng@163.com
- Not yet recruiting
Hunan Cancer Hospital
Changsha, Hunan, 410000
Zhenyang Liu, Doctor, +86 18673181133, 1323081926@qq.com
- Recruiting
Fuyang Cancer Hospital
Fuyang, Anhui, 236010
Hesheng Qian, Bachelor, +86 13956814015, qianhesheng@soho.com
- Recruiting
Fujian Cancer Hospital
Fuzhou, Fujian, 350001
Rongbo Lin, Bachelor, +86 13705919382, rongbo_lin@163.com
- Not yet recruiting
Huai Nan First People's Hospital
Huainan, Anhui, 232007
Yanshun Zhang, Bachelor, +86 18155498761, zhangyanshun2006@163.com
- Not yet recruiting
Affiliated Hospital of Jining Medical University
Jining, Shandong, 272007
Junye Wang, Bachelor, +86 18678766866, 18678766866@163.com
- Not yet recruiting
The people's hospital of Leshan
Leshan, Sichuan, 614003
Jing Tian, Master, +86 13981302204, 5635452@qq.com
- Not yet recruiting
Meizhou People's Hospital (Huangtang Hospital)
Meizhou, Guangdong, 514031
Xiwen Huang, Bachelor, +86 13751952289, 811253076@qq.com
- Not yet recruiting
Mianyang central hospital
Mianyang, Sichuan, 621009
Xiaobo Du, Doctor, +86 13550822229, Duxiaobo2005@126.com
- Recruiting
Guangxi Medical University Cancer Hospital
Nanning, Guangxi, 530021
Yongqiang Li, Master, +86 13457161928, lyq702702@126.com
- Not yet recruiting
The First Hospital of China Medical University
Shenyang, Liaoning, 110002
Xiujuan Qu, Doctor, +86 13604031355, qu_xiujuan@hotmail.com
- Not yet recruiting
Shanxi Cancer Hospital
Taiyuan, Shanxi, 030013
Wenhui Yang, Doctor, +86 15835133400, yangwenhui-10012@163.com
- Not yet recruiting
The First Affiliated Hospital of Air Force Medical University
Xi'an, Shaanxi, 710000
Hai chuan Su, Doctor, +86 18629190366, cntdgcp@163.com
- Not yet recruiting
The First Affiliated Hospital of Xi'an Jiao Tong University
Xi'an, Shaanxi, 710000
Aili Suo, Doctor, +86 18991232561, ailisuo@mail.xjtu.edu.cn
- Not yet recruiting
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, 361003
Jiayi Li, Master, +86 13799792820, ljy778848@qq.com
About this study
Official title: 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.
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.
- Conditions
- Colorectal Cancer
- Being tested
- TQB2618 injection, Penpulimab injection, Anlotinib hydrochloride capsules
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TQB2618 injectionDrug
TQB2618 is a monoclonal antibody targeting T cell immunoglobulin and mucin domain-3 (TIM-3) receptor.
Penpulimab injectionDrug
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 capsulesDrug
Anlotinib hydrochloride is a muti-target tyrosine kinase inhibitor.
| Study group | Role | What they receive |
|---|---|---|
| TQB2618 injection+Penpulimab injection +Anlotinib hydrochloride capsules | Experimental | TQB2618 injection combined with Penpulimab injection and Anlotinib hydrochloride capsules, 3 weeks as a treatment cycle. Receives: Drug: TQB2618 injection; Drug: Penpulimab injection; Drug: Anlotinib hydrochloride capsules |
| TQB2618 injection+Penpulimab injection | Experimental | TQB2618 injection combined with Penpulimab injection, 3 weeks as a treatment cycle. Receives: Drug: TQB2618 injection; Drug: Penpulimab injection |
| TQB2618 injection | Experimental | TQB2618 injection, 3 weeks as a treatment cycle. Receives: Drug: TQB2618 injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: From first administration until disease progression or withdrawal due to other reasons, estimated to not exceed 8 months.
Secondary outcomes (7)
Overall survival (OS)
The time from randomization to death from any cause.
Measured: Baseline up to death, estimated to not exceed 12 months
Progress free survival (PFS)
The time from randomization to the first disease progression or death from any cause, whichever occurs first.
Measured: From randomization to the time of disease progression or death from any cause, estimated to not exceed 12 months.
Disease control rate (DCR)
Percentage of subjects with complete response, partial response, or stable disease as determined by RECIST 1.1 or iRECIST.
Measured: 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 the time the tumor first assessed as complete or partial response to the time of first disease progression or death from any causes.
Measured: 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)
The incidence and severity of adverse events as determined by the Common Terminology Criteria for Adverse Events (CTC AE).
Measured: From first administration to 28 days after withdrawal or the start time of the new anti-tumor treatment, whichever comes first.
Anti-drug antibodies (ADA)
The occurrence of ADA
Measured: Cycle 1 Day 1, Cycle 2 Day 1, Cycle 4 Day 1, Cycle 8 Day 1, 30 days and 90 days after the last dose. Each cycle is 21 days.
Neutralizing antibodies (NaB)
The occurrence of neutralizing antibodies
Measured: Cycle 1 Day 1, Cycle 2 Day 1, Cycle 4 Day 1, Cycle 8 Day 1, 30 days and 90 days after the last dose. Each cycle is 21 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2023
- Study start13 Jan 2024
- Primary completionMar 2025 (estimated)
- Study completionJul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06010901
- Sponsor's protocol ID
- TQ2618-AK105-Ib-05
- Status last verified
- Aug 2023
- First submitted
- 21 Aug 2023
- Last updated
- 23 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT06010901
- Acronym / sponsor ID
- TQ2618-AK105-Ib-05
- Conditions
- Colorectal Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 13 Jan 2024 (actual)
- Primary completion
- Mar 2025 (estimated)
- Study completion
- Jul 2025 (estimated)
- First posted
- 25 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| TQB2618 injection+Penpulimab injection +Anlotinib hydrochloride capsules | Experimental | Drug: TQB2618 injection, Drug: Penpulimab injection, Drug: Anlotinib hydrochloride capsulesTQB2618 injection combined with Penpulimab injection and Anlotinib hydrochloride capsules, 3 weeks as a treatment cycle. |
| TQB2618 injection+Penpulimab injection | Experimental | Drug: TQB2618 injection, Drug: Penpulimab injectionTQB2618 injection combined with Penpulimab injection, 3 weeks as a treatment cycle. |
| TQB2618 injection | Experimental | Drug: TQB2618 injectionTQB2618 injection, 3 weeks as a treatment cycle. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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);
Key exclusion criteria (27 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TQB2618 injectionTQB2618 is a monoclonal antibody targeting T cell immunoglobulin and mucin domain-3 (TIM-3) receptor. | Drug | TQB2618 injection, TQB2618 injection+Penpulimab injection, TQB2618 injection+Penpulimab injection +Anlotinib hydrochloride capsules |
| Penpulimab injectionPenpulimab 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. | Drug | TQB2618 injection+Penpulimab injection, TQB2618 injection+Penpulimab injection +Anlotinib hydrochloride capsules |
| Anlotinib hydrochloride capsulesAnlotinib hydrochloride is a muti-target tyrosine kinase inhibitor. | Drug | TQB2618 injection+Penpulimab injection +Anlotinib hydrochloride capsules |
Primary outcome
Objective response rate (ORR)
Time frame: From first administration until disease progression or withdrawal due to other reasons, estimated to not exceed 8 months.
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).
7 secondary outcomes
Overall survival (OS)
Time frame: Baseline up to death, estimated to not exceed 12 months
Progress free survival (PFS)
Time frame: From randomization to the time of disease progression or death from any cause, estimated to not exceed 12 months.
Disease control rate (DCR)
Time frame: From first administration to the time of disease progression or withdrawal from any cause, estimated to not exceed 12 months.
Duration of response (DOR)
Time frame: 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)
Time frame: From first administration to 28 days after withdrawal or the start time of the new anti-tumor treatment, whichever comes first.
Anti-drug antibodies (ADA)
Time frame: Cycle 1 Day 1, Cycle 2 Day 1, Cycle 4 Day 1, Cycle 8 Day 1, 30 days and 90 days after the last dose. Each cycle is 21 days.
Neutralizing antibodies (NaB)
Time frame: Cycle 1 Day 1, Cycle 2 Day 1, Cycle 4 Day 1, Cycle 8 Day 1, 30 days and 90 days after the last dose. Each cycle is 21 days.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TQB2618 injection, Penpulimab injection and Anlotinib hydrochloride capsules in people with Colorectal Cancer, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 15 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ruihua Xu, Doctor (+86 13922206676, 13247323687@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (ORR) (time frame: From first administration until disease progression or withdrawal due to other reasons, estimated to not exceed 8 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2024.