Advanced Malignant TumorPhase 1NCT05198505
Clinical Trial of TQB2868 Injection in Subjects With Advanced Malignant Tumors
A Phase 1 study testing TQB2868 Injection in people with Advanced Malignant Tumor, run by Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. at 3 sites in China.
Trial summary
The TQB2868 protein in this study targeted programmed cell death protein 1 (PD-1) and transforming growth factor-β (TGF-β). The bifunctional fusion protein targets and neutralizes TGF-β in the tumor microenvironment. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Malignant Tumor
- What is being tested?
- TQB2868 Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 280 participants
- Where
- 3 sitesChina
- Study dates
- 27 Apr 2022to Jun 2024
- 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
- 1 Subjects voluntarily join the study and sign an informed consent form.
- 2 Age: 18-75 years old (when signing the informed consent form); Eastern Cooperative Oncology Group Performance status (ECOG PS) score: 0~1 points.
- 3 Advanced malignant tumors clearly diagnosed by histology or cytology.
- 4 Patients with advanced malignant tumors who have been diagnosed by tissue and/or cytology and have failed standard treatments or lack effective treatment options.
- 5 The main organs are in good function, and the following examination results are good: routine blood examination, biochemical examination, blood coagulation function examination, heart color Doppler ultrasound evaluation.
- 6 Female subjects of childbearing age should agree to use contraceptive measures (such as intrauterine devices, contraceptives, or condoms) during the study period and within 6 months after the end of the study; serum pregnancy/urine within 7 days before study entry The pregnancy test is negative and must be a non-lactating subject; male subjects should agree that contraception must be used during the study period and within 6 months after the end of the study period.
Who cannot join
- 1 Combined diseases and medical history:
- Has had other malignant tumors within 3 years before the first medication. The following two conditions can be included in the group: other malignant tumors treated with a single operation to achieve disease-free survival (DFS) for 5 consecutive years; cured cervical carcinoma in situ, non-melanoma skin cancer and superficial bladder tumors [ Ta (non-invasive tumor), Tis (carcinoma in situ) and T1 (tumor infiltrating basement membrane)];
- Unrelieved toxic reactions higher than Common Terminology Criteria Adverse Events (CTC AE) level 1 or higher caused by any previous treatment, excluding hair loss;
- Major surgical treatment, obvious traumatic injury or long-term unhealed wounds or fractures have been received within 28 days before the first medication;
- Arterial/venous thrombosis occurred within 6 months before the first administration, such as cerebrovascular accident (including temporary ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis and pulmonary embolism;
- Existence of active pulmonary tuberculosis, history of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonia, radiation pneumonia requiring treatment or active pneumonia with clinical symptoms;
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- People who have a history of psychotropic drug abuse and cannot be quit or have mental disorders;
- Previous recipients of allogeneic bone marrow transplantation or solid organ transplantation.
- Subjects with any severe and / or uncontrolled disease.
- 2 Tumor-related symptoms and treatment:
- Have received chemotherapy, radiotherapy or other anti-cancer therapies within 4 weeks before the first medication (the washout period will be calculated from the end of the last treatment); if you have received local radiotherapy in the past, you can join the group if the following conditions are met: End of radiotherapy more than 4 weeks from the start of the study treatment (brain radiotherapy is more than 2 weeks); and the target lesion selected for this study is not in the radiotherapy area; or the target lesion is located in the radiotherapy area, but progress has been confirmed.
- Received Chinese patent medicine treatment with anti-tumor indications specified in the National Medical Products Administration (NMPA) approved drug instructions within 2 weeks before the first medication;
- Have previously received immunological double-antibody therapeutic drugs against the same target of TQB2868 injection;
- Uncontrollable pleural effusion, pericardial effusion or ascites that still needs to be drained repeatedly (investigator's judgment);
- Known to have spinal cord compression, cancerous meningitis, accompanied by brain metastasis symptoms, or symptom control time less than 2 weeks;
- 3 Research and treatment related:
- The history of live attenuated vaccine vaccination within 28 days before the first administration or the planned live attenuated vaccine vaccination during the research period;
- Those who have had severe hypersensitivity reactions after using macromolecular drugs;
- An active autoimmune disease that requires systemic treatment (such as the use of disease-relieving drugs, corticosteroids, or immunosuppressive agents) occurred within 2 years before the first medication. Alternative therapies (such as thyroxine, insulin, or physiological corticosteroids for adrenal or pituitary insufficiency, etc.) are not considered systemic treatments;
- Diagnosed with immunodeficiency or receiving systemic glucocorticoid therapy or any other form of immunosuppressive therapy (dose>10mg/day prednisone or other curative hormones), and continue within 2 weeks of the first administration in use;
- 4 Participated in other anti-tumor drug clinical trials within 4 weeks before the first medication;
- 5 According to the judgment of the researcher, there are situations that seriously endanger the safety of the subjects or affect the completion of the research by the subjects.
Trial locations and contacts
3 sites in 1 country.
China3 sites, 3 recruiting
- Recruiting
Linyi Cancer Hospital
Linyi, Shandong, 276002
Jianhua Shi, Master, 0539-8127192, shijianhualy@126.com
- Recruiting
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, 200433
Caicun Zhou, Doctor, 18796218833, caicunzhoudr@163.com
- Recruiting
Henan Cancer Hospital
Zhengzhou, Henan, 450003
Suxia Luo, Doctor, 0371-65588009, luosxrm@163.com
About this study
Official title: Phase I Clinical Trial to Evaluate the Tolerability and Pharmacokinetics of TQB2868 Injection in Subjects With Advanced Malignant Tumors
The TQB2868 protein in this study targeted programmed cell death protein 1 (PD-1) and transforming growth factor-β (TGF-β). The bifunctional fusion protein targets and neutralizes TGF-β in the tumor microenvironment. On the basis of inhibiting PD-1 / programmed death ligand 1 (PD-L1) pathway, T cells can restore activity, enhance immune response, and more effectively improve the effect of inhibiting tumor occurrence and development.
- Conditions
- Advanced Malignant Tumor
- Being tested
- TQB2868 Injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TQB2868 InjectionDrug
TQB2868 protein is a bi-functional fusion protein targeting PD-1 and TGF-β
| Study group | Role | What they receive |
|---|---|---|
| TQB2868 Injection | Experimental | The drug was administered once every 3 weeks (administration time window: ± 3 days), the dose of each administration was 1.5-600 mg, and 3 weeks was a treatment cycle until the disease progressed or the investigator judged that it was not suitable to continue the drug use. Receives: Drug: TQB2868 Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-limiting toxicity (DLT)
DLT definition: the subject has the following adverse events related to the test drug within one treatment cycle (21 days) after the first administration.
- Grade ≥ 3 neutropenia with fever; Grade 4 neutropenia that cannot be recovered within 3 days after symptomatic treatment; Grade 3 anemia that cannot be recovered within 14 days; ≥ Grade 3 thrombocytopenia with bleeding; Other hematological toxicity above grade 4 (inclusive);
- ≥ Grade 3 non hematological toxicity; Nausea, vomiting, diarrhea, rash and electrolyte disorder that cannot be recovered to grade ≤ 2 within 7 days after symptomatic treatment; Grade 3 general fatigue, fatigue and headache with duration ≥ 7 days; Laboratory examination abnormalities with isolated ≥ grade 3 and significant clinical symptoms;
- Adverse events related to ≥ grade 3 infusion reaction occurred, and did not return to normal within 6 hours after stopping infusion
Measured: up to 10 months
Recommended Phase II Dose (RP2D)
To evaluate RP2D of TQB2868 injection in adult patients with advanced malignant tumors
Measured: up to 10 months
Maximum Tolerated Dose (MTD)
Defined as the highest dose when dose-limiting toxicity (DLT) occurred in less than 33% of subjects.
Measured: up to 10 months
All adverse events (AE), serious adverse events (SAE), and treatment-related adverse events (TEAEs)
ncidence of all adverse events (AE), serious adverse events (SAE), and treatment-related adverse events (TEAEs)
Measured: up to 17 months
Secondary outcomes (24)
Time to reach maximum(peak )plasma concentration following drug administration (Tmax)
To characterize the pharmacokinetics of TQB2868 by assessment of time to reach maximum plasma concentration after single and multiple dosing
Measured: up to 17 months
Maximum (peak) plasma drug concentration (Cmax)
Cmax is the maximum plasma concentration of TQB2868.
Measured: up to 17months
Maximum (peak) steady-state plasma drug concentration during a dosage interval (Css-max)
Cmax is the steady state maximum concentration of TQB2868 .
Measured: up to 17 months
Title：The plasma concentration time curve at steady state, from 0 to τ area under curve of time. (AUC0-τ)
To characterize the pharmacokinetics of TQB2868 by assessment of area under the plasma concentration time curve from the first dose to a certain time point.
Measured: up to 17 months
Area under the plasma concentration-time curve from time zero to time t (AUC0-t)
To characterize the pharmacokinetics of TQB2868 by assessment of area under the plasma concentration time curve from the first dose to a certain time point.
Measured: up to 17 months
Area under the plasma concentration-time curve from time zero to infinity(AUC0-∞)
To characterize the pharmacokinetics of TQB2868 by assessment of area under the plasma concentration time curve from the first dose to infinity.
Measured: up to 17 months
Apparent total clearance of the drug from plasma after oral administration (CL/F)
CL/F is total clearance rate for TQB2868.
Measured: up to 17 months
Elimination half-life (t1/2)
t1/2 is time it takes for the blood concentration of TQB2868 to drop by half.
Measured: up to 17 months
Apparent volume of distribution of intravenous infusion(Vss/F)
Steady-state apparent volume of distribution of TQB2868 injection by intravenous infusion
Measured: up to 17 months
Elimination rate constant(λ)
λ is the elimination rate constant when TQB2868 participates in the calculation of metabolism in the body
Measured: up to 17 months
Area under the plasma concentration-time curve from time zero to time 24h.( AUC0-24h)
Characterize the pharmacokinetics of TQB2868 by evaluating the area under the plasma concentration-time curve from the first administration to 24h
Measured: up to 17 months
Mean residence time (MRT)
MRT describes the average time that TQB2868 remains in the body.
Measured: up to 17 months
Minimum steady-state plasma drug concentration during a dosage interval (Css-min)
Css-min is the minimum plasma concentration of TQB2868.
Measured: up to 17 months
Degree of fluctuation(DF)
DF is the volatility coefficient of TQB2868.
Measured: up to 17 months
Average steady-state plasma drug concentration during multiple-dose administration (Css-avg)
Css-avg is the average of steady-state plasma concentration of TQB2868 .
Measured: up to 17 months
Anti-drug antibodies(ADA)
ADA is antibodies that make TQB2868 clear in the body quickly
Measured: up to 17 months
Receptor Occupancy(RO)
RO is a receptor occupancy for TQB2868 involved in metabolism in the body
Measured: up to 17 months
Progression-free survival (PFS)
PFS is defined as the time from the first treatment to the first disease progression or death from any cause
Measured: up to 29 months
Overall response rate (ORR)
Percentage of participants achieving complete response (CR) and partial response (PR).
Measured: up to 29 months
Disease control rate（DCR）
Percentage of participants achieving CR and PR and stable disease (SD).
Measured: up to 29 months
Duration of Response (DOR)
The period from the participants first achieving CR or PR to disease progression.
Measured: up to 29 months
Overall survival (OS)
OS is defined as the time from the first administration to all-cause death.
Measured: up to 29 months
PD-L1 expression in tumor tissue
To evaluate the expression of PD -L1
Measured: up to 17 months
TGF-β expression in blood samples
To evaluate the expression of TGF-β
Measured: up to 17 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2022
- Study start27 Apr 2022
- Primary completionJun 2023 (estimated)
- Study completionJun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Malignant TumorStudies of the same condition, open and under way.
- More trials run by Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 280 participants (estimated)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05198505
- Sponsor's protocol ID
- TQB2868-I-01
- Status last verified
- Apr 2022
- First submitted
- 19 Jan 2022
- Last updated
- 2 May 2022
- 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 2 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Clinical Trial to Evaluate the Tolerability and Pharmacokinetics of TQB2868 Injection in Subjects With Advanced Malignant Tumors
- ClinicalTrials.gov ID
- NCT05198505
- Acronym / sponsor ID
- TQB2868-I-01
- Conditions
- Advanced Malignant Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 280 participants (estimated)
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 27 Apr 2022 (actual)
- Primary completion
- Jun 2023 (estimated)
- Study completion
- Jun 2024 (estimated)
- First posted
- 20 Jan 2022 (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.
The TQB2868 protein in this study targeted programmed cell death protein 1 (PD-1) and transforming growth factor-β (TGF-β). The bifunctional fusion protein targets and neutralizes TGF-β in the tumor microenvironment. On the basis of inhibiting PD-1 / programmed death ligand 1 (PD-L1) pathway, T cells can restore activity, enhance immune response, and more effectively improve the effect of inhibiting tumor occurrence and development.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TQB2868 Injection | Experimental | Drug: TQB2868 InjectionThe drug was administered once every 3 weeks (administration time window: ± 3 days), the dose of each administration was 1.5-600 mg, and 3 weeks was a treatment cycle until the disease progressed or the investigator judged that it was not suitable to continue the drug use. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 1 Subjects voluntarily join the study and sign an informed consent form.
- 2 Age: 18-75 years old (when signing the informed consent form); Eastern Cooperative Oncology Group Performance status (ECOG PS) score: 0~1 points.
- 3 Advanced malignant tumors clearly diagnosed by histology or cytology.
- 4 Patients with advanced malignant tumors who have been diagnosed by tissue and/or cytology and have failed standard treatments or lack effective treatment options.
- 5 The main organs are in good function, and the following examination results are good: routine blood examination, biochemical examination, blood coagulation function examination, heart color Doppler ultrasound evaluation.
Key exclusion criteria (22 listed)
- 1 Combined diseases and medical history:
- 2 Tumor-related symptoms and treatment:
- 3 Research and treatment related:
- 4 Participated in other anti-tumor drug clinical trials within 4 weeks before the first medication;
- 5 According to the judgment of the researcher, there are situations that seriously endanger the safety of the subjects or affect the completion of the research by the subjects.
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 |
|---|---|---|
| TQB2868 InjectionTQB2868 protein is a bi-functional fusion protein targeting PD-1 and TGF-β | Drug | TQB2868 Injection |
Primary outcome
Dose-limiting toxicity (DLT)
Time frame: up to 10 months
DLT definition: the subject has the following adverse events related to the test drug within one treatment cycle (21 days) after the first administration. 1. Grade ≥ 3 neutropenia with fever; Grade 4 neutropenia that cannot be recovered within 3 days after symptomatic treatment; Grade 3 anemia that cannot be recovered within 14 days; ≥ Grade 3 thrombocytopenia with bleeding; Other hematological toxicity above grade 4 (inclusive); 2. ≥ Grade 3 non hematological toxicity; Nausea, vomiting, diarrhea, rash and electrolyte disorder that cannot be recovered to grade ≤ 2 within 7 days after symptomatic treatment; Grade 3 general fatigue, fatigue and headache with duration ≥ 7 days; Laboratory examination abnormalities with isolated ≥ grade 3 and significant clinical symptoms; 3. Adverse events related to ≥ grade 3 infusion reaction occurred, and did not return to normal within 6 hours after stopping infusion
Recommended Phase II Dose (RP2D)
Time frame: up to 10 months
To evaluate RP2D of TQB2868 injection in adult patients with advanced malignant tumors
Maximum Tolerated Dose (MTD)
Time frame: up to 10 months
Defined as the highest dose when dose-limiting toxicity (DLT) occurred in less than 33% of subjects.
All adverse events (AE), serious adverse events (SAE), and treatment-related adverse events (TEAEs)
Time frame: up to 17 months
ncidence of all adverse events (AE), serious adverse events (SAE), and treatment-related adverse events (TEAEs)
24 secondary outcomes
Time to reach maximum(peak )plasma concentration following drug administration (Tmax)
Time frame: up to 17 months
Maximum (peak) plasma drug concentration (Cmax)
Time frame: up to 17months
Maximum (peak) steady-state plasma drug concentration during a dosage interval (Css-max)
Time frame: up to 17 months
Title：The plasma concentration time curve at steady state, from 0 to τ area under curve of time. (AUC0-τ)
Time frame: up to 17 months
Area under the plasma concentration-time curve from time zero to time t (AUC0-t)
Time frame: up to 17 months
Area under the plasma concentration-time curve from time zero to infinity(AUC0-∞)
Time frame: up to 17 months
Apparent total clearance of the drug from plasma after oral administration (CL/F)
Time frame: up to 17 months
Elimination half-life (t1/2)
Time frame: up to 17 months
Apparent volume of distribution of intravenous infusion(Vss/F)
Time frame: up to 17 months
Elimination rate constant(λ)
Time frame: up to 17 months
Area under the plasma concentration-time curve from time zero to time 24h.( AUC0-24h)
Time frame: up to 17 months
Mean residence time (MRT)
Time frame: up to 17 months
Minimum steady-state plasma drug concentration during a dosage interval (Css-min)
Time frame: up to 17 months
Degree of fluctuation(DF)
Time frame: up to 17 months
Average steady-state plasma drug concentration during multiple-dose administration (Css-avg)
Time frame: up to 17 months
Anti-drug antibodies(ADA)
Time frame: up to 17 months
Receptor Occupancy(RO)
Time frame: up to 17 months
Progression-free survival (PFS)
Time frame: up to 29 months
Overall response rate (ORR)
Time frame: up to 29 months
Disease control rate（DCR）
Time frame: up to 29 months
Duration of Response (DOR)
Time frame: up to 29 months
Overall survival (OS)
Time frame: up to 29 months
PD-L1 expression in tumor tissue
Time frame: up to 17 months
TGF-β expression in blood samples
Time frame: up to 17 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2022.
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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.
3 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 TQB2868 Injection in people with Advanced Malignant Tumor, run by Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. at 3 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 6 inclusion and 22 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 2 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 Caicun Zhou, Doctor (18796218833, caicunzhoudr@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose-limiting toxicity (DLT) (time frame: up to 10 months). The study lists 4 primary outcomes in all. 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 2 May 2022.