Advanced TumorsPhase 1NCT05213767
Clinical Study to Evaluate the Tolerability and Pharmacokinetics of TQB2916 Injection in Patients With Advanced Malignant Tumors
A Phase 1 study testing TQB2916 injection in people with Advanced Tumors, run by Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
This project is an open, dose escalation and expansion phase I clinical study. The first phase is a dose escalation study, and the second phase is a dose expansion study based on the Maximum tolerated dose (MTD) / Recommended Phase II Dose (RP2D) obtained in the first phase. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Tumors
- What is being tested?
- TQB2916 injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 190 participants
- Where
- 1 siteChina
- Study dates
- Feb 2022to Jul 2023
- 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 with advanced malignant tumors clearly diagnosed by pathology and / or cytology, lack of conventional effective treatment methods, failure or relapse after treatment.
- 2 18-75 years old; Eastern Cooperative Oncology Group (ECOG) physical status: 0-1; at least 3 months expected survival period.
- 3 The function of main organs is normal.
- 4 Subjects must need to adopt effective methods of contraception.
- 5 Subjects voluntarily joined the study, signed informed consent form, and with good compliance.
Who cannot join
- 1 Patients has had or is currently having other malignant tumors within 3 years. The following two conditions can be included in the group: other malignant tumors treated with a single operation to achieved R0 resection without recurrence and metastasis. Cured cervical carcinoma in situ, non-melanoma skin cancer, nasopharyngeal carcinoma and superficial bladder tumors [Ta (non-invasive tumor), Tis (carcinoma in situ) and T1 (tumor infiltrating basement membrane)].
- 2 The toxicity of previous antitumor treatment is not recovered to ≤ grade 1 (Common Terminology Criteria for Adverse Events (CTCAE) 5.0).
- 3 Received major surgical treatment, open biopsy or obvious traumatic injury within 28 days before treatment.
- 4 Subjects had an arteriovenous thrombosis event within 6 months.
- 5 Subjects occurred Evans syndrome within 3 months.
- 6 History of drug abuse, alcohol or drug abuse or mental disorder.
Show all 18Show fewer
- 7 Subjects who suffered from Active tuberculosis within 1 year.
- 8 The subjects had any history of bleeding or coagulopathy.
- 9 Cirrhosis, active hepatitis.
- 10 The subjects was diagnosed with renal failure and required hemodialysis or peritoneal dialysis.
- 11 History of immunodeficiency, including positive human immunodeficiency virus (HIV) test or other acquired, congenital immunodeficiency disease, or history of organ transplantation.
- 12 Subjects who have epilepsy and require treatment.
- 13 Received the treatment of proprietary Chinese medicines with anti-tumor indications clearly stated in the National Medical Products Administration (NMPA) approved drug instructions within 2 weeks of starting treatment.
- 14 The symptoms of subjects with known central nervous system metastasis, spinal cord compression, meningeal metastasis, or leptomeningeal disease.
- 15 Vaccination history of live attenuated vaccine before 28 days of starting treatment, or planned vaccination of live attenuated vaccine during the study period.
- 16 History of severe allergy to macromolecule drugs or known components of TQB2916 injection.
- 17 Receiving any other investigational agent within 4 weeks before first dose.
- 18 According to the investigator's judgment, there are concomitant diseases that seriously endanger the safety of the subject or affect the completion of the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase I Clinical Study to Evaluate the Tolerability and Pharmacokinetics of TQB2916 Injection in Patients With Advanced Malignant Tumors
This project is an open, dose escalation and expansion phase I clinical study. The first phase is a dose escalation study, and the second phase is a dose expansion study based on the Maximum tolerated dose (MTD) / Recommended Phase II Dose (RP2D) obtained in the first phase. The purpose is to evaluate the safety, tolerability, and pharmacokinetic characteristics of TQB2916 injection in patients with advanced tumors, and to initially evaluate the antitumor efficacy of TQB2916 injection.
- Conditions
- Advanced Tumors
- Being tested
- TQB2916 injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TQB2916 injectionDrug
TQB2916 injection is a kind of Tumor necrosis factor receptor superfamily member 5 (CD40) agonist, which is a humanized immunoglobulinG2 (IgG2) monoclonal antibody targeting CD40. This product can bind to CD40 on target cells to activate downstream signaling pathways and generate anti-tumor immune responses. At the same time, it can promote the apoptosis of B-cell lymphoma Ramos cells.
| Study group | Role | What they receive |
|---|---|---|
| TQB2916 injection | Experimental | 2.5mg/ quaque die (QD) was used as the initial dose, 21 days as a treatment cycle. The drug is administered on the first day of each cycle until the disease progresses or the investigator judges that it is not suitable for subject to continue to take medicine. Receives: Drug: TQB2916 injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose (MTD)
To evaluate MTD of TQB2916 injection in patients with advanced solid tumors
Measured: Baseline up to 52 weeks
Dose limited toxicity (DLT)
To evaluate DLT of TQB2916 injection in Chinese adult patients with advanced solid tumors
Measured: Baseline up to 52 weeks
Recommended Phase II Dose (RP2D)
To evaluate RP2D of TQB2916 injection in Chinese adult patients with advanced solid tumors
Measured: Baseline up to 52 weeks
Secondary outcomes (12)
Adverse events (AE) , serious adverse events (SAE) and treatment-related adverse events (TRAE)
The occurrence of all adverse events (AE), serious adverse events (SAE) and treatment-related adverse events (TRAE)
Measured: Baseline up to 104 weeks
Tmax
Time to reach maximum (peak) plasma concentration following drug administration
Measured: (-1 to 0 hour) (pre-dose), 0，1, 2, 4, 8, 24, 48,72,144,312,480 hours after intravenous injection of Cycle 1/3 Day 1; In 1 hour before intravenous injection on Cycle 2 Day 1, Cycle 4 Day 1, Cycle 5 Day 1, Cycle 6 Day 1, Cycle 7 Day 1 and Cycle 8 Day 1.
Maximum (peak) plasma drug concentration (Cmax)
Cmax is the maximum plasma concentration of TQB2916.
Measured: (-1 to 0 hour) (pre-dose), 0, 1, 2, 4, 8, 24, 48,72,144,312,480 hours after intravenous injection of Cycle 1/3 Day 1; In 1 hour before intravenous injection on Cycle 2 Day 1, Cycle 4 Day 1, Cycle 5 Day 1, Cycle 6 Day 1, Cycle 7 Day 1 and Cycle 8 Day 1.
Elimination half-life (t1/2)
t1/2 is time it takes for the blood concentration of TQB2916 or metabolite(s) to drop by half.
Measured: (-1 to 0 hour) (pre-dose), 0, 1, 2, 4, 8, 24, 48,72,144,312,480 hours after intravenous injection of Cycle 1/3 Day 1; In 1 hour before intravenous injection on Cycle 2 Day 1, Cycle 4 Day 1, Cycle 5 Day 1, Cycle 6 Day 1, Cycle 7 Day 1 and Cycle 8 Day 1.
Area under the plasma concentration-time curve from time zero to time t (AUC0-t)
To characterize the pharmacokinetics of TQB2916 by assessment of area under the plasma concentration time curve from the first dose to infinity.
Measured: (-1 to 0 hour) (pre-dose), 0, 1, 2, 4, 8, 24, 48,72,144,312,480 hours after intravenous injection of Cycle 1/3 Day 1; In 1 hour before intravenous injection on Cycle 2 Day 1, Cycle 4 Day 1, Cycle 5 Day 1, Cycle 6 Day 1, Cycle 7 Day 1 and Cycle 8 Day 1.
Maximum (peak) steady-state plasma drug concentration during a dosage interval (Cmax,ss)
Cmax is the maximum plasma concentration of TQB2916
Measured: (-1 to 0 hour) (pre-dose), 0, 1, 2, 4, 8, 24, 48,72,144,312,480 hours after intravenous injection of Cycle 1/3 Day 1; In 1 hour before intravenous injection on Cycle 2 Day 1, Cycle 4 Day 1, Cycle 5 Day 1, Cycle 6 Day 1, Cycle 7 Day 1 and Cycle 8 Day 1.
Concentration at the end of the dosing interval AUCtau,ss
To characterize the pharmacokinetics of TQB2916 by assessment of area The concentration at the end of the administration interval
Measured: (-1 to 0 hour) (pre-dose), 0, 1, 2, 4, 8, 24, 48,72,144,312,480 hours after intravenous injection of Cycle 1/3 Day 1; In 1 hour before intravenous injection on Cycle 2 Day 1, Cycle 4 Day 1, Cycle 5 Day 1, Cycle 6 Day 1, Cycle 7 Day 1 and Cycle 8 Day 1.
Minimum steady-state plasma drug concentration during a dosage interval (Css-min)
Cmin is the minimum plasma concentration of TQB2916
Measured: (-1 to 0 hour) (pre-dose), 0, 1, 2, 4, 8, 24, 48,72,144,312,480 hours after intravenous injection of Cycle 1/3 Day 1; In 1 hour before intravenous injection on Cycle 2 Day 1, Cycle 4 Day 1, Cycle 5 Day 1, Cycle 6 Day 1, Cycle 7 Day 1 and Cycle 8 Day 1.
Progress Free Survival (PFS)
Time from the first dose to the first documentation of progressive disease (PD) or death from any cause, whichever occurs first
Measured: up to 96 weeks
Disease control rate (DCR)
Percentage of participants achieving complete response (CR) and partial response (PR) and stable disease (SD).
Measured: up to 96 weeks
Duration of Response (DOR)
The time when the participants first achieved complete or partial remission to disease progression.
Measured: up to 96 weeks
Overall survival (OS)
the time from start of study treatment to date of death due to any cause
Measured: up to 96 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2022
- Study startFeb 2022 (estimated)
- Primary completionMay 2023 (estimated)
- Study completionJul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced TumorsStudies 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
- 190 participants (estimated)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05213767
- Sponsor's protocol ID
- TQB2916- I -01
- Status last verified
- Jan 2022
- First submitted
- 26 Jan 2022
- Last updated
- 28 Jan 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 28 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Clinical Study to Evaluate the Tolerability and Pharmacokinetics of TQB2916 Injection in Patients With Advanced Malignant Tumors
- ClinicalTrials.gov ID
- NCT05213767
- Acronym / sponsor ID
- TQB2916- I -01
- Conditions
- Advanced Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 190 participants (estimated)
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Feb 2022 (estimated)
- Primary completion
- May 2023 (estimated)
- Study completion
- Jul 2023 (estimated)
- First posted
- 28 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.
This project is an open, dose escalation and expansion phase I clinical study. The first phase is a dose escalation study, and the second phase is a dose expansion study based on the Maximum tolerated dose (MTD) / Recommended Phase II Dose (RP2D) obtained in the first phase. The purpose is to evaluate the safety, tolerability, and pharmacokinetic characteristics of TQB2916 injection in patients with advanced tumors, and to initially evaluate the antitumor efficacy of TQB2916 injection.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TQB2916 injection | Experimental | Drug: TQB2916 injection2.5mg/ quaque die (QD) was used as the initial dose, 21 days as a treatment cycle. The drug is administered on the first day of each cycle until the disease progresses or the investigator judges that it is not suitable for subject to continue to take medicine. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 1 Subjects with advanced malignant tumors clearly diagnosed by pathology and / or cytology, lack of conventional effective treatment methods, failure or relapse after treatment.
- 2 18-75 years old; Eastern Cooperative Oncology Group (ECOG) physical status: 0-1; at least 3 months expected survival period.
- 3 The function of main organs is normal.
- 4 Subjects must need to adopt effective methods of contraception.
- 5 Subjects voluntarily joined the study, signed informed consent form, and with good compliance.
Key exclusion criteria (18 listed)
- 1 Patients has had or is currently having other malignant tumors within 3 years. The following two conditions can be included in the group: other malignant tumors treated with a single operation to achieved R0 resection without recurrence and metastasis. Cured cervical carcinoma in situ, non-melanoma skin cancer, nasopharyngeal carcinoma and superficial bladder tumors [Ta (non-invasive tumor), Tis (carcinoma in situ) and T1 (tumor infiltrating basement membrane)].
- 2 The toxicity of previous antitumor treatment is not recovered to ≤ grade 1 (Common Terminology Criteria for Adverse Events (CTCAE) 5.0).
- 3 Received major surgical treatment, open biopsy or obvious traumatic injury within 28 days before treatment.
- 4 Subjects had an arteriovenous thrombosis event within 6 months.
- 5 Subjects occurred Evans syndrome within 3 months.
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 |
|---|---|---|
| TQB2916 injectionTQB2916 injection is a kind of Tumor necrosis factor receptor superfamily member 5 (CD40) agonist, which is a humanized immunoglobulinG2 (IgG2) monoclonal antibody targeting CD40. This product can bind to CD40 on target cells to activate downstream signaling pathways and generate anti-tumor immune responses. At the same time, it can promote the apoptosis of B-cell lymphoma Ramos cells. | Drug | TQB2916 injection |
Primary outcome
Maximum tolerated dose (MTD)
Time frame: Baseline up to 52 weeks
To evaluate MTD of TQB2916 injection in patients with advanced solid tumors
Dose limited toxicity (DLT)
Time frame: Baseline up to 52 weeks
To evaluate DLT of TQB2916 injection in Chinese adult patients with advanced solid tumors
Recommended Phase II Dose (RP2D)
Time frame: Baseline up to 52 weeks
To evaluate RP2D of TQB2916 injection in Chinese adult patients with advanced solid tumors
12 secondary outcomes
Adverse events (AE) , serious adverse events (SAE) and treatment-related adverse events (TRAE)
Time frame: Baseline up to 104 weeks
Tmax
Time frame: (-1 to 0 hour) (pre-dose), 0，1, 2, 4, 8, 24, 48,72,144,312,480 hours after intravenous injection of Cycle 1/3 Day 1; In 1 hour before intravenous injection on Cycle 2 Day 1, Cycle 4 Day 1, Cycle 5 Day 1, Cycle 6 Day 1, Cycle 7 Day 1 and Cycle 8 Day 1.
Maximum (peak) plasma drug concentration (Cmax)
Time frame: (-1 to 0 hour) (pre-dose), 0, 1, 2, 4, 8, 24, 48,72,144,312,480 hours after intravenous injection of Cycle 1/3 Day 1; In 1 hour before intravenous injection on Cycle 2 Day 1, Cycle 4 Day 1, Cycle 5 Day 1, Cycle 6 Day 1, Cycle 7 Day 1 and Cycle 8 Day 1.
Elimination half-life (t1/2)
Time frame: (-1 to 0 hour) (pre-dose), 0, 1, 2, 4, 8, 24, 48,72,144,312,480 hours after intravenous injection of Cycle 1/3 Day 1; In 1 hour before intravenous injection on Cycle 2 Day 1, Cycle 4 Day 1, Cycle 5 Day 1, Cycle 6 Day 1, Cycle 7 Day 1 and Cycle 8 Day 1.
Area under the plasma concentration-time curve from time zero to time t (AUC0-t)
Time frame: (-1 to 0 hour) (pre-dose), 0, 1, 2, 4, 8, 24, 48,72,144,312,480 hours after intravenous injection of Cycle 1/3 Day 1; In 1 hour before intravenous injection on Cycle 2 Day 1, Cycle 4 Day 1, Cycle 5 Day 1, Cycle 6 Day 1, Cycle 7 Day 1 and Cycle 8 Day 1.
Maximum (peak) steady-state plasma drug concentration during a dosage interval (Cmax,ss)
Time frame: (-1 to 0 hour) (pre-dose), 0, 1, 2, 4, 8, 24, 48,72,144,312,480 hours after intravenous injection of Cycle 1/3 Day 1; In 1 hour before intravenous injection on Cycle 2 Day 1, Cycle 4 Day 1, Cycle 5 Day 1, Cycle 6 Day 1, Cycle 7 Day 1 and Cycle 8 Day 1.
Concentration at the end of the dosing interval AUCtau,ss
Time frame: (-1 to 0 hour) (pre-dose), 0, 1, 2, 4, 8, 24, 48,72,144,312,480 hours after intravenous injection of Cycle 1/3 Day 1; In 1 hour before intravenous injection on Cycle 2 Day 1, Cycle 4 Day 1, Cycle 5 Day 1, Cycle 6 Day 1, Cycle 7 Day 1 and Cycle 8 Day 1.
Minimum steady-state plasma drug concentration during a dosage interval (Css-min)
Time frame: (-1 to 0 hour) (pre-dose), 0, 1, 2, 4, 8, 24, 48,72,144,312,480 hours after intravenous injection of Cycle 1/3 Day 1; In 1 hour before intravenous injection on Cycle 2 Day 1, Cycle 4 Day 1, Cycle 5 Day 1, Cycle 6 Day 1, Cycle 7 Day 1 and Cycle 8 Day 1.
Progress Free Survival (PFS)
Time frame: up to 96 weeks
Disease control rate (DCR)
Time frame: up to 96 weeks
Duration of Response (DOR)
Time frame: up to 96 weeks
Overall survival (OS)
Time frame: up to 96 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TQB2916 injection in people with Advanced Tumors, run by Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. at 1 site 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 5 inclusion and 18 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 28 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Yi Ba, Doctor (18622221230, bayi@tjmuch.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum tolerated dose (MTD) (time frame: Baseline up to 52 weeks). The study lists 3 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 28 Jan 2022.