Clinical Study to Evaluate the Tolerability and Pharmacokinetics of TQB2916 Injection in Patients With Advanced Malignant Tumors
- 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. 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.
- Short title
- Clinical Study to Evaluate the Tolerability and Pharmacokinetics of TQB2916 Injection in Patients With Advanced Malignant Tumors
- Official title
- Phase I Clinical Study to Evaluate the Tolerability and Pharmacokinetics of TQB2916 Injection in Patients With Advanced Malignant Tumors
- Control arm
- Open label
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Unknown
- Phase
- Phase 1
- Study type
- Interventional
- Completion date
- 2023-07-01
- First posted
- 2022-01-28
- Registry last updated
- 2022-01-28
- Primary completion date
- 2023-05-01
- Start date
- 2022-02-01
- Participants
- Participant count basis
- Estimated
- Planned participants
- Protocol amendments
- Number of sites
- Registry sponsor category
- Industry
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT05213767
- ClinicalTrials.gov ID
- NCT05213767
- Registry record
- Open registry record
- Allocation
- Not applicable
- Model
- Single group
- Purpose
- Treatment
- Masking
- No masking
Maximum tolerated dose (MTD)
Timeframe: Baseline up to 52 weeks
To evaluate MTD of TQB2916 injection in patients with advanced solid tumors
Dose limited toxicity (DLT)
Timeframe: Baseline up to 52 weeks
To evaluate DLT of TQB2916 injection in Chinese adult patients with advanced solid tumors
Recommended Phase II Dose (RP2D)
Timeframe: Baseline up to 52 weeks
To evaluate RP2D of TQB2916 injection in Chinese adult patients with advanced solid tumors
Adverse events (AE) , serious adverse events (SAE) and treatment-related adverse events (TRAE)
Timeframe: Baseline up to 104 weeks
The occurrence of all adverse events (AE), serious adverse events (SAE) and treatment-related adverse events (TRAE)
Tmax
Timeframe: (-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.
Time to reach maximum (peak) plasma concentration following drug administration
Maximum (peak) plasma drug concentration (Cmax)
Timeframe: (-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.
Cmax is the maximum plasma concentration of TQB2916.
Elimination half-life (t1/2)
Timeframe: (-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.
t1/2 is time it takes for the blood concentration of TQB2916 or metabolite(s) to drop by half.
Area under the plasma concentration-time curve from time zero to time t (AUC0-t)
Timeframe: (-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.
To characterize the pharmacokinetics of TQB2916 by assessment of area under the plasma concentration time curve from the first dose to infinity.
Maximum (peak) steady-state plasma drug concentration during a dosage interval (Cmax,ss)
Timeframe: (-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.
Cmax is the maximum plasma concentration of TQB2916
Concentration at the end of the dosing interval AUCtau,ss
Timeframe: (-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.
To characterize the pharmacokinetics of TQB2916 by assessment of area The concentration at the end of the administration interval
Minimum steady-state plasma drug concentration during a dosage interval (Css-min)
Timeframe: (-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.
Cmin is the minimum plasma concentration of TQB2916
Progress Free Survival (PFS)
Timeframe: up to 96 weeks
Time from the first dose to the first documentation of progressive disease (PD) or death from any cause, whichever occurs first
Disease control rate (DCR)
Timeframe: up to 96 weeks
Percentage of participants achieving complete response (CR) and partial response (PR) and stable disease (SD).
Duration of Response (DOR)
Timeframe: up to 96 weeks
The time when the participants first achieved complete or partial remission to disease progression.
Overall survival (OS)
Timeframe: up to 96 weeks
the time from start of study treatment to date of death due to any cause
- Sex
- All
- Age groups
- Adults, Older adults
- Minimum age
- 18 Years
- Maximum age
- 75 Years
- Healthy volunteers
- No
- 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.
- 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.
- 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.
- Tianjin Cancer HospitalTianjin, China