Status unknownNCT05213767Updated Jan 28, 2022

Clinical Study to Evaluate the Tolerability and Pharmacokinetics of TQB2916 Injection in Patients With Advanced Malignant Tumors

A Phase 1 interventional study of TQB2916 injection in Advanced Tumors, sponsored by Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.. Status unknown at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2022-01-28.

Sponsored by Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. · Phase 1, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jan 2022), so the status shown — last known as Not yet recruiting — may be out of date.

Phase: Phase 1
Study type: Interventional
Enrollment: 190
Allocation: Not applicable
Ages: 18 Years to 75 Years
Sex: All

Study 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.

Conditions studied

Advanced Tumors

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Neoplasms 9,365

In context

Neoplasms

9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.

This study's planned enrollment of 190 is above the median of 50 across 7,253 interventional studies indexed under Neoplasms.

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Lead sponsor

Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. is the lead sponsor of 53 studies on the registry; 29 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 75 Years
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

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.

Exclusion criteria

Exclusion Criteria:

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.

Study design

Phase: Phase 1
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 190 participants (estimated)

Study arms

Experimental
TQB2916 injection
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.
Drug: TQB2916 injection

Interventions

DrugTQB2916 injection
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.

What researchers measure

Primary outcomes

Maximum tolerated dose (MTD)
To evaluate MTD of TQB2916 injection in patients with advanced solid tumors
Time frame: Baseline up to 52 weeks
Dose limited toxicity (DLT)
To evaluate DLT of TQB2916 injection in Chinese adult patients with advanced solid tumors
Time frame: Baseline up to 52 weeks
Recommended Phase II Dose (RP2D)
To evaluate RP2D of TQB2916 injection in Chinese adult patients with advanced solid tumors
Time frame: Baseline up to 52 weeks

Secondary outcomes

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)
Time frame: Baseline up to 104 weeks
Tmax
Time to reach maximum (peak) plasma concentration following drug administration
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)
Cmax is the maximum plasma concentration of TQB2916.
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)
t1/2 is time it takes for the blood concentration of TQB2916 or metabolite(s) to drop by half.
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)
To characterize the pharmacokinetics of TQB2916 by assessment of area under the plasma concentration time curve from the first dose to infinity.
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)
Cmax is the maximum plasma concentration of TQB2916
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
To characterize the pharmacokinetics of TQB2916 by assessment of area The concentration at the end of the administration interval
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)
Cmin is the minimum plasma concentration of TQB2916
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 from the first dose to the first documentation of progressive disease (PD) or death from any cause, whichever occurs first
Time frame: up to 96 weeks
Disease control rate (DCR)
Percentage of participants achieving complete response (CR) and partial response (PR) and stable disease (SD).
Time frame: up to 96 weeks
Duration of Response (DOR)
The time when the participants first achieved complete or partial remission to disease progression.
Time frame: up to 96 weeks
Overall survival (OS)
the time from start of study treatment to date of death due to any cause
Time frame: up to 96 weeks

Study locations

1 site

Tianjin Cancer Hospital
Tianjin, Tianjin 300060, China

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jan 28, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT05213767
Lead sponsor: Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.
Responsible party: Sponsor
First posted: Jan 28, 2022
Start date: Feb 2022 (estimated)
Primary completion: May 2023 (estimated)
Completion: Jul 2023 (estimated)
Last update: Jan 28, 2022

Study contacts

Yi Ba, Doctor

Contact

bayi@tjmuch.com

18622221230

Huilai Zhang, Doctor

Contact

zhlwgq@126.com

18622221228

Oversight

FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.

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