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

NCT05213767 | Unknown Phase 1

• 1 other identifier: TQB2916- I -01
• Study Type: interventional
• Target: 190
• Locations: 1 country
• Sites: 1

Brief 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

Advanced Tumors

Outcome Measures

Primary Outcomes (3)

• Maximum tolerated dose (MTD)

  To evaluate MTD of TQB2916 injection in patients with advanced solid tumors

  Baseline up to 52 weeks

• Dose limited toxicity (DLT)

  To evaluate DLT of TQB2916 injection in Chinese adult patients with advanced solid tumors

  Baseline up to 52 weeks

• Recommended Phase II Dose (RP2D)

  To evaluate RP2D of TQB2916 injection in Chinese adult patients with advanced solid tumors

  Baseline up to 52 weeks

Secondary Outcomes (12)

• Adverse events (AE) , serious adverse events (SAE) and treatment-related adverse events (TRAE)

  Baseline up to 104 weeks

• Tmax

  (-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)

  (-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)

  (-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)

  (-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.

Study Arms (1)

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.

Drug: TQB2916 injection

Interventions

TQB2916 injection DRUG

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.

TQB2916 injection

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects with advanced malignant tumors clearly diagnosed by pathology and / or cytology, lack of conventional effective treatment methods, failure or relapse after treatment.
• years old; Eastern Cooperative Oncology Group (ECOG) physical status: 0-1; at least 3 months expected survival period.
• The function of main organs is normal.
• Subjects must need to adopt effective methods of contraception.
• Subjects voluntarily joined the study, signed informed consent form, and with good compliance.

You may not qualify if:

• 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 \[Ta (non-invasive tumor), Tis (carcinoma in situ) and T1 (tumor infiltrating basement membrane)\].
• The toxicity of previous antitumor treatment is not recovered to ≤ grade 1 (Common Terminology Criteria for Adverse Events (CTCAE) 5.0).
• Received major surgical treatment, open biopsy or obvious traumatic injury within 28 days before treatment.
• Subjects had an arteriovenous thrombosis event within 6 months.
• Subjects occurred Evans syndrome within 3 months.
• History of drug abuse, alcohol or drug abuse or mental disorder.
• Subjects who suffered from Active tuberculosis within 1 year.
• The subjects had any history of bleeding or coagulopathy.
• Cirrhosis, active hepatitis.
• The subjects was diagnosed with renal failure and required hemodialysis or peritoneal dialysis.
• History of immunodeficiency, including positive human immunodeficiency virus (HIV) test or other acquired, congenital immunodeficiency disease, or history of organ transplantation.
• Subjects who have epilepsy and require treatment.
• 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.
• The symptoms of subjects with known central nervous system metastasis, spinal cord compression, meningeal metastasis, or leptomeningeal disease.
• Vaccination history of live attenuated vaccine before 28 days of starting treatment, or planned vaccination of live attenuated vaccine during the study period.

Sponsors & Collaborators

• Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Tianjin Cancer Hospital

Tianjin, Tianjin Municipality, 300060, China

Location

Central Study Contacts

Yi Ba, Doctor

CONTACT

18622221230; bayi@tjmuch.com

Huilai Zhang, Doctor

CONTACT

18622221228; zhlwgq@126.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2022
• First Posted: January 28, 2022
• Study Start: February 1, 2022
• Primary Completion: May 1, 2023
• Study Completion: July 1, 2023
• Last Updated: January 28, 2022

Record last verified: 2022-01

Locations

CN (1)