Status:
UNKNOWN
Clinical Study to Evaluate the Tolerability and Pharmacokinetics of TQB2916 Injection in Patients With Advanced Malignant Tumors
Lead Sponsor:
Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.
Conditions:
Advanced Tumors
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2023
Estimated Enrollment :
190 Patients enrolled
Trial Details
Trial ID
NCT05213767
Start Date
February 1 2022
End Date
July 1 2023
Last Update
January 28 2022
Active Locations (1)
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1
Tianjin Cancer Hospital
Tianjin, Tianjin Municipality, China, 300060