A Study to Evaluate the Tolerance and Pharmacokinetics of TQB2858 Injection in Subjects With Terminal Malignant Tumors

NCT ID: NCT04805060

Last Updated: 2021-06-04

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-23
• Study Completion Date: 2025-12-12

Brief Summary

This study is a phase I study to evaluate the safety and tolerability of TQB2858 injection in patients with advanced malignancy.

Conditions

Terminal Malignant Tumors

Study Design

• Allocation Method: NA
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

TQB2858 injection

TQB2858 administered intravenously (IV) once every 3 week

Group Type: EXPERIMENTAL

TQB2858 injection

Intervention Type: DRUG

TQB2858 administered intravenously (IV) on Day 1 of each 21-day. The established dose of TQB2858 is diluted with normal saline \[0.9% (w/v) sodium chloride solution\], and the infusion time is 60 ± 10 min.

Interventions

TQB2858 injection

TQB2858 administered intravenously (IV) on Day 1 of each 21-day. The established dose of TQB2858 is diluted with normal saline \[0.9% (w/v) sodium chloride solution\], and the infusion time is 60 ± 10 min.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Patients with advanced malignancies diagnosed histologically and/or cytologically, where standard treatment has failed or there is no effective treatment;
• Age: 18-75 years old;
• ECOG score: 0 ~ 1;
• Expected survival of more than 3 months;
• The main organs are functioning normally;
• Women of childbearing age must be negative for serum or urine HCG within 7 days prior to study enrollment and must be non-lactating;Patients should agree to use contraception during the study period and for 6 months after the study period.
• Patients voluntarily joined the study and signed the informed consent, showing good compliance.

Exclusion Criteria

-Complicated disease and history: A) Has developed other malignant tumors within 2 years or is currently suffering from the same tumor; B) unmitigated toxic reactions above CTC AE grade 1 due to any prior treatment, excluding hair loss and peripheral sensory nerve disorders; C) received major surgical treatment or significant traumatic injury (excluding needle biopsy) within 28 days prior to the commencement of study treatment; D) Long-term unhealed wounds or fractures; E) The occurrence of arterial/venous thrombosis events within 6 months, such as cerebrovascular accidents (including temporary ischemic attack, cerebral hemorrhage, cerebral infarction), deep venous thrombosis and pulmonary embolism; F) People with a history of psychotropic substance abuse and inability to quit or with mental disorders; G) subjects with any severe and/or uncontrolled disease;"

-Tumor-related symptoms and treatment: A) had undergone surgery, chemotherapy, radiation or other anticancer therapy within 4 weeks prior to the start of study treatment (washout period was calculated from the end of the last treatment); B) Chinese patent drugs with anti-tumor indications specified in the NMPA approved drug specifications (including compound cantharide capsule, Kangai injection, Kanglaite capsule/injection, Aidi injection, Brucea oil injection/capsule, Xiaoaoping tablet/injection, Huabenin capsule, etc.) were received within 2 weeks before the start of the study; C) previously received immunodouble antibody therapy targeting the same target of TQB2858 injection; D) uncontrolled pleural effusion, pericardial effusion, or ascites that still require repeated drainage (as determined by the investigator); E) Patients with brain metastases whose symptoms stabilized less than 4 weeks after discontinuation of dehydrants and steroids;"

-Research Treatment Related: A) a history of live attenuated vaccine vaccination within 28 days prior to the study treatment initiation or a planned live attenuated vaccine vaccination during the study period; B) Previous history of severe allergy to macromolecular drugs or known components of TQB2858 injection; C) Study the occurrence of active autoimmune disease requiring systemic treatment (e.g., use of palliative drugs, corticosteroids, or immunosuppressants) within 2 years prior to treatment initiation.Alternative therapies (such as thyroxine, insulin, or physiological corticosteroids for adrenal or pituitary insufficiency) are not considered systemic; D) have been diagnosed with immunodeficiency or are receiving systemic glucocorticoid therapy or any other form of immunosuppressive therapy.(dose of >10mg/ day prednisone or other equivalent efficacy hormone), and continued to use within 2 weeks of the first administration;" Participants had participated in other antitumor drug clinical trials in the previous 4 weeks;

-Subject who, in the Investigator's judgment, has a concomitant disease that seriously endangers the subject's safety or affects the completion of the study, or is considered unsuitable for inclusion for other reasons.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Jinlin Cancer Hospital

Changchun, Jilin, China

Site Status: RECRUITING

Countries

China

Central Contacts

Ying Cheng, Doctor

Role: CONTACT

jl.cheng@163.com

+86-0431-80596315

Facility Contacts

Ying Cheng, Doctor

Role: primary

jl.cheng@163.com

+86-0431-80596315

Other Identifiers

TQB2858-I-01

Identifier Type: -

Identifier Source: org_study_id