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

A Phase I, Open-label, Dose Escalation Study to Evaluate the Tolerance and Pharmacokinetics of TQB2858 Injection in Subjects With Terminal Malignant Tumor

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

Study Overview

• Status: Recruiting
• Conditions: Terminal Malignant Tumors
• Intervention / Treatment: Drug: TQB2858 injection

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Ying Cheng, Doctor; Phone Number: +86-0431-80596315; Email: jl.cheng@163.com

Study Locations

• China
  • Jilin
    • Changchun, Jilin, China, 130000
      • Recruiting
      • Jinlin Cancer Hospital
      • Contact: Ying Cheng, Doctor; Phone Number: +86-0431-80596315; Email: jl.cheng@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SEQUENTIAL
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: TQB2858 injection; TQB2858 administered intravenously (IV) once every 3 week	Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of adverse events	The incidence of all adverse events (AE), serious adverse events (SAE) and treatment-related adverse events (TEAEs)	Each subject started from the signing of the informed consent until 30 days after the last administration or the start of a new target indication

Collaborators and Investigators

• Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 23, 2021
• Primary Completion (ANTICIPATED): December 12, 2021
• Study Completion (ANTICIPATED): December 12, 2025

Study Registration Dates

• First Submitted: March 16, 2021
• First Submitted That Met QC Criteria: March 16, 2021
• First Posted (ACTUAL): March 18, 2021

Study Record Updates

• Last Update Posted (ACTUAL): June 4, 2021
• Last Update Submitted That Met QC Criteria: June 2, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: TQB2858-I-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No