Clinical Trial of the TQB2928 Injection in Patients With Advanced Cancers

NCT ID: NCT05192512

Last Updated: 2022-03-03

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 180 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-24
• Study Completion Date: 2025-01-31

Brief Summary

TQB2928 is a promising new molecular entity that mediates blockade of CD47 and SIRPα (Signal Regulatory Protein Alpha) and enhances the phagocytosis of cancer cells by macrophages. This is a study to evaluate the safety, tolerability and effectiveness of TQB2928 injection in subjects with advanced malignancies.

Conditions

Advanced Cancer

Study Design

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

Study Groups

TQB2928 injection

weekly intravenous (IV) infusions for four times (Days 1, 8, 15, and 22) of TQB2928 in each 28-day treatment cycle

Group Type: EXPERIMENTAL

TQB2928 injection

Intervention Type: DRUG

TQB2928 injection is a CD47 Blocker.

Interventions

TQB2928 injection

TQB2928 injection is a CD47 Blocker.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 1 Male or female patient ≥18 years of age, an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1, and life expectancy ≥12 weeks;
• 2 Must have adequate organ and bone marrow function;
• 3 Pregnancy test (for females of childbearing potential) negative within 7 days before first dose. Male and female patients of childbearing potential and at risk for pregnancy must agree to use highly effective method(s) of contraception throughout the study and for at least 6 months after the last dose of assigned treatment;
• 4 Evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study;
• 5 Histologically or cytologically confirmed, locally advanced unresectable or metastatic solid tumors, or hematological malignancies, or lymphoma;
• 6 Solid tumors or hematological malignancies that failed from standard therapy, or lymphoma patients who have had at least two regimens of systemic therapy failures, or who refused other systemic therapy;

Exclusion Criteria

• 1 Patients with known symptomatic brain metastases
• 2 Concurrent secondary malignancy. or other malignancy with no evidence of disease for more than 3 years
• 3 Uncontrolled pleural effusion or pericardial effusion with clinical significance and require repeated drainage as assessed by the Investigators
• 4 Prior treatment with monospecific or bispecific antibodies or fusion proteins targeting CD47 or signal regulatory protein alpha (SIRPα)
• 5 Therapeutic or experimental antibodies within 3 months prior to first dose
• 6 Approved tyrosine kinase inhibitor (TKI) therapy within less than 5 half-lives prior to enrollment.
• 7 Major surgical procedure, radiotherapy, chemotherapy, or immunotherapy within 3 months prior to first dose;
• 8 Liver abnormalities including hepatitis B (HBV) and hepatitis C (HCV).
• 9 History of hemolytic anemia or Evans syndrome within 3 months.
• 10 Unstable or serious concurrent medical conditions, as assessed by the Investigators, that would substantially increase the risk-benefit ratio of participating in the study.

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

Sponsors

Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Sun Yat-sen University Cancer Cen

Guangzhou, Guangdong, China

Site Status: RECRUITING

Ruijin Hospital Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

weili Zhao, Doctor

Role: CONTACT

zwl_trial@163.com

021-64150275

li Zhang, Doctor

Role: CONTACT

zhangli@sysucc.org.cn

020-87343458

Other Identifiers

TQB2928-I-02

Identifier Type: -

Identifier Source: org_study_id