Overview
Clinical Trial of the TQB2928 Injection in Patients With Advanced Cancers
Status:
Not yet recruiting
Not yet recruiting
Trial end date:
2025-01-01
2025-01-01
Target enrollment:
0
0
Participant gender:
All
All
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.Phase:
Phase 1Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.
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.