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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
180
TQB2928 injection is a CD47 Blocker.
Sun Yat-sen University Cancer Cen
Guangzhou, Guangdong, China
RECRUITINGRuijin Hospital Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
RECRUITINGDose Limiting Toxicity (DLT)
DLT will be assessed during the first 28 days of treatment for dose-escalation and are defined as toxicities that meet pre-defined severity criteria, and assessed as having a suspected relationship to study drug, and unrelated to disease, disease progression, inter-current illness, or concomitant medications that occurs within the first cycle (28 days) of treatment.
Time frame: During the first 28 days
Maximum tolerated dose (MTD)
MTD is defined as the highest dosing schedule cohort level at which no more than 1 of 6 patients experience a Dose Limiting Toxicity (DLT).
Time frame: During the first 28 days
Pharmacokinetics: T1/2
Terminal half-life (T1/2)
Time frame: Cycle 1 Day 1 and Cycle 1 Day 22: pre-dose, and 0.08, 2, 6, 24 and 72 hours after infusion. Cycle 1 Day 8, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Cycle 3 Day 1: pre-dose and end of the infusion. Each cycle is 28days.
Pharmacokinetics: AUC
The area under the curve (AUC) of serum concentration of TQB2928
Time frame: Cycle 1 Day 1 and Cycle 1 Day 22: pre-dose, and 0.08, 2, 6, 24 and 72 hours after infusion. Cycle 1 Day 8, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Cycle 3 Day 1: pre-dose and end of the infusion. Each cycle is 28days.
Pharmacokinetics: Cmin
Minimum observed concentration (Cmin) of TQB2928 at steady state
Time frame: Cycle 1 Day 1 and Cycle 1 Day 22: pre-dose, and 0.08, 2, 6, 24 and 72 hours after infusion. Cycle 1 Day 8, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Cycle 3 Day 1: pre-dose and end of the infusion. Each cycle is 28days.
Objective Response Rate (ORR)
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Defined as the percentage of Complete Response (CR) plus partial response (PR) assessed by Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 criteria for solid tumors, Lugano 2014 criteria and lymphoma response to immunomodulatory therapy criteria (LYRIC) for lymphoma, and acute myeloid leukemia (AML) IWG 2003 response criteria for AML.
Time frame: up to 2 years
Disease control rate (DCR)
Defined as the proportion of subjects with CR, PR, or SD (Stable Disease).
Time frame: up to 2 years
Duration of Response (DOR)
Defined as the time from first documented response to documented disease progression.
Time frame: up to 2 years
Progression-free survival (PFS)
Defined as the time from the first dose of TQB2928 to the first occurrence of disease progression or death from any cause.
Time frame: up to 2 years
Number of patients with adverse events (AEs) and serious adverse events (SAEs)
Assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Time frame: From the time of informed consent signed to 90 days after the last dose
Percentage of anti-drug antibody (ADA) positive patients
Percentage of ADA positive patients will be calculated to evaluate immunogenicity of TQB2928.
Time frame: From the time of informed consent signed through 90 days after the last dose.