TQB2928 is a promising new molecular entity that mediates blockade of CD47 and SIRPα and enhances the phagocytosis of cancer cells by macrophages. In preclinical in vivo models, TQB2928 was active against a wide range of solid tumors and hematologic malignancies. This is the first-in-human phase 1 trial of TQB2928 in patients with advanced solid tumors and hematological malignancies.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
4 weekly IV infusions (Days 1, 8, 15, and 22) of TQB2928 in each 28-day treatment cycle until unacceptable toxicity, documentation of confirmed progressive disease (PD), or subject withdrawal.
Dose Limiting Toxicities (DLTs)
DLTs 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
Number of patients with adverse events (AEs) and serious adverse events (SAEs)
Assessed by CTCAE v5.0
Time frame: From the time of informed consent signed through 90 days after the last dose
Pharmacokinetics: Cmax
Maximum observed concentration (Cmax) of TQB2928 after administration
Time frame: From the time of informed consent signed through 90 days after the last dose
Pharmacokinetics: Cmin
Minimum observed concentration (Cmin) of TQB2928 at steady state
Time frame: From the time of informed consent signed through 90 days after the last dose
Pharmacokinetics: Tmax
Time to maximum concentration (Tmax)
Time frame: From the time of informed consent signed through 90 days after the last dose
Pharmacokinetics: AUC
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The area under the curve (AUC) of serum concentration of TQB2928
Time frame: From the time of informed consent signed through 90 days after the last dose
Pharmacokinetics: T1/2
Terminal half-life (T1/2)
Time frame: From the time of informed consent signed through 90 days after the last dose
Percentage of ADA positive patients
Number of patients who develop detectable anti-drug antibody (ADA), and 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
Objective Response Rate (ORR)
Defined as the percentage of Complete Response (CR) plus partial response (PR) assessed by iRECIST v1.1 criteria for solid tumors, Lugano2014 criteria and lymphoma response to immunomodulatory therapy criteria (LYRIC) for lymphoma, and AML IWG 2003 response criteria for acute myeloid leukemia (AML).
Time frame: up to 2 years
Disease control rate (DCR)
Defined as the proportion of subjects with CR, PR, or SD.
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