This is a multicenter, open-label, multi-cohort Phase Ib trial to evaluate the efficacy and safety of TQB2928 injection combined with anlotinib hydrochloride capsule in patients with relapsed/metastatic osteosarcoma and other relapsed/metastatic solid tumors.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
20
TQB2928 is a novel humanized immunoglobulin G4 (IgG4) subtype monoclonal antibody targeting Cluster of Differentiation 47 (CD47).
TQB2928 is a novel humanized igG4 subtype monoclonal antibody targeting CD47.
Beijing jishuitan hospital
Beijing, Beijing Municipality, China
Pekjing university people's hospital
Beijing, Beijing Municipality, China
Beijing cancer hospital
Beijing, Beijing Municipality, China
Hunan cancer hospital
Changsha, Hunan, China
Cohort 1: Progression-Free Survival (PFS) of 6 months
Cohort 1: Kaplan-Meier method was used to plot the survival curve, in which the cumulative survival rate and 95% confidence interval corresponding to the progression-free survival time of 6 months were obtained.
Time frame: Up to 6 months
Cohort 2: Overall response rate (ORR)
Cohort 2: The percentage of subjects with complete (CR) or partial response (PR) as determined by the investigator according to the RECIST 1.1 criteria.
Time frame: Up to 6 months
Cohort 1: Progression-Free Survival (PFS) of 4 months
Cohort 1: Survival curve was plotted using Kaplan-Meier method. In the curve, the corresponding cumulative survival rate and 95% confidence interval for progression-free survival of 4 months were obtained.
Time frame: Up to 4 months
Cohort 1: Overall response rate (ORR)
Cohort 1: The percentage of subjects with complete (CR) or partial response (PR) as determined by the investigator according to the RECIST 1.1 criteria.
Time frame: Baseline up to 96 weeks
Cohort 2: Progression-Free Survival (PFS) of 6 months
Cohort 2: Kaplan-Meier method was used to plot the survival curve with the corresponding cumulative survival rate and 95% confidence interval (95% CI) when the progression-free survival time was 6 months. The overall population and 2 dose groups were counted separately (including participants in the safe introduction period and the extended period).
Time frame: Up to 6 months
Progression-Free Survival (PFS) of Cohort 1 and Cohort 2
The time between medication or random initiation and objective progression of disease or death from any cause, whichever comes first.
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Tianjin medical university cancer institute&hospital
Tianjin, Tianjin Municipality, China
Time frame: Up to 96 weeks
Disease control rate (DCR) of Cohort 1 and Cohort 2
The percentage of subjects with complete response (CR), partial response (PR), or stable disease (SD) for 6 weeks or more as determined by the investigator based on RECIST 1.1.
Time frame: Up to 6 weeks
Duration of response(DOR) of Cohort 1 and Cohort 2
For subjects whose optimal response was complete response (CR) or partial response (PR), defined as from the date when tumor response was first documented to the date when disease progression was first documented or the date of death from any cause, whichever came first.
Time frame: Baseline up to 96 weeks
Overall survival (OS) of Cohort 1 and Cohort 2
From randomization to the time of death from any cause.
Time frame: Baseline up to 96 weeks
Adverse event rate of Cohort 1 and Cohort 2
Incidence and severity of adverse events (AES) and serious adverse events (SAEs), abnormal laboratory test indicators and treatment-related adverse events (TEAEs).
Time frame: Baseline up to 96 weeks
Incidence of Anti-drug antibody (ADA )and Neutralizing Antibody( NAb )
The positive rates of immunogenicity (ADA and NAb) in subjects were summarized and descriptive statistical analysis was performed.
Time frame: 30 minutes before administration on day 1 of cycles 1, 2, 4 and 8 (each cycle is 21 days), day 90 after the last administration (±7 days)