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This study was closed due to business reasons. Closure was not prompted by any safety or efficacy concerns.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1200mg of TQB2928 injection +Anlotinib | Experimental | 21 days as a treatment cycle. |
|
| 1800mg of TQB2928 injection+Anlotinib | Experimental | 21 days as a treatment cycle. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 1200mg of TQB2928 injection+Anlotinib | Drug | TQB2928 is a novel humanized immunoglobulin G4 (IgG4) subtype monoclonal antibody targeting Cluster of Differentiation 47 (CD47). |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | Up to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 4 months |
| Cohort 1: Overall response rate (ORR) |
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Inclusion Criteria:
Pathological diagnosis of high-grade osteosarcoma(cohort I),dedifferentiated liposarcoma or polytypic liposarcoma(cohort II),unsuitable for local treatment;
The requirements for front-line treatment received by subjects are as follows:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing jishuitan hospital | Beijing | Beijing Municipality | 100035 | China | ||
| Pekjing university people's hospital |
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| 1800mg of TQB2928 injection+Anlotinib | Drug | TQB2928 is a novel humanized igG4 subtype monoclonal antibody targeting CD47. |
|
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. |
| 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). | 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. | 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. | 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. | Baseline up to 96 weeks |
| Overall survival (OS) of Cohort 1 and Cohort 2 | From randomization to the time of death from any cause. | 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). | 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. | 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) |
| Beijing |
| Beijing Municipality |
| 100044 |
| China |
| Beijing cancer hospital | Beijing | Beijing Municipality | 100142 | China |
| Hunan cancer hospital | Changsha | Hunan | 410031 | China |
| Tianjin medical university cancer institute&hospital | Tianjin | Tianjin Municipality | 300181 | China |
| ID | Term |
|---|---|
| D012516 | Osteosarcoma |
| ID | Term |
|---|---|
| D018213 | Neoplasms, Bone Tissue |
| D009372 | Neoplasms, Connective Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D012509 | Sarcoma |
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