Osteosarcoma, Other Solid Tumors
Conditions
Brief summary
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.
Interventions
DRUG1200mg of TQB2928 injection+Anlotinib
TQB2928 is a novel humanized immunoglobulin G4 (IgG4) subtype monoclonal antibody targeting Cluster of Differentiation 47 (CD47).
DRUG1800mg of TQB2928 injection+Anlotinib
TQB2928 is a novel humanized igG4 subtype monoclonal antibody targeting CD47.
Sponsors
Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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: 1. Subjects with osteosarcoma have failed at least first-line chemotherapy and are not suitable for re-receiving first-line chemotherapy ,or progression within 6 months of the end of first-line therapy; 2. Subjects with dedifferentiated liposarcoma or polytype liposarcoma who have received at least first-line chemotherapy failure for recurrent/metastatic sites or relapse during postoperative adjuvant chemotherapy or within 6 months after treatment(considered first-line treatment failure).
Exclusion criteria
* History of hemolytic anemia from any cause (including Evans syndrome) within 3 months prior to first dosing; * Subjects with osteosarcoma or dedifferentiated liposarcoma/polytype liposarcoma who have previously used antiangiogenic tyrosine kinase inhibitors (TKI) or bevacizumab or its biosimilar, such as anlotinib, apatinib, lenvatinib, sorafenib, sunitinib, regorafenib, fruquintinib; * Previous antibody or fusion protein or small molecule drug targeting CD47 or Signal-regulatory protein α (SIRRP-α).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cohort 1: Progression-Free Survival (PFS) of 6 months | Up to 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. |
| Cohort 2: Overall response rate (ORR) | Up to 6 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cohort 2: Progression-Free Survival (PFS) of 6 months | Up to 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). |
| Progression-Free Survival (PFS) of Cohort 1 and Cohort 2 | Up to 96 weeks | The time between medication or random initiation and objective progression of disease or death from any cause, whichever comes first. |
| Disease control rate (DCR) of Cohort 1 and Cohort 2 | Up to 6 weeks | 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. |
| Cohort 1: Progression-Free Survival (PFS) of 4 months | Up to 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. |
| Overall survival (OS) of Cohort 1 and Cohort 2 | Baseline up to 96 weeks | From randomization to the time of death from any cause. |
| Adverse event rate of Cohort 1 and Cohort 2 | Baseline up to 96 weeks | Incidence and severity of adverse events (AES) and serious adverse events (SAEs), abnormal laboratory test indicators and treatment-related adverse events (TEAEs). |
| Incidence of Anti-drug antibody (ADA )and Neutralizing Antibody( NAb ) | 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) | The positive rates of immunogenicity (ADA and NAb) in subjects were summarized and descriptive statistical analysis was performed. |
| Duration of response(DOR) of Cohort 1 and Cohort 2 | Baseline up to 96 weeks | 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. |
| Cohort 1: Overall response rate (ORR) | Baseline up to 96 weeks | 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. |
Countries
China
Outcome results
None listed