TQB2928 Injection Combined Anlotinib Hydrochloride Capsule in Recurrent/Metastatic Osteosarcoma and Other Solid Tumors

Osteosarcoma Clinical Trial

Official title:

A Multicenter, Open-label, Multi-cohort Phase Ib Trial Evaluating the Efficacy and Safety of TQB2928 Injection Combined With Anlotinib Hydrochloride Capsule in Relapsed/Metastatic Osteosarcoma and Other Relapsed/Metastatic Solid Tumors

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06438783
• Other study ID #: TQB2928-ALTN-Ib-01
• Status: Recruiting
• Phase: Phase 1
• Start date: February 15, 2024
• Est. completion date: February 2026

Study information

• Verified date: September 2023
• Source: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
• Contact: Lu Xie, Doctor
• Phone: 13401044719
• Email: xie.lu[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 43
• Est. completion date: February 2026
• Est. primary completion date: October 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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 a (SIRRP-a).

Related Conditions & MeSH terms

• Osteosarcoma
• Other Solid Tumors

Intervention

Drug:
• 1200mg of TQB2928 injection+Anlotinib
TQB2928 is a novel humanized immunoglobulin G4 (IgG4) subtype monoclonal antibody targeting Cluster of Differentiation 47 (CD47).
• 1800mg of TQB2928 injection+Anlotinib
TQB2928 is a novel humanized igG4 subtype monoclonal antibody targeting CD47.

Locations

Country	Name	City	State
China	Beijing cancer hospital	Beijing	Beijing
China	Beijing jishuitan hospital	Beijing	Beijing
China	Pekjing university people's hospital	Beijing	Beijing
China	Hunan cancer hospital	Changsha	Hunan
China	Tianjin medical university cancer institute&hospital	Tianjin	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Secondary	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
Secondary	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.	Baseline up to 96 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Overall survival (OS) of Cohort 1 and Cohort 2	From randomization to the time of death from any cause.	Baseline up to 96 weeks
Secondary	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
Secondary	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)