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

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

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 Overview

• Status: Terminated
• Conditions: Osteosarcoma; Other Solid Tumors
• Intervention / Treatment: Drug: 1200mg of TQB2928 injection+Anlotinib; Drug: 1800mg of TQB2928 injection+Anlotinib

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100142
      • Beijing Cancer Hospital
    • Beijing, Beijing Municipality, China, 100035
      • Beijing Jishuitan Hospital
    • Beijing, Beijing Municipality, China, 100044
      • Pekjing university people's hospital
  • Hunan
    • Changsha, Hunan, China, 410031
      • Hunan Cancer Hospital
  • Tianjin Municipality
    • Tianjin, Tianjin Municipality, China, 300181
      • Tianjin Medical University Cancer Institute&Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1200mg of TQB2928 injection +Anlotinib; 21 days as a treatment cycle.	Drug: 1200mg of TQB2928 injection+Anlotinib; TQB2928 is a novel humanized immunoglobulin G4 (IgG4) subtype monoclonal antibody targeting Cluster of Differentiation 47 (CD47).
Experimental: 1800mg of TQB2928 injection+Anlotinib; 21 days as a treatment cycle.	Drug: 1800mg of TQB2928 injection+Anlotinib; TQB2928 is a novel humanized igG4 subtype monoclonal antibody targeting CD47.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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)	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)

Collaborators and Investigators

• Sponsor: Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2024
• Primary Completion (Actual): June 18, 2025
• Study Completion (Actual): June 18, 2025

Study Registration Dates

• First Submitted: May 27, 2024
• First Submitted That Met QC Criteria: May 30, 2024
• First Posted (Actual): June 3, 2024

Study Record Updates

• Last Update Posted (Actual): December 12, 2025
• Last Update Submitted That Met QC Criteria: December 5, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Sarcoma; Neoplasms, Connective and Soft Tissue; Neoplasms, Bone Tissue; Neoplasms, Connective Tissue; Osteosarcoma
• Other Study ID Numbers: TQB2928-ALTN-Ib-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No