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

NCT06438783 | Terminated Phase 1

• 1 other identifier: TQB2928-ALTN-Ib-01
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 5

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.

Conditions

Osteosarcoma; Other Solid Tumors

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (9)

• Cohort 1: Progression-Free Survival (PFS) of 4 months

  Up to 4 months

• Cohort 1: Overall response rate (ORR)

  Baseline up to 96 weeks

• Cohort 2: Progression-Free Survival (PFS) of 6 months

  Up to 6 months

• Progression-Free Survival (PFS) of Cohort 1 and Cohort 2

  Up to 96 weeks

• Disease control rate (DCR) of Cohort 1 and Cohort 2

  Up to 6 weeks

Study Arms (2)

1200mg of TQB2928 injection +Anlotinib

EXPERIMENTAL

21 days as a treatment cycle.

Drug: 1200mg of TQB2928 injection+Anlotinib

1800mg of TQB2928 injection+Anlotinib

EXPERIMENTAL

21 days as a treatment cycle.

Drug: 1800mg of TQB2928 injection+Anlotinib

Interventions

1200mg of TQB2928 injection+Anlotinib DRUG

TQB2928 is a novel humanized immunoglobulin G4 (IgG4) subtype monoclonal antibody targeting Cluster of Differentiation 47 (CD47).

1200mg of TQB2928 injection +Anlotinib

1800mg of TQB2928 injection+Anlotinib DRUG

TQB2928 is a novel humanized igG4 subtype monoclonal antibody targeting CD47.

1800mg of TQB2928 injection+Anlotinib

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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;
• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

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

Study Sites (5)

Beijing jishuitan hospital

Beijing, Beijing Municipality, 100035, China

Location

Pekjing university people's hospital

Beijing, Beijing Municipality, 100044, China

Location

Beijing cancer hospital

Beijing, Beijing Municipality, 100142, China

Location

Hunan cancer hospital

Changsha, Hunan, 410031, China

Location

Tianjin medical university cancer institute&hospital

Tianjin, Tianjin Municipality, 300181, China

Location

MeSH Terms

Conditions

Osteosarcoma

Condition Hierarchy (Ancestors)

Neoplasms, Bone Tissue; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Sarcoma

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2024
• First Posted: June 3, 2024
• Study Start: February 15, 2024
• Primary Completion: June 18, 2025
• Study Completion: June 18, 2025
• Last Updated: December 12, 2025

Record last verified: 2025-12

Locations

CN (5)