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

Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.5 sites in 1 country20 target enrollmentFebruary 15, 2024

ConditionsOsteosarcoma Other Solid Tumors

Interventions1800mg of TQB2928 injection+Anlotinib 1200mg of TQB2928 injection+Anlotinib

Drugs1200mg of TQB2928 injection+Anlotinib 1800mg of TQB2928 injection+Anlotinib

Overview

Phase: Phase 1
Intervention: 1800mg of TQB2928 injection+Anlotinib
Conditions: Osteosarcoma
Sponsor: Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.
Enrollment: 20
Locations: 5
Primary Endpoint: Cohort 1: Progression-Free Survival (PFS) of 6 months
Status: Terminated
Last Updated: 4 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

February 15, 2024

End Date

June 18, 2025

Last Updated

4 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

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:
•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).

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).

Arms & Interventions

1800mg of TQB2928 injection+Anlotinib

21 days as a treatment cycle.

Intervention: 1800mg of TQB2928 injection+Anlotinib

1200mg of TQB2928 injection +Anlotinib

21 days as a treatment cycle.

Intervention: 1200mg of TQB2928 injection+Anlotinib

Outcomes

Primary Outcomes

Cohort 1: Progression-Free Survival (PFS) of 6 months

Time Frame: 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)

Time Frame: 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 Outcomes

Disease control rate (DCR) of Cohort 1 and Cohort 2(Up to 6 weeks)
Cohort 2: Progression-Free Survival (PFS) of 6 months(Up to 6 months)
Overall survival (OS) of Cohort 1 and Cohort 2(Baseline up to 96 weeks)
Adverse event rate of Cohort 1 and Cohort 2(Baseline up to 96 weeks)
Cohort 1: Progression-Free Survival (PFS) of 4 months(Up to 4 months)
Cohort 1: Overall response rate (ORR)(Baseline up to 96 weeks)
Progression-Free Survival (PFS) of Cohort 1 and Cohort 2(Up to 96 weeks)
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))
Duration of response(DOR) of Cohort 1 and Cohort 2(Baseline up to 96 weeks)