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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-15

Study Completion Date

2025-06-18

Brief Summary

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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.

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Detailed Description

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Conditions

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Osteosarcoma Other Solid Tumors

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1200mg of TQB2928 injection +Anlotinib

21 days as a treatment cycle.

Group Type EXPERIMENTAL

1200mg of TQB2928 injection+Anlotinib

Intervention Type DRUG

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

1800mg of TQB2928 injection+Anlotinib

21 days as a treatment cycle.

Group Type EXPERIMENTAL

1800mg of TQB2928 injection+Anlotinib

Intervention Type DRUG

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

Interventions

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1200mg of TQB2928 injection+Anlotinib

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

Intervention Type DRUG

1800mg of TQB2928 injection+Anlotinib

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

Intervention Type DRUG

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No