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

CTTQ

Status and phase: Enrolling; Phase 1

Conditions: Other Solid Tumors; Osteosarcoma

Treatments: Drug: 1800mg of TQB2928 injection+Anlotinib; Drug: 1200mg of TQB2928 injection+Anlotinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT06438783

TQB2928-ALTN-Ib-01

Details and patient eligibility

About

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.

Enrollment: 43 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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43 participants in 2 patient groups

1200mg of TQB2928 injection +Anlotinib

Experimental group

Description:

21 days as a treatment cycle.

Treatment:

Drug: 1200mg of TQB2928 injection+Anlotinib

1800mg of TQB2928 injection+Anlotinib

Experimental group

Description:

21 days as a treatment cycle.

Treatment:

Drug: 1800mg of TQB2928 injection+Anlotinib