Combining TQB2928 injection with Anlotinib for treating recurrent 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 study is testing if a new injection combined with a cancer pill can help people with recurrent osteosarcoma and other solid tumors that haven't responded to other treatments.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 43 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. (Industry-sponsored)
• Drugs / interventions: bevacizumab, anlotinib, apatinib, lenvatinib, sunitinib, fruquintinib, chemotherapy
• Locations: 5 sites (Beijing, Beijing and 4 other locations)
• Trial ID: NCT06438783 on ClinicalTrials.gov

What this trial studies

This multicenter, open-label Phase Ib trial aims to evaluate the safety and efficacy of TQB2928 injection in combination with Anlotinib hydrochloride capsules for patients with recurrent or metastatic osteosarcoma and other solid tumors. The study will involve multiple cohorts, focusing on patients who have not responded to previous treatments. Participants will receive specific dosages of TQB2928 injection alongside Anlotinib to assess the potential benefits of this combination therapy.

Who should consider this trial

Good fit: Ideal candidates include patients with high-grade osteosarcoma or dedifferentiated liposarcoma who have failed first-line chemotherapy and are not suitable for further first-line treatment.

Not a fit: Patients with a history of hemolytic anemia or those who have previously used certain treatments for their conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with difficult-to-treat recurrent or metastatic solid tumors.

How similar studies have performed: While this approach is novel, similar studies combining targeted therapies have shown promise in treating various cancers.

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:

  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).

Where this trial is running

Beijing, Beijing and 4 other locations

• Beijing jishuitan hospital — Beijing, Beijing, China (Not_yet_recruiting)
• Pekjing university people's hospital — Beijing, Beijing, China (Recruiting)
• Beijing cancer hospital — Beijing, Beijing, China (Not_yet_recruiting)
• Hunan cancer hospital — Changsha, Hunan, China (Not_yet_recruiting)
• Tianjin medical university cancer institute&hospital — Tianjin, Tianjin, China (Not_yet_recruiting)

Study contacts

• Study coordinator: Lu Xie, Doctor

Conditions Osteosarcoma; Other Solid Tumors