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

Status: Recruiting
Location: See all (5) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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).

Locations
Other Locations
China
Beijing cancer hospital
NOT_YET_RECRUITING
Beijing
Beijing jishuitan hospital
NOT_YET_RECRUITING
Beijing
Pekjing university people's hospital
RECRUITING
Beijing
Hunan cancer hospital
NOT_YET_RECRUITING
Changsha
Tianjin medical university cancer institute&hospital
NOT_YET_RECRUITING
Tianjin
Contact Information
Primary
Lu Xie, Doctor
xie.lu@hotmail.com
13401044719
Time Frame
Start Date: 2024-02-15
Estimated Completion Date: 2026-02
Participants
Target number of participants: 43
Treatments
Experimental: 1200mg of TQB2928 injection +Anlotinib
21 days as a treatment cycle.
Experimental: 1800mg of TQB2928 injection+Anlotinib
21 days as a treatment cycle.
Related Therapeutic Areas
Sponsors
Leads: Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.

This content was sourced from clinicaltrials.gov

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