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Recruiting Phase 1, Phase 2 NCT05301764

A Study of LVGN6051 Combined with Anlotinib in Patient with Soft Tissue Sarcoma

Trial Parameters

Condition Soft Tissue Sarcoma
Sponsor Lyvgen Biopharma Holdings Limited
Study Type INTERVENTIONAL
Phase Phase 1, Phase 2
Enrollment 65
Sex ALL
Min Age 18 Years
Max Age 70 Years
Start Date 2022-05-25
Completion 2025-03-19
Interventions
LVGN6051 and Anlotinib

Brief Summary

The purpose of this study is to asess the safety and tolerability and efficacy of LVGN6051 combined with anlotinib in patient with soft tissue sarcoma.

Eligibility Criteria

Inclusion Criteria: 1. Males or females aged ≥ 18 years, who was histologically or cytologically diagnosed unresectable locally advanced, metastatic or recurrent refractory soft tissue sarcoma. 2. Ability to understand and willingness to sign a written informed consent document (ICF). Informed consent of subjects must be performed before the study, and the written informed consent shall be voluntarily signed by himself or his guardian; The subject or his guardian can communicate well with the investigator, and perform according to the protocol. 3. Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1. 4. Estimated life expectancy, in the judgment of the Investigator, of at least 90 days. 5. Adequate bone marrow function, as defined by all of the following: 1. hemoglobin (Hb) ≥ 90 g/L, and 2. absolute neutrophil count (ANC) ≥ 1.5x109/L, and 3. platelet count (PLT) ≥ 75x109/L. 6. Adequate liver function, as defined by all of the following: 1. Total bilirubin ≤ 1.5 × U

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