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

NCT05301764 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 39

Last updated 2026-05-20

No results posted yet for this study

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.

Conditions

  • Soft Tissue Sarcoma

Interventions

COMBINATION_PRODUCT

LVGN6051 and Anlotinib

LVGN6051: Route of administration is IV infusion, and the frequency of administration is once every 3 weeks(Q3W). One cycle is 3 weeks, and treatment can be up to 35 cycles if patients receive benefits. Anlotinib: Rout of administration is oral. The initial dose of anlotinib was 12 mg for subjects with body surface area ≥ 1.5m2 and 10 mg for subjects with body surface area \< 1.5m2. If the subjects in the combined treatment group were not tolerated, the dose of anlotinib was reduced to 10 mg for subjects with body surface area ≥ 1.5m2 and 8 mg for subjects with body surface area \< 1.5m2. One cycle is 3 weeks, including oral for 2 weeks and withdrawal for 1 week.

Sponsors & Collaborators

  • Lyvgen Biopharma Holdings Limited

    lead INDUSTRY

Principal Investigators

  • Haiyan Hu · Shanghai 6th People's Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-25
Primary Completion
2025-12-19
Completion
2025-12-19

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05301764 on ClinicalTrials.gov