RecruitingPhase 1Phase 2NCT05301764

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

An Open Label, Phase Ib/II Trial of LVGN6051 Combined with Anlotinib in the Treatment of Locally Advanced, Metastatic or Recurrent Refractory Soft Tissue Sarcoma

Sponsor

Lyvgen Biopharma Holdings Limited

Enrollment

65 participants

Start Date

May 25, 2022

Study Type

INTERVENTIONAL

Conditions

Soft Tissue Sarcoma

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

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This trial tests a combination of two drugs — LVGN6051 (an immune-boosting antibody) and anlotinib (a drug that cuts off tumor blood supply) — in patients with advanced soft tissue sarcoma that cannot be removed by surgery or has spread. **You may be eligible if...** - You are 18 or older with a confirmed diagnosis of advanced, metastatic, or recurrent soft tissue sarcoma that cannot be surgically removed - Your cancer has come back or is no longer responding to standard treatment - You have good enough physical function (ECOG 0–2) - You have adequate kidney, liver, and blood function **You may NOT be eligible if...** - Your organ function is too low for the treatment - You have other serious medical conditions affecting heart, liver, or kidney - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

COMBINATION_PRODUCTLVGN6051 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.