NCT05301764

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

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 65 (estimated)
• Sponsor: Lyvgen Biopharma Holdings Limited · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a phase 1b/II, open-label, multicenter study of LVGN6051 combined with anlotinib in patients with locally advanced, metastatic or recurrent refractory soft tissue sarcoma. The study is comprised of a dose escalation phase (Ib) to determine the RP2D and an expansion phase (II) to further explore the safety and efficacy of combination treatment.

Conditions

• Soft Tissue Sarcoma

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-05-25
• Primary completion: 2025-03-19
• Completion: 2025-10-19
• First posted: 2022-03-31
• Last updated: 2024-10-15

Locations

5 sites across 1 country: China