NCT06490068

Study of LTC004 Combine With Toripalimab in Patient With Solid Tumors Resistant to Immunotherapy

An Open, Single-arm, Phase II Clinical Study to Evaluate the Efficacy and Safety of LTC004 in Combination With Toripalimab in Patients With Advanced Solid Tumors Resistant to First-line Immunotherapy

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the efficacy and safety of LTC004 in combination with Toripalimab in 10 patients with advanced solid tumors resistant to first-line immunotherapy, all eligible subjects will receive LTC004 on day 1 of Week 1 and day 1 of week 3. Beginning at week 5, all subjects will receive LTC004 in combination with Toripalimab regimen until disease progression, intolerance, informed withdrawal or up to 2 years of dosing, whichever occurred first.

Detailed description

All eligible subjects will receive LTC004 on day 1 of Week 1 and day 1 of week 3. Beginning at week 5, all subjects will receive LTC004 in combination with Toripalimab regimen until disease progression, intolerance, informed withdrawal or up to 2 years of dosing, whichever occurred first.

Conditions

• Advanced Solid Tumor

Interventions

Type	Name	Description
DRUG	LTC004+Toripalimab	LTC004 on D1 of Week 1 and D1 of week 3. IV,90μg/kg. Beginning at week 5, all subjects will receive LTC004 in combination with Toripalimab. LTC004:D3,iv,45μg/kg,Q3W. Toripalimab:D1,iv,240mg,Q3W.

Timeline

• Start date: 2024-06-04
• Primary completion: 2026-03-31
• Completion: 2026-03-31
• First posted: 2024-07-08
• Last updated: 2024-07-08

Locations

1 site across 1 country: China