NCT06898437

Study of 177Lu-LNC1004 Injection in FAP-positive Radioiodine-refractory Differentiated Thyroid Cancer

Clinical Trial to Evaluate the Antitumor Efficacy and Safety of 177Lu-LNC1004 Injection in Patients With Fibroblast Activating Protein (FAP)-Positive Radioiodine-refractory Differentiated Thyroid Cancer (RAIR-DTC) Who Have Failed TKIs Treatment or Refuse Standard Treatment

• Status: Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Peking Union Medical College Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

177Lu-LNC1004 Injection, a radiopharmaceutical targeting FAP, has demonstrated preliminary antitumor effect in advanced FAP-positive solid tumor patients. The primary purpose of this study is to evaluate the efficacy of 177Lu-LNC1004 Injection in patients with FAP-positive RAIR-DTC who have failed first-line TKIs treatment or refuse standard treatment. All subjects will receive 80 mCi (± 10%) 177Lu-LNC1004 Injection intravenously every 6 weeks for 2 cycles.

Detailed description

This prospective, single-arm, open label, single-center clinical trial is planned to enroll approximately 20 RAIR-DTC subjects s who have failed TKIs treatment or refuse standard treatment. All subjects will receive 80 mCi (± 10%) 177Lu-LNC1004 Injection intravenously every 6 weeks for 2 cycles. Disease progression and occurrence of AEs will be monitored during the trial. Based on tumor response assessment and AEs occurrence in the first 2 cycles, subjects may continue to receive 177Lu-LNC1004 Injection for a maximum of 6 cycles.

Conditions

• Radioiodine Refractory Differentiated Thyroid Cancer

Interventions

Type	Name	Description
DRUG	177Lu-LNC1004 Injection	Intravenous administration: a single dose of 80 mCi per Cycle

Timeline

• Start date: 2025-03-24
• Primary completion: 2026-03-23
• Completion: 2027-03-23
• First posted: 2025-03-27
• Last updated: 2025-04-15

Locations

1 site across 1 country: China