NCT06211647

A Clinical Study of [177Lu]Lu-XT117 Injection in Patients With Advanced Solid Tumors

A Clinical Study to Evaluate the Safety, Tolerability, Dosimetry and Preliminary Efficacy of [177Lu]Lu-XT117 Injection in FAP-positive Patients With Advanced Solid Tumors

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Ruimin Wang · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a single-center, single-arm clinical study to evaluate the safety, tolerability, dosimetry and preliminary efficacy of \[177Lu\]Lu-XT117 injection in patients with FAP-positive advanced solid tumors. Dose escalation will be conducted to determine the Dose Limiting Toxicity (DLT), Maximum Tolerated Dose (MTD), Recommended Phase 2 Dose (RP2D), and to assess dosimetry characteristics.

Conditions

• Advanced Solid Tumor

Interventions

Type	Name	Description
DRUG	[177Lu]Lu-XT117	\[177Lu\]Lu-XT117 is a radiopharmaceutical therapy in which an beta emitter, Lu-177, is conjugated to XT117. Patients will receive \[177Lu\]Lu-XT117 administration at fixed dose levels at an interval of 6 weeks between each dose.

Timeline

• Start date: 2024-01-01
• Primary completion: 2025-12-01
• Completion: 2026-12-01
• First posted: 2024-01-18
• Last updated: 2024-01-18

Locations

1 site across 1 country: China