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RECRUITING
NCT06211647
PHASE1

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

Sponsor: Ruimin Wang

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

20

Start Date

2024-01

Completion Date

2026-12

Last Updated

2024-01-18

Healthy Volunteers

No

Interventions

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.

Locations (1)

The First Medical Center, Chinese PLA General Hospital

Beijing, China