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

NCT06211647 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2024-01-18

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Sinotau Pharmaceutical Group

    collaborator INDUSTRY

  • Ruimin Wang

    lead OTHER

Principal Investigators

  • Ruimin Wang · The First Medical Center, Chinese PLA General Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-31
Primary Completion
2025-12-31
Completion
2026-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06211647 on ClinicalTrials.gov