MedTrace Logo

A Dose Escalation and Expansion Study of [177Lu]Lu-SN201 in Participants With Advanced Cancer

NCT06184035 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2025-11-20

No results posted yet for this study

Summary

The purpose of this first-in-human (FIH) study is to determine the maximum tolerated dose (MTD) and to characterize the safety, tolerability, PK, and dosimetry profile of \[177Lu\]Lu-SN201 in adult participants with advanced solid tumors who have no standard of care treatment options.

\[177Lu\]Lu-SN201 is a radiolabeled, nanomedical investigational medicinal product (IMP) whose mechanism of delivery is based on the Enhanced Permeability and Retention (EPR) effect.

Conditions

Interventions

DRUG

[177Lu]Lu-SN201

Intravenous infusion

Sponsors & Collaborators

  • Spago Nanomedical AB

    lead INDUSTRY

Principal Investigators

  • Kim Taubman · St Vincent Hospital Melbourne

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-06
Primary Completion
2027-12-01
Completion
2027-12-31

Countries

  • Australia

Study Locations

More Related Trials

Entities

Diseases

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 NCT06184035 on ClinicalTrials.gov