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177Lu-anti-PD-L1 sdAb in Metastatic Solid Tumors

NCT06305962 · Status: RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-02-19

No results posted yet for this study

Summary

This is a Phase 0/1, First-in-Human (FIH), study to evaluate safety, tolerability, biodistribution, radiation dosimetry and preliminary anti-tumour activities of 177Lu-RAD204 in participants with selected solid tumours, to identify the MTDs/ recommended doses of 177Lu-RAD204 for future exploration.

The study will consist of a Pre-screening Period (if applicable for PD-L1 testing), a Screening Period of up to 4 weeks, followed by a Phase 0 (Imaging) Period for imaging and dosimetry to 177Lu-RAD204im and a Phase I (Treatment) Period for 177Lu-RAD204tr dose escalation.

Conditions

  • PDL1 Gene Mutation
  • Non Small Cell Lung Cancer
  • Small Cell Lung Cancer ( SCLC )
  • TNBC, Triple Negative Breast Cancer
  • Cutaneous Melanoma
  • HNSCC
  • Endometrial Cancer
  • Mmr Deficiency
  • MSI-High

Interventions

DRUG

177Lu-RAD204

177Lu-RAD204 administered at Imaging (im) and Treatment (tr) doses

Sponsors & Collaborators

  • Radiopharm Theranostics, Ltd

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-03
Primary Completion
2027-12-31
Completion
2027-12-31
FDA Drug
Yes

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 NCT06305962 on ClinicalTrials.gov