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A Study of [177Lu]Lu-A9-0631 and [225Ac]Ac-A9-0642 With [68Ga]Ga-A9-6217 or [177Lu]Lu-A9-0631 Imaging in GRPR+ Solid Tumors

NCT07661641 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 115

Last updated 2026-06-22

No results posted yet for this study

Summary

This is a Phase 1-1b multicenter clinical study to evaluate the safety, efficacy, and dosimetry of \[177Lu\]Lu-A9-0631 and \[225Ac\]Ac-0642 in participants with Gastrin-Releasing Peptide Receptor (GRPR) expressing locally advanced, unresectable or metastatic solid tumors.

Conditions

Interventions

DIAGNOSTIC_TEST

[68Ga]Ga-A9-6217

Administered IV

DIAGNOSTIC_TEST

Low dose [177Lu]Lu-A9-0631

Administered IV

DRUG

[177Lu]Lu-A9-0631

Administered IV

DRUG

[225Ac]Ac-A9-0642

Administered IV

Sponsors & Collaborators

  • Alpha-9 Oncology USA Inc.

    lead INDUSTRY

Principal Investigators

  • Stephen Hull, MD · Alpha 9 Oncology

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-01
Primary Completion
2028-12-31
Completion
2029-12-31

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 NCT07661641 on ClinicalTrials.gov