What is this study trying to find out about GRPR-positive advanced solid tumors?

This study is evaluating the safety, effectiveness, and dosimetry of two investigational treatments, [177Lu]Lu-A9-0631 and [225Ac]Ac-A9-0642, in adults with GRPR-positive advanced solid tumors. It aims to establish safe dosing and understand how these treatments affect tumors and normal organs. The research is sponsored by Alpha-9 Oncology USA Inc.

Who may be eligible for this GRPR-positive solid tumor clinical trial?

Adults aged 18 years or older with GRPR-positive locally advanced, unresectable, or metastatic solid tumors such as breast, prostate, or colorectal cancer may be eligible. Participants should have an ECOG performance status of 0 or 1 and meet specific treatment history requirements. Please review eligibility criteria for more details.

Is there any cost to participate in this GRPR-positive solid tumor clinical trial?

Study-related care, including the study drug or procedure and all trial visits, is provided at no cost. However, personal travel expenses and other costs related to participation may vary and are not guaranteed to be covered.

Actively Recruiting

Phase 1

Age: 18Years +

All Genders

ID07661641

Phase 1-1b Study Evaluating Safety and Effectiveness of 177LuLu-A9-0631 and 225AcAc-A9-0642 in Adults With GRPR-Positive Advanced Solid Tumors

Led by Alpha-9 Oncology USA Inc. · Updated on 2026-06-22

115

Participants Needed

Research Sites

52 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the safety, effectiveness, and dosimetry of two treatments, 177LuLu-A9-0631 and 225AcAc-A9-0642, in adults with locally advanced, unresectable, or metastatic solid tumors that express the Gastrin-Releasing Peptide Receptor GRPR. This multicenter Phase 1-1b study focuses on several cancers including breast, prostate, colorectal, and other GRPR-positive tumors. The study aims to find safe doses and assess how these treatments affect tumors and normal organs. The study consists of two parts Phase 1 involves increasing doses to determine safety, tolerability, and the recommended dose for Phase 2. Phase 1b expands to more participants to further evaluate safety, efficacy, and dosimetry at the recommended dose. Treatments are given intravenously, and diagnostic imaging with 68GaGa-A9-6217 or low-dose 177LuLu-A9-0631 helps confirm GRPR expression and monitor responses. Participants will undergo multiple assessments including imaging scans, laboratory tests, and safety evaluations throughout the study. The main outcomes measured are the frequency and severity of side effects, dose-limiting toxicities, and response rates. Dosimetry will be assessed up to 7 days after each injection over several treatment cycles, and participants will be monitored for up to 12 months after treatment to track disease progression and treatment effects.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Participant has provided written informed consent prior to any study-specific procedure.
Age 18 years or older.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
Measurable target lesion per RECIST v1.1.
Disease progression from, intolerance to, or ineligibility for local standard of care therapies.
Diagnosis of locally advanced or metastatic prostate cancer, HR+/HER2- breast cancer, colorectal cancer, or other GRPR-positive solid tumors.
GRPR expression confirmed by PET/CT or SPECT imaging.
Adequate organ function within 14 days prior to first treatment.
At least 4 weeks since prior major surgery.

You will not qualify if you...

Received anticancer treatment including chemotherapy, antibody therapy, immunotherapy, gene therapy, vaccine therapy, angiogenesis inhibitors, or experimental drugs within 14 days prior (or 28 days for checkpoint inhibitors and antibody therapies) or 5 half-lives before first treatment.
History of uncontrolled allergic reactions or hypersensitivity to peptide-based imaging or therapeutic agents or excipients in study drugs.
Major surgery within 4 weeks before planned first treatment.
Prior external beam radiation therapy to more than 25% of bone marrow.
Pregnant, breastfeeding, or unwilling to use birth control during study participation.
Any active infection.

Research Team

Stephen Hull, MD

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Phase 1-1b Study Evaluating Safety and Effectiveness of 177LuLu-A9-0631 and 225AcAc-A9-0642 in Adults With GRPR-Positive Advanced Solid Tumors

On this page

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Research Team

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria