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 | Recruiting Phase 1 DMC

• 1 other identifier: A9-0600-01
• Study Type: interventional
• Target: 115
• Locations: 1 country
• Sites: 2

Brief 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

Breast Cancer; Prostate Cancer; Colorectal Cancer; GRPR-positive Solid Tumors

Keywords

breast cancer; prostate cancer; colorectal cancer (CRC); GRPR-positive solid tumors; radiopharmaceuticals; theranostics

Outcome Measures

Primary Outcomes (3)

• Phase 1-1b: Incidence of Adverse Events by Frequency, Duration, and Severity

  An AE is defined as any untoward medical occurrence in a participant administered study drug, which does not necessarily have to have a causal relationship with the study drug. The number of patients experiencing an AE in Part 1 will be reported.

  From the first dose of study drug up to the End of Treatment (30 days after the last dose)

• Phase 1: Number of Patients with Dose-Limiting Toxicities (DLTs).

  DLTs is defined as any predefined AE occurring during the DLT observation period.

  Up to 28 days following first study treatment

• Phase 1: Maximum tolerated dose (MTD)

  Incidence of dose-limiting toxicity (DLT) per dose level of \[177Lu\]Lu-A9-0631 and/or \[225Ac\]Ac-A9-0642.

  Up to 28 days following first study treatment

Secondary Outcomes (2)

• Phase 1-1b: Absorbed dose estimates (Gy) in normal organs for [177Lu]Lu-A9-0631 and/or [225Ac]Ac-A9-0642

  Up to 7 days after each injection for up to 6 cycles (each cycle is 28 days)

• Phase 1-1b: Objective Response Rate (ORR)

  Every 8 ± 1 weeks until radiographic disease progression or up to 12 months after the last dose of [177Lu]Lu-A9-0631 and/or [225Ac]Ac-A9-0642

Study Arms (2)

Phase 1 Dose Escalation

EXPERIMENTAL

Diagnostic Test: [68Ga]Ga-A9-6217; Diagnostic Test: Low dose [177Lu]Lu-A9-0631; Drug: [177Lu]Lu-A9-0631; Drug: [225Ac]Ac-A9-0642

Phase 1B Dose Expansion

EXPERIMENTAL

Diagnostic Test: [68Ga]Ga-A9-6217; Diagnostic Test: Low dose [177Lu]Lu-A9-0631; Drug: [177Lu]Lu-A9-0631; Drug: [225Ac]Ac-A9-0642

Interventions

[68Ga]Ga-A9-6217 DIAGNOSTIC_TEST

Administered IV

Phase 1 Dose Escalation; Phase 1B Dose Expansion

Low dose [177Lu]Lu-A9-0631 DIAGNOSTIC_TEST

Administered IV

Phase 1 Dose Escalation; Phase 1B Dose Expansion

[177Lu]Lu-A9-0631 DRUG

Administered IV

Phase 1 Dose Escalation; Phase 1B Dose Expansion

[225Ac]Ac-A9-0642 DRUG

Administered IV

Phase 1 Dose Escalation; Phase 1B Dose Expansion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant has provided written informed consent prior to any study-specific procedure.
• Age ≥ 18 years old.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
• Have measurable target lesion per RECIST v1.1.
• Progression from, intolerant to, or ineligible for (due to unavailability or contraindication) local standard of care therapies and have one of the following locally advanced or metastatic tumor types: prostate cancer; HR+/HER2- breast cancer; colorectal cancer; and GRPR-positive solid tumors.
• Have GRPR-expressing disease as confirmed by PET / CT or SPECT imaging.
• Adequate organ function within 14 days of first administration of investigational therapeutic product.
• At least 4 weeks from prior major surgery.

You may not qualify if:

• Received anticancer treatment including but not limited to chemotherapy, antibody therapy, immunotherapy, gene therapy, vaccine therapy, angiogenesis inhibitors, or experimental drugs ≤ 14 days prior (≤ 28 days prior in case of checkpoint inhibitor therapy and other antibody therapies) or 5 half-lives, (t1/2) whichever is shorter, to the administration of therapeutic investigational product.
• History of uncontrolled allergic reactions and/or known or expected hypersensitivity to a peptide-based imaging or therapeutic agent or any excipient present in either of the therapeutic investigational products.
• Major surgery within 4 weeks of planned first dose of the therapeutic investigational product.
• Prior external beam radiation therapy to more than 25% of the bone marrow.
• Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study.
• Any active infection.

Sponsors & Collaborators

• Alpha-9 Oncology USA Inc.: lead

Study Sites (2)

Melbourne Theranostic Innovation Center

Melbourne N., Victoria, 3051, Australia

RECRUITING

GenesisCare Murdoch

Murdoch, Western Australia, 6150, Australia

NOT YET RECRUITING

MeSH Terms

Conditions

Breast Neoplasms; Prostatic Neoplasms; Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Stephen Hull, MD

  Alpha 9 Oncology

  STUDY DIRECTOR

Central Study Contacts

Stephen Hull, MD

CONTACT

+1-778-715-3303; shull@a9oncology.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2026
• First Posted: June 22, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2029
• Last Updated: June 22, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

AU (2)