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OncoMatch/Clinical Trials/NCT07661641

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

Is NCT07661641 recruiting? Yes, currently enrolling (Jul 2026). This Phase 1 trial studies multiple treatments including [177Lu]Lu-A9-0631 and [225Ac]Ac-A9-0642 for breast cancer.

Phase 1RecruitingAlpha-9 Oncology USA Inc.NCT07661641Data as of Jul 2026Location: Australia

Treatment: [177Lu]Lu-A9-0631 · [225Ac]Ac-A9-0642This 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.

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Extracted eligibility criteria

Treatments studied

Other

[177Lu]Lu-A9-0631[225Ac]Ac-A9-0642

Cancer type

Breast Carcinoma

Prostate Cancer

Colorectal Cancer

Biomarker criteria

Required: GRPR expression (testing required; no eligibility threshold specified)

Have GRPR-expressing disease as confirmed by PET / CT or SPECT imaging

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Cannot have received: external beam radiation therapy to more than 25% of the bone marrow

Prior external beam radiation therapy to more than 25% of the bone marrow

Lab requirements

Blood counts

Adequate organ function within 14 days of first administration of investigational therapeutic product

Kidney function

Adequate organ function within 14 days of first administration of investigational therapeutic product

Liver function

Adequate organ function within 14 days of first administration of investigational therapeutic product

Adequate organ function within 14 days of first administration of investigational therapeutic product

Structured fields extracted by AI. May contain errors — verify against the official protocol.

Frequently asked questions

Is NCT07661641 currently recruiting?

Yes, this trial is currently recruiting patients.

Are there prior therapy exclusions?

Yes. Prior external beam radiation therapy to more than 25% of the bone marrow disqualifies patients from enrollment.

Does this trial require GRPR?

Yes, GRPR expression is a required biomarker for enrollment.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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