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[68Ga]Ga-A9-6217 / [177Lu]Lu-A9-0631 / Colorectal Cancer · Phase 1 Trial
ClinicalTrials.gov · September 4, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is an active Phase 1–1b registry entry for a multicenter dose-escalation and safety study of two novel GRPR-targeting radiopharmaceuticals ([177Lu]Lu-A9-0631 and [225Ac]Ac-A9-0642) in patients with GRPR-positive solid tumors. No efficacy or safety results are posted in this registry record; the study is currently recruiting.
Phase 1, Interventional, Non Randomized, Parallel, Open label, Treatment purpose. Breast Cancer, Prostate Cancer, Colorectal Cancer, GRPR-positive Solid Tumors; age from 18 Years. Intervention: Phase 1 Dose Escalation; Phase 1B Dose Expansion. n = 115. 2 sites: Australia.
This is an active Phase 1–1b registry entry for a multicenter dose-escalation and safety study of two novel GRPR-targeting radiopharmaceuticals ([177Lu]Lu-A9-0631 and [225Ac]Ac-A9-0642) in patients with GRPR-positive solid tumors. No efficacy or safety results are posted in this registry record; the study is currently recruiting.
Phase 1 design is not powered for efficacy endpoints; safety and tolerability are the primary focus. Efficacy data, pharmacokinetics, and dosimetry outcomes are not yet reported.
Clinicians should not infer efficacy or safety from this registry entry. Once results are available, this Phase 1 data will inform dose selection and tolerability profile for future Phase 2 efficacy studies of GRPR-targeted radiopharmaceutical therapy.
Phase 1 trial in early recruitment with no results posted; addresses safety, tolerability, and dose-finding in a novel radiopharmaceutical setting.
As stated by the source record.
Quoted from the source exactly as published.
Clinicians should not infer efficacy or safety from this registry entry. Once results are available, this Phase 1 data will inform dose selection and tolerability profile for future Phase 2 efficacy studies of GRPR-targeted radiopharmaceutical therapy.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT07661641). This is a study registration, not published results. Lead sponsor: Alpha-9 Oncology USA Inc.. Recruitment status: RECRUITING. Phase: PHASE1. Study type: INTERVENTIONAL. Enrollment: 115 participants (ESTIMATED). Conditions: Breast Cancer, Prostate Cancer, Colorectal Cancer, GRPR-positive Solid Tumors. Interventions: DIAGNOSTIC_TEST: [68Ga]Ga-A9-6217; DIAGNOSTIC_TEST: Low dose [177Lu]Lu-A9-0631; DRUG: [177Lu]Lu-A9-0631; DRUG: [225Ac]Ac-A9-0642. Primary outcome measures: Phase 1-1b: Incidence of Adverse Events by Frequency, Duration, and Severity , 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). , Up to 28 days following first study treatment; Phase 1: Maximum tolerated dose (MTD) , Up to 28 days following first study treatment. 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.
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.