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

Sponsor
Alpha-9 Oncology USA Inc.
Study ID
NCT07661641
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • [68Ga]Ga-A9-6217 — DIAGNOSTIC_TEST
    Administered IV
  • Low dose [177Lu]Lu-A9-0631 — DIAGNOSTIC_TEST
    Administered IV
  • [177Lu]Lu-A9-0631 — DRUG
    Administered IV
  • [225Ac]Ac-A9-0642 — DRUG
    Administered IV

Study Details

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.

Key Dates

First listed
Jun 22, 2026
Start date
Jul 1, 2026
Status verified
Jun 2026
Primary completion
Dec 31, 2028
Completion
Dec 31, 2029

Study Design

Enrollment
115 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Phase 1 Dose Escalation
  • Experimental: Phase 1B Dose Expansion

Primary Outcome Measure

Phase 1-1b: Incidence of Adverse Events by Frequency, Duration, and Severity [ Time Frame: From the first dose of study drug up to the End of Treatment (30 days after the last dose) ]

Central Contacts

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