A Study of [225Ac]Ac-AKY-1189 in Patients With Solid Tumors

Part of paid clinical trials in Duarte, California.

Sponsor
Aktis Oncology, Inc.
Study ID
NCT07020117
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

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

Interventions

  • [225Ac]Ac-AKY-1189 (therapeutic) — DRUG
    \[225Ac\]Ac-AKY-1189 Injection
  • [64Cu]Cu-AKY-1189 (imaging) — DRUG
    \[64Cu\]Cu-AKY-1189 Injection

Study Details

This is a first-in-human Phase 1b, 2-part, multicenter open-label clinical study to evaluate safety and efficacy of a Nectin-4 radiopharmaceutical (\[225Ac\]Ac-AKY-1189) in patients with locally advanced or metastatic solid tumors and to establish the maximum tolerated dose (MTD) or maximum administered dose (MAD) and the recommended Phase 2 dose.

Key Dates

Start date
Aug 22, 2025
Status verified
Nov 2025
Primary completion
Dec 31, 2027
Completion
Jun 30, 2032

Study Design

Enrollment
150 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: [225Ac]Ac-AKY-1189

Primary Outcome Measure

Part 1: Number of Patients with Dose-Limiting Toxicities [ Time Frame: From enrollment to the end of Cycle 1 (each cycle is 28 days) ]

Central Contacts

Locations (9)

FacilityCityStateZIPSite coordinators
City of HopeDuarteCalifornia91010
Abhishek Tripathi, MD
[email protected]
626-256-4673
Hoag Memorial Hospital PresbyterianIrvineCalifornia92618
Ryan Reddy, MD
[email protected]
949-764-4577
Biogenix Molecular, LLCMiamiFlorida33165
Jerry Joseph
[email protected]
786-791-1799
University of IowaIowa CityIowa52242
Kristin West
[email protected]
319-356-3656
Kristin Plichta, MD, PhD
United TheranosticsGlen BurnieMaryland21061
Amanda Huggins
[email protected]
667-467-3669
BAMF HealthGrand RapidsMichigan49503
[email protected]
616-330-2735
Icahn School of Medicine at Mt. SinaiNew YorkNew York10029
Sophia Rhoads
[email protected]
317-903-4419
Patricia Acon
[email protected]
UPMCPittsburghPennsylvania15232
Samantha Demko, RN, BSN
[email protected]
412-623-1400
MD Anderson Cancer CenterHoustonTexas77030
Natalie Velez
[email protected]
713-792-1478

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