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Clinical Trials in the USA / NCT07020117
Recruiting Phase 1

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

NCT07020117 · tracked via the Priya Life Science USA tracker
Sponsor
Aktis Oncology, Inc
Phase
Phase 1
Started
2025-08-22
Last updated
2026-09-17

Condition(s) studied

Urothelial Carcinoma BladderTriple Negative Breast Cancer (TNBC)Hormone Receptor Positive Breast AdenocarcinomaNon Small Cell Lung CancerCervical AdenocarcinomaColorectal AdenocarcinomaHead and Neck Cancer

Investigational drug(s) / intervention(s)

[225Ac]Ac-AKY-1189 (therapeutic)[64Cu]Cu-AKY-1189 (imaging)

[225Ac]Ac-AKY-1189 (therapeutic): \[225Ac\]Ac-AKY-1189 Injection

[64Cu]Cu-AKY-1189 (imaging): \[64Cu\]Cu-AKY-1189 Injection

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Histologic or cytologic confirmation of locally advance or metastatic disease * Radiologic confirmation on CT of at least one measurable tumor lesion per RECIST v1.1 * ECOG Performance Status of 0 or 1 * Adequate end-organ function * Ability to give informed consent and comply with study requirements * Patients with CNS metastases are eligible if they have received therapy and are neurologically stable, asymptomatic and not receiving corticosteroids * Documented disease progression on prior line of therapy for metastatic disease Exclusion Criteria: * Prior treatment with a therapeutic radiopharmaceutical * Prior treatment with a Nectin-4 targeted therapy, except enfortumab vedotin * Received an investigational agent within the previous 28days * Prior treatment with a cytotoxic chemotherapy, targeted therapy, biologic agent, immunotherapy or external-beam radiotherapy in the 3 weeks prior to study treatment * Concurrent serious medical condition that would impair study participation or impact the assessment of treatment related toxicity

Primary outcome measure(s)

  • Part 1: Number of Patients with Dose-Limiting Toxicities — From enrollment to the end of Cycle 1 (each cycle is 28 days)
    • Dose-limiting toxicities (DLTs) is defined as any predefined AE occurring during the DLT observation period, except those that are clearly and incontrovertibly due to extraneous circumstances. The number of patients who experience a DLT in Part 1, will be reported by dose level.
  • Part 1: Occurence of Adverse Events by Severity — Up to the End of Treatment (30 days after the last dose)
    • 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.
  • Part 2: Objective Response Rate (ORR) — Up to 30 days following last administration
    • Objective response rate is defined as the percentage of patients who achieved a best overall response of confirmed Complete Response (CR) or Partial Response (PR), as determined by the investigator based on RECIST 1.1, by tumor types.

Trial sites (14)

FacilityCityRegionStatus
City of Hope Duarte California Recruiting
Hoag Memorial Hospital Presbyterian Irvine California Recruiting
Biogenix Molecular, LLC Miami Florida Recruiting
Advent Health Medical Group Radiation Oncology at Central Florida Orlando Florida Recruiting
Moffitt Cancer Center Tampa Florida Recruiting
University of Iowa Iowa City Iowa Recruiting
University of Kansas Westwood Kansas Recruiting
United Theranostics Glen Burnie Maryland Recruiting
BAMF Health Grand Rapids Michigan Recruiting
Icahn School of Medicine at Mt. Sinai New York New York Recruiting
Memorial Sloan Kettering Cancer Center New York New York Recruiting
UPMC Pittsburgh Pennsylvania Recruiting
MD Anderson Cancer Center Houston Texas Recruiting
Huntsman Cancer Institute Salt Lake City Utah Recruiting

More Aktis Oncology, Inc. trials in the USA

A Study of [225Ac]Ac-AKY-2519 in Patients With B7-H3 Expressing Solid Tumors Recruiting
A Study of [225Ac]Ac-AKY-2519 in Patients With Metastatic Castration-Resistant Prostate Cancer Recruiting

Other trials for the same condition

A Study Evaluating AB248 Alone or in Combination With Pembrolizumab in Adult Patients With Solid Tumors Active, not recruiting
Study of TUB-040 in Participants With Unresectable or Metastatic Nonsquamous Non-small Cell Lung Cancer Starting soon
Phase 1 Study of a Self-amplifying RNA Vaccine (ITI-5000) in Stage 2-3 Triple Negative Breast Cancer Recruiting
PQ203 in Advanced Malignant Tumors Including Triple Negative Breast Cancer Recruiting
SI-B036-ST-101 in Advanced/Metastatic Solid Tumors Starting soon
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07020117 on ClinicalTrials.gov ↗ ← All trials in the USA