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

NCT07020117

RecruitingPhase 1

Sponsor: Aktis Oncology, Inc.

Conditions: Urothelial Carcinoma Bladder, Triple Negative Breast Cancer (TNBC), Hormone Receptor Positive Breast Adenocarcinoma, Non Small Cell Lung Cancer, Cervical Adenocarcinoma

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

Countries: United States

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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

Locations (13)

Duarte, California, United States
Irvine, California, United States
Miami, Florida, United States
Orlando, Florida, United States
Iowa City, Iowa, United States
Westwood, Kansas, United States
Glen Burnie, Maryland, United States
Grand Rapids, Michigan, United States
New York, New York, United States
New York, New York, United States
Pittsburgh, Pennsylvania, United States
Houston, Texas, United States
Salt Lake City, Utah, United States