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

Aktis Oncology, Inc.

Status and phase

Enrolling

Phase 1

Conditions

Colorectal Adenocarcinoma

Cervical Adenocarcinoma

Triple Negative Breast Cancer (TNBC)

Urothelial Carcinoma Bladder

Non Small Cell Lung Cancer

Head and Neck Cancer

Hormone Receptor Positive Breast Adenocarcinoma

Treatments

Drug: [64Cu]Cu-AKY-1189 (imaging)

Drug: [225Ac]Ac-AKY-1189 (therapeutic)

Study type

Interventional

Funder types

Industry

Identifiers

NCT07020117

AKY-1189-01

Details and patient eligibility

About

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.

Full description

This study consists of two parts (Part 1 and 2).

Part 1 is the dose escalation portion of the study, which will investigate ascending doses of [225Ac]Ac-AKY-1189 (up to 6 cycles) in patients with locally advanced or metastatic solid tumors. The aim of Part 1 is to determine the maximum tolerated dose (MTD) or maximum administered dose (MAD) and the recommended Phase 2 dose.

Part 2 will be the dose expansion portion of the study and will enroll locally advanced or metastatic solid tumor patients who are identified as Nectin-4 positive by [64Cu] Cu-AKY-1189. Part 2 aims to further assess the efficacy of [225Ac]Ac-AKY-1189 at the RP2D in 3 different cohorts of patients.

Enrollment

150 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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