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NCT07020117 | RECRUITING | Urothelial Carcinoma Bladder

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

Aktis Oncology, Inc.

Brief 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.

Condition or disease

Urothelial Carcinoma Bladder

Triple Negative Breast Cancer (TNBC)

Hormone Receptor Positive Breast Adenocarcinoma

Non Small Cell Lung Cancer

Cervical Adenocarcinoma

Colorectal Adenocarcinoma

Head and Neck Cancer

Intervention/treatment

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

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

Phase

PHASE1

Detailed 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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 150 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : NECTINIUM-2: A Phase 1b, 2 Part, Multicenter, Single Arm, Open Label Study to Evaluate the Safety and Efficacy of a Nectin-4 Radiopharmaceutical ([225Ac]Ac-AKY-1189) in Patients With Previously Treated Locally Advanced or Metastatic Solid Tumors
Actual Study Start Date : 2025-08-22
Estimated Primary Completion Date : 2027-12
Estimated Study Completion Date : 2032-06

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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
A Study of [225Ac]Ac-AKY-1189 in Patients With Solid Tumors

Location Details

NCT07020117

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, California

City of Hope

Duarte, California, United States, 91010

RECRUITING

United States, California

Hoag Memorial Hospital Presbyterian

Irvine, California, United States, 92618

RECRUITING

United States, Florida

Biogenix Molecular, LLC

Miami, florida, United States, 33165

RECRUITING

United States, Iowa

University of Iowa

Iowa City, Iowa, United States, 52242

RECRUITING

United States, road cancer

BAMF Health

Grand Rapids, road cancer, United States, 49503

RECRUITING

United States, New York

Icahn School of Medicine at Mt. Sinai

New York, New York, United States, 10029

RECRUITING

United States, Texas

MD Anderson Cancer Center

Houston, Texas, United States, 77030