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Recruiting NCT07020117

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

Phase I Interventional Urothelial Carcinoma Bladder Triple Negative Breast Cancer (TNBC) Hormone Receptor Positive Breast Adenocarcinoma Non Small Cell Lung Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: [225Ac]Ac-AKY-1189 (therapeutic), [64Cu]Cu-AKY-1189 (imaging).
Who it may be relevant to
Registry conditions: Urothelial Carcinoma Bladder, Triple Negative Breast Cancer (TNBC), Hormone Receptor Positive Breast Adenocarcinoma, Non Small Cell Lung Cancer. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

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.

Interventions

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

Primary outcome measures

  • Part 1: Number of Patients with Dose-Limiting Toxicities [Time frame: From enrollment to the end of Cycle 1 (each cycle is 28 days)]
  • Part 1: Occurence of Adverse Events by Severity [Time frame: Up to the End of Treatment (30 days after the last dose)]
  • Part 2: Objective Response Rate (ORR) [Time frame: Up to 30 days following last administration]
Secondary outcome measures (4)
  • Part 1: Objective Response Rate (ORR) [Time frame: Up to 30 days following last adminstration]
  • Part 2: Occurence of Adverse Events by Severity [Time frame: Up to End of Treatment (30 days after the last dose)]
  • Part 1 and 2: Duration of Response (DOR) [Time frame: Up to 5 years after first administration]
  • Part 1 and 2: Progression-Free Survival (PFS) [Time frame: Up to 5 years after first administration]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 12 centers
  • City of Hope — Duarte
  • Hoag Memorial Hospital Presbyterian — Irvine
  • Biogenix Molecular, LLC — Miami
  • Advent Health Medical Group Radiation Oncology at Central Florida — Orlando
  • University of Iowa — Iowa City
  • University of Kansas — Westwood
  • United Theranostics — Glen Burnie
  • BAMF Health — Grand Rapids
  • … and 4 more centers

Identifiers

NCT: NCT07020117 · AKY-1189-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗