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

a study on Transitional Cell Carcinoma Breast Cancer Triple-Negative Breast Cancer Hormone Receptor Positive Breast Cancer Lung Cancer Non-Small Cell Lung Cancer Cervical Cancer Colorectal Cancer Head and Neck Cancer Solid Tumor Head and Neck Tumor

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCSF
Dates
study started
study ends around
Principal Investigator
by Vadim Koshkin (ucsf)
Headshot of Vadim Koshkin
Vadim Koshkin

Description

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.

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

Details

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.

Keywords

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, Triple Negative Breast Neoplasms, Non-Small-Cell Lung Carcinoma, Head and Neck Neoplasms, Therapeutics, X-Rays, [225Ac]Ac-AKY-1189 (therapeutic), [64Cu]Cu-AKY-1189 (imaging), [225Ac]Ac-AKY-1189

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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

You CAN'T join if...

  • 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

  • Hoag Memorial Hospital Presbyterian accepting new patients
    Irvine California 92618 United States
  • City of Hope accepting new patients
    Duarte California 91010 United States

Lead Scientist at University of California Health

  • Vadim Koshkin (ucsf)
    I am a genitourinary medical oncologist and in this capacity I specialize in caring for patients with bladder, prostate, kidney and testicular cancers.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Aktis Oncology, Inc.
ID
NCT07020117
Phase
Phase 1 research study
Study Type
Interventional
Participants
Expecting 150 study participants
Last Updated
Contact us about this trial