RECRUITING

A Phase 1b Study of [225Ac]Ac-AKY-1189 in Patients With Solid Tumors

Description

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 Part 2 dose.

Conditions

Urothelial Carcinoma BladderTriple Negative Breast Cancer (TNBC)Hormone Receptor Positive Breast AdenocarcinomaNon Small Cell Lung CancerCervical AdenocarcinomaColorectal AdenocarcinomaHead and Neck Cancer
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Related Conditions:

Urothelial Carcinoma BladderTriple Negative Breast Cancer (TNBC)Hormone Receptor Positive Breast AdenocarcinomaNon Small Cell Lung CancerCervical AdenocarcinomaColorectal AdenocarcinomaHead and Neck Cancer

Study Overview

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Study Details

Study 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 Part 2 dose.

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

A Phase 1b Study of [225Ac]Ac-AKY-1189 in Patients With Solid Tumors

Condition
Urothelial Carcinoma Bladder
Intervention / Treatment

-

Contacts and Locations

Grand Rapids

BAMF Health, Grand Rapids, Michigan, United States, 49503

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * Prior treatment with a therapeutic radiopharmaceutial
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Aktis Oncology, Inc.,

Study Record Dates

2032-06