RightFit
RecruitingPhase 1

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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests [225Ac]Ac-AKY-1189, a drug that carries radiation and targets a protein called Nectin-4, in people with solid tumors that have spread nearby or to other parts of the body. It is the first study of this drug in humans and will check its safety, how well it works, and what dose to use in future studies.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Tests of tissue or cells confirm cancer that has spread nearby or to other parts of the body.
  • A CT scan shows at least one tumor that can be measured using study rules.
  • You can do all usual activities, or have limits only with hard physical activity.
  • Your major organs work well enough for the study.
  • You can give informed consent and follow study requirements.
  • If cancer has spread to your brain or spinal cord, it has been treated, is stable, causes no symptoms, and you are not taking corticosteroid drugs.
  • Records show that your cancer got worse after a prior treatment for cancer that had spread.

Who can't join

  • You have had treatment with a drug that carries radiation.
  • You have had treatment that targets Nectin-4, other than enfortumab vedotin.
  • You received an experimental drug in the past 28 days.
  • You received chemotherapy, targeted therapy, biologic therapy, immunotherapy, or radiation from a machine outside the body within 3 weeks before study treatment.
  • You have another serious medical condition that could keep you from taking part or make treatment side effects hard to assess.

Simplified for readability. The official criteria below are what the study team uses.

Official 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

Study sites (14)

CA

FL

IA

KS

MD

MI

NY

PA

TX

UT