Clinical Trial 24205

• Overview

  Study 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

  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.

  Objective:

  Part 1 Primary Objectives: - Evaluate the safety and tolerability of [225Ac]Ac-AKY-1189 in patients with previously treated locally advanced or metastatic solid tumors. Part 1 Secondary Objectives: - Evaluate the safety and tolerability of [64Cu]Cu-AKY-1189 in patients with previously treated locally advanced or metastatic solid tumors. - Characterize the radioactivity level of [225Ac]Ac-AKY-1189 in serial blood/urine collections from patients following Cycle 1 administration of [225Ac]Ac-AKY-1189. - Characterize the population-based dosimetry of an [225Ac]Ac-AKY-1189 therapeutic using [64Cu]Cu-AKY-1189 as a surrogate. - Determine the objective response rate, duration of objective response, and progression free survival rate by dose level to [225Ac]Ac-AKY-1189, utilizing RECIST v1.1 as determined by the Investigator, in patients with previously treated locally advanced or metastatic solid tumors. Part 2 Primary Objectives: - Determine the objective response rate by tumor type to [225Ac]Ac-AKY-1189, utilizing RECIST v1.1 as determined by the Investigator, in patients with previously treated locally advanced or metastatic solid tumors. Part 2 Secondary Objectives: - Determine the duration of objective response, progression-free and overall survival rates in each tumor type for patients treated with [225Ac]Ac-AKY-1189. - Further characterize the safety and tolerability of [225Ac]Ac-AKY-1189 in patients with previously treated locally advanced or metastatic cancers. - Further characterize the safety and tolerability of [64Cu]Cu-AKY-1189 in patients with previously treated locally advanced or metastatic cancers. - Characterize the population-based dosimetry of [225Ac]Ac-AKY-1189 using [64Cu]Cu-AKY-1189 as a surrogate.

• Treatments

  Therapies:

  Radiopharmaceutical; Selective Nectin-4 binder

  Medications:

  [225Ac]Ac-AKY-1189 (); [64Cu]Cu-AKY-1189 ()

• Inclusion Criteria

  Key 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

  Key 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.

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