Clinical Trial 21948

• Overview

  Study Title:

  A phase 1, open-label, multicentre, safety, pharmacokinetic, pharmacodynamic study of ALX148 in combination with enfortumab vedotin and/or other anticancer therapies in subjects with urothelial carcinoma (ASPEN-07)

  Summary:

  This is a Phase 1, open-label, multicenter, safety, pharmacokinetic, pharmacodynamic study of ALX148 in combination with enfortumab vedotin and/or other anticancer therapies in subjects with urothelial carcinoma.

  Objective:

  Primary Objectives: To evaluate the safety and tolerability of ALX148 in combination with enfortumab vedotin in subjects with previously treated locally advanced or metastatic urothelial carcinoma To determine the maximum tolerated dose (MTD) and the recommended Phase 2 dose (RP2D) of ALX148 in combination with enfortumab vedotin Secondary Objectives: To evaluate the overall safety profile of ALX148 in combination with enfortumab vedotin To characterize the single and multiple-dose pharmacokinetics (PK) of ALX148 in combination with enfortumab vedotin To evaluate the immunogenicity of ALX148 To evaluate evidence of the antitumor activity of ALX148 in combination with enfortumab vedotin

• Treatments

  Therapies:

  Therapy (NOS)

  Medications:

  ALX148 (); Enfortumab Vedotin (Padcev)

• Inclusion Criteria

  Inclusion Criteria:
  • Histologically confirmed, unresectable locally advanced or metastatic urothelial carcinoma.
  • Must have received prior treatment with an immune checkpoint inhibitor (CPI).
  • Patients must have received prior treatment with platinum-containing chemotherapy.
  • Patients must have had progression or recurrence of urothelial cancer.
  • Patients must have measurable disease according to RECIST (Version 1.1).
  • Adequate bone marrow function.
  • Adequate renal function.
  • Adequate liver function.
  • Adequate Eastern Cooperative Oncology Group (ECOG) performance status.
  • Other criteria may apply

• Exclusion Criteria

  Exclusion Criteria:
  • Preexisting sensory or motor neuropathy Grade ≥2.
  • Presence of symptomatic or uncontrolled central nervous system (CNS) metastases.
  • Prior treatment with enfortumab vedotin or other monomethylauristatin (MMAE)-based antibody-drug conjugate (ADCs)
  • Prior treatment with any anti-CD47 or anti-signal regulatory protein-α (SIRPα) agent.
  • > Known active keratitis or corneal ulcerations. Patients with superficial punctate keratitis are allowed if the disorder is being adequately treated.
  • History of uncontrolled diabetes mellitus within 3 months of the first dose of study drug.
  • Other criteria may apply

If you are interested in learning more about clinical trials, our clinical trial navigators can discuss your options and recommend opportunities that may be suitable for you. Call 813-745-6100 or 1-800-679-0775 (toll-free) or submit a clinical trials inquiry form.