A Phase I Study of ALX148 Immunotherapy plus Enfortumab Vedotin and/or Other Anticancer Therapies in People with Advanced Urothelial Cancer


Full Title

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 (ASPEN-07)


Researchers are doing this study to find the highest dose of the investigational immunotherapy drug ALX148 that can be given with enfortumab vedotin in people with inoperable or metastatic urothelial cancer, such as bladder cancer, that has progressed after standard immunotherapy and chemotherapy treatment. ALX148 works with the immune system to attack cancer cells. It blocks a protein called CD47 that can prevent the immune system from recognizing and destroying cancer cells. By attaching to CD47, ALX148 activates the immune system to find and kill cancer cells. The medications used in this study are given intravenously (by vein).

Who Can Join

To be eligible for this study, patients must meet several requirements, including:

  • Participants must have inoperable or metastatic urothelial cancer that continues to grow despite prior treatment that included immunotherapy and platinum-containing chemotherapy.
  • At least 4 weeks must pass since the completion of chemotherapy, immunotherapy, and other anticancer medications and 2 weeks since any radiation therapy or major surgery and receipt of the study therapy.
  • Patients must be physically well enough that they are able to be mobile, take care of themselves, and engage in all but physically strenuous activities. For example, they must be well enough that they could carry out office work or light housework.
  • This study is for people age 18 and older.


For more information about this study and to ask about eligibility, please contact the office of Dr. Samuel Funt at 646-888-4770.




Phase I (phase 1)

Disease Status

Relapsed or Refractory



ClinicalTrials.gov ID