AVZO-103 Wins FDA Designation for Previously Treated Urothelial Cancer

The U.S. Food and Drug Administration (FDA) has granted fast track designation to AVZO-103, a potential best-in-class Nectin4/TROP2 bispecific antibody-drug conjugate for the treatment of adult patients with locally advanced or metastatic urothelial cancer who have previously received treatment with Padcev (enfortumab vedotin-ejfv), a common therapy for this disease, according to a news release from Avenzo Therapeutics, Inc.

Notably, the release continues, there are currently no approved antibody-drug conjugates for patients who have progressed after Padcev, highlighting a critical unmet medical need.

“Receiving fast track designation for AVZO-103 highlights the significant need for treatment options for patients with urothelial cancer who have progressed on Padcev,” said Dr. Mohammad Hirmand, co-founder and chief medical officer of Avenzo Therapeutics. “We believe AVZO-103 has the potential to become a promising treatment option for patients and we are committed to rapidly advancing its clinical development.”

Understanding the Fast Track Process and Its Benefits for Patients

The FDA states that the fast track program is designed to help advance the development of drugs for serious or life-threatening conditions and to expedite their review, allowing patients faster access to therapies that address unmet medical needs. The fast track designation provides several potential benefits, including more frequent meetings and communications with the FDA regarding the drug’s development, guidance on clinical trial design and discussion of potential biomarker use, the news release emphasized.

Drugs with fast track status may also be eligible for accelerated approval, priority review and rolling review of their biologic license application or new drug application if relevant criteria are met. For patients, this can translate into faster access to promising therapies that could improve outcomes for aggressive cancers like urothelial cancer.

AVZO-103 is a bispecific antibody-drug conjugate, meaning it is designed to target two specific proteins, Nectin4 and TROP2, commonly found on cancer cells, the news release continued. By targeting these proteins, AVZO-103 aims to deliver its anticancer payload more precisely to tumor cells, potentially reducing side effects. Although AVZO-103 is still in early clinical testing, these features make it a promising candidate for patients who have limited treatment options after standard therapies.

First-in-Human Study of AVZO-103 Launches Across Multiple U.S. Sites

AVZO-103 is currently being studied in a phase 1/2 first-in-human, open-label clinical trial, according to the trials ClinicalTrial.gov landing page. This study is designed to evaluate the safety, tolerability, pharmacokinetics (how the drug moves through the body), pharmacodynamics (how the drug affects the body) and antitumor activity of AVZO-103 as both a single agent and in combination with other therapies. Phase 1 focuses on dose escalation to determine the maximum tolerated dose and the recommended phase 2 dose. Phase 2 expands the study to assess antitumor activity in a larger patient population.

The trial is actively recruiting patients across four locations in the United States, including Orlando, Florida; Myrtle Beach, South Carolina; Nashville, Tennessee; and Austin, Texas. Patients with locally advanced or metastatic urothelial cancer or other solid tumors may be eligible to participate. The study uses intravenous (in the vein, or IV) administration of AVZO-103 either alone or in combination with other agents, offering flexibility in exploring the best treatment strategies for patients.

By targeting an unmet medical need and utilizing a bispecific approach, AVZO-103 may be a potential therapy for patients with urothelial cancer who have exhausted standard options. The FDA’s fast track designation is a critical step in potentially bringing this therapy to patients sooner, offering hope to those seeking new treatment avenues.

Patients interested in participating in the clinical trial should consult their healthcare provider to determine eligibility and discuss potential benefits and risks.

References

1. “Avenzo Therapeutics Granted Fast Track Designation For AVZO-103, A Potential Best-In-Class Nectin4/TROP2 Bispecific Antibody-Drug Conjugate, For The Treatment Of Patients With Urothelial Cancer Previously Treated With Enfortumab Vedotin,” by Avenzo Therapeutics, Inc. News release; Nov. 24, 2025.
2. “Fast Track,” by the U.S. FDA. Aug. 13, 2024. https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/fast-track
3. “Study of AVZO-103 as a Single Agent and in Combination Therapy in Patients With Locally Advanced or Metastatic Urothelial Cancer or Other Solid Tumors (AVZO-103-1001),” by Avenzo Therapeutics, Inc. ClinicalTrials.gov; Last Update Nov. 12, 2025. https://clinicaltrials.gov/study/NCT07193511

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