FDA grants fast track designation to AVZO-103 for urothelial carcinoma

The FDA has granted fast track designation to AVZO-103, a Nectin-4/TROP2 biospecific antibody-drug conjugate for adult patients with urothelial carcinoma who have previously received enfortumab vedotin-ejfv (Padcev), Avenzo Therapeutics announced in a news release.¹

Fast track designation is awarded to novel agents that are intended to treat or prevent serious or life-threatening conditions and have the potential to address an unmet medical need. With this designation, the development process for AVZO-103 can benefit from more frequent engagement with the FDA as well as eligibility for accelerated approval and priority review.

“Receiving Fast Track designation for AVZO-103 highlights the significant need for treatment options for patients with urothelial cancer who have progressed on enfortumab vedotin,” said Mohammad Hirmand, MD, Co-founder and Chief Medical Officer of Avenzo Therapeutics, in the news release.¹ “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.”

AVZO-103 is currently under investigation in a phase 1/2 first-in-human, open-label clinical trial (NCT07193511) in patients with locally advanced or metastatic urothelial carcinoma and other solid tumors.² The study is designed to evaluate the safety, tolerability, and preliminary efficacy of AVZO-103 when administered intravenously as a monotherapy or in combination therapy.

In total, the study plans to enroll 355 patients across clinical trial sites in the US. The study will begin with the phase 1 dose escalation phase, which will explore the safety and tolerability of AVZO-103 and seek to determine the maximum tolerated dose (MTD) and the recommended phase 2 dose. The study will then proceed to phase 2, which will evaluate the preliminary anti-tumor activity of AVZO-103 as a single agent or in combination therapy.

To be eligible for enrollment, patients need to have an ECOG performance status of ≤ 1 and a life expectancy of more than 3 months. Patients are not eligible for enrollment if they have active central nervous system metastases, prior Stevens-Johnson syndrome/toxic epidermal necrolysis, or a history of drug-induced interstitial lung disease, any serious cardiovascular condition, or allogenic stem cell or solid organ transplant.

The primary outcome measures for phase 1 of the study are the occurrence of dose-limiting toxicities, the determination of a MTD, and the number of patients with treatment-emergent adverse events. The primary outcome measure for phase 2 is objective response rate. Secondary end points in both phases of study include duration of response, disease control rate, progression-free survival, and overall survival.

Study completion is expected in 2030.

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. News release. Avenzo Therapeutics, Inc. November 24, 2025. Accessed November 24, 2025. https://avenzotx.com/press-releases/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-previo/

2. 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). ClinicalTrials.gov. Last updated November 12, 2025. Accessed November 24, 2025. https://clinicaltrials.gov/study/NCT07193511