FDA Grants Fast Track Designation to AVZO-103 for Urothelial Cancer

The FDA has granted fast track designation (FTD) to AVZO-103, a potential best-in-class Nectin4/TROP2 bispecific antibody-drug conjugate (ADC) for the treatment of patients with locally advanced or metastatic urothelial cancer who have previously received enfortumab vedotin (Padcev).¹

There are no approved ADCs for patients previously treated with enfortumab vedotin.

AVZO-103 is currently being studied in a phase 1/2 first-in-human, open-label clinical study (NCT07193511).² The study is designed to assess the safety, tolerability, and preliminary clinical activity of AVZO-103 as a single agent and in combination therapy in patients with advanced solid tumors.

“Receiving [FTD] 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 a 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.”

FTD is granted to agents that treat serious conditions and fill an unmet medical need. With this designation, AVZO-103 has the eligibility for accelerated approval and priority review if the relevant criteria are met.

About the AVZO-103-1001 Trial

Phase 1 of the study is a dose-escalation phase which will assess the safety and tolerability of AVZO-103 and determine the maximum tolerated dose and preliminary recommended phase 2 dose of AVZO-103 as monotherapy. Phase 2 is a dose-expansion phase that will aim to assess the antitumor activity of the agent as a monotherapy and in combination therapy.²

The estimated completion date of the study is September 2030, and it has an estimated enrollment of 355 patients. The study has 4 locations in the US.

Patient inclusion criteria include but are not limited to having an ECOG score of ≤1 and a life expectancy of >3 months, having histologically or cytologically confirmed locally advanced or metastatic malignancies for tumor types in urothelial cancer and other solid tumors, and agreeing to provide molecular test report results to confirm eligibility and archival tumor samples and/or fresh biopsy as applicable.

Patient exclusion criteria include but are not limited to having active central nervous system metastases, prior Stevens-Johnson syndrome/toxic epidermal necrolysis, history of drug-induced interstitial lung disease, history of any serious cardiovascular condition, infection requiring intravenous antibiotics, antivirals, or antifungals within 2 weeks prior to first dose, and history of allogenic stem cell or solid organ transplant.

History of Enfortumab Vedotin

Enfortumab vedotin is currently approved as a single agent for the treatment of patients with locally advanced or metastatic urothelial cancer who have previously received a PD-1/PD-L1 inhibitor and platinum-containing chemotherapy, or are ineligible for cisplatin-containing chemotherapy and have previously received 1 or more prior lines of therapy; in combination with pembrolizumab (Keytruda) for the treatment of patients with locally advanced or metastatic urothelial cancer (UC) who are not eligible to receive cisplatin-containing chemotherapy; and in combination with pembrolizumab for the treatment of patients with muscle-invasive bladder cancer.

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. Published and accessed November 24, 2025. https://tinyurl.com/yfwhr77d

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. Updated November 12, 2025. Accessed November 25, 2025. https://clinicaltrials.gov/study/NCT07193511