P2, N=35, Active, not recruiting, National Cancer Institute (NCI) | Trial completion date: Dec 2025 --> Jan 2027

P2, N=35, Active, not recruiting, National Cancer Institute (NCI) | Trial completion date: Dec 2025 --> Jan 2027

P2, N=20, Active, not recruiting, National Cancer Institute (NCI) | Trial completion date: Dec 2025 --> Dec 2026

In 21 patients who received erdafitinib after testing, the median progression-free survival is 7.5 months, and one patient with a ctDNA-exclusive FGFR alteration remained on erdafitinib for 33 months. Our results support clinical uptake of ctDNA FGFR testing in combination with tissue-based approaches in mUC.

Recovery studies in spiked human serum and urine samples yielded excellent results (95.7-104.8% recovery, RSD ≤ 3.65%), validating the sensor's real-world applicability. Importantly, the sensor offers scalable fabrication, requires no toxic reducing agents, and exhibits strong selectivity and long-term stability, making it a novel and sustainable platform for therapeutic drug monitoring, pharmacokinetics, and point-of-care diagnostics.

This has broadened the treatment landscape of the disease to include novel agents, such as antibody-drug conjugates (e.g., enfortumab vedotin) and targeted therapies, including the pan-fibroblast growth factor receptor (FGFR) inhibitor erdafitinib. Equally important is the standardization and timely implementation of FGFR3 testing in clinical practice to optimize treatment planning. This review addresses key considerations in FGFR3 testing in mUC and discusses how it can be routinely incorporated into clinical practice.

Furthermore, [68Ga]Ga-DOTA-cHW8 validated FGFR1 dynamic modulation during erdafitinib treatment in CDX and PDX models, establishing its efficacy for noninvasive UM treatment response assessment. This study reports a cyclic peptide-based radiotracer, [68Ga]Ga-DOTA-cHW8, for FGFR1 PET imaging in UM. Through rational design and preclinical validation in UM models, we establish its high specificity, favorable pharmacokinetics properties, and capability to monitor FGFR1 dynamics during targeted therapy.

P2, N=11, Terminated, M.D. Anderson Cancer Center | Trial completion date: Jun 2026 --> Feb 2026 | Active, not recruiting --> Terminated | Trial primary completion date: Jun 2026 --> Feb 2026; <75% participation

P2, N=239, Active, not recruiting, Janssen Research & Development, LLC | Trial completion date: Dec 2026 --> Mar 2027

Survey-based opinions can effectively capture treatment selection preferences for mUC and could inform future clinical trial design. Additional data, including the impact of residual toxicity from 1L EVP, are needed to better understand real-world treatment sequencing patterns.

First-line erdafitinib monotherapy and erdafitinib plus cetrelimab demonstrated antitumor activity and a manageable safety profile in cisplatin-ineligible patients with mUC.