At a glance
ClinicalIndex Comparison Record- ✓Histopathologically-confirmed locally-advanced, unresectable or metastatic urothelial cancer
- ✓Urothelial cancer originating from renal pelvis, ureters, bladder, or urethra
- ✓At least one measurable lesion by RECIST v1.1
- ✓HER2-expression IHC 1+, 2+, or 3+ by central laboratory
- ✕Known hypersensitivity to disitamab vedotin or components
- ✕Prior antitumor treatment within 2 weeks of study start
- ✕Unrecovered toxicity from prior treatment (Grade >1, except Grade 2 alopecia)
- ✕Prior MMAE-based ADCs (e.g., enfortumab vedotin) or HER2-directed therapy (Cohorts A,B,C,E)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 2 Multi-Cohort, Open-Label, Multi-Center Clinical Study Evaluating the Efficacy and Safety of Disitamab Vedotin (RC48-ADC) Alone or in Combination With Pembrolizumab in Subjects With Locally-Advanced Unresectable or Metastatic Urothelial Carcinoma That Expresses HER2
In Brief
A Phase 2 clinical trial evaluating disitamab vedotin and pembrolizumab for Urothelial Carcinoma. Currently recruiting, targeting 372 participants across 223 sites in 12 countries.
Signals
Detailed Summary
This study is being done to see if a drug called disitamab vedotin, alone or with pembrolizumab, works to treat HER2 expressing urothelial cancer. It will also test how safe the drug is for participants. Participants will have cancer that has spread in the body near where it started (locally advanced) and cannot be removed (unresectable) or has spread through the body (metastatic). It will also study what side effects happen when participants get the drug. A side effect is anything a drug does to your body besides treating the disease.
Study Details
Timeline
Interventions
Given into the vein (IV; intravenous) every 2 weeks.
Given by IV on Day 1 of each 6-week cycle.