C5731002 - 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

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2022-500030-28-01

Acronym

RC48G001

Enrollment

Registered

2024-04-24

Start date

2024-06-10

Completion date

Unknown

Last updated

2025-09-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Urothelial carcinoma

Brief summary

cORR (confirmed CR and confirmed PR) per RECIST v1.1 as assessed by BICR, cORR per RECIST v1.1 as assessed by BICR

Detailed description

cORR per RECIST v1.1, as assessed by the investigator, Confirmed DOR per RECIST v1.1, as assessed by BICR ● Confirmed DOR per RECIST v1.1, as assessed by the investigator, PFS per RECIST v1.1, as assessed by BICR ● PFS per RECIST v1.1, as assessed by the investigator, DCR (confirmed CR, confirmed PR, and stable disease) per RECIST v1.1, as assessed by BICR ● DCR per RECIST v1.1, as assessed by the investigator, OS, Type, incidence, relatedness, severity and seriousness of AEs ● Treatment discontinuations, dose reductions, or dose delays due to AEs ● Type, incidence and severity of laboratory abnormalities ● ECG abnormalities, including changes in QTc ● Effect on LVEF, PK parameters of disitamab vedotin, free MMAE, and TAb, Incidence of ADA and NABs against disitamab vedotin

Interventions

DRUGDisitamab Vedotin

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
cORR (confirmed CR and confirmed PR) per RECIST v1.1 as assessed by BICR, cORR per RECIST v1.1 as assessed by BICR	—

Secondary

Measure	Time frame
cORR per RECIST v1.1, as assessed by the investigator, Confirmed DOR per RECIST v1.1, as assessed by BICR ● Confirmed DOR per RECIST v1.1, as assessed by the investigator, PFS per RECIST v1.1, as assessed by BICR ● PFS per RECIST v1.1, as assessed by the investigator, DCR (confirmed CR, confirmed PR, and stable disease) per RECIST v1.1, as assessed by BICR ● DCR per RECIST v1.1, as assessed by the investigator, OS, Type, incidence, relatedness, severity and seriousness of AEs ● Treatment discontinuations, dose reductions, or dose delays due to AEs ● Type, incidence and severity of laboratory abnormalities ● ECG abnormalities, including changes in QTc ● Effect on LVEF, PK parameters of disitamab vedotin, free MMAE, and TAb, Incidence of ADA and NABs against disitamab vedotin	—

Measure

Time frame

—

Countries

Belgium, France, Italy, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026