A Phase 2 Multi-Cohort, Open-Label, Multi-Center Clinical Study Evaluating the Efficacy and Safety of Disitamab Vedotin (RC48-ADC) Alone and in Combination with Pembrolizumab in Subjects with Locally Advanced Unresectable or Metastatic Urothelial Carcinoma That Expresses HER2

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, PK parameters of pembrolizumab, Incidence of ADA against disitamab vedotin, Incidence of ADA to pembrolizumab

Related papers

No related papers found yet.

Interventions

DRUGDisitamab Vedotin

DRUGKEYTRUDA 25 mg/mL concentrate for solution for infusion

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, PK parameters of pembrolizumab, Incidence of ADA against disitamab vedotin, Incidence of ADA to pembrolizumab	—

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, PK parameters of pembrolizumab, Incidence of ADA against disitamab vedotin, Incidence of ADA to pembrolizumab

—

Countries

Belgium, Hungary, Italy, Spain

Outcome results

None listed