A Study to Evaluate Enfortumab Vedotin in Subjects With Locally Advanced or Metastatic Malignant Solid Tumors (EV-202)

Summary

Objectives

This study will consist of 3 periods: screening/baseline, treatment and follow-up.

Screening/baseline period will take place up to 28 days prior to the first dose of study
treatment.

In the treatment period, starting at cycle 1, participants in cohorts 1 to 8 will receive
enfortumab vedotin on days 1, 8, and 15 every 28-day cycle until one of the treatment
discontinuation criteria are met. participants in cohort 9 will receive enfortumab
vedotin on days 1, 8, and pembrolizumab on day 1 of every 21-day cycle until one of the
treatment discontinuation criteria are met. Disease assessment will be performed at
screening/baseline and repeated every 8 weeks (56 days ± 7 days) for cohorts 1 to 8 and
first assessment at week 9 and thereafter every 6 weeks (42 days ± 7 days) for cohort 9
from the first dose of study treatment throughout the study until the participant has
radiologically confirmed disease progression, initiates a new subsequent anticancer
therapy, dies, withdraws consent, is lost to follow-up or the study closes, whichever
occurs first.

Participants who discontinue study treatment for reasons other than
radiologically-confirmed disease progression by RECIST Version 1.1 will enter into a post
treatment follow-up period and continue to receive imaging scans every 8 weeks (56 days ±
7 days) for cohorts 1 to 8 and for cohort 9 first scan will be performed at 9 week and
thereafter every 6 weeks (42 days ± 7 days) until the subject has radiologically
confirmed disease progression (for cohort 9 confirmed progressive disease [iCPD] per
modified RECIST 1.1 for immune-based therapeutics [iRECIST]), initiates a new anticancer
therapy, dies, withdraws consent, is lost to follow-up or the study closes, whichever
occurs first.

After 1 year on study treatment, the frequency of disease assessment will be reduced to
every 12 weeks (84 days ± 7 days) for cohorts 1 to 8.

After 18 months on study treatment, the frequency of disease assessment will be reduced
to every 9 weeks (63 days ± 7 days) for cohort 9.

Participants in cohorts 1to 8 who discontinue study treatment for reasons other than
radiologically-confirmed disease progression by RECIST Version 1.1 will enter into a post
treatment follow-up period and continue to receive imaging scans every 8 weeks (56 days ±
7 days).

Participants in cohort 9 who discontinue study treatment for reasons other than
radiologically confirmed disease progression per iRECIST will enter into a post treatment
follow-up period and have physical exams, ECOG and disease assessments every 6 weeks (± 7
days) up to 18 months after first dose, then every 9 weeks (± 7 days) until the subject
has radiologically confirmed disease progression per iRECIST.

After radiologically-confirmed disease progression or initiation of subsequent anticancer
therapy, whichever occurs first, participants will be contacted every 12 weeks in the
long-term follow-up period for survival status until death, withdrawal of consent, lost
to follow-up or study closure, whichever occurs first.