A Study of TAK-676 and TAK-676 in Combination With Pembrolizumab in Adults With Advanced Solid Tumors
Status:
Recruiting
Trial end date:
2023-03-11
Target enrollment:
Participant gender:
Summary
It is hoped that TAK-676, when given on its own or given with pembrolizumab will eventually
help people with advanced or metastatic solid tumors.
The main aim of this study is to check if people with advanced solid tumors have side effects
from TAK-676, and to check how much TAK-676 they can receive without getting side effects
from it.
At the first visit, the study doctor will check who can take part. Participants will receive
TAK-676 slowly through a vein (infusion). This will happen on 3 different days during a
21-day cycle. Different small groups of participants will receive lower to higher doses of
TAK-676. Some participants will receive TAK-676 by itself and others will receive TAK-676
with pembrolizumab.
Participants will stay in the clinic or hospital for 24 hours after each infusion of TAK-676
in the first cycle of treatment. Sometimes the study doctor will carry out a physical exam
before the participant goes home. Participants will be given an emergency card to carry with
them at all times. The card has information about the study including contact details and a
24-hour emergency number.
Some participants, who receive TAK-676 and are willing and able, will be asked to wear a
removable patch on their chest to record vital signs for 21 days in the first cycle of
treatment. Also, in the first cycle of treatment, participants will record their oral
temperatures twice a day for 21 days in a diary when they go home after each infusion.
Throughout treatment, the clinic will regularly telephone the participants to check on their
health.