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 significant side
effects from it when given alone and in combination with pembrolizumab. The study will be
conducted in two phases including a dose escalation phase and a dose expansion phase. In the
dose escalation phase, escalating doses of TAK-676 are being tested alone and in combination
with pembrolizumab to treat participants who have advanced or metastatic solid tumors. In the
dose expansion phase, TAK-676 will be studied with pembrolizumab with or without chemotherapy
in participants with untreated metastatic or recurrent, unresectable squamous cell carcinoma
of head and neck (SCCHN) and in combination with pembrolizumab in third-line or later
recurrent locally advanced or metastatic microsatellite instability-high /mismatch repair
deficient (MSI-H/dMMR) and third-line recurrent locally advanced or metastatic microsatellite
stable/mismatch repair proficient (MSS/pMMR) colorectal cancer (CRC).
The drug being tested in this study is called TAK-676. TAK-676 is being tested to treat
people who have advanced or metastatic solid tumors.
The study will enroll approximately 288 participants. Part 1 consists of an initial Safety
Lead-in to Dose Escalation Phase; Part 2 and Part 3 compose the Expansion Phase in 2 specific
indications namely, previously untreated metastatic or recurrent, unresectable SCCHN (Part 2)
and third-line or later recurrent locally advanced or metastatic MSI-H/dMMR and third-line
recurrent locally advanced or metastatic MSS/pMMR CRC (Part 3). Participants will be assigned
to the following treatment groups in the respective Phases of the study:
Part 1 (Dose Escalation Phase): Safety Lead-in + TAK-676 SA [Part 1A] TAK-676 0.1
milligram (mg) in the Safety Lead-in followed by TAK-676 as escalating doses (0.2 mg and
above) in Part 1A.
Part 1B (Combination Dose Escalation Phase): TAK-676 as escalating doses (0.2 mg and
above) + Pembrolizumab
Once a safe and effective dose is recommended from Part 1, participants of select advanced or
metastatic solid tumors will receive TAK-676 in below defined cohorts in the expansion phase:
Part 2A (SCCHN Dose Expansion Phase): TAK-676 + Pembrolizumab
Part 3A (Expansion Phase in CRC): TAK-676 + Pembrolizumab in MSI-H/dMMR CRC
Part 3B (Expansion Phase in CRC): TAK-676 + Pembrolizumab in MSS/pMMR CRC
This multi-center trial will be conducted worldwide. The overall time to participate in this
study is 54 months. Participants will make multiple visits to the clinic, including 30 days
after last dose of study drug for a follow-up assessment. Patients in Parts 2 and 3 will be
followed for survival for up to 12 months after the last dose of study drug.
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.