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A Study of TAK-188 in Adults With Advanced or Spreading Solid Tumors

Sponsored by Takeda

About this trial

Last updated 10 days ago

Study ID

TAK-188-1501

Status

Recruiting

Type

Interventional

Phase

Phase 1/Phase 2

Placebo

No

Accepting

18-75 Years
18+ Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Started 5 months ago

What is this trial about?

TAK-188 is a new medicine that targets a protein called CCR8, which is found on the surface of certain cells (Tregs) inside tumors. These cells can weaken the body's ability to fight cancer. TAK-188 may help to remove these Tregs. Removing these Tregs may allow more cancer-fighting cells (CD8+ T cells) to attack the tumor and potentially stop tumors from growing. In this study, researchers want to learn if TAK-188 can help the body's immune system better fight cancer in adults with advanced cancers which have not gotten better with regular treatments. The main aims of this study are to check if TAK-188 is safe in adults with advanced or spreading (metastatic) solid tumors, if participants tolerate the treatment with TAK-188 and to learn if TAK-188 works well in adults with certain advanced cancers after their previous treatments didn't work. Participants may receive TAK-188 for up to 1 year. Their health will be monitored after the treatment has ended for up to another year.

What are the participation requirements?

Yes

Inclusion Criteria

Men and women can take part.
Must be 18 years or older.
Must have the following types of cancers which have progressed after routine treatment or treatment is not tolerated: stomach-related (esophageal, gastroesophageal, and gastric), cancer of the pancreas, certain non-small cell lung cancers, squamous cell cancer head and neck cancer, cancer of the colon or rectum (colorectal).
Must be able to perform daily activities well (Eastern Cooperative Oncology Group or ECOG performance status of 0 or 1).
Must have good kidney and liver function and blood counts
No

Exclusion Criteria

Cannot have been diagnosed with any heart conditions within 6 months of study start
Cannot have a current diagnosis of a lung condition (e.g chronic obstructive pulmonary disease or other lung conditions that make it hard to breathe)
Cannot have a history of untreated brain metastases
Cannot recently have had a major surgery where the participant has not yet fully recovered

Additional entry criteria will be discussed with the study doctor.

Locations

Location

Status

Recruiting
Recruiting
Recruiting
Recruiting
Recruiting
Recruiting
Recruiting
Recruiting
Recruiting
Not yet recruiting
Not yet recruiting
Not yet recruiting
Not yet recruiting
Not yet recruiting
Not yet recruiting

For more information, view the full study details:

NCT07205718