Actively Recruiting
A Study of TAK-188 in Adults With Advanced or Spreading Solid Tumors
Led by Takeda · Updated on 2026-04-24
223
Participants Needed
15
Research Sites
213 weeks
Total Duration
On this page
AI-Summary
What this Trial Is 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.
CONDITIONS
Official Title
A Study of TAK-188 in Adults With Advanced or Spreading Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants 18 years or older at the time of signing consent
- ECOG performance status of 0 to 1
- Ability to provide biopsy samples taken within 28 days prior to treatment or archival biopsies under specific conditions
- Adequate bone marrow, kidney, and liver function based on lab tests
- Left Ventricular Ejection Fraction (LVEF) above 50% before treatment
- Recovery from prior treatment side effects to Grade 1 or baseline (except specific exceptions)
- Female participants must be postmenopausal, surgically sterile, or agree to effective contraception or true abstinence
- Male participants must agree to effective barrier contraception or true abstinence
- Voluntary written consent given before any trial procedures
- Participants with controlled HIV with CD4 count above 350 and undetectable viral load for at least one year
- Participants with certain advanced cancers who have progressed after all standard treatments
- Presence of measurable disease on imaging according to RECIST 1.1 criteria
- Specific criteria for non-small cell lung cancer (NSCLC), squamous cell carcinoma of head and neck (SCCHN), and gastroesophageal adenocarcinoma (GEA) for expansion cohorts
You will not qualify if you...
- History of serious cardiac illnesses within 6 months before treatment
- Prolonged QT interval or congenital long QT syndrome
- Oxygen saturation below 90% on room air at screening
- Treatment with other CCR8 targeting agents within past 6 months
- Active lung conditions including pneumonitis, interstitial lung disease, severe COPD, pulmonary embolism, or uncontrolled pleural effusion
- Known brain metastases or leptomeningeal disease unless stable and without neurologic dysfunction
- Fever of malignant origin Grade 2 or higher
- Systemic infection requiring IV antibiotics within 14 days before treatment or severe infections during treatment
- Uncontrolled autoimmune disease (with some exceptions)
- Diagnosed congenital or acquired immunodeficiency (except controlled HIV)
- Chronic active hepatitis without viral suppression
- Significant ascites requiring active treatment
- Medical or psychiatric conditions limiting trial participation or consent ability
- Recent major surgery or unresolved major bleeding event
- Concurrent malignancy requiring active treatment (except chronic hormonal therapy)
- Recent treatment with certain monoclonal antibodies or investigational anticancer therapies
- Concurrent chemotherapy, immunotherapy, biologic, or hormonal therapy except specific exceptions
- Recent radiation therapy or radionuclide treatment within specified timeframes
- Use of systemic corticosteroids or immunosuppressive therapy within 7 days before treatment except specific exceptions
- Receipt of live attenuated vaccines within 28 days before treatment
- Recipients of stem cell or organ transplantation
- Lactating females or positive pregnancy tests during screening or on treatment start
- Trial site employees or those in dependent relationships with site employees
- Vulnerable persons as defined by local regulations requiring exclusion
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 15 locations
1
UCLA Health-Santa Monica Cancer Care (Cancer Care - Santa Monica)
Santa Monica, California, United States, 90404
Not Yet Recruiting
2
Yale School of Medicine - Smilow Cancer Hospital - Center for Thoracic Cancers
New Haven, Connecticut, United States, 06511
Actively Recruiting
3
Florida Cancer Specialists - Lake Nona
Orlando, Florida, United States, 32827
Actively Recruiting
4
Johns Hopkins
Baltimore, Maryland, United States, 21231
Not Yet Recruiting
5
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
Actively Recruiting
6
START Midwest
Grand Rapids, Michigan, United States, 49546
Actively Recruiting
7
Washington University
St Louis, Missouri, United States, 63108
Actively Recruiting
8
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States, 44106-1716
Actively Recruiting
9
Providence Cancer Institute, Franz Clinic
Portland, Oregon, United States, 97213-2933
Not Yet Recruiting
10
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111-2497
Actively Recruiting
11
SCRI Oncology
Nashville, Tennessee, United States, 37203
Actively Recruiting
12
MD Anderson Cancer Center
Houston, Texas, United States, 77030-4000
Not Yet Recruiting
13
NEXT Dallas
Irving, Texas, United States, 75039
Actively Recruiting
14
START San Antonio
San Antonio, Texas, United States, 78229
Actively Recruiting
15
NEXT Virginia
Fairfax, Virginia, United States, 22031
Actively Recruiting
Research Team
T
Takeda Contact
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
6
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