Actively Recruiting
An Open-label Trial to Evaluate Safety, Tolerability, and Effectiveness of TAK-188 in Adults With Advanced or Metastatic Solid Tumors
Led by Takeda · Updated on 2026-06-05
223
Participants Needed
15
Research Sites
51 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying TAK-188, a new medicine that targets a protein called CCR8 found on certain cells inside tumors that can weaken the body's ability to fight cancer. This trial aims to learn if TAK-188 can help the immune system better attack advanced or spreading solid tumors in adults whose cancers have not improved with regular treatments. The study focuses on checking the safety, tolerance, and effectiveness of TAK-188 in adults with these advanced cancers. Participants will receive TAK-188 through intravenous infusions at various doses and schedules depending on their cancer type, such as squamous cell carcinoma of the head and neck, non-small cell lung cancer, or gastroesophageal adenocarcinoma. Treatment cycles typically last 21 or 28 days, with infusions given weekly or every two weeks for up to 12 months. The trial includes dose escalation stages to find the best dose and expansion phases to further evaluate treatment effects. During the study, participants will undergo regular health monitoring including blood tests, heart function checks, imaging scans, and biopsies to assess tumor response and safety. Researchers will track side effects, how well participants tolerate TAK-188, and tumor changes using standard criteria over up to 24 months. Participants' health will also be followed for up to one year after treatment ends to observe long-term effects. The total participation time can last over a year, involving multiple visits and assessments.
CONDITIONS
Brief 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 aged 18 years or older at time of consent
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
- Ability to provide biopsy samples within required timeframes unless unsafe
- Adequate bone marrow, kidney, and liver function based on lab tests
- Recovery from prior treatment toxicities to Grade 1 or baseline
- Female participants must be postmenopausal, surgically sterile, or use effective contraception
- Male participants must use effective barrier contraception or true abstinence
- Voluntary written consent must be given
- Controlled HIV infection with CD4 >350 cells/mm³ and undetectable viral load for at least a year allowed
- Diagnosis of locally advanced or metastatic solid tumors including specific types as listed
- Radiographically measurable disease per RECIST criteria
- Specific criteria for NSCLC, SCCHN, and gastroesophageal adenocarcinoma expansion cohorts including prior treatment history and PD-L1 status
You will not qualify if you...
- History of serious cardiac illnesses within 6 months before first dose
- Prolonged QT interval or use of QT-prolonging medications not meeting criteria
- Oxygen saturation below 90% on room air
- Prior treatment with CCR8 targeting agents within past 6 months
- Active lung diseases including pneumonitis and interstitial lung disease
- Known brain metastases unless stable and without neurologic dysfunction
- Fever of malignant origin Grade 2 or higher
- Serious infections or systemic infections requiring IV antibiotics within 14 days
- Uncontrolled autoimmune diseases except specified exceptions
- Diagnosed immunodeficiency or uncontrolled HIV
- Chronic active hepatitis with detectable virus
- Significant ascites requiring active treatment
- Medical or psychiatric conditions limiting trial compliance or consent
- Recent major surgery or unresolved major bleeding
- Concurrent malignancy needing active treatment except hormonal therapy
- Recent treatment with certain anticancer or investigational therapies within defined washout periods
- Concurrent chemotherapy, immunotherapy, or biologic therapy except specified exceptions
- Recent radiation therapy or radionuclide treatment within specified timeframes
- Use of systemic corticosteroids or immunosuppressive therapy near study start except specified exceptions
- Receipt of live attenuated vaccines within 28 days of first dose
- Prior stem cell or organ transplantation
- Lactating females or positive pregnancy test at screening or first dose
- Trial site employees or related persons involved in the study
- Vulnerable persons as defined by local regulations requiring exclusion if applicable
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 12 months
Participants receive TAK-188 via intravenous infusion on Days 1, 8, and 15 in each 21-day cycle or once every 2 weeks in 28-day cycles, depending on their cohort and dose. Treatment continues for up to 12 months.
Weekly or biweekly visits depending on cohort assignment
Duration - Up to 24 months
Participants are monitored for safety and effectiveness after treatment ends, including assessment of adverse events and response for up to 24 months.
Periodic visits for safety and response assessments
Trial Site Locations
Total: 15 locations
1
UCLA Health-Santa Monica Cancer Care (Cancer Care - Santa Monica)
Santa Monica, California, United States, 90404
Actively 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
Actively 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
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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