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

Recruiting now · Phase 1/Phase 2

Conditions studied: Advanced or Metastatic Solid Tumors

In brief

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.

Key facts

Study ID

NCT07205718

Run by

Takeda

People needed

223

Starts

2025-11-19

Expected to finish

2029-12-21

Last updated by the study team

2026-07-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participants ≥18 years or ≥ the local legal age of majority, as applicable, at the time of signing the ICF.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
• Participants must provide biopsy samples (core needle or other surgical procedure) collected within 28 days prior to C1D1 and also on treatment unless procedure is determined to be unsafe following discussion with sponsor. Participants with an archival biopsy specimen collected within 90 days prior to C1D1 of TAK-188 who have not received any other cancer-specific treatment (with the exception of adjuvant endocrine therapy for a history of breast cancer) at least 14 days prior to the biopsy and throughout the period leading up to C1D1 may use that archival specimen in lieu of a new pretreatment biopsy. Archival biopsy from the same tumor must be provided, if available.
• Adequate bone marrow, renal, and hepatic functions, as determined by the following laboratory parameters:
• Absolute neutrophil count (ANC) ≥1500 per microliter (μL), platelet count ≥75,000/μL, and hemoglobin (Hgb) ≥8.0 g/dL without growth factor support for ANC or transfusion support for platelets within 14 days before the first trial treatment dose. Transfusion of packed red blood cells is allowed, post infusion Hgb must be greater than 8.0 g/dL.
• Total bilirubin ≤1.5 times the institutional upper limit of the normal range (ULN). For participants with Gilbert's disease, ≤3 milligrams per deciliter (mg/dL).
• Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3.0 × ULN or baseline or ≤5.0 × ULN or baseline with liver metastases.
• Albumin ≥3.0 grams per deciliter (g/dL).
• Calculated creatinine clearance CLCR (using the Cockcroft-Gault formula) ≥60 mL/minute.
• Left Ventricular Ejection Fraction (LVEF) >50%, as measured by echocardiogram or multiple-gated acquisition scan (MUGA) within 4 weeks before receiving the first dose of TAK-188.
• Clinically significant toxic effects of previous therapy have recovered to Grade 1 (per NCI CTCAE v5.0) or baseline, except for alopecia, Grade 2 peripheral neuropathy, and/or autoimmune endocrinopathies with stable endocrine replacement therapy.
• Female participants must be:
• Postmenopausal (natural amenorrhea and not due to other medical reasons) for at least 1 year before the screening visit, or
• Surgically sterile, or
• If they are of childbearing potential, agree to practice 2 effective methods of contraception at the same time, from the time of signing the informed consent through 180 days after the last dose of TAK-188, or
• Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the participant.
• Periodic abstinence (for example, calendar ovulation, symptothermal, postovulation methods), withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception.
• Male participants, even if surgically sterilized (that is, status postvasectomy), must:
• Agree to practice effective barrier contraception (that is, a condom) during the entire trial treatment period and through 180 days after the last dose of TAK-188, or
• Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the participant.
• Periodic abstinence (for example, calendar ovulation, symptothermal, postovulation methods), withdrawal, and spermicides only are not acceptable methods of contraception.
• Voluntary written consent must be given before performance of any trial-related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the participant at any time without prejudice to future medical care.
• Participants with controlled Human Immunodeficiency Virus (HIV) are allowed:
• Cluster of differentiation 4 (CD4) cell count greater than 350 cell per cubic millimeters (cell/mm\^3).
• Viral load undetectable for at least a year.

You may not qualify if…

• History of any of the following cardiac illnesses within 6 months before first dose of TAK-188:
• Congestive heart failure New York Heart Association Grade III or IV.
• Unstable angina, myocardial infarction.
• Persistent hypertension ≥160/100 mm mercury (Hg) despite optimal medical therapy.
• Ongoing cardiac arrhythmias of Grade >2 (including atrial flutter/fibrillation or intermittent ventricular tachycardia).
• Other ongoing serious cardiac conditions (for example, Grade 3 pericardial effusion or Grade 3 restrictive cardiomyopathy).
• Symptomatic cerebrovascular events.
• Chronic, stable atrial fibrillation on stable anticoagulation therapy, including low molecular-weight heparin, is allowed.
• Baseline prolongation of Fridericia-corrected QT interval (QTcF) (for example, repeated demonstration of QTc >480 milliseconds, history of congenital long QT syndrome, or torsades de pointes) on a 12-lead ECG during the screening period. If participants are taking medications known to prolong QTc at screening, participants may continue to take these medications as long as their baseline QTcF is <480 milliseconds. Participants may not start using such medications on or after C1D1.
• Oxygen saturation of <90% of room air at screening.
• Participants treated with other chemokine (C-C motif) receptor 8 (CCR8) targeting agents within the past 6 months.
• Active diagnosis of lung conditions including:
• Pneumonitis.
• Interstitial lung disease.
• Severe chronic obstructive pulmonary disease.
• Idiopathic pulmonary fibrosis.
• Other restrictive lung diseases.
• Acute symptomatic pulmonary embolism.
• Grade ≥2 pleural effusion not controlled by tap or requiring indwelling catheters.
• History of known brain metastasis or leptomeningeal disease unless:
• Brain metastases are stable on cranial imaging (that is, ≥4 weeks) following prior surgery, whole-brain radiation OR
• Stereotactic radiosurgery and off corticosteroids for brain metastases
• Must be without neurologic dysfunction that would confound the evaluation of neurologic and other AEs.
• Grade ≥2 fever of malignant origin.
• Systemic infection requiring IV antibiotic therapy or other serious infection within 14 days before the first dose of TAK-188 or severe infections on continued treatment.

Where it is running

• UCLA Health-Santa Monica Cancer Care (Cancer Care - Santa Monica) — Santa Monica, California, United States (enrolling)
• Yale School of Medicine - Smilow Cancer Hospital - Center for Thoracic Cancers — New Haven, Connecticut, United States (enrolling)
• Florida Cancer Specialists - Lake Nona — Orlando, Florida, United States (enrolling)
• Johns Hopkins — Baltimore, Maryland, United States (enrolling)
• Barbara Ann Karmanos Cancer Institute — Detroit, Michigan, United States (enrolling)
• START Midwest — Grand Rapids, Michigan, United States (enrolling)
• Washington University — St Louis, Missouri, United States (enrolling)
• University Hospitals Cleveland Medical Center — Cleveland, Ohio, United States (enrolling)
• Providence Cancer Institute, Franz Clinic — Portland, Oregon, United States (enrolling)
• Fox Chase Cancer Center — Philadelphia, Pennsylvania, United States (enrolling)
• SCRI Oncology — Nashville, Tennessee, United States (enrolling)
• MD Anderson Cancer Center — Houston, Texas, United States (enrolling)
• NEXT Dallas — Irving, Texas, United States (enrolling)
• START San Antonio — San Antonio, Texas, United States (enrolling)
• NEXT Virginia — Fairfax, Virginia, United States (enrolling)

Full record on ClinicalTrials.gov

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