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A Study of TAK-188 in Adults With Advanced or Spreading Solid Tumors | Clinical Trials | Clareo Health

RECRUITINGPHASE1/PHASE2

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

An Open-label, Dose Escalation and Expansion, Phase 1/2 Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of TAK- 188, an Anti-CCR8 Antibody-Drug- Conjugate, as a Single Agent in Adult Participants With Locally Advanced or Metastatic Solid Tumors

NCT07205718•Takeda

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Participants ≥18 years or ≥ the local legal age of majority, as applicable, at the time of signing the ICF.
•2. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
•3. 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.
•4. Adequate bone marrow, renal, and hepatic functions, as determined by the following laboratory parameters:
•1. 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.
•2. 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).
•3. Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3.0 × ULN or baseline or ≤5.0 × ULN or baseline with liver metastases.
•4. Albumin ≥3.0 grams per deciliter (g/dL).
•5. Calculated creatinine clearance CLCR (using the Cockcroft-Gault formula) ≥60 mL/minute.
•6. 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.
+39 more criteria

Exclusion Criteria

•1. History of any of the following cardiac illnesses within 6 months before first dose of TAK-188:
•1. Congestive heart failure New York Heart Association Grade III or IV.
•2. Unstable angina, myocardial infarction.
•3. Persistent hypertension ≥160/100 mm mercury (Hg) despite optimal medical therapy.
•4. Ongoing cardiac arrhythmias of Grade \>2 (including atrial flutter/fibrillation or intermittent ventricular tachycardia).
•5. Other ongoing serious cardiac conditions (for example, Grade 3 pericardial effusion or Grade 3 restrictive cardiomyopathy).
•6. Symptomatic cerebrovascular events.
•7. Chronic, stable atrial fibrillation on stable anticoagulation therapy, including low molecular-weight heparin, is allowed.
•2. 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.
•3. Oxygen saturation of \<90% of room air at screening.
+36 more criteria

Locations (15)

UCLA Health-Santa Monica Cancer Care (Cancer Care - Santa Monica)

Santa Monica, California, United States

Yale School of Medicine - Smilow Cancer Hospital - Center for Thoracic Cancers

New Haven, Connecticut, United States

Florida Cancer Specialists - Lake Nona

Orlando, Florida, United States

Johns Hopkins

Baltimore, Maryland, United States

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, United States

START Midwest

Grand Rapids, Michigan, United States

Washington University

St Louis, Missouri, United States

Case Comprehensive Cancer Center

Cleveland, Ohio, United States

Providence Cancer Institute, Franz Clinic

Portland, Oregon, United States

Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States

Key Dates

Start Date

November 19, 2025

Primary Completion Date

December 26, 2028

Completion Date

December 21, 2029

Last Updated

February 6, 2026

Enrollment

223

ESTIMATED participants

Conditions

Advanced or Metastatic Solid Tumors

Interventions

TAK-188

DRUG

Contacts

Takeda Contact

CONTACT

+1-877-825-3327 medinfoUS@takeda.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 6, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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