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

NCT07205718 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: TAK-188-1501
• Study Type: interventional
• Target: 223
• Locations: 1 country
• Sites: 15

Brief 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.

Conditions

Advanced or Metastatic Solid Tumors

Keywords

Drug Therapy

Outcome Measures

Primary Outcomes (8)

• Phase 1: Number of Participants with Treatment-emergent Adverse Events (TEAEs)

  An adverse event (AE) is any untoward medical occurrence in a participant administered a medicinal investigational drug. The untoward medical occurrence does not necessarily have to have a causal relationship with treatment. A TEAE is defined as an AE that occurs after administration of first dose of study drug and through 30 days after last dose of study drug or until start of subsequent antineoplastic therapy.

  From the signing of the informed consent form (ICF) through 90 days after the last dose (Up to approximately 16 months)

• Phase 1: Number of Participants with TEAEs Based on Severity

  An AE is any untoward medical occurrence in a participant administered a medicinal investigational drug. The untoward medical occurrence does not necessarily have to have a causal relationship with treatment. A TEAE is defined as an AE that occurs after administration of first dose of study drug and through 30 days after last dose of study drug or until start of subsequent antineoplastic therapy. Severity for each TEAE will be determined using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 5.0.

  From the signing of the ICF through 90 days after the last dose (Up to approximately 16 months)

• Phase 1: Number of Participants with Dose- limiting Toxicities (DLTs)

  DLTs will be evaluated according to NCI CTCAE, Version 5.0 except cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS), will be graded according to American society for transplantation and cellular therapy (ASCST) Consensus Grading for CRS.

  Up to Cycle 1 (21 days)

• Phase 1: Number of Participants with Treatment-emergent Serious Adverse Events (SAEs)

  An AE is any untoward medical occurrence in a participant administered a medicinal investigational drug. The untoward medical occurrence does not necessarily have to have a causal relationship with treatment. An SAE is any untoward medical occurrence that results in death; is life-threatening; requires inpatient hospitalization or prolongation of present hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect or is a medically important event.

  From the signing of the ICF through 90 days after the last dose (Up to approximately 16 months)

• Phase 1: Number of Participants with Treatment-emergent Adverse Events Leading to Dose Modifications and Treatment Discontinuations

  From the signing of the ICF through 90 days after the last dose (Up to approximately 16 months)

• Phase 2: Overall Response Rate (ORR) as Assessed by the Investigator According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1

  ORR is defined as the percentage of participants who achieve Complete Response (CR) and Partial Response (PR) (determined by the investigator) during the study according to RECIST Version 1.1. CR is defined as the disappearance of all evidence of disease and PR is defined as regression of measurable disease by 30% and no new sites of disease. Stable disease (SD) is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD). PD is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study).

  Up to 24 months

• Phase 2: Disease Control Rate (DCR)

  DCR is defined as the percentage of participants who achieve SD or better (CR+PR+SD determined by the investigator) equal to or more than (≥) 6 weeks during the study.

  Up to 24 months

• Phase 2: Duration of Response (DOR)

  DOR is defined as the time from the date of first documentation of a confirmed partial response (cPR) or better to the date of first documentation of PD or death for responders (cPR or better).

  Up to 24 months

Secondary Outcomes (25)

• Phase 1: Recommended Dose for Expansion [RDE(s)] of TAK-188

  Up to 12 months

• Phase 1: Cmax: Maximum Observed Plasma Concentration

  Cycles 1 & 3: Day 1 (pre-dose, end of infusion, 5, 24, 48 & 72 hours post infusion); Days 8 & 15 (pre-dose); Cycles 2 & 4: Day 1 (pre-dose, end of infusion); Cycles 5,7 & 9: Day 1 (pre-dose) & at end of treatment (Cycle length:21 days)

• Phase 1: Tmax: Time to Reach the Maximum Plasma Concentration (Cmax)

  Cycles 1 & 3: Day 1 (pre-dose, end of infusion, 5, 24, 48 & 72 hours post infusion); Days 8 & 15 (pre-dose); Cycles 2 & 4: Day 1 (pre-dose, end of infusion); Cycles 5,7 & 9: Day 1 (pre-dose) & at end of treatment (Cycle length:21 days)

• Phase 1: AUC0-last: Area Under The Concentration-Time Curve From Time 0 to Time of the Last Quantifiable Concentration

  Cycles 1 & 3: Day 1 (pre-dose, end of infusion, 5, 24, 48 & 72 hours post infusion); Days 8 & 15 (pre-dose); Cycles 2 & 4: Day 1 (pre-dose, end of infusion); Cycles 5,7 & 9: Day 1 (pre-dose) & at end of treatment (Cycle length:21 days)

• Phase 1: AUC0-inf: Area Under The Plasma Concentration-Time Curve From Time 0 to Infinity

  Cycles 1 & 3: Day 1 (pre-dose, end of infusion, 5, 24, 48 & 72 hours post infusion); Days 8 & 15 (pre-dose); Cycles 2 & 4: Day 1 (pre-dose, end of infusion); Cycles 5,7 & 9: Day 1 (pre-dose) & at end of treatment (Cycle length:21 days)

Study Arms (6)

Phase 1: TAK-188 Dose Escalation

EXPERIMENTAL

Participants will receive escalating doses of TAK-188 with a starting dose of 40 micrograms per kilogram (μg/kg), intravenously (IV) infusion, on Days 1, 8, and 15 \[once weekly (QW)\] in each 21-day treatment cycles until recommended dose for expansion (RDE) is determined (for a maximum of 12 months).

Drug: TAK-188

Phase 1b: Backfill Cohort

EXPERIMENTAL

Participants with squamous cell carcinoma of head and neck (SCCHN) will receive TAK-188 at RDE1 (recommended dose for expansion in Phase 1), IV infusion on Days 1, 8, and 15 (QW) in each 21-day treatment cycle (for a maximum of 12 months).

Drug: TAK-188

Phase 2; Dose Expansion: Cohort A

EXPERIMENTAL

Participants with non-squamous non-small cell lung cancer (NSCLC) will receive TAK-188 at RDE1, IV infusion on Days 1, 8, and 15 (QW) in each 21-day treatment cycle (for a maximum of 12 months).

Drug: TAK-188

Phase 2; Dose Expansion: Cohort B

EXPERIMENTAL

Participants with NSCLC will receive TAK-188 at RDE2 (a lower dose than RDE1 or an alternate dose schedule), IV infusion, on Days 1, 8, and 15 (QW) in each 21-day treatment cycle or once every 2 weeks (Q2W) in each 28-day treatment cycle (for a maximum of 12 months).

Drug: TAK-188

Phase 2; Dose Expansion: Cohort C

EXPERIMENTAL

Participants with NSCLC will receive TAK-188 at RDE3 (recommended dose for expansion at an alternate dose schedule), IV infusion, Q2W in each 28-day treatment cycle (for a maximum of 12 months).

Drug: TAK-188

Phase 2; Dose Expansion: Cohort D

EXPERIMENTAL

Participants with gastroesophageal adenocarcinoma (GEA) will receive TAK-188, IV infusion on Days 1, 8, and 15 (QW) in each 21-day treatment cycle (for a maximum of 12 months).

Drug: TAK-188

Interventions

TAK-188 DRUG

TAK-188 IV infusion

Phase 1: TAK-188 Dose Escalation; Phase 1b: Backfill Cohort; Phase 2; Dose Expansion: Cohort A; Phase 2; Dose Expansion: Cohort B; Phase 2; Dose Expansion: Cohort C; Phase 2; Dose Expansion: Cohort D

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

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.

Sponsors & Collaborators

• Takeda: lead

Study Sites (15)

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

Santa Monica, California, 90404, United States

NOT YET RECRUITING

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

New Haven, Connecticut, 06511, United States

RECRUITING

Florida Cancer Specialists - Lake Nona

Orlando, Florida, 32827, United States

RECRUITING

Johns Hopkins

Baltimore, Maryland, 21231, United States

NOT YET RECRUITING

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

RECRUITING

START Midwest

Grand Rapids, Michigan, 49546, United States

RECRUITING

Washington University

St Louis, Missouri, 63108, United States

RECRUITING

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106-1716, United States

RECRUITING

Providence Cancer Institute, Franz Clinic

Portland, Oregon, 97213-2933, United States

NOT YET RECRUITING

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111-2497, United States

RECRUITING

SCRI Oncology

Nashville, Tennessee, 37203, United States

RECRUITING

MD Anderson Cancer Center

Houston, Texas, 77030-4000, United States

NOT YET RECRUITING

NEXT Dallas

Irving, Texas, 75039, United States

RECRUITING

START San Antonio

San Antonio, Texas, 78229, United States

RECRUITING

NEXT Virginia

Fairfax, Virginia, 22031, United States

RECRUITING

Related Links

• Click here for more information about this trial in easy-to-understand language, including a Plain Language Summary of the results if the trial has been completed.
• Click here to ask Takeda's chatbot for comprehensive and easy-to-understand information about clinical trials - even across products and indications - in your local language.

Study Officials

• Study Director

  Takeda

  STUDY DIRECTOR

Central Study Contacts

Takeda Contact

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2025
• First Posted: October 3, 2025
• Study Start: November 19, 2025
• Primary Completion (Estimated): December 26, 2028
• Study Completion (Estimated): December 21, 2029
• Last Updated: April 24, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Access Criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.

Locations

US (15)