TAK-188 for Advanced or Spreading Solid Tumors
This study is testing TAK-188 in adults with advanced or spreading (metastatic) solid tumors that haven't responded to previous treatments. TAK-188 aims to help your body's immune system fight cancer by targeting a protein called CCR8 on certain cells (Tregs) that can weaken the immune response. By removing these Tregs, TAK-188 may allow more cancer-fighting cells to attack the tumor. Researchers want to see if TAK-188 is safe, how well people tolerate it, and if it works against these cancers. You may be eligible if you are at least 18 years old, have a good general health status (ECOG performance status of 0 to 1), and can provide biopsy samples. The study plans to enroll 223 participants.
- Study design
- This is an interventional study, meaning participants will receive TAK-188 as an intravenous (IV) infusion. The study aims to enroll 223 participants.
- What's involved
- You would need to provide biopsy samples within 28 days before starting treatment and potentially during treatment. The study will monitor for side effects for up to 90 days after your last dose, which could be up to approximately 16 months.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be monitored for treatment-emergent adverse events (side effects) for up to 90 days after their last dose, which could be up to approximately 16 months.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
A Study of TAK-188 in Adults With Advanced or Spreading Solid Tumors
At a glance
Conditions
Where it's being run
15 sites across 12 statesStudy leadership
- Study Director · STUDY_DIRECTOR · Takeda
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- Phase 1: Number of Participants with Treatment-emergent Adverse Events (TEAEs)From the signing of the informed consent form (ICF) through 90 days after the last dose (Up to approximately 16 months)
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.
- Phase 1: Number of Participants with TEAEs Based on SeverityFrom the signing of the ICF through 90 days after the last dose (Up to approximately 16 months)
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.
- Phase 1: Number of Participants with Dose- limiting Toxicities (DLTs)Up to Cycle 1 (21 days)
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.
- Phase 1: Number of Participants with Treatment-emergent Serious Adverse Events (SAEs)From the signing of the ICF through 90 days after the last dose (Up to approximately 16 months)
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.
- Phase 1: Number of Participants with Treatment-emergent Adverse Events Leading to Dose Modifications and Treatment DiscontinuationsFrom 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 1.1Up to 24 months
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).
- Phase 2: Disease Control Rate (DCR)Up to 24 months
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.
- Phase 2: Duration of Response (DOR)Up to 24 months
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).