TAK-188 for Cancer

Not yet recruiting at 14 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Takeda

Must not be taking: CCR8 agents, Immunosuppressants

Disqualifiers: Cardiac illness, Lung conditions, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 12 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new medicine, TAK-188, to determine if it can enhance the immune system's ability to combat advanced cancers that have not improved with standard treatments. TAK-188 targets a specific protein in certain tumor cells, which can weaken the body's defense against cancer. The trial aims to assess whether TAK-188 is safe and effective, enabling more cancer-fighting cells to attack tumors. Suitable participants have advanced cancers, such as lung or gastroesophageal cancer, that have not responded to previous treatments. Participants will receive TAK-188 through IV infusions and will be monitored for up to a year. As a Phase 1 trial, participants will be among the first to receive TAK-188, aiding researchers in understanding how this new treatment works in people.

Will I have to stop taking my current medications?

The trial does not specify if you must stop taking your current medications. However, you cannot take certain treatments like other cancer therapies or immunosuppressive drugs close to starting the trial. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that TAK-188 is likely to be safe for humans?

Research has shown that TAK-188 is being tested for safety in treating several advanced cancers, including non-small cell lung cancer (NSCLC), gastroesophageal adenocarcinoma (GEA), and squamous cell carcinoma of the head and neck (SCCHN).

For NSCLC, studies found that serious side effects occurred in 11% of patients. Common side effects included nausea, diarrhea, and vomiting. Importantly, no treatment-related deaths were reported, suggesting that while side effects exist, they may not be life-threatening.

For GEA and SCCHN, specific safety data on TAK-188 is not clearly available. However, since the trial is in early stages (Phase 1 and 2), the main focus is on safety. Researchers closely monitor any severe side effects and adjust doses to find the safest levels for patients.

Overall, TAK-188 is still under study to better understand its safety. Participants in these studies will be closely monitored to manage any side effects and ensure the treatment remains as safe as possible. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about TAK-188 because it offers a potentially innovative approach to treating non-small cell lung cancer (NSCLC) and gastroesophageal adenocarcinoma (GEA). Unlike traditional chemotherapy, which often targets rapidly dividing cells indiscriminately, TAK-188 is designed to be more selective, potentially reducing side effects. It uses an intravenous infusion method, which might enhance how the drug is delivered directly to cancer cells. Moreover, varying doses and infusion schedules in the trial could provide insights into optimizing treatment efficacy and safety for different cancer types and patient needs.

What evidence suggests that TAK-188 could be an effective treatment for advanced cancers?

Research has shown that TAK-188 targets a protein called CCR8 on certain tumor cells. These cells, known as Tregs, can weaken the body's cancer-fighting ability. By removing Tregs, TAK-188 may enable more immune cells, specifically CD8+ T cells, to attack cancer more effectively. Early evidence suggests that TAK-188 could help stop tumors from growing by boosting the immune response. This trial will study TAK-188 in various cancers, including non-small cell lung cancer, gastroesophageal adenocarcinoma, and squamous cell carcinoma of the head and neck. Although TAK-188 remains under study, it may offer help when other treatments have not worked. ^{1 4 6 7 8}

Who Is on the Research Team?

Study Director

Principal Investigator

Takeda

Are You a Good Fit for This Trial?

This trial is for adults with advanced solid tumors that haven't improved after standard treatments. Participants should be able to receive TAK-188 for up to a year and agree to health monitoring post-treatment.

Inclusion Criteria

Voluntary written consent is required before any trial-related procedure

Participants with controlled Human Immunodeficiency Virus (HIV) must meet specific criteria

Specific solid tumor participants are allowed based on certain criteria

Exclusion Criteria

Baseline prolongation of Fridericia-corrected QT interval (QTcF)

Oxygen saturation of <90% of room air at screening

Uncontrolled, known or suspected, autoimmune disease

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive TAK-188 via IV infusion in 21-day or 28-day cycles for up to 12 months

12 months

IV infusion on Days 1, 8, and 15 in each cycle

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

What Are the Treatments Tested in This Trial?

Interventions

• TAK-188

Trial Overview TAK-188, a new drug targeting the CCR8 protein on certain immune cells within tumors, is being tested. The goal is to see if it can boost the body's cancer-fighting abilities by removing these cells in patients with advanced cancers.

How Is the Trial Designed?

Group I: Phase 2; Dose Expansion: Cohort D Experimental Treatment 1 Intervention

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).

Group II: Phase 2; Dose Expansion: Cohort C Experimental Treatment 1 Intervention

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).

Group III: Phase 2; Dose Expansion: Cohort B Experimental Treatment 1 Intervention

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).

Group IV: Phase 2; Dose Expansion: Cohort A Experimental Treatment 1 Intervention

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).

Group V: Phase 1b: Backfill Cohort Experimental Treatment 1 Intervention

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).

Group VI: Phase 1: TAK-188 Dose Escalation Experimental Treatment 1 Intervention

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).

Who Is Running the Clinical Trial?

Takeda

Lead Sponsor

Trials

1,255

Recruited

4,219,000+

Dr. Naoyoshi Hirota

Takeda

Chief Medical Officer since 2020

MD from University of Tokyo

Christophe Weber

Takeda

Chief Executive Officer since 2015

PhD in Molecular Biology from Université de Montpellier

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07205718

A Study of TAK-188 in Adults With Advanced or Spreading ... TAK-188 is a new medicine that targets a protein called CCR8, which is found on the surface of certain cells (Tregs) inside tumors.

2. withpower.com withpower.com/trial/phase-2-advanced-or-metastatic-solid-tumors-10-2025-d02f7

TAK-188 for Cancer · Info for Participants 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 ...

3. ichgcp.net ichgcp.net/clinical-trials-registry/555325-a-study-of-tak-188-in-adults-with-advanced-or-spreading-solid-tumors

TAK-188 Clinical Trial for Advanced Solid Tumors - ICH GCP Clinical trial investigating TAK-188 for adults with advanced solid tumors including lung, gastroesophageal, and head/neck cancers.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8286155/

Recent Advances in Systemic Treatments for HER-2 Positive ... The only available biomarkers able to guide the effective treatment of advanced GC are HER2 overexpression, MSI/PD-L1 status, and FGFR alterations.

5. oncodaily.com oncodaily.com/oncolibrary/gastroesophageal-adenocarcinoma-tigit

Dual Immune Checkpoint Blockade Targeting TIGIT and ... In the overall study population of 41 patients, the median overall survival (OS) reached 26.7 months(90% CI: 18.4–not estimable), with a 24- ...

6. adisinsight.springer.com adisinsight.springer.com/trials/700387055

188, an Anti-CCR8 Antibody-Drug- Conjugate, as a Single ... TAK-188 is a new medicine that targets a protein called CCR8, which is found on the surface of certain cells (Tregs) inside tumors.

7. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/nda/2024/215151Orig1s000IntegratedR.pdf

215151Orig1s000 INTEGRATED REVIEW - accessdata.fda.gov Long-term safety data of vonoprazan from VISION were consistent with the safety findings in the original review. No new safety signals were identified. The ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11825931/

Integrated Analysis of Vonoprazan Safety for Symptomatic ... Its safety profile from both clinical trial and post‐marketing data were consistent and comparable to that of its PPI comparators with respect ...