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

Conditions

• Advanced or Metastatic Solid Tumors

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• TAK-188 — DRUG
  TAK-188 IV infusion

Study Details

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 Dates

Start date

Nov 19, 2025

Status verified

Jun 2026

Primary completion

Dec 26, 2028

Completion

Dec 21, 2029

Study Design

Enrollment

223 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

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

Primary Outcome Measure

Phase 1: Number of Participants with Treatment-emergent Adverse Events (TEAEs) [ Time Frame: From the signing of the informed consent form (ICF) through 90 days after the last dose (Up to approximately 16 months) ]

Central Contacts

• Takeda Contact
  +1-877-825-3327
  [email protected]

Locations (15)

Find similar trials in Santa Monica, CA

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