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
Takeda
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 range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 exc…
Interventions
- DrugTAK-188
TAK-188 IV infusion
Locations (15)
- UCLA Health-Santa Monica Cancer Care (Cancer Care - Santa Monica)Santa Monica, California
- Yale School of Medicine - Smilow Cancer Hospital - Center for Thoracic CancersNew Haven, Connecticut
- Florida Cancer Specialists - Lake NonaOrlando, Florida
- Johns HopkinsBaltimore, Maryland
- Barbara Ann Karmanos Cancer InstituteDetroit, Michigan
- START MidwestGrand Rapids, Michigan