TAK-188 / Takeda, Heidelberg Pharma - LARVOL DELTA

A phase 1/2, first-in-human, open-label, dose-escalation and -expansion study of TAK-188, a novel antibody-drug conjugate (ADC) targeting CCR8+ regulatory T cells, in adult patients with locally advanced or metastatic solid tumors. (ASCO 2026) - P1/2 | "Exploratory objectives include the impact of TAK-188 on CCR8+ Tregs, molecular response determined by circulating tumor DNA (ctDNA) analysis, and changes in cytokines and chemokines in peripheral blood. The study plans to enroll up to 223 patients in the USA (47 patients across 15 sites for dose-escalation; 62–176 patients across ~35 sites in cohort-expansion)."

ADC • Clinical • First-in-human • Metastases • P1/2 data • Colorectal Cancer • Esophageal Squamous Cell Carcinoma • Gastroesophageal Junction Adenocarcinoma • Head and Neck Cancer • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Ductal Adenocarcinoma • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • CCR8

TAK-188, an antibody-drug conjugate with a novel amanitin payload, disrupts immune suppression and leads to potent anti-tumor immunity through selective depletion of CCR8+ intratumoral regulatory T-cells (AACR 2026) - P1/2 | "In conclusion, TAK-188 robustly depletes CCR8+ cells both in vitro and in vivo and demonstrates anti-tumor activity as a single agent in nonclinical models. Based on this promising preclinical data, a Phase 1 study of TAK-188 has been opened (NCT07205718)."

ADC • IO biomarker • Oncology • Solid Tumor • CCR8 • CD4 • CD8

A Study of TAK-188 in Adults With Advanced or Spreading Solid Tumors (clinicaltrials.gov) - P1/2 | N=223 | Recruiting | Sponsor: Takeda | Not yet recruiting ➔ Recruiting

Enrollment open • Lung Cancer • Non Small Cell Lung Cancer • Solid Tumor • Squamous Cell Carcinoma of Head and Neck

A Study of TAK-188 in Adults With Advanced or Spreading Solid Tumors (clinicaltrials.gov) - P1/2 | N=223 | Not yet recruiting | Sponsor: Takeda

New P1/2 trial • Lung Cancer • Non Small Cell Lung Cancer • Solid Tumor • Squamous Cell Carcinoma of Head and Neck