Study of ESG401 in Adults With Solid Tumors

Summary

The primary objective in Phase I is to evaluate the safety and tolerability of ESG401 as a single agent administered in 21-day treatment cycles in previously treated participants with advanced epithelial cancer. In Phase II, the primary objective is to evaluate the safety and efficacy of ESG401 administered in 21-day treatment cycles at a dose selected in Phase I. Tumor types in the study will include: cervical, colorectal, endometrial, ovarian, esophageal, gastric adenocarcinoma, glioblastoma multiforme, head and neck cancers- squamous cell, hepatocellular, prostate, non-small-cell lung cancer, pancreatic, renal cell, small-cell lung cancer, non-triple negative breast cancer (non-TNBC), triple-negative breast cancer (TNBC) and metastatic urothelial cancer (mUC).

Timeline

Start

2021-09-14

Primary completion

2025-06-30

Completion

2025-06-30

Publications

• Wang J, Zhang Y, Bai R, Wu Y, Tong Z, Liu A, Zhang Y, Wang H, Wu X, Cheng Y, Yang H, Zhou Q, Xing X, Chen X, Qiu F, Ma F. Novel TROP2 antibody-drug conjugates for treatment of HER2-negative metastatic breast cancer patients with brain metastases: a promising option☆. ESMO Open. 2025 May;10(5):105059. doi: 10.1016/j.esmoop.2025.105059. Epub 2025 May 12.
• Wang J, Tong Z, Tan Y, Shi Y, Wu Y, Zhou Q, Xing X, Chen X, Qiu F, Ma F. Phase 1a study of ESG401, a Trop2 antibody-drug conjugate, in patients with locally advanced/metastatic solid tumors. Cell Rep Med. 2024 Sep 17;5(9):101707. doi: 10.1016/j.xcrm.2024.101707. Epub 2024 Aug 30.

Drugs

Indications