NCT06979674

Study of ESG406 in Adults With Solid Tumors

An Open-Label, Multiple Dose, Dose Escalation and Cohort Expansion Phase I Study to Investigate the Safety, Tolerability, Pharmacokinetics and Antitumor Activities of ESG406 in Subjects With Locally Advanced/Metastatic Solid Tumors

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 556 (estimated)
• Sponsor: Shanghai Escugen Biotechnology Co., Ltd · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This study is an open-label, dose-escalation and cohort expansion Phase I study, aiming to evaluate the safety, tolerability, PK characteristics and preliminary efficacy of ESG406, and determine the MTD, RP2D and administration regimens of ESG406. The study includes the dose escalation study in Phase Ia and the cohort expansion study in Phase Ib.

Conditions

• Locally Advanced/Metastatic Solid Tumors

Interventions

Type	Name	Description
DRUG	ESG406	Administered via intravenous (IV) infusion.

Timeline

• Start date: 2025-06-04
• Primary completion: 2028-04-01
• Completion: 2028-06-01
• First posted: 2025-05-20
• Last updated: 2025-09-12

Locations

3 sites across 1 country: China