NCT05735366

A Phase 1 Study of SAIL66 in Patients With CLDN6-positive Locally Advanced or Metastatic Solid Tumors

A Phase I Open-label, Multicenter Study to Evaluate the Safety, Efficacy, Pharmacokinetics and Pharmacodynamics of SAIL66 in Patients With CLDN6-positive Locally Advanced or Metastatic Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Chugai Pharmaceutical · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 1 dose-escalation and expansion study that will evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and preliminary efficacy of SAIL66 in patients with CLDN6-positive locally advanced or metastatic solid tumors.

Conditions

• Solid Tumor

Interventions

Type	Name	Description
DRUG	SAIL66	SAIL66 as a IV infusion

Timeline

• Start date: 2023-04-17
• Primary completion: 2026-01-26
• Completion: 2026-01-26
• First posted: 2023-02-21
• Last updated: 2026-03-10

Locations

9 sites across 2 countries: United States, Japan

Regulatory

• FDA-regulated drug study