NCT06244485

A Study of Valemetostat Tosylate in Combination With DXd ADCs in Subjects With Solid Tumors

A Phase 1b, Multicenter, Open-Label Study of Valemetostat Tosylate in Combination With DXd ADCs in Subjects With Solid Tumors

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 210 (estimated)
• Sponsor: Daiichi Sankyo · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the safety, tolerability, and efficacy of valemetostat tosylate in combination with DXd ADC in patients with advanced solid tumors.

Detailed description

This is a 2-part study of valemetostat in combination with DXd ADCs in patients with HER2-positive gastric cancer, non-squamous NSCLC, or unresectable or metastatic HER2 low breast cancer. The study will begin with a Part 1 Dose-escalation Phase and will continue until the recommended dose for expansion "RDE" of valemetostat is determined and will then be followed by a Part 2 Dose-expansion Phase to further evaluate the safety and tolerability of the combination.

Conditions

• Advanced Solid Tumor

Interventions

Type	Name	Description
DRUG	Valemetostat tosylate	Administered orally once daily
DRUG	T-DXd	One IV infusion Q3W on Day 1 of each 21-day cycle
DRUG	Dato-DXd	One IV infusion Q3W on Day 1 of each 21-day cycle.

Timeline

• Start date: 2024-02-16
• Primary completion: 2028-11-01
• Completion: 2028-11-01
• First posted: 2024-02-06
• Last updated: 2026-02-04

Locations

38 sites across 4 countries: United States, China, Italy, Japan

Regulatory

• FDA-regulated drug study