A Phase 1b, Multicenter, Open-Label Study of Valemetostat Tosylate in Combination With DXd ADCs in Subjects With Solid Tumors
Daiichi Sankyo
Summary
This study will evaluate the safety, tolerability, and efficacy of valemetostat tosylate in combination with DXd ADC in patients with advanced solid tumors.
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Key Inclusion Criteria All participants must meet all of the following criteria, as well as all criteria from the relevant sub-protocol to be eligible for enrollment: * At least 18 years or the minimum legal adult age (whichever is greater) at the time the ICF is signed. * Has at least 1 measurable lesion based on investigator imaging assessment (computed tomography or magnetic resonance imaging) using RECIST v 1.1 at Screening. * Is willing to provide an adequate tumor sample. * Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1 at Screening. Additional Key Inclusion…
Interventions
- DrugValemetostat tosylate
Administered orally once daily
- DrugT-DXd
One IV infusion Q3W on Day 1 of each 21-day cycle
- DrugDato-DXd
One IV infusion Q3W on Day 1 of each 21-day cycle.
Locations (38)
- City of Hope At Orange County Lennar Foundation Cancer CenterIrvine, California
- Valkyrie Clinical TrialsLos Angeles, California
- Sharp Memorial HospitalSan Diego, California
- Brcr Medical Center, Inc Dba Boca Raton Clinical ResearchPlantation, Florida
- H. Lee Moffitt Cancer Center and Research Institute, IncTampa, Florida
- University of Hawaii At ManoaHonolulu, Hawaii