Status and phase
Conditions
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About
This study will evaluate the safety, tolerability, and efficacy of valemetostat tosylate in combination with DXd ADC in patients with advanced solid tumors.
Full 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.
Enrollment
Sex
Ages
Volunteers
Inclusion and exclusion criteria
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:
Additional Key Inclusion for Sub-Protocol A:
Diagnosed with pathologically documented breast cancer that:
Is unresectable or metastatic.
Has progressed on and would no longer benefit from endocrine therapy in hormone receptor-positive subjects in the opinion of the investigator.
Has been treated with at least 1 and at most 2 prior lines of chemotherapy in the recurrent or metastatic setting.
Has a history of low HER2 expression, defined as IHC 2+ /ISH-negative or IHC 1+ (ISH-negative or untested). ), as classified by the American Society of Clinical Oncology/College of American Pathologists 2018 HER2 testing guidelines.
Was never previously HER2-positive (IHC 3+ or IHC 2+/ISH+) on prior pathology testing (per American Society of Clinical Oncology/College of American Pathologists guidelines
Additional Key Inclusion for Sub-Protocol B:
• Gastric or GEJ adenocarcinoma that is (a) unresectable or metastatic or (b) has progressed on trastuzumab or approved trastuzumab biosimilar-containing regimen.
Additional Key Inclusion for Sub-Protocol C:
Pathologically documented Stage IIIB, IIIC, or IV non-squamous NSCLC with or without AGA at the time of enrollment.
Must meet prior therapy requirements:
Key Exclusion Criteria
Additional Key Exclusion for Sub-Protocol A:
Additional Key Exclusion for Sub-Protocol B:
* Participants who have received an antibody-drug conjugate consisting of an exatecan derivative that is a topoisomerase I inhibitor.
Additional Key Exclusion for Sub-Protocol C:
* Has received any agent, including an ADC, containing a chemotherapeutic agent targeting topoisomerase I or TROP2-targeted therapy including Dato-DXD
Primary purpose
Allocation
Interventional model
Masking
210 participants in 6 patient groups
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Central trial contact
Daiichi Sankyo Contact for Clinical Trial Information
Data sourced from clinicaltrials.gov
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