A Study of Valemetostat Tosylate in Combination With DXd ADCs in Subjects With Solid Tumors
ConditionAdvanced Solid Tumor
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorDaiichi Sankyo
About this trial
This study will evaluate the safety, tolerability, and efficacy of valemetostat tosylate in combination with DXd ADC in patients with advanced solid tumors.
Eligibility criteria
Qualifiers
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.
Disqualifiers
Has previously been treated with any enhancer of zeste homolog inhibitors.
Uncontrolled or significant cardiovascular disease.
Has spinal cord compression or clinically active central nervous system metastases, defined as untreated and symptomatic, or requiring therapy with corticosteroids or anticonvulsants to control associated symptoms.
Has leptomeningeal carcinomatosis or metastasis.
Trial design
Treatments tested in this trial
- Valemetostat tosylate
- T-DXd
- Dato-DXd
Treatment groups
210 Participants
are divided into 6 treatment groups6
Treatment groupsSee each treatment group below.
Sponsors and collaborators
Source ClinicalTrials.gov