First-in-Human Trial of DS1025a in Participants With Advanced Solid Tumors
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorDaiichi Sankyo
About this trial
This clinical trial is designed to assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy signals of DS1025a, given as a single agent to participants with advanced, metastatic, or unresectable solid tumors.
Eligibility criteria
Qualifiers
Sign and date the main ICF, prior to the start of any trial-specific procedures.
Adults ≥18 years of age at the time the ICF is signed (Please follow local regulatory requirements if the legal age of consent for trial participation is >18 years old).
Histologically documented, advanced, metastatic, or unresectable solid tumors.
Relapsed or refractory disease, following at least 1 line of therapy, not amenable to standard therapy.
Disqualifiers
None
Trial design
Treatments tested in this trial
- DS1025a
Treatment groups
45 Participants
are divided into 1 treatment groupLocations
3National Cancer Center Hospital East277-8577, Chiba Japan
Kansai Medical University Hospital573-1191, Osaka Japan
The Cancer Institute Hospital of JFCR135-8550, Tokyo Japan
Sponsors and collaborators
Daiichi Sankyo
Lead sponsor
Source ClinicalTrials.gov