First-in-human Study of DB-1419 for Advanced/Metastatic Solid Tumors
ConditionSolid Tumor, Adult
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorDualityBio Inc.
About this trial
A Phase 1/2a First-in-Human Study of DB-1419 in Advanced/Metastatic Solid Tumors
Eligibility criteria
Qualifiers
Adults aged ≥ 18 years at the time of voluntarily signing informed consent.
Histologically or cytologically confirmed unresectable advanced/metastatic solid tumor that has relapsed or progressed on or after standard systemic treatments, or refused the standard treatment, or for which no standard treatment is available.
At least one measurable lesion as assessed by the Investigator according to RECIST v1.1 criteria (Only applicable to backfill participants in phase 1a and participants in phase 1b/2a). CRPC participants with bone-only disease may be eligible on a case-by-case basis after discussion with the Medical Monitor.
Has a life expectancy of ≥ 3 months.
Disqualifiers
Prior treatment with B7-H3 targeted therapy or prior treatment with ADC containing a topoisomerase I inhibitor payload.
Has a medical history of symptomatic congestive heart failure (New York Heart Association [NYHA] classes II-IV or serious cardiac arrhythmia requiring treatment.
Has a medical history of myocardial infarction or unstable angina within 6 months before enrollment.
Has an average of Fredericia's formula-QT corrected interval (QTcF) prolongation to > 470 millisecond (ms) in males and females based on a 12-lead electrocardiogram (ECG) in triplicate.
Trial design
Treatments tested in this trial
- DB-1419
Treatment groups
360 Participants
are divided into 17 treatment groups17
Treatment groupsSee each treatment group below.
Sponsors and collaborators
Source ClinicalTrials.gov