A Study of DB-1317 in Selected Advanced/Metastatic Solid Tumors
ConditionAdvanced/Metastatic Solid Tumors
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorDualityBio Inc.
About this trial
This is a multicenter, open-label, multiple-dose, FIH Phase 1a/1b study. Phase 1a adopts an accelerated titration design and a BOIN design to identify the MTD or MAD of DB-1317; Phase 1b includes up to 3 randomized dose expansion cohorts to further evaluate the safety, tolerability and preliminary efficacy of DB-1317 in selected solid tumors and to identify optimal RP2D.
Eligibility criteria
Qualifiers
Male or female adults
Unresectable advanced or metastatic selected solid tumors that have relapsed or progressed on or after standard systemic treatments.
Only applicable to backfilling participants in Phase 1a and participants in Phase 1b: At least one measurable lesion as assessed by the investigator according to RECIST version 1.1 criteria. Participants with non-measurable disease are allowed for CRPC participants.
Has a life expectancy of ≥ 3 months.
Disqualifiers
Prior treatment with ADAM9 targeted therapy.
Prior treatment with antibody-drug conjugate with topoisomerase I inhibitor.
Has a medical history of symptomatic congestive heart failure or serious cardiac arrhythmia requiring treatment.
Has a medical history of myocardial infarction or unstable angina within 6 months before enrollment.
Trial design
Treatments tested in this trial
- DB-1317
Treatment groups
233 Participants
are divided into 8 treatment groups8
Treatment groupsSee each treatment group below.
Sponsors and collaborators
Source ClinicalTrials.gov