A Study of DB-1310 in Advanced/Metastatic Solid Tumors
ConditionAdvanced Solid Tumor
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorDualityBio Inc.
About this trial
This is a dose-escalation and dose-expansion Phase 1/2a trial to evaluate the safety and tolerability of DB-1310 in subjects with advanced solid tumors.
Eligibility criteria
Qualifiers
Male or female adults (defined as ≥ 18 years of age or acceptable age according to local regulations at the time of voluntarily signing of informed consent).
Have relapsed or progressed on or after standard systemic treatments, or intolerable with standard treatment, or for which no standard treatment is available. Documented radiological disease progression during/after most recent treatment regimen for advanced/unresectable, or metastatic disease.
At least one measurable lesion as assessed by the investigator according to response evaluation criteria in solid tumors (RECIST) version 1.1 criteria.
Has a life expectancy of ≥ 3 months.
Disqualifiers
Prior treatment with HER3 targeted therapy.
Prior treatment with antibody drug conjugate with topoisomerase I inhibitor (except topoisomerase I inhibitor HER2 ADC for backfilled subjects in Combo A of Phase 1 and subjects in Cohort 2e of Phase 2a, and not applicable for subjects enrolled for DLT observation in Phase 1).
Has a medical history of symptomatic congestive heart failure (CHF) (New York Heart Association [NYHA] classes II-IV) or serious cardiac arrhythmia requiring treatment.
Has a medical history of myocardial infarction or unstable angina or cerebrovascular accident including transient ischemic attack (TIA) within 6 months before first dose. Or has uncontrolled hypertension (defined as systolic blood pressure > 160 mmHg or diastolic blood pressure > 100 mmHg).
Trial design
Treatments tested in this trial
- DB-1310
- Trastuzumab
- Osimertinib
- capecitabine
Treatment groups
1,000 Participants
are divided into 25 treatment groups25
Treatment groupsSee each treatment group below.
Sponsors and collaborators
Source ClinicalTrials.gov