First-in-human study of DB-1419 for advanced solid tumors
Phase 1/2
360
about 2.5 years
18+
9 sites in CA, DC, FL +5
What this study is about
Researchers are testing a new medication, DB-1419, in people with advanced or metastatic solid tumors. The trial will last about 908 days and involve approximately 360 participants.
Simplified from trial records by PatientMatch.
What you may be asked to do
- 1.Take DB-1419
Participation Burden
What's physically and logistically required of participants.
Requires travel to a study site
How treatment is administered
Everyone gets the investigational treatment.
Extracted study details
Pulled from the trial record to show what is being tested and what the study is measuring.
Primary: Phase 1/2a: Percentage of Participants with Adverse events (AE) serious AE (SAE), Phase 1/2a: Percentage of Participants with serious AE (SAE), Phase 1a: Maximum Tolerated Dose (MTD), Phase 1b/2a: Objective Response Rate (ORR) determined by Investigator per RECIST v1.1
Secondary: Phase 1/2a: Cmax, Phase 1/2a: OS, Phase 1/2a: Progression free survival (PFS) determined from tumor assessments by Investigator per response evaluation criteria in solid tumors version 1.1 (RECIST v1.1, Phase 1/2a: Tmax, Phase 1a: ORR determined from tumor assessments by Investigator per RECIST v1.1