A Phase 1/2a, Multicenter, Open-Label, First in Human Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of DB-1419 in Participants With Advanced/Metastatic Solid Tumors
DualityBio Inc.
Summary
A Phase 1/2a First-in-Human Study of DB-1419 in Advanced/Metastatic Solid Tumors
Description
A Phase 1/2a, Multicenter, Open-Label, First in Human Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of DB-1419 in Participants with Advanced/Metastatic Solid Tumors
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Adults aged ≥ 18 years at the time of voluntarily signing informed consent. 2. 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. 3. 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 ca…
Interventions
- DrugDB-1419
Administered Injection of Vein (I.V.)
Locations (36)
- Site USA12-0Los Angeles, California
- Site USA08-0Newport Beach, California
- Site USA06-0Washington D.C., District of Columbia
- Site USA02-0Florida City, Florida
- Site USA11-0Chicago, Illinois
- Site USA03Huntersville, North Carolina