A Phase 1/2, Multicenter, Open-Label, First-in-Human Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of DB-1324 in Participants With Advanced/Metastatic Gastrointestinal Tumors
DualityBio Inc.
Summary
This study, the first clinical trial, aims to determine the safety, tolerability, pharmacokinetics, pharmacodynamics, maximum tolerated dose, and antitumor activity of DB-1324.
Description
This is a multicenter, open-label, multiple-dose, FIH Phase 1/2 study to explore the safety, tolerability, and efficacy of DB-1324 in participants with malignant GI tumors. The Phase 1, which includes Dose Escalation, Backfill, and Dose Expansion to identify the MTD and determine the RDEs and RP2D. Phase 2 will confirm the safety, tolerability, and explore efficacy in selected malignant GI tumors. For both Phase 1 and Phase 2, participants will receive study treatment until 1) disease progression, 2) loss of clinical benefit in the opinion of the investigator, 3) unacceptable toxicity, 4) w…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Pathologically documented advanced/unresectable, or metastatic GI tumor. 2. Have relapsed or progressed on or after standard systemic treatments, or are intolerant to standard treatment, or for which no standard treatment is available. 3. At least one measurable lesion as assessed by the investigator according to response evaluation criteria in RECIST v1.1. 4. Has a life expectancy of ≥ 3 months. 5. Has an ECOG PS of 0-1. 6. Has LVEF ≥ 50% by either ECHO or MUGA within 28 days before enrollment. 7. Has adequate organ functions within 7 days prior to Day 1 of Cycle 1. 8.…
Interventions
- DrugDB-1324
Administered I.V.
Locations (6)
- USA02-0Grand Rapids, Michigan
- USA01-0Huntersville, North Carolina
- USA03-0Cincinnati, Ohio
- AUS02-0Randwick, New South Wales
- AUS03-0South Brisbane, Queensland
- AUS01-0Nedlands, Western Australia