Trials / Not Yet Recruiting
Not Yet RecruitingNCT07481357
A First-In-Human Phase I/IIa Study to Evaluate DA 3501 in Patients With Advanced Gastric or Gastro-esophageal Junction Adenocarcinoma and Pancreatic Ductal Adenocarcinoma
A First-In-Human Phase I/IIa Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of DA 3501 in Patients With Advanced Gastric or Gastro-esophageal Junction Adenocarcinoma and Pancreatic Ductal Adenocarcinoma
- Status
- Not Yet Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 51 (estimated)
- Sponsor
- Dong-A ST Co., Ltd. · Industry
- Sex
- All
- Age
- 19 Years
- Healthy volunteers
- Not accepted
Summary
The goal of this clinical trial is to determine the MTD or OBED of DA-3501 given in Q3W to determine a wRP2D in patients with advanced CLDN18.2 expressing (CLDN18.2+) GC/GEJ and advanced CLDN18.2+ PDAC. Participants will receive the assigned dose once every three weeks and, according to the study procedures, will undergo tumor assessments as well as safety assessments, PK evaluations, and ADA testing.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | DA-3501 | Participant will receive DA-3501 at the assigned dose level administered intravenously once every three weeks. |
Timeline
- Start date
- 2026-02-01
- Primary completion
- 2028-02-01
- Completion
- 2029-02-01
- First posted
- 2026-03-18
- Last updated
- 2026-03-18
Source: ClinicalTrials.gov record NCT07481357. Inclusion in this directory is not an endorsement.