Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastric (Stomach) Cancer | Childhood Gastric Carcinoma | ALIAS | 0.90 |
| GastroEsophageal Cancer | Gastric Neoplasm | PROBABILISTIC | 0.70 |
| Pancreatic Ductal Adenocarcinoma (mPDAC) | Pancreatic Ductal Adenocarcinoma | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| DA-3501 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (11)
- type
- EXPERIMENTAL
- label
- Dose Level 1
- description
- Participants will receive DA-3501 at dose level 1 administered intravenously once every three weeks.
- interventionNames
- Drug: DA-3501
- type
- EXPERIMENTAL
- label
- Dose Level 2
- interventionNames
- Drug: DA-3501
- type
- EXPERIMENTAL
- label
- Dose Level 3
- interventionNames
- Drug: DA-3501
- type
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients aged ≥ 19 years 2. Histologically or cytologically documented advanced CLDN18.2+ GC/GEJ adenocarcinoma or advanced CLDN18.2+ PDAC 3. Measurable disease as defined by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) 4. Life expectancy ≥12 weeks as judged by the Investigator Exclusion Criteria: 1. Cardiac abnormalities 2. Gastrointestinal abnormalities 3. Active and clinically significant bacterial, fungal, or viral infection, including known hepatitis B virus (HBV), known hepatitis C virus (HCV), known human immunodeficiency virus (HIV). 4. Active systemic infection requiring IV antibiotics therapy.
References
Publications (0)
Data not yet available