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
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: DA-3501.
- Who it may be relevant to
- Registry conditions: Gastric (Stomach) Cancer, GastroEsophageal Cancer, Pancreatic Ductal Adenocarcinoma (mPDAC). Basic parameters: from 19 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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.
Interventions
- Drug DA-3501
Participant will receive DA-3501 at the assigned dose level administered intravenously once every three weeks.
Primary outcome measures
- Maximum Tolerated Dose (MTD) based on Dose-Limiting Toxicities (DLTs) during Cycle 1 [Time frame: 21 days]
- Optimal Biological Effective Dose (OBED) Based on best Overall Response Rate (ORR) [Time frame: 42 days]
Eligibility criteria
Inclusion criteria
- Patients aged ≥ 19 years
- Histologically or cytologically documented advanced CLDN18.2+ GC/GEJ adenocarcinoma or advanced CLDN18.2+ PDAC
- Measurable disease as defined by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)
- Life expectancy ≥12 weeks as judged by the Investigator
Exclusion criteria
- Cardiac abnormalities
- Gastrointestinal abnormalities
- 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).
- Active systemic infection requiring IV antibiotics therapy.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
South Korea · 3 centers
- CHA University Bundang Medical Center — Seongnam
- Seoul National University Bundang Hospital — Seongnam
- Severance Hospital — Seoul
Identifiers
NCT: NCT07481357 · DA3501_AMST_I/IIa