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
Recruiting
Phase 1
Interventional Study
Gastric (Stomach) Cancer
GastroEsophageal Cancer
Pancreatic Ductal Adenocarcinoma (mPDAC)
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 19 and older
- Sex
- Any
- Trial phase
- Phase 1
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 51 (estimated)
- Sponsor
- Dong-A ST Co., Ltd. · Industry
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About This Trial
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 tes…
Trial Locations
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Eligibility Criteria
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 a…
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