Gastric (Stomach) CancerPhase 1NCT07481357
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 Phase 1 study testing DA-3501 in people with Gastric (Stomach) Cancer and GastroEsophageal Cancer, run by Dong-A ST Co., Ltd. at 3 sites in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Gastric (Stomach) Cancer, GastroEsophageal Cancer, Pancreatic Ductal Adenocarcinoma (mPDAC)
- What is being tested?
- DA-3501
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 3 sitesSouth Korea
- Study dates
- 18 May 2026to Feb 2029
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea3 sites, 3 recruiting
- Recruiting
CHA University Bundang Medical Center
Seongnam, Bundang, 13496
- Recruiting
Seoul National University Bundang Hospital
Seongnam, Bundang, 13620
- Recruiting
Severance Hospital
Seoul, Seoul, 03722
About this study
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
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
- Gastric (Stomach) Cancer, GastroEsophageal Cancer, Pancreatic Ductal Adenocarcinoma (mPDAC)
- Being tested
- DA-3501
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DA-3501Drug
Participant will receive DA-3501 at the assigned dose level administered intravenously once every three weeks.
| Study group | Role | What they receive |
|---|---|---|
| Dose Level 1 | Experimental | Participants will receive DA-3501 at dose level 1 administered intravenously once every three weeks. Receives: Drug: DA-3501 |
| Dose Level 2 | Experimental | Not described Receives: Drug: DA-3501 |
| Dose Level 3 | Experimental | Not described Receives: Drug: DA-3501 |
| Dose Level 4 | Experimental | Not described Receives: Drug: DA-3501 |
| Dose Level 5 | Experimental | Not described Receives: Drug: DA-3501 |
| Dose Level 6 | Experimental | Not described Receives: Drug: DA-3501 |
| Dose Level 7 | Experimental | Not described Receives: Drug: DA-3501 |
| Dose Level 8 | Experimental | Not described Receives: Drug: DA-3501 |
| Dose Level 9 | Experimental | Not described Receives: Drug: DA-3501 |
| Dose Level 10 | Experimental | Not described Receives: Drug: DA-3501 |
| Dose Level 11 | Experimental | Not described Receives: Drug: DA-3501 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose (MTD) based on Dose-Limiting Toxicities (DLTs) during Cycle 1
Measured: 21 days
Optimal Biological Effective Dose (OBED) Based on best Overall Response Rate (ORR)
Measured: 42 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2026
- Study start18 May 2026
- Primary completionFeb 2028 (estimated)
- Study completionFeb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric (Stomach) CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 51 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dong-A ST Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07481357
- Sponsor's protocol ID
- DA3501_AMST_I/IIa
- Status last verified
- May 2026
- First submitted
- 25 Feb 2026
- Last updated
- 20 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07481357
- Acronym / sponsor ID
- DA3501_AMST_I/IIa
- Conditions
- Gastric (Stomach) Cancer, GastroEsophageal Cancer, Pancreatic Ductal Adenocarcinoma (mPDAC)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 51 participants (estimated)
- Lead sponsor
- Dong-A ST Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 18 May 2026 (actual)
- Primary completion
- Feb 2028 (estimated)
- Study completion
- Feb 2029 (estimated)
- First posted
- 18 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 11
| Arm | Type | Receives |
|---|---|---|
| Dose Level 1 | Experimental | Drug: DA-3501Participants will receive DA-3501 at dose level 1 administered intravenously once every three weeks. |
| Dose Level 2 | Experimental | Drug: DA-3501 |
| Dose Level 3 | Experimental | Drug: DA-3501 |
| Dose Level 4 | Experimental | Drug: DA-3501 |
| Dose Level 5 | Experimental | Drug: DA-3501 |
| Dose Level 6 | Experimental | Drug: DA-3501 |
| Dose Level 7 | Experimental | Drug: DA-3501 |
| Dose Level 8 | Experimental | Drug: DA-3501 |
| Dose Level 9 | Experimental | Drug: DA-3501 |
| Dose Level 10 | Experimental | Drug: DA-3501 |
| Dose Level 11 | Experimental | Drug: DA-3501 |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DA-3501Participant will receive DA-3501 at the assigned dose level administered intravenously once every three weeks. | Drug | Dose Level 1, Dose Level 10, Dose Level 11, Dose Level 2, Dose Level 3, Dose Level 4, Dose Level 5, Dose Level 6, Dose Level 7, Dose Level 8, Dose Level 9 |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing DA-3501 in people with Gastric (Stomach) Cancer and GastroEsophageal Cancer, run by Dong-A ST Co., Ltd. at 3 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jiwon Shin (82-2-920-8768, jiwon_shin@donga.co.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Tolerated Dose (MTD) based on Dose-Limiting Toxicities (DLTs) during Cycle 1 (time frame: 21 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2026.