New antibody drug tested in patients with advanced stomach and gut cancers

NCT ID NCT05639153

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-stage study tested a new drug called DR30303 in 13 people with advanced digestive system cancers that had stopped responding to standard treatments. The drug is a lab-made antibody designed to target a protein called CLDN18.2 found on some cancer cells. The main goals were to check safety, find the best dose, and see if the drug could shrink tumors.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

13 people

The number who actually took part.

Started

May 2022

Finished

Mar 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Fully informed of this study and voluntarily sign informed consent form (ICF). 2. Aged 18 to 75 years, gender is not limited. 3. Part 1: Dose escalation stage - the subject have histologically or cytologically confirmed locally advanced or metastatic malignant solid tumors who have failed or are intolerant to prior systemic therapy. 4. Part 2: Dose expansion stage- CLDN18.2 positive confirmed by central laboratory locally advanced unresectable or metastatic gastric cancer (GC)/gastroesophageal junction (GEJ ) or Pancreatic cancer those who had failed or were intolerant to at least 1 line of systemic therapy. 5. The Eastern Cooperative Oncology Group (ECOG) score is 0 to 1. 6. Expected survival ≥ 3 months. 7. Adequate organ function. 8. Referring to the RECIST 1.1 standard, there is at least one measurable lesion. Exclusion Criteria: 1. Radical radiotherapy was performed within 12 weeks before the first dose of study drug. 2. Subjects who have received other systemic anti-tumor therapy within 4 weeks before the first dose of study drug. 3. Subjects who received or are scheduled to receive live attenuated vaccine within 4 weeks. 4. Received systemic steroids equivalent to \>10mg/d prednisone within 2 weeks before the first dose of study drug, except inhaled steroids. 5. Subjects who have undergone or are expected to undergo major surgery, or have severe unhealed wounds, etc. prior to the first dose of study drug. 6. Ever received any treatments targeting Claudin18.2. 7. Subject who have a history of allergy to any component in the DR30303. 8. Subject with uncontrolled intracranial metastases. 9. Uncontrollable pleural effusion, pericardial effusion and ascites effusion existed before enrollment. 10. hepatitis B virus (HBV), hepatitis C virus (HCV), HIV or syphilis infection. 11. Diseases or associated risks that are judged by the investigator to be inappropriate for enrollment, such as poorly controlled diabetes,etc. 12. Subjects with interstitial lung disease requiring treatment such as oral or intravenous corticosteroids. 13. Subjects with previous or concomitant malignancies, with the following exceptions: non- melanoma skin carcinoma in situ, superficial bladder cancer, etc. 14. Clinically significant cardiovascular and cerebrovascular diseases within 6 months before the first dose of study drug, such as New York Heart Association (NYHA) class III or IV congestive heart failure, etc. 15. Female patients who are breastfeeding. 16. The investigator assesses that the subject is unable or unwilling to comply with the requirements of the research protocol. 17. Participated in other clinical studies within the past 4 Weeks.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Sir Run Run Shaw Hospital,Zhejiang University School of Medicine

    Hanzhou, Zhejiang, 311100, China

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