New antibody drug tested in patients with advanced stomach and gut cancers
NCT ID NCT05639153
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 Hide 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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Advanced solid tumor are added.
By submitting, you agree to our Terms of use
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
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- A multicenter, Dose-Escalation and expansion phase I/IIa clinical study to evaluate the safety, tolerability, pharmacokinetic characteristics, immunogenicity, and preliminary efficacy of SGT003 in patients with advanced solid tumors
- Can a pill duo outsmart a Hard-to-Treat pancreatic cancer mutation?
- Can a new drug combo outsmart RAS-Mutated pancreatic cancer?
- Can a new drug shrink advanced solid tumors?
- Can a pill replace chemo for stomach cancer in the elderly?
- Can a new drug shrink tumors that resist standard care?