Evaluating a new treatment for advanced solid tumors
Official title: An Open, Phase I, Dose Escalation and Dose Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of DR30303 in Patients With Advanced Solid Tumors
Run by Zhejiang Doer Biologics Co., Ltd. · NCT05639153 · Data updated 2026-05-14
This study is no longer in our active list. It may have stopped recruiting or finished. The details below are as of 2026-05-14 and are kept for reference. Check ClinicalTrials.gov for its current status, or see similar studies below.
This study is testing a new treatment for people with advanced solid tumors to see if it is safe and effective, especially for those with gastric and pancreatic cancers.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 94 (estimated) |
| Sponsor | Zhejiang Doer Biologics Co., Ltd. Industry-sponsored |
| Drugs / interventions | prednisone |
| Locations | 1 site (Hanzhou, Zhejiang) |
| Trial ID | NCT05639153 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include adults aged 18 to 75 with advanced solid tumors who have failed or are intolerant to previous therapies.
✕Probably not a fit
Patients with early-stage tumors or those who have not yet undergone systemic therapy may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This open-label Phase 1 trial investigates the safety, tolerability, pharmacokinetics, and preliminary efficacy of DR30303, a monoclonal antibody targeting Claudin18.2, in patients with advanced solid tumors. The study consists of two parts: a dose escalation stage to determine the optimal dosage and a dose expansion stage focusing on specific cancer types such as gastric and pancreatic cancers. Participants will receive the treatment and be monitored for responses and side effects.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced solid tumors that are difficult to treat.
How similar studies have gone: Other studies targeting Claudin18.2 have shown promise, indicating potential for success with this approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
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Sir Run Run Shaw Hospital,Zhejiang University School of Medicine
Hanzhou, Zhejiang, China Recruiting
Study contacts
- Principal investigator: Hongming Pan, MD,PhD — Sir Run Run Shaw Hospital
- Study coordinator: Senior Clinical Operations Director
- Email: yg@doerbio.com
- Phone: +86 151 9440 2868
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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DR30206 with standard chemotherapy for advanced gastrointestinal cancers
This trial tests whether adding the experimental drug DR30206 to standard chemotherapy helps adults with advanced or metastatic gastrointestinal cancers.
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Evaluating a new treatment for advanced solid tumors
This study is testing a new drug for people with advanced solid tumors who have run out of treatment options to see if it is safe and how well it works.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.