Evaluating a new treatment for advanced solid tumors

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

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
• Enrollment: 94 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Zhejiang Doer Biologics Co., Ltd. (Industry-sponsored)
• Drugs / interventions: prednisone
• Locations: 1 site (Hanzhou, Zhejiang)
• Trial ID: NCT05639153 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 to 75 with advanced solid tumors who have failed or are intolerant to previous therapies.

Not a fit: Patients with early-stage tumors or those who have not yet undergone systemic therapy may not benefit from this study.

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 performed: Other studies targeting Claudin18.2 have shown promise, indicating potential for success with this approach.

Eligibility 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 this trial is running

Hanzhou, Zhejiang

• 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

Conditions Malignant Neoplasm of Digestive System; Malignant neoplasm of digestive system