Overview

This is an open, two-stage, phase I study to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of AB011 injection in patients with CLDN18.2-positive advanced solid tumors.

Eligibility

Inclusion Criteria:

• 1. Aged 18 to 80 years, either sex;
• 2. Patients with histologically or pathologically confirmed advanced solid tumors should have failed the standard treatment, or have no standard treatment regimen available, or have no access to standard treatment;
• 3. Tumor tissue samples is CLDN18.2 positive detected by central laboratory;
• 4. According to RECIST1.1, there are at least one evaluable tumor lesion during dose escalation period (period 1), and at least one measurable tumor lesion during dose expansion period (period 2);
• 5. The ECOG score is 0 to 1;
• 6. Expected survival > 3 months;
• 7. Various organs in good condition;
• 8. Fertile eligible patients (male and female) and their partners are willing to use a reliable method of contraception (hormones, barriers or abstinence) during the study and within 90 days after the last study treatment; women of childbearing potential must be tested for serum or urine pregnancy within 7 days before enrollment with negative results;
• 9. Patients are informed of this study before the trial and sign written informed consent form.

Exclusion Criteria:

• 1. Received anti-tumor therapies within 4 weeks prior to first administration of study drug, except: within 6 weeks for nitrosoureas or mitomycin C, within 2 weeks or 5 half-life of drugs (whichever longer) for oral fluorouracils and small molecular targeted drugs, and within 2 weeks for traditional Chinese medicines with indications of anti-tumor;
• 2. Received other non-marketed clinical trial drugs within 4 weeks prior to first administration of study drugs;
• 3. Received major surgery or had significant trauma within 4 weeks prior to first administration of study drug;
• 4. Received systemic corticosteroids or other immunosuppressors within 14 days prior to first administration of study drug;
• 5. Patients with AEs from previous treatment that have not recovered to CTCAE 5.0 1;
• 6. Patients have central nervous system (CNS) metastasis or meningeal metastasis, or other evidences which demonstrate the CNS metastasis or meningeal metastasis are not controlled, resulting that patients are not eligible for enrollment at the investigator's discretion;
• 7. Patients with any active infection which requires systemic treatment with of anti-infection currently;
• 8. Patients with medical history of immune deficiency;
• 9. Patients with hepatitis B; with HCV infection;
• 10. Patients have interstitial lung disease at present, or had medical history of interstitial lung disease;
• 11. Patients have significant medical history of cardiovascular and cerebrovascular diseases;
• 12. Have high risks of gastrointestinal hemorrhage at the investigator's discretion;
• 13. Patients who need long-term use of non-steroidal anti-inflammatory drugs (NSAIDs) ;
• 14. Known alcohol use or drug dependence;
• 15. Patients with mental disorders or poor compliance;
• 16. Pregnant or lactating women;
• 17. Patients have other serious systemic diseases or cannot participate in this trial due to other reasons, at the investigator's discretion.