Evaluation of the Safety and Efficacy of NBL-015 in Patients With Advanced Solid Tumors

Inclusion Criteria:

1. Age ≥18, ≤75 years, (subject to the date of signing the informed consent) whovoluntarily sign the informed consent.
2. Positive expression of Claudin 18.2 which is defined as moderate to severe membranestaining (2+/3+) in ≥50% of tumor cells tested by central laboratoryimmunohistochemistry (IHC).
3. Histologically or cytologically confirmed diagnosis of advanced or metastatic solidtumors.
4. At least one measurable lesion as per RECIST version 1.1.
5. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1.
6. Life expectancy ≥12 weeks.
7. Adequate major organ function within 7 days prior to treatment.
8. Serum pregnancy tests were negative in women of reproductive age (WOCBP) within 7 daysprior to initial use of the investigational drug. Patients and their spouses mustagree to take adequate contraceptive measures from the time of signing the informedconsent until 6 months after the last dose. During this period, women are notbreastfeeding and men avoid sperm donation.

Exclusion Criteria:

1. A history of other malignancies within 3 years prior to first dose, except for locallycurable cancers.
2. Patients with central nervous system metastases.
3. Gastrointestinal abnormalities include: A) Pyloric obstruction or persistent recurrent vomiting (defined as ≥3 times ofvomiting in 24 hours); B) There is a high risk of gastrointestinal bleeding or thatthere are other gastrointestinal abnormalities affecting the drug toxicity assessmentdetermined by the investigator.
4. Patient with a history of serious cardiovascular disease.
5. A history of severe autoimmune disease that the investigator judged inappropriate forinclusion.
6. Patients with active hepatitis B or C, or active syphilis infection, or HIV positive.
7. Patients who are known to have severe allergic reactions and/or contraindications toprescription ingredients of NPL-015 or monoclonal antibodies, or who are intolerant tocombination drugs;
8. Patients who underwent major surgery (excluding needle biopsy) within 4 weeks prior toinitial use of the investigational drug, or who required elective surgery during thetrial period, or who had severe unhealed wounds, traumatic ulcers, etc.
9. Toxicity of previous antitumor therapy did not return to grade 1 or below (CTCAEV5.0), except for toxicity of alopecia and other toxicity that researchers judged tohave no safety risk.
10. Patients have previously been treated with a drug targeting Claudin18.2.
11. The time interval between the last anti-tumor treatment and the first use ofexperimental drug should meet the following requirements: A) Received antitumor therapy such as chemotherapy, radiotherapy (except localradiation therapy for pain relief), targeted therapy, immunotherapy, and otherinvestigational agents within 4 weeks prior to initial administration; B) Receivedoral fluorouracil, small-molecule targeted drugs and traditional Chinese medicine withanti-tumor indications within 2 weeks prior to initial administration.
12. Receiving a corticosteroid (prednisone>10 mg/ day or equivalent dose of the same kindof drug) or other immunosuppressant treatment, except for: A) Local, ocular, intraarticular, intranasal, and inhaled glucocorticoids; B)Short-term use of glucocorticoids for prophylactic treatment (e.g. to prevent contrastallergy).
13. Live attenuated vaccine is received within 2 weeks prior to the first use of theinvestigational drug or is planned for the study period.
14. Other conditions that the investigator considers inappropriate for participation inthis clinical trial.