Phase
Condition
Neoplasms
Treatment
BA1301
Clinical Study ID
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Voluntarily signed informed consent and able to follow the trial treatment protocoland visit plan;
Age ≥ 18 years old and ≤ 75 years old, male or female;
Patients with locally advanced or metastatic malignant solid tumours that cannot besurgically resected as histologically or cytologically confirmed by standard therapyfailure or refusal or inability to tolerate standard treatment regimens.
Agree to provide archival or fresh tumour tissue for immunohistochemical evaluationfor immunohistochemical detection of CLDN18.2 expression.
Eastern Cooperative Oncology Group (ECOG) Strength Status Score of 0 or 1.
At least one evaluable lesion according to the efficacy evaluation criteria forsolid tumours (RECIST1.1).
Adequate organ function.
Estimated survival ≥ 3 months;
Negative blood pregnancy test result for females of childbearing potential atscreening.
Exclusion
Exclusion Criteria:
Poorly controlled hypertension as judged by the investigator
Received any chemotherapy, radiotherapy, targeted therapy, cell therapy,immunotherapy, ADC drug therapy, major surgery, or other anti-cancer therapy within 28 days prior to the first dose of trial drug.
Known hypersensitivity to any ingredient of the therapeutic drug used in the studyprotocol;
Positive hepatitis B virus surface antigen (HBsAg) test; Positive hepatitis C virus (HCV) antibody, treponema pallidum antibody, human immunodeficiency virus (HIV)antibody;
Pregnant or lactating females, those who have recently planned to become pregnant;
Those who have participated in and received any clinical trial drugs (excludingvitamins and minerals) or clinical trial device intervention within 28 days beforesigning informed consent;
Other serious physical or psychiatric illness or laboratory test abnormalities atscreening that may increase the risk of participating in the study, or interferewith the results of the study, and patients who, in the opinion of the investigator,are not suitable to participate in this study.
Study Design
Connect with a study center
Cancer Hospital Affiliated to Harbin Medical University
Harbin, Heilongjiang
ChinaActive - Recruiting

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