Advanced Solid Tumours
Conditions
Brief summary
This is an open label Phase 1, First in Human trial designed to evaluate the safety, tolerability pharmacokinetics, preliminary efficacy of BA1301 in participants with advanced solid tumors.
Interventions
DRUGBA1301
BA1301 is administered intravenously once every three weeks.
Sponsors
Shandong Boan Biotechnology Co., Ltd
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Voluntarily signed informed consent and able to follow the trial treatment protocol and visit plan; 2. Age ≥ 18 years old and ≤ 75 years old, male or female; 3. Patients with locally advanced or metastatic malignant solid tumours that cannot be surgically resected as histologically or cytologically confirmed by standard therapy failure or refusal or inability to tolerate standard treatment regimens. 4. Agree to provide archival or fresh tumour tissue for immunohistochemical evaluation for immunohistochemical detection of CLDN18.2 expression. 5. Eastern Cooperative Oncology Group (ECOG) Strength Status Score of 0 or 1. 6. At least one evaluable lesion according to the efficacy evaluation criteria for solid tumours (RECIST1.1). 7. Adequate organ function. 8. Estimated survival ≥ 3 months; 9. Negative blood pregnancy test result for females of childbearing potential at screening.
Exclusion criteria
1. Poorly controlled hypertension as judged by the investigator 2. 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. 3. Known hypersensitivity to any ingredient of the therapeutic drug used in the study protocol; 4. Positive hepatitis B virus surface antigen (HBsAg) test; Positive hepatitis C virus (HCV) antibody, treponema pallidum antibody, human immunodeficiency virus (HIV) antibody; 5. Pregnant or lactating females, those who have recently planned to become pregnant; 6. Those who have participated in and received any clinical trial drugs (excluding vitamins and minerals) or clinical trial device intervention within 28 days before signing informed consent; 7. Other serious physical or psychiatric illness or laboratory test abnormalities at screening that may increase the risk of participating in the study, or interfere with the results of the study, and patients who, in the opinion of the investigator, are not suitable to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) (according to NCI CTCAE 5.0). | From the initiation of study treatment to the completion of safety follow-up after the end of study treatment, up to 2 years. |
Countries
China
Contacts
Primary ContactZhang Yanqiao
Outcome results
None listed