A Trial to Evaluate Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of BA1301 in Advanced Solid Tumors.
Trial Parameters
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.
Eligibility Criteria
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.