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

Launched by SHANDONG BOAN BIOTECHNOLOGY CO., LTD · Apr 7, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called BA1301 for patients with advanced solid tumors, which are types of cancer that have spread and cannot be surgically removed. The goal of the trial is to assess how safe the treatment is, how well it is tolerated, how it moves through the body, and if it shows any early signs of effectiveness. The study is currently looking for participants aged 18 to 75 who have not responded to standard cancer treatments and who can provide tumor tissue for testing.

To join the trial, participants need to be in relatively good health, meaning they should have a good level of daily functioning and certain organ functions should be working well. They also need to have at least one measurable tumor. Participants can expect regular check-ups to monitor their health and how they respond to the treatment. It's important to note that those with certain health issues or who have had recent cancer treatments may not be eligible to participate. This trial is a first step in understanding how BA1301 might help treat advanced solid tumors.

Gender

ALL

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. 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.