Evaluating a new treatment for advanced solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This open-label Phase 1 trial aims to assess the safety, tolerability, pharmacokinetics, and preliminary efficacy of BA1301 in patients with advanced solid tumors. Participants will receive BA1301 and will be monitored for adverse effects and treatment response. The study will include adults aged 18 to 75 with unresectable malignant tumors who have not responded to standard therapies. Tumor tissue samples will be collected for further analysis of treatment targets.

Why it matters

Who can join: the full rules

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.

Where it's running

• Cancer Hospital Affiliated to Harbin Medical University
  Harbin, Heilongjiang, China Recruiting

Study contacts

• Study coordinator: Zhang Yanqiao
• Email: yanqiaozhang@126.com
• Phone: 13845120210

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Testing EBC-129 for advanced solid tumors

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.