Actively Recruiting
A Phase 1 Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of BA1301 in Adults With Advanced Solid Tumors
Led by Shandong Boan Biotechnology Co., Ltd · Updated on 2025-04-15
70
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting an open-label Phase 1 clinical trial to study BA1301 in adults with advanced solid tumors that cannot be surgically removed or treated effectively with standard therapies. The trial aims to evaluate the safety, tolerability, how the drug behaves in the body (pharmacokinetics), and preliminary effectiveness of BA1301. This trial is sponsored by Shandong Boan Biotechnology Co., Ltd and involves participants aged 18 to 75 years. Participants receive BA1301 through intravenous infusion once every three weeks. This treatment schedule continues as part of the study's main phase. The trial does not involve randomization or placebo control, focusing solely on the effects of BA1301. No additional study periods or extension phases are described. During the study, participants will be closely monitored for adverse events and serious adverse events from the start of treatment through up to two years after treatment ends. Researchers will assess safety and tolerability using standard criteria. Participants will also undergo evaluations to measure tumor lesions and organ function, and females of childbearing potential will have pregnancy tests. The total duration of participation depends on individual treatment and follow-up schedules.
CONDITIONS
Brief Title
A Trial to Evaluate Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of BA1301 in Advanced Solid Tumors.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily signed informed consent and able to follow the trial treatment protocol and visit plan
- Age 18 to 75 years, male or female
- Locally advanced or metastatic malignant solid tumors not suitable for surgery, confirmed by standard tests after failure, refusal, or inability to tolerate standard treatments
- Willing to provide archival or fresh tumor tissue for immunohistochemical testing of CLDN18.2 expression
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- At least one measurable tumor lesion according to RECIST1.1 criteria
- Adequate organ function
- Estimated survival of at least 3 months
- Negative blood pregnancy test for females of childbearing potential at screening
You will not qualify if you...
- Poorly controlled high blood pressure as judged by the investigator
- Received chemotherapy, radiotherapy, targeted therapy, cell therapy, immunotherapy, ADC drug therapy, major surgery, or other anticancer treatments within 28 days before starting trial drug
- Known allergy to any ingredient of the study drug
- Positive tests for hepatitis B surface antigen, hepatitis C antibody, syphilis antibody, or HIV antibody
- Pregnant or breastfeeding females or those planning pregnancy
- Participation in another clinical trial involving drugs or devices (excluding vitamins and minerals) within 28 days before consent
- Serious physical or psychiatric illness or abnormal lab tests that increase risk or interfere with study results, as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 2 years or until discontinuation
Participants receive the study drug BA1301 administered intravenously once every three weeks.
Visits every 3 weeks for drug administration and safety monitoring
Duration - Up to 2 years after end of treatment
Participants are followed for safety and adverse event monitoring after treatment ends.
Periodic visits for safety follow-up
Trial Site Locations
Total: 1 location
1
Cancer Hospital Affiliated to Harbin Medical University
Harbin, Heilongjiang, China
Actively Recruiting
Research Team
Z
Zhang Yanqiao
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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