Actively Recruiting
A Trial to Evaluate Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of BA1301 in Advanced Solid Tumors.
Led by Shandong Boan Biotechnology Co., Ltd · Updated on 2025-04-15
70
Participants Needed
1
Research Sites
207 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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...
- Signed informed consent and able to follow the trial protocol and visits
- Age 18 to 75 years, male or female
- Locally advanced or metastatic malignant solid tumors not surgically resectable, confirmed by standard methods after failure or intolerance of standard treatments
- Agree to provide archival or fresh tumor tissue for CLDN18.2 testing
- Eastern Cooperative Oncology Group (ECOG) score of 0 or 1
- At least one measurable lesion according to RECIST1.1 criteria
- Adequate organ function
- Estimated survival of 3 months or more
- Negative pregnancy test for females of childbearing potential at screening
You will not qualify if you...
- Poorly controlled hypertension
- Received chemotherapy, radiotherapy, targeted therapy, cell therapy, immunotherapy, antibody drug conjugate therapy, major surgery, or other anti-cancer therapy within 28 days before first dose
- Known allergy to any component of the study drug
- Positive tests for hepatitis B surface antigen, hepatitis C antibody, syphilis antibody, or HIV antibody
- Pregnant or breastfeeding females or planning pregnancy
- Participation in other clinical trials with investigational drugs or devices within 28 days before consent
- Serious physical or psychiatric illness or lab abnormalities that increase risk or interfere with study or judged unsuitable by investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Cancer Hospital Affiliated to Harbin Medical University
Harbin, Heilongjiang, China
Actively Recruiting
Research Team
Z
Zhang Yanqiao
CONTACT
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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