Actively Recruiting
Evaluate the Safety, Tolerability and Pharmacokinetic Characteristics of BAT8008 for Injection
Led by Bio-Thera Solutions · Updated on 2026-02-09
182
Participants Needed
2
Research Sites
234 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Objectives:To evaluate the safety and tolerability of BAT8008 for injection in patients with advanced solid tumors, explore the maximum tolerated dose (MTD), and provide the recommended dose for subsequent clinical trials.
CONDITIONS
Official Title
Evaluate the Safety, Tolerability and Pharmacokinetic Characteristics of BAT8008 for Injection
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older, any gender
- Voluntarily signed informed consent
- Histopathologically or cytologically confirmed advanced or metastatic epithelial-derived solid tumors
- Failed, intolerant to, or refused standard therapy
- At least one measurable tumor lesion per RECIST1.1
- ECOG Performance Status score of 0 or 1
- Expected survival of at least 12 weeks
- Adequate organ and bone marrow function
- Fertile females and males willing to use effective contraception during the study
- Willing to provide archived or fresh tumor tissue samples
- Able and willing to comply with study and follow-up procedures
You will not qualify if you...
- Received experimental drug treatment or participated in medical device clinical research within 4 weeks before first study drug administration
- Received other anti-tumor treatments within 4 weeks prior, including chemotherapy, radiotherapy (except palliative radiotherapy completed at least 2 weeks prior), targeted therapy, immunotherapy, or hormone therapy (except alternative therapy)
- Used traditional Chinese medicine, Chinese patent medicine, or immunomodulatory drugs with anti-tumor effects within 2 weeks before first dose
- Persistent adverse events greater than grade 1 from previous anti-tumor treatments, except alopecia, pigmentation, or irreversible distal toxicity
- Required major surgery within 4 weeks before first dose or expected during study
- Previously received Trop2 targeted therapy
- History of treatment with exatecan, irinotecan, or other topoisomerase I inhibitors with grade 3 or higher adverse events or treatment failure
- History of allograft cell or solid organ transplantation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Affiliated Cancer Hospital of Chongqing University
Chongqing, Chongqing Municipality, China
Actively Recruiting
2
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
Actively Recruiting
Research Team
W
WeiNing Li
CONTACT
Z
Zhaohe Wang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
7
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