Actively Recruiting
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of GenSci140 in Participants With Advanced Solid Tumors
Led by Changchun GeneScience Pharmaceutical Co., Ltd. · Updated on 2025-12-24
170
Participants Needed
1
Research Sites
155 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a phase I, multi-center, open-label, dose-escalation (Part 1) and dose-expansion (Part 2) first-in-human study in China to evaluate the safety, tolerability, PK profile and efficacy of GenSci140 in participants with advanced solid tumors, and to determine the MTD (if any) and RDE. The dose-expansion study aims to evaluate the efficacy, safety and PK profile of GenSci140 in the treatment of ovarian cancer or other FRα-positive advanced solid tumors at different dose levels, and to select an appropriate RP2D (if applicable).
CONDITIONS
Official Title
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of GenSci140 in Participants With Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to understand and willing to sign informed consent
- Age between 18 and 75 years inclusive
- Diagnosed with advanced solid tumors
- Agree to provide fresh biopsy or archived tumor tissues for testing
- Have at least one evaluable lesion (dose-escalation) or measurable lesion (dose-expansion)
- Eastern Cooperative Oncology Group performance status 0 or 1
- Life expectancy of 3 months or more
- Adequate blood and organ function before first GenSci140 dose
- Previous anti-tumor therapy toxicities resolved to Grade 1 or less, except alopecia and peripheral neurotoxicity (Grade 2 or less)
- For congestive heart failure, must be Grade 1 or less and fully recovered before enrollment
- Normal QT interval on electrocardiogram at screening
- Negative for HIV, hepatitis B, and hepatitis C
- Women of childbearing potential must have negative pregnancy test and agree to avoid pregnancy
- Men with female partners of childbearing potential must use contraception or abstinence
You will not qualify if you...
- Past history of cancers
- Symptomatic primary central nervous system tumors, metastases, leptomeningeal carcinomatosis, or untreated spinal cord compression
- Use of investigational or anti-tumor therapy within 5 half-lives or 4 weeks before first GenSci140 dose
- Major surgery within 4 weeks prior to first dose
- Radiotherapy involving 20% or more of bone marrow or large area within 4 weeks prior to first dose or not recovered from acute radiotherapy effects
- Active significant cardiovascular disorder or heart attack within 6 months prior to first dose
- Uncontrolled active infections or serious systemic diseases despite best supportive care
- History of multiple sclerosis, demyelinating diseases, Eaton-Lambert syndrome, alcoholic liver disease, recent internal bleeding or stroke, or bleeding disorders unsuitable for enrollment
- Suspected or current treatment-related pneumonitis requiring steroids or unclear on imaging
- Uncontrolled pleural, pericardial, abdominal, or pelvic fluid requiring drainage or diuretics within 14 days prior to first dose
- Pregnant or breastfeeding women
- Known allergy to prior monoclonal antibody therapy
- Previous bone marrow transplantation
- Investigator deems participant unsuitable for the study
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
The First Hospital of China Medical University
Shenyang, Liaoning, China, 110001
Actively Recruiting
Research Team
W
Wen Xu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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