Actively Recruiting
IBI3014 in Participants With Unresectable Locally Advanced or Metastatic Solid Tumors
Led by Innovent Biologics (Suzhou) Co. Ltd. · Updated on 2026-01-29
250
Participants Needed
3
Research Sites
114 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a phase 1/2 multicenter, multi-regional, open-label, first-in-human study of IBI3014 in participants with unresectable locally advanced or metastatic solid tumors.
CONDITIONS
Official Title
IBI3014 in Participants With Unresectable Locally Advanced or Metastatic Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to understand and provide written informed consent for all study procedures
- Male or female participants aged 18 years or older
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Expected life expectancy of 12 weeks or longer
- Not of childbearing potential or willing to use effective contraception from screening until 6 months after last dose
- Adequate bone marrow and organ function
- At least one measurable lesion per RECIST v1.1 (or one evaluable lesion for dose escalation participants)
- Not eligible for curative surgery or radical chemoradiation
You will not qualify if you...
- Use of prohibited drugs or treatments
- Unresolved adverse reactions from previous anti-tumor therapies above Grade 1 toxicity (except certain mild conditions)
- Prior use of Camptothecin-derived agents or immune checkpoint inhibitors with severe adverse reactions affecting safety
- Allergic or hypersensitive to monoclonal antibodies, Camptothecin-based therapy, or IBI3014 ingredients
- Symptomatic central nervous system metastases; asymptomatic stable CNS metastases allowed with conditions
- History of pneumonitis requiring corticosteroids or significant lung diseases
- Clinically significant cardiovascular disease
- Significant gastrointestinal disease
- Untreated biliary obstruction or elevated bilirubin above 1.5 times the upper limit of normal
- Symptomatic ascites, pleural or pericardial effusion requiring intervention
- Hepatic encephalopathy, hepatorenal syndrome, or severe liver cirrhosis
- Significant malnutrition requiring intravenous fluids (unless corrected for over 4 weeks)
- Tumor invasion of vital structures or risk of gastrointestinal/respiratory fistula
- Uncontrolled or significant infections
- History of immunodeficiency or organ transplantation
- Other uncontrolled active diseases or lab abnormalities increasing risk or affecting study results
- History of other primary cancers
- Pregnant or lactating women
- Neurological, psychiatric, or social conditions impairing consent or increasing risk
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Fujian cancer hospital
Fuzhou, Fujian, China, 350014
Actively Recruiting
2
Hunan Cancer Hospital
Changsha, Hunan, China, 410000
Actively Recruiting
3
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, China, 200433
Actively Recruiting
Research Team
W
Wei Zhang
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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