Actively Recruiting
Phase 1 Study of IBI3001 Given by Intravenous Infusion in Adults With Unresectable, Locally Advanced or Metastatic Solid Tumors
Led by Innovent Biologics (Suzhou) Co. Ltd. · Updated on 2025-01-27
250
Participants Needed
5
Research Sites
155 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting a Phase 1, open-label, first-in-human study of IBI3001 in participants with unresectable, locally advanced, or metastatic solid tumors. The study aims to find the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of IBI3001, and to explore its preliminary effectiveness in this population. Participants must have tumors that are refractory to or intolerant of standard treatment, or no standard treatment available. IBI3001 is administered by intravenous infusion at planned provisional dose levels, with the possibility of adding additional or intermediate doses during the study. The study includes both dose escalation and dose expansion phases based on tumor lesion evaluation following specific criteria. Treatment will continue while monitoring for safety and tolerability. Participants will be monitored for adverse events, changes in physical exams, and vital signs over 24 months. Researchers will assess dose-limiting toxicities to determine the MTD or RP2D. Participants must have adequate organ function, measurable or evaluable lesions, and an expected life expectancy of at least 12 weeks. Safety and preliminary efficacy will be evaluated throughout the study.
CONDITIONS
Official Title
IBI3001 in Participants With Unresectable, Locally Advanced or Metastatic Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female participants 18 years or older
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Anticipated life expectancy of at least 12 weeks
- Adequate bone marrow and organ function
- At least 1 evaluable lesion for dose escalation or 1 measurable lesion for dose expansion according to RECIST Version 1.1
- Documented unresectable, locally advanced or metastatic solid tumor refractory or intolerant to standard treatment, or no standard treatment available, or able to suspend/refuse standard therapy without major risks
You will not qualify if you...
- Progressed or refractory to an antibody-drug conjugate with an Exatecan derivative or intolerant to such therapy
- Planning to receive other antitumor therapy during the study, except palliative radiotherapy for symptom relief that does not affect tumor assessment
- Pyloric obstruction or persistent recurrent vomiting (3 or more times in 24 hours)
- Gastrointestinal perforation or fistula within 6 months prior to study drug administration and not recovered after surgery
- Known symptomatic central nervous system metastases
- History of pneumonia requiring corticosteroids or clinically significant lung diseases; uncontrolled diseases
- History of endotracheal or gastrointestinal stent implantation
- Symptomatic ascites, pleural effusion, or pericardial effusion requiring intervention
- Esophageal or gastric varices requiring immediate intervention
- Not eligible at investigator's discretion
- Inadequate treatment washout period before study drug administration
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
Wollongong Public
Wollongong, New South Wales, Australia, 2500
Actively Recruiting
2
Cancer Research SA
Adelaide, South Australia, Australia, 5000
Actively Recruiting
3
Chinese PLA General Hospital
Beijing, Beijing Municipality, China, 100853
Not Yet Recruiting
4
Shanghai East Hospital
Shanghai, Shanghai Municipality, China, 200120
Not Yet Recruiting
5
The First Affiliated Hospital of zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310003
Not Yet Recruiting
Research Team
S
Sujie Zhang
Y
Yue Qu
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here