Actively Recruiting
Study of IBI3020 Treatment in Participants With Late-Stage Solid Tumors
Led by Innovent Biopharmaceutical Technology (Hangzhou) Co., LTD. · Updated on 2025-06-06
285
Participants Needed
9
Research Sites
152 weeks
Total Duration
On this page
Sponsors
I
Innovent Biopharmaceutical Technology (Hangzhou) Co., LTD.
Lead Sponsor
F
Fortvita Biologics (USA)Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
The main purpose of this study is to evaluate the safety and tolerability of IBI3020 and to determine the maximum tolerated dose (MTD) and/or the recommended dose for expansion (RP2D) of IBI3020.
CONDITIONS
Official Title
Study of IBI3020 Treatment in Participants With Late-Stage Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ability to understand and provide written informed consent for the trial
- Male or female participants aged 18 to 75 years for Part 1
- Histologically or cytologically confirmed unresectable, locally advanced or metastatic solid tumors with disease progression or unacceptable toxic effects after standard therapies
- At least one measurable lesion per RECIST v1.1 within 28 days before first dose
- Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1
- Minimum life expectancy of 12 weeks
- Adequate bone marrow and organ function confirmed at screening
- Participants not of childbearing potential or agreeing to use at least one highly effective contraception method during the study
You will not qualify if you...
- Previous treatment with CEACAM5-targeted therapy
- Prior anti-cancer therapy within the wash-out period
- Received live vaccines within 4 weeks or cancer vaccine within 3 months
- Use of potent CYP3A4 inhibitors within 2 weeks or 5 half-lives
- Adverse reactions from previous anti-tumor therapies not resolved to Grade 0 or 1 toxicity
- Known allergies, hypersensitivity, or intolerance to IBI3020 or its excipients
- Major surgery within 4 weeks or severe unhealed wounds
- Known symptomatic central nervous system metastases
- Uncontrolled diseases or conditions
- History of pneumonitis requiring corticosteroids or significant lung diseases
- History of thromboembolic event within 6 months
- Neurological, psychiatric, or social conditions
- Pregnant, positive pregnancy test, or lactating women
- Investigator discretion deeming participant ineligible
- Participation in other interventional clinical research
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 9 locations
1
Mayo Clinic - Arizona
Pheonix, Arizona, United States, 85054
Actively Recruiting
2
Mayo Clinic - Florida
Jacksonville, Florida, United States, 32224
Actively Recruiting
3
Mayo Clinic - Rochester
Rochester, Minnesota, United States, 55905
Actively Recruiting
4
Montefiore Cancer Center
New York, New York, United States, 10461
Actively Recruiting
5
NEXT Houston
Houston, Texas, United States, 77054
Actively Recruiting
6
NEXT Dallas
Irving, Texas, United States, 75039
Actively Recruiting
7
The sixth affiliated hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
Actively Recruiting
8
Shandong Cancer Hospital
Jinan, Shandong, China
Actively Recruiting
9
Shanxi Cancer Hospital
Taiyuan, Shanxi, China
Actively Recruiting
Research Team
S
Serena Dong
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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