Actively Recruiting
A First-in-human Study of IBI354 in Subjects with Locally Advanced Unresectable or Metastatic Solid Tumors
Led by Innovent Biologics (Suzhou) Co. Ltd. · Updated on 2025-03-20
368
Participants Needed
6
Research Sites
134 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a Phase 1/2, open-label, multicenter study designed to evaluate the safety, tolerability, and DLTs to establish the maximum tolerated dose (MTD) or maximum administered dose (MAD), and the RP2D of sequential doses of IBI354 (study drug), and to explore and confirm the efficacy, safety and tolerability of IBI354 in subjects with locally advanced unresectable or metastatic solid tumors.
CONDITIONS
Official Title
A First-in-human Study of IBI354 in Subjects with Locally Advanced Unresectable or Metastatic Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female subjects 18 years or older
- Phase 1a: Pathologically confirmed advanced/unresectable or metastatic solid tumor with HER2 alterations (IHC 1+, 2+, 3+, ISH+, or NGS confirmed mutation or amplification)
- Phase 1b/2: Selected solid tumors with advanced gastric cancer, breast cancer, biliary tract cancer, colorectal cancer, or gynecologic tumors with HER2 expression (IHC 1+, 2+, 3+, or ISH+)
- Adequate bone marrow and organ function
- Male and female subjects either not of childbearing potential or agree to use at least one highly effective contraception method during the study starting from screening or within 2 weeks before first dose until 6 months after last dose
- Ability to understand and provide written informed consent
- Left ventricular ejection fraction (LVEF) of 50% or higher by echocardiography within 28 days before study drug administration
You will not qualify if you...
- Received anti-tumor therapy within 4 weeks or 5 half-lives before first dose, whichever is shorter
- Planning to receive other antitumor therapy during the study except palliative radiotherapy for symptom relief without impacting tumor assessment
- Use of potent cytochrome P450 3A4 inhibitors within 2 weeks or 5 half-lives before first administration
- Unresolved adverse reactions from prior antitumor therapies above Grade 1 toxicity (except alopecia, fatigue, pigmentation, or conditions without safety risk)
- Known symptomatic central nervous system metastases
- History of pneumonia requiring corticosteroids, significant lung diseases, or suspected lung diseases by imaging at screening
- Uncontrolled diseases including infections requiring systemic treatment within 2 weeks, HIV infection, hepatitis B or C with high viral load, active COVID-19, active or recent tuberculosis or syphilis infection
- Symptomatic congestive heart failure Grade II-IV, uncontrolled arrhythmias, QTc > 480 ms, or history of congenital long/short QT syndrome
- High blood pressure (systolic ≥ 160 mmHg or diastolic ≥ 100 mmHg)
- History of arterial thromboembolic events within 6 months before first dose
- Risk or history of intestinal obstruction or perforation, inflammatory bowel disease, Crohn's disease, ulcerative colitis, or chronic diarrhea
- Inadequate treatment washout periods before study drug administration including major surgery, radiation, transplantation, hormonal therapy, chemotherapy, immunotherapy, or CYP3A4 strong inhibitors as specified
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 6 locations
1
Scientia Clinical Research Ltd
Randwick, New South Wales, Australia, 2031
Completed
2
Westmead Hospital
Sydney, New South Wales, Australia, 2145
Completed
3
Sunshine Coast University Private Hospital
Sunshine Coast, Queensland, Australia, 4575
Completed
4
Monash Health
Clayton, Victoria, Australia, 3168
Completed
5
Peking University Cancer Hospital
Beijing, Beijing Municipality, China, 100142
Actively Recruiting
6
Affiliated Cancer Hospital of Chongqing University
Chongqing, Chongqing Municipality, China, 400030
Actively Recruiting
Research Team
Y
yuan lei
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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