Actively Recruiting
A Study of IBI363 in Subjects With Advanced Malignancies
Led by Innovent Biologics (Suzhou) Co. Ltd. · Updated on 2024-07-18
556
Participants Needed
1
Research Sites
132 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is an open-label, multicenter Phase Ib study to evaluate the safety, tolerability, and efficacy of IBI363 in advanced malignancies patients
CONDITIONS
Official Title
A Study of IBI363 in Subjects With Advanced Malignancies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent and able to follow the study visit schedule and procedures
- Male or female aged between 18 and 75 years
- Histologically or cytologically confirmed advanced malignancy
- Disease progressed on or unsuitable for standard therapy, or refused standard therapy; for some groups, no prior systemic therapy for advanced disease
- At least one measurable tumor lesion according to RECIST v1.1
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- Life expectancy of 3 months or more
- Female participants of childbearing potential and male participants with partners of childbearing potential agree to use effective contraception during treatment and for 6 months after
You will not qualify if you...
- Pregnant or breastfeeding women or those intending to become pregnant before, during, or within 6 months after last study drug dose
- Active or untreated brain metastases; asymptomatic brain metastases allowed
- History of active thrombosis, deep vein thrombosis, or pulmonary embolism within 4 weeks before first dose
- Clinically significant cardiovascular or cerebrovascular disease
- Lung conditions requiring steroids or other therapy, or history of severe lung disease
- History of allergies, asthma, or atopic dermatitis
- Pleural or pericardial effusion needing repeated drainage or causing significant symptoms
- Active autoimmune disease needing systemic therapy within 2 years prior to first dose
- History of allogeneic organ or stem cell transplantation
- Known or suspected allergy to study drug or its components
- Prior serious toxicity from immune checkpoint inhibitors requiring stopping treatment
- Unresolved significant toxicities from prior cancer treatments, except certain stable ones
- Incomplete recovery from major surgery within 4 weeks before first dose
- Active uncontrolled bleeding or bleeding disorders
- Recent major gastrointestinal disease or condition
- Uncontrolled tumor pain or symptomatic high calcium levels
- Positive HIV test, active hepatitis B or C, or tuberculosis
- Severe or uncontrolled infections within 2 weeks before first dose
- Another cancer diagnosis within 5 years except certain treated skin, prostate, or thyroid cancers
- Contraindications to combination medications such as irinotecan therapy
- Any disease, treatment, or condition that may compromise safety or compliance
- Mental illness or substance abuse preventing informed consent or study participation
- Investigator's judgment that participant cannot meet protocol requirements
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Shanghai Chest Hospita
Shanghai, Shanghai Municipality, China, 20030
Actively Recruiting
Research Team
B
binbin Min
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
9
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