NCT06281678 · Innovent Biologics (Suzhou) Co. Ltd.
A Study of IBI363 in Subjects with Advanced Solid Malignancies
What this study is about
This is a Phase 2, where both patients and doctors know the treatment given, conducted at multiple hospitals study designed to evaluate the effectiveness, safety and how well patients handle the treatment of IBI363 (study drug) in subjects with advanced, refractory solid malignancies.
View original scientific description
This is a Phase 2, open-label, multicenter study designed to evaluate the efficacy, safety and tolerability of IBI363 (study drug) in subjects with advanced, refractory solid malignancies.
Interventions
DRUG
IBI363
IBI363 will be administered as an intravenous (IV) infusion every 2 weeks or every 3 weeks. Subjects will receive study medication until disease progression, toxicity intolerance, withdrawal of consent, the duration of treatment reaches 24 months, or any other reason that requires discontinuation of the study treatment, whichever occurs first.
Primary outcome measures
Objective response rate (ORR)
Time frame: up to 2 years
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Subjects have the ability to understand and give written informed consent for participation in this trial, including all evaluations and procedures as specified by this protocol; 2. Male or female subjects ≥ 18 years old; 3. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1; 4. Anticipated life expectancy of ≥ 3 months;
Exclusion criteria
- Inadequate bone marrow and organ function; 2. Received previous anti-tumor therapy: Any chemotherapy or targeted small molecule therapy (standard or investigational) within 2 weeks or 5 plasma half-lives. Received Nitrosoureas and mitomycin C within 6 weeks prior to first dose of study drug and during study; Any anti-cancer monoclonal antibody (mAb) within 4 weeks prior to first dose 3. Received live vaccines within 28 days prior to first administration of the study drug or plan on receiving any live vaccine during the study; 4. Has adverse reactions resulting from previous antitumor therapies, w
Where
- San Francisco, California
- Ocala, Florida
- Plantation, Florida
- Fairway, Kansas
- Dearborn, Michigan
- Troy, Michigan
- Houston, Texas
- Seattle, Washington
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Dec 19, 2024 · Source of record for eligibility and locations