Actively Recruiting
Phase Ib Study Evaluating Safety, Tolerability, and Preliminary Efficacy of IBI363 Combination Therapy in Advanced Malignancies
Led by Innovent Biologics (Suzhou) Co. Ltd. · Updated on 2024-07-18
556
Participants Needed
1
Research Sites
78 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, and preliminary effectiveness of a drug called IBI363 combined with chemotherapy or standard care in patients with advanced cancers. This Phase Ib, open-label multicenter study includes patients whose cancers have progressed after standard treatments or who are receiving first-line treatment in some cohorts. The study aims to assess how well IBI363 works and how safe it is in these advanced malignancies. Participants will receive IBI363 combined with chemotherapy or Investigator's Choice Standard of Care, depending on their specific cancer type and treatment history. The study includes several groups focusing on different advanced cancers such as non-small cell lung cancer, colorectal cancer, biliary tract tumors, esophageal squamous cell carcinoma, gastric cancer, triple-negative breast cancer, and platinum-resistant ovarian cancer. Some groups involve patients who have failed prior therapies, while others include those receiving first-line treatment. Treatment is given according to each group's protocol and monitored carefully. During the study, participants will have regular assessments for adverse events up to 90 days after treatment and ongoing evaluations of cancer response and survival for up to two years. Researchers will monitor blood levels of IBI363 and immune responses as well. The study includes safety checks, physical exams, and imaging to measure tumors. Participants are expected to comply with visit schedules and follow-up assessments to help researchers understand the treatment's impact and safety profile over time.
CONDITIONS
Brief 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 study visit schedule and procedures
- Male or female aged 18 to 75 years
- Histologically or cytologically confirmed advanced malignancy
- Disease progressed on, unsuitable for, lacking, or refused standard therapy; some cohorts may include patients without prior systemic therapy
- At least one measurable lesion per RECIST v1.1
- ECOG Performance Status of 0 or 1
- Life expectancy of 3 months or more
- Agreement to use effective contraception during treatment and for 6 months after (for females of childbearing age and male partners)
You will not qualify if you...
- Pregnant, lactating, or planning pregnancy before, during, or within 6 months after last study drug dose
- Active or untreated CNS metastases; asymptomatic brain metastases allowed
- History of active thrombosis, deep vein thrombosis, or pulmonary embolism within 4 weeks prior to first dose
- Significant cardiovascular or cerebrovascular disease
- Lung diseases requiring steroids or history of severe abnormal lung function
- History of allergies, asthma, or atopic dermatitis
- Pleural or pericardial effusion needing repeated drainage or causing symptoms
- Active autoimmune disease requiring systemic therapy within 2 years prior to first dose
- History of organ or stem cell transplantation
- Known hypersensitivity to study drug or excipients
- Prior severe toxicity from immune checkpoint inhibitors requiring discontinuation
- Unresolved Grade >1 toxicity from prior cancer therapy, except certain stable conditions
- Incomplete recovery from recent major surgery
- Active uncontrolled bleeding or bleeding disorders
- Recent major gastrointestinal disease
- Uncontrolled tumor-related pain or symptomatic hypercalcemia
- Positive HIV, active hepatitis B or C, or tuberculosis
- Severe or uncontrolled infection within 2 weeks prior to first dose
- Other malignancy diagnosed within 5 years, with specified exceptions
- Contraindications to combination medications like irinotecan
- Conditions or history compromising safety, consent, compliance, or study evaluation
- Mental illness or substance abuse interfering with consent or evaluations
- Investigator judgment of inability to fulfill protocol requirements
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 2 years or until disease progression or discontinuation
Participants receive IBI363 combined with chemotherapy or Investigator's Choice Standard of Care as part of their treatment for advanced malignancies.
Regular visits for treatment administration and monitoring
Duration - Up to 90 days after the last administration
Participants are monitored for safety and treatment outcomes after the last administration of study drugs.
Approximately 3 visits during follow-up
Trial Site Locations
Total: 1 location
1
Shanghai Chest Hospita
Shanghai, Shanghai Municipality, China, 20030
Actively Recruiting
Research Team
B
binbin Min
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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