Actively Recruiting
Phase I Study to Evaluate the Safety, Tolerability and Efficacy of IBI363 in Combination With Bevacizumab or Furuitinib in Subjects With Advanced Colorectal Cancer
Led by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Updated on 2025-02-12
260
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, and effectiveness of IBI363 combined with either Bevacizumab or Furuitinib in adults with advanced colorectal cancer who have progressed on or are unsuitable for standard therapies. This Phase 1 study focuses on understanding how these drug combinations work together in this patient population and is sponsored by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology. Participants receive one of two treatment combinations: IBI363 with Bevacizumab or IBI363 with Furuitinib. IBI363 is given by intravenous injection every two or three weeks, while Bevacizumab is administered intravenously and Furuitinib is taken orally. The study includes two groups receiving these combinations, with careful monitoring throughout the treatment period. During the study, participants will be closely monitored for adverse events, treatment responses, and disease control up to two years. Assessments include tracking treatment-emergent side effects, objective response rate, time to response, duration of response, progression-free survival, and overall survival. Participants will have regular visits to evaluate their health, tumor status, and any side effects, ensuring thorough safety and efficacy data collection over the study period.
CONDITIONS
Brief Title
A Study of IBI363 in Combination With Bevacizumab or Furuitinib in Subjects With Advanced Colorectal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed written informed consent and ability to comply with visit schedule and procedures
- Male or female subjects aged 18 to 75 years
- Histologically or cytologically confirmed advanced colorectal cancer
- Progressed on standard therapy, unsuitable for standard therapy, lacking standard therapy, or refused standard therapy
- Adequate organ function
- At least one measurable lesion according to RECIST v1.1
- Eastern Cooperative Oncology Group Performance Status of 0 or 1
- Life expectancy of 3 months or more
- Female subjects of childbearing potential and male subjects with partners of childbearing potential agree to effective contraception during treatment and for 6 months after
You will not qualify if you...
- Pregnant or lactating women, or those intending to become pregnant before, during, or within 6 months after last dose
- Active epileptic seizures or active central nervous system metastases
- Clinically significant cardiovascular or cerebrovascular disease
- Lung conditions requiring steroid or other therapy, or history of severe lung function abnormalities
- History of allergies, asthma, or atopic dermatitis
- Large amounts of pleural effusion or ascites
- Active autoimmune disease requiring systemic therapy within 2 years
- History of allogeneic organ or hematopoietic stem cell transplantation
- Known or suspected hypersensitivity to study drugs or excipients
- Prior severe toxicity from immune checkpoint inhibitors or Bevacizumab requiring permanent discontinuation
- Unresolved toxicity greater than Grade 1 from previous antineoplastic therapy (except certain alopecia or neuropathy)
- Active uncontrolled bleeding or bleeding tendency
- Major surgery within 4 weeks prior to first dose
- Positive HIV, active hepatitis B or C, or tuberculosis
- Severe or uncontrolled infections requiring intravenous antibiotics or unexplained fever within 2 weeks prior to first dose
- Diagnosis of another malignancy within 5 years except certain treated skin cancers, localized prostate cancer, or papillary thyroid cancer
- Any disease, treatment, or condition that may compromise safety, consent, compliance, or safety evaluation as judged by investigator
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
Participants receive IBI363 in combination with either Bevacizumab or Furuitinib as part of their treatment for advanced colorectal cancer.
Visits every 2 or 3 weeks for drug administration
Duration - Up to 2 years
Participants are monitored for safety and efficacy outcomes after treatment ends.
Periodic visits as scheduled by the study team
Trial Site Locations
Total: 1 location
1
Union Hospital, Tongji Medical College, Huazhong University Hospital
Wuhan, Hubei, China, 430000
Actively Recruiting
Research Team
Y
yanxi pu
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
FACTORIAL
Primary Purpose
TREATMENT
Number of Arms
2
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