Actively Recruiting
A Clinical Study on Evaluating Intravenous Administration of IDOV-SAFE
Led by Peking University · Updated on 2025-12-23
89
Participants Needed
1
Research Sites
181 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Subjects were Chinese patients with histologically or cytologically confirmed advanced malignant solid tumors (mainly focused on MSS type colon and rectal cancer) who had failed standard systemic therapy and were inoperable. The first stage was the dose escalation stage, which was divided into 4 dose groups according to the "3+3" dose escalation principle. One patient was enrolled in the first dose group, and 3-6 patients were enrolled in each of the latter three dose groups, with a total of 10-19 patients enrolled. The second stage is the security extension stage, which is selected by SMC 1-2 dose cohorts were expanded for safety and divided into three cohorts in total(IIA, IIB, IIC) to explore the safety of sequential or combined administration modes with immune targeted therapy. Each cohort included 6-12 subjects at different dose levels, and three cohorts could be carried out at the same time. The third stage is the dose expansion stage. According to the safety, PK and clinical data of the three cohorts in the second stage, 1-2 cohorts were selected by SMC for dose expansion. The sample size of each cohort was expanded to 20 cases on the original basis. The estimated ORR of the trial drug was 24%, and the ORR of the standard treatment was 5%. When the type I error was one-sided 0.025, and the power was 80%, the sample size was estimated by the normal approximation method. So each dose expansion phase A minimum of 20 subjects were required to be enrolled in the cohort.
CONDITIONS
Official Title
A Clinical Study on Evaluating Intravenous Administration of IDOV-SAFE
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Fully understand the study and voluntarily sign informed consent
- Age between 18 and 75 years at screening
- Diagnosed with advanced malignant digestive system tumors confirmed by histology or cytology, including MSS colorectal, bile duct, stomach, esophageal, or liver cancer
- Disease progressed after or during standard treatment, or no standard treatment available, or intolerance to chemotherapy, or progressed after two lines of systemic therapy
- Physical status score (ECOG) of 0 or 1 at screening
- Life expectancy of at least 3 months as assessed by investigator
- Adequate bone marrow function: neutrophils ≥1.5x10^9/L, hemoglobin ≥90 g/L, platelets ≥75x10^9/L
- Adequate liver function: ALT and AST ≤1.5 times upper limit of normal (ULN) or ≤3 times ULN for liver metastasis or hepatocellular carcinoma; total bilirubin ≤1.5 ULN or ≤2.5 ULN for liver metastasis, hepatocellular carcinoma, or certain benign conditions
- Adequate kidney function: serum creatinine ≤1.5x ULN or creatinine clearance ≥50 mL/min
- Fertile female participants must have a negative blood beta-HCG test within 7 days before enrollment
- Agree to use effective contraception from start of informed consent until study end
- Have at least one measurable lesion per RECIST v1.1 that has not received radiotherapy or shows progression after radiotherapy
You will not qualify if you...
- Tumors that can be cured by radical treatment at screening
- Untreated or symptomatic brain metastases or uncontrolled central nervous system involvement
- Severe chronic or active infections including active hepatitis B, hepatitis C, HIV, or other serious infections within 4 weeks before treatment
- History of active autoimmune diseases or ongoing treatment with systemic steroids >10 mg/day prednisone equivalent or immunosuppressants within 14 days before treatment
- Previous allogeneic tissue or organ transplantation
- Clinically significant immunodeficiency conditions
- Use of anticoagulants or antiplatelet drugs that cannot be stopped safely before treatment
- History of severe cardiovascular or cerebrovascular disease including heart failure, reduced heart function, prolonged QT interval, recent serious cardiac events, or uncontrolled high blood pressure
- Received chemotherapy, radiotherapy, biotherapy, endocrine therapy, immunotherapy, or other treatments within 4 weeks before study drug
- Other medical conditions considered unsuitable by the investigator
- Vaccination against smallpox or monkeypox within 10 years before study drug
- Allergy to macromolecular antibody drugs or small molecule tyrosine kinase inhibitor drugs
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Beijing Cancer Hospital
Beijing, China
Actively Recruiting
Research Team
L
Lin Shen, PHD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
6
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