Actively Recruiting
Treatment of Advanced and Metastatic Solid Tumors With MIL97
Led by Beijing Mabworks Biotech Co., Ltd. · Updated on 2024-03-13
62
Participants Needed
1
Research Sites
254 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a Phase 1, global, multi-center, open-label, multiple-dose, first-in-human study of MIL97 to evaluate the safety, tolerability, pharmacokinetics, biomarkers and efficacy in subjects with advanced or metastatic solid tumor. The study consists of a dose escalation phase and a dose expansion phase. An accelerated titration design (cohorts 1-2 only) followed by 3+3 dose-escalation design will be used in dose escalation phase. The starting dose for dose escalation phase is 0.01 mg/kg Q3W, followed by 5 dose cohorts (0.03mg/kg Q3W, 0.1mg/kg Q3W, 0.2mg/kg Q3W, 0.3mg/kg Q3W and 0.45mg/kg Q3W). Duration of dose limiting toxicity (DLT) observation is 21 days. Based on data of 3-week treatment regimen, one or two dose levels may be chosen for Q2w regimen. Duration of dose limiting toxicity (DLT) observation is 28 days. One or two dose cohorts will be chosen (either 2-week regimen or 3-week regimen cohorts) to expand to total of 10 subjects in each cohort for further exploration of PK as well as safety and efficacy.
CONDITIONS
Official Title
Treatment of Advanced and Metastatic Solid Tumors With MIL97
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult patients, 18 years of age or older
- Diagnosis of refractory or relapsed metastatic and/or unresectable solid tumors
- At least one measurable extracranial lesion that has not been irradiated
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Life expectancy of at least 12 weeks
- Adequate organ and bone marrow function within 7 days before enrollment
- Able and willing to provide written informed consent and follow the study protocol
You will not qualify if you...
- History of myocardial infarction within 6 months or arterial thromboembolic event within 3 months before first dose
- Medical conditions interfering with therapy including interstitial pneumonia, symptomatic congestive heart failure, unstable angina, uncontrolled hypertension, severe cardiac arrhythmia, active coagulopathy, uncontrolled diabetes, or prolonged QTc interval
- Known or suspected autoimmune disorders except certain controlled conditions
- History of central nervous system metastases or primary brain tumor, leptomeningeal disease, or spinal cord compression
- Receipt of allograft or allogeneic hematopoietic stem cell transplant
- Presence of another active invasive cancer
- Active serious infections requiring intravenous antibiotics
- History of primary immunodeficiency or HIV/AIDS-related illness
- Active significant bacterial, fungal, or viral infections including hepatitis B or C
- Antitumor therapy within 4 weeks prior to study (except palliative radiotherapy)
- Major surgery within 4 weeks prior or expected during study
- Use of immunosuppressive agents within 14 days before treatment except certain steroids
- Previous exposure to CD40 antibodies
- Live attenuated vaccine within 28 days before study or planned during study without approval
- Unresolved toxicities from prior therapy greater than grade 1
- Known allergy or sensitivity to MIL97 or related substances
- Pregnancy or lactation; refusal to use birth control during study and 6 months after
- Participation in another therapeutic clinical study within specified timeframes
- Any significant psychiatric, social, or medical condition that might increase risk or interfere with participation
AI-Screening
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Trial Site Locations
Total: 1 location
1
Chinese PLA General Hospital
Beijing, Beijing Municipality, China, 100853
Actively Recruiting
Research Team
J
Jianming Xu, Ph.D
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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