Actively Recruiting
A Clinical Study of 9MW2821 in Advanced Malignant Solid Tumors
Led by Mabwell (Shanghai) Bioscience Co., Ltd. · Updated on 2024-09-19
40
Participants Needed
2
Research Sites
132 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is a Phase 1, first-in-human, open-label, dose-escalation and cohort expansion study designed to characterize the safety, tolerability, pharmacokinetics, preliminary antitumor activity and immunogenicity of 9MW2821 administered by intravenous (IV) infusion.
CONDITIONS
Official Title
A Clinical Study of 9MW2821 in Advanced Malignant Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to understand and sign informed consent approved by ethics committee
- Male or female aged 18 to 80 years
- ECOG performance status of 0 or 1
- Histologically or cytologically confirmed advanced malignant solid tumors, except sarcoma; for Phase Ib, only locally advanced or metastatic urothelial carcinoma
- Previously treated with immune checkpoint inhibitors or GC/GP chemotherapy
- Able to submit tumor tissue samples for testing
- Life expectancy of at least 3 months
- Measurable disease as defined by RECIST version 1.1
- Adequate organ function
- Sexually active fertile participants and partners must agree to use contraception during the study and for 6 months after treatment
- Willingness to comply with study procedures
You will not qualify if you...
- Chemotherapy, radiotherapy, or immunotherapy within 14 days before first dose
- Preexisting treatment-related toxicity Grade 2 or higher, except alopecia
- Major surgery within 28 days before first dose
- Uncontrolled diabetes mellitus
- Preexisting peripheral neuropathy Grade 2 or higher
- Prior treatment with antibody-drug conjugates containing MMAE payload
- Any live vaccines within 4 weeks before first dose or during study
- Significant cardiac or cerebrovascular disease within 6 months before first dose
- Severe or uncontrolled diseases such as respiratory disease, thromboembolic events, active bleeding, or infection
- Uncontrolled central nervous system metastases
- History of another malignancy within 3 years before first dose, except curable malignancies
- Autoimmune disease requiring systemic treatment within 2 years before first dose
- Eye conditions increasing risk of corneal damage
- Known sensitivity to study drug ingredients, history of drug abuse or mental illness
- Use of P-glycoprotein or CYP3A4 inducers/inhibitors with strong or medium effect within 14 days before first dose
- Use of any investigational drug or device within 30 days before first dose
- Conditions that pose significant risk to participant
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Beijing Cancer Hospital
Beijing, Beijing Municipality, China, 100142
Actively Recruiting
2
Beijing University Cancer Hospital
Beijing, Beijing Municipality, China, 100142
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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