A Clinical Study of 9MW2821 in Advanced Malignant Solid Tumors
- Registration Number
- NCT05773937
- Lead Sponsor
- Mabwell (Shanghai) Bioscience Co., Ltd.
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria
- Competent to comprehend, sign, and date an independent ethics committee/institutional review board/research ethics board (IEC/IRB/REB) approved informed consent form.
- Male or female subjects aged 18 to 80 years (including 18 and 80 years).
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Phase Ia：Histologically or cytologically confirmed advanced malignant solid tumors (except sarcoma). Phase Ib：Only local advanced or metastatic UC tumors.
- Subjects must have received ICIs or GC/GP therapies in the previous treatment.
- Subjects must submit tumor tissues for test.
- Life expectancy of ≥ 3 months.
- Subjects must have measurable disease according to RECIST (version 1.1).
- Adequate organ functions.
- Sexually active fertile subjects, and their partners, must agree to use methods of contraception during the study and at least 6 months after termination of study therapy.
- Subjects are willing to follow study procedures.
Exclusion Criteria
- Chemotherapy、radiotherapy or immunotherpy within 14 days prior to the first dose of study drug.
- Preexisting treatment related toxicity Grade ≥ 2 (except alopecia).
- Major surgery within 28 days prior to first dose of study drug.
- History of uncontrolled diabetes mellitus.
- Preexisting peripheral neuropathy Grade ≥ 2.
- Received treatment of ADCs with MMAE payload.
- Any live vaccines within 4 weeks before first dose of study drug or during the study.
- Documented history of clinically significant cardiac or cerebrovascular diseases within 6 months prior to the first dose of study drug.
- Other severe or uncontrolled disease, i.e. severe respiratory system disease, thromboembolic events, active bleeding or active infection.
- Uncontrolled central nervous system metastases.
- History of another malignancy within 3 years before the first dose of study drug. Subjects with curable malignancies are allowed.
- History of autoimmune disease requiring systemic treatment within 2 years before the first dose of study drug.
- Has ocular conditions that may increase the risk of corneal epithelium damage.
- Known sensitivity to any of the ingredients of the investigational product; History of drug abuse or mental illness.
- Any P-glycoprotein (P-gp) inducers/inhibitors or CYP3A4 inducers/inhibitors for high and medium effect within 14 days prior to the first dose of study drug.
- Use of any investigational drug or device within 30 days prior to the first dose of study drug.
- Conditions or situations which may put the subject at significant risk.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 9MW2821 9MW2821 -
- Primary Outcome Measures
Name Time Method Incidence of adverse events Up to 28 days post last drug administration
- Secondary Outcome Measures
Name Time Method Disease Control Rate Up to 24 months DCR
Pharmacokinetic parameter：total antibody (TAb), antibody drug conjugate (ADC), and Monomethyl Auristatin E (MMAE) 24 months Clearance (CL)
Objective Response Rate Up to 24 months ORR
Progression Free Survival Up to 24 months PFS
Incidence of Anti-Drug Antibody (ADA) Up to 24 months ADA
Duration of Response Up to 24 months DoR
Time to Response Up to 24 months TTR
Overall Survival Up to 24 months OS
Trial Locations
- Locations (2)
Beijing Cancer Hospital
🇨🇳Beijing, Beijing, China
Beijing University Cancer Hospital
🇨🇳Beijing, Beijing, China