Advanced Malignant Solid Tumors
Conditions
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.
Interventions
DRUG9MW2821
All subjects will receive a single intravenous (IV) infusion of 9MW2821 once weekly for the first 3 weeks of every 4 week cycle (i.e., on Days 1, 8 and 15).
Sponsors
Mabwell (Shanghai) Bioscience Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of adverse events | Up to 28 days post last drug administration |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response Rate | Up to 24 months | ORR |
| Disease Control Rate | Up to 24 months | DCR |
| Duration of Response | Up to 24 months | DoR |
| Pharmacokinetic parameter：total antibody (TAb), antibody drug conjugate (ADC), and Monomethyl Auristatin E (MMAE) | 24 months | Maximum observed concentration (Cmax) |
| Progression Free Survival | Up to 24 months | PFS |
| Overall Survival | Up to 24 months | OS |
| Incidence of Anti-Drug Antibody (ADA) | Up to 24 months | ADA |
| Time to Response | Up to 24 months | TTR |
Countries
China
Outcome results
None listed