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Trial Title:
A Clinical Study of 9MW2821 in Advanced Malignant Solid Tumors
NCT ID:
NCT05773937
Condition:
Advanced Malignant Solid Tumors
Conditions: Official terms:
Neoplasms
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
9MW2821
Description:
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).
Arm group label:
9MW2821
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.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Beijing Cancer Hospital
Address:
City:
Beijing
Zip:
100142
Country:
China
Status:
Recruiting
Contact:
Last name:
Jun Guo, Professor
Phone:
13911233048
Email:
guoj307@126.com
Facility:
Name:
Beijing University Cancer Hospital
Address:
City:
Beijing
Zip:
100142
Country:
China
Status:
Recruiting
Contact:
Last name:
Jun Guo, Professor
Phone:
139 1123 3048
Email:
guoj307@126.com
Investigator:
Last name:
Jun Guo, Professor
Email:
Principal Investigator
Start date:
June 21, 2022
Completion date:
December 31, 2024
Lead sponsor:
Agency:
Mabwell (Shanghai) Bioscience Co., Ltd.
Agency class:
Industry
Source:
Mabwell (Shanghai) Bioscience Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05773937
