A Clinical Study of 9MW2821 in Advanced Malignant Solid Tumors
A Phase I Clinical Study of the Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of 9MW2821 in Advanced Malignant Solid Tumors
1 other identifier
interventional
40
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Jun 2022
Typical duration for phase_1
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 21, 2022
CompletedFirst Submitted
Initial submission to the registry
February 22, 2023
CompletedFirst Posted
Study publicly available on registry
March 17, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2024
CompletedSeptember 19, 2024
September 1, 2024
2.5 years
February 22, 2023
September 9, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Incidence of adverse events
Up to 28 days post last drug administration
Secondary Outcomes (11)
Pharmacokinetic parameter：total antibody (TAb), antibody drug conjugate (ADC), and Monomethyl Auristatin E (MMAE)
24 months
Pharmacokinetic parameter：total antibody (TAb), antibody drug conjugate (ADC), and Monomethyl Auristatin E (MMAE)
24 months
Pharmacokinetic parameter：total antibody (TAb), antibody drug conjugate (ADC), and Monomethyl Auristatin E (MMAE)
24 months
Pharmacokinetic parameter：total antibody (TAb), antibody drug conjugate (ADC), and Monomethyl Auristatin E (MMAE)
24 months
Objective Response Rate
Up to 24 months
- +6 more secondary outcomes
Study Arms (1)
9MW2821
EXPERIMENTALInterventions
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).
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142, China
Beijing University Cancer Hospital
Beijing, Beijing Municipality, 100142, China
Related Publications (1)
Zhou W, Fang P, Yu D, Ren H, You M, Yin L, Mei F, Zhu H, Wang Z, Xu H, Cao Y, Sun X, Xu X, Bi J, Wang J, Ma L, Wang X, Chen L, Zhang Y, Cen X, Zhu X, Lou L, Liu D, Tan X, Yang J, Meng T, Shen J. Preclinical Evaluation of 9MW2821, a Site-Specific Monomethyl Auristatin E-based Antibody-Drug Conjugate for Treatment of Nectin-4-expressing Cancers. Mol Cancer Ther. 2023 Aug 1;22(8):913-925. doi: 10.1158/1535-7163.MCT-22-0743.
PMID: 37196158DERIVED
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 22, 2023
First Posted
March 17, 2023
Study Start
June 21, 2022
Primary Completion
December 31, 2024
Study Completion
December 31, 2024
Last Updated
September 19, 2024
Record last verified: 2024-09