Phase I/II Clinical Study of the Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of 9MW2821 in Subjects With Advanced Malignant Solid Tumors

Mabwell (Shanghai) Bioscience Co., Ltd.1 site in 1 country208 target enrollmentJune 11, 2022

ConditionsSolid Tumors

Interventions9MW2821

Drugs9MW2821

Overview

Phase: Phase 1
Intervention: 9MW2821
Conditions: Solid Tumors
Sponsor: Mabwell (Shanghai) Bioscience Co., Ltd.
Enrollment: 208
Locations: 1
Primary Endpoint: Incidence of adverse events
Status: Recruiting
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials Related News

Overview

Brief Summary

This study is a Phase 1/2, 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.

Registry

clinicaltrials.gov

Start Date

June 11, 2022

End Date

December 2025

Last Updated

3 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Mabwell (Shanghai) Bioscience Co., Ltd.

Responsible Party

Sponsor

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
•Histologically or cytologically confirmed advanced malignant solid tumors (except sarcoma).
•For Cohort Expansion: Subjects must submit tumor tissue for Nectin-4 expression.
•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 or radiotherapy within 21 days prior to the first dose of study drug, or any other anticancer therapy 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 ≥
•Received treatment of nectin-4 targeted ADC 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.

Arms & Interventions

9MW2821

Intervention: 9MW2821

Outcomes

Primary Outcomes

Incidence of adverse events

Time Frame: Up to 28 days post last drug administration

Objective Response Rate (Phase 2)

Time Frame: Up to 24 months

Defined as the percentage of subjects who experience a best response of either CR or PR. CR and PR must be confirmed ≥ 28 days later.

Secondary Outcomes

Pharmacokinetic parameter for total antibody (TAb), antibody drug conjugate (ADC), and Monomethyl Auristatin E (MMAE)(24 months)
Progression Free Survival(Up to 24 months)
Disease Control Rate(Up to 24 months)
Duration of Response(Up to 24 months)
Time to Response(Up to 24 months)
Overall Survival(Up to 24 months)
Incidence of Anti-Drug Antibody (ADA)(Up to 24 months)