Recruiting
A Phase I Clinical Study of the Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of 9MW2821 in Advanced Malignant Solid Tumors
What is being tested
9MW2821
Drug
Who is being recruted
From 18 to 80 Years
+28 Eligibility Criteria
How is the trial designed
Treatment Study
Phase 1
Interventional
Study Start: June 2022
Summary
Principal SponsorMabwell (Shanghai) Bioscience Co., Ltd.
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner
Study start date: June 21, 2022
Actual date on which the first participant was enrolled.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.
Official TitleA Phase I Clinical Study of the Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of 9MW2821 in Advanced Malignant Solid Tumors
Principal SponsorMabwell (Shanghai) Bioscience Co., Ltd.
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
40 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Criteria
Any sex
Biological sex of participants that are eligible to enroll.From 18 to 80 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Criteria
11 inclusion criteria required to participate
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.
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17 exclusion criteria prevent from participating
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.
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Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 2 locations
Recruiting
Recruiting
Beijing University Cancer Hospital
Beijing, ChinaRecruiting
2 Study Centers