A Clinical Study of 9MW2821 in Advanced Malignant Solid Tumors
ConditionAdvanced Malignant Solid Tumors
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-80
SponsorMabwell (Shanghai) Bioscience Co., Ltd.
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- 9MW2821
Treatment groups
40 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov