Health TrialsbyHealthPanel

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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • 9MW2821

    Drug

    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).

Treatment groups

40 Participants
are divided into 1 treatment group
Group A: 9MW2821Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of adverse events

Time frame
Up to 28 days post last drug administration

Secondary outcomes

1

Pharmacokinetic parameter：total antibody (TAb), antibody drug conjugate (ADC), and Monomethyl Auristatin E (MMAE)

Maximum observed concentration (Cmax)

Time frame
24 months
2

Pharmacokinetic parameter：total antibody (TAb), antibody drug conjugate (ADC), and Monomethyl Auristatin E (MMAE)

Area under the concentration-time curve (AUC)

Time frame
24 months
3

Pharmacokinetic parameter：total antibody (TAb), antibody drug conjugate (ADC), and Monomethyl Auristatin E (MMAE)

Half-life (t1/2)

Time frame
24 months
4

Pharmacokinetic parameter：total antibody (TAb), antibody drug conjugate (ADC), and Monomethyl Auristatin E (MMAE)

Clearance (CL)

Time frame
24 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mabwell (Shanghai) Bioscience Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov
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