Health TrialsbyHealthPanel

A Clinical Study of 9MW2821 (and PD-1 Inhibitor) in Locally Advanced or Metastatic Triple-Negative Breast Cancer

ConditionTriple-Negative Breast Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorMabwell (Shanghai) Bioscience Co., Ltd.

About this trial

This study is a Phase 2, open-label,multicenter study designed to evaluate the efficacy and safety of 9MW2821monotherapy or combined with PD-1 inhibitor in locally advanced or metastatic Triple-Negative Breast Cancer.

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 75 years (including 18 and 75 years).

Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

Histopathological diagnosed of locally advanced or metastatic triple negative breast cancer. Not suitable for radical therapy.

Disqualifiers

Preexisting treatment related toxicity Grade ≥ 2 and Grade ≥ 3 immune related adverse reactions

Preexisting peripheral neuropathy Grade ≥ 2.

Hemoglobin A1C (HbA1c) ≥ 8%.

Has ocular conditions that may increase the risk of corneal epithelium damage.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 9MW2821

    Drug

    Subjects will receive intravenous (IV) infusion of 9MW2821 as per protocol

  • PD-1 inhibitior

    Drug

    Subjects will receive intravenous (IV) infusion of PD-1 inhibitor as per protocol

Treatment groups

160 Participants
are divided into 3 treatment groups
Group A: Treatment Cohort A:9MW2821Experimental treatment 1 intervention
Group B: Treatment Cohort B:9MW2821+PD-1 inhibitiorExperimental treatment 2 interventions
Group C: Treatment Cohort C:9MW2821 ±PD-1 inhibitiorExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Objective Response Rate

ORR

Time frame
Up to 24 months

Secondary outcomes

1

Duration of Response

DoR

Time frame
Up to 24 months
2

Time to Response

TTR

Time frame
Up to 24 months
3

Disease Control Rate

DCR

Time frame
Up to 24 months
4

Progression Free Survival

PFS

Time frame
Up to 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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