A Clinical Study of 9MW2821 Monotherapy or Combined With Other Anticancer Therapy in Advanced Solid Tumors

ConditionSolid Tumors
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorMabwell (Shanghai) Bioscience Co., Ltd.

About this trial

This study is a Phase Ib/ll, open-label, multicenter study designed to evaluate the safety and efficacy of 9MW2821 monotherapy or combined with other anticancer therapy in advanced solid tumors.

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 recurrent or locally advanced or metastatic solid tumors.

Disqualifiers

History of another malignancy within 3 years before the first dose of study drug.

Ongoing clinically significant toxicities related to prior treatment.

Grade ≥ 2 peripheral neuropathy.

Severe or uncontrolled gastrointestinal diseases.

Trial design

Design model

Single group

Treatments tested in this trial

  • 9MW2821

    Drug

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

  • Other anti-cancer therapy

    Drug

    Subjects will receive other anticancer therapy as per protocol

Treatment groups

188 Participants
are divided into 2 treatment groups
Group A: Combination CohortExperimental treatment 2 interventions
Group B: Single agent CohortExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of AE/SAE (phase Ib)

Adverse event (AE), serious adverse event (SAE)

Time frame
Up to approximately 24 months
2

Objective Response Rate, ORR (phase II)

The proportion of participants with complete response (CR) or partial response (PR)

Time frame
Up to approximately 24 months

Secondary outcomes

1

Duration of Response, DOR

Time from the date of the first CR or PR to the earliest date of disease progression or death

Time frame
Up to approximately 24 months
2

Time To Response, TTR

Time from the date of first infusion to the date of CR or PR

Time frame
Up to approximately 24 months
3

Disease Control Rate, DCR

The percentage of subjects who experience CR, PR or stable disease (SD)

Time frame
Up to approximately 24 months
4

Progression-Free Survival, PFS

Time from the date of first infusion to the earliest date of disease progression or death

Time frame
Up to approximately 24 months

Other outcomes

Sponsors and contacts

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

This trial is not recruiting at the moment. You can still explore other options: