9MW2821 Combined With Other Antitumor Drugs in Patients With Advanced Gynecological Tumors

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

About this trial

To evaluate the safety, tolerability, and preliminary efficacy of 9MW2821 in combination with other anti-tumor agents in patients with advanced gynecological malignancies.

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.

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 advanced gynecological tumors.

Disqualifiers

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

Patients with ongoing clinically significant toxicities related to prior treatment.

Presence of Grade ≥ 2 peripheral neuropathy.

Exclusion of prior diseases and prior treatments as specified in the protocol.

Trial design

Design model

Single group

Treatments tested in this trial

  • 9MW2821+other anticancer therapy

    Drug

    Subjects will receive intravenous (IV) infusion of 9MW2821 +other anticancer therapy as per protocol

Treatment groups

260 Participants
are divided into 1 treatment group
Group A: Treatment CohortExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

ORR

Objective Response Rate

Time frame
Up to 24 months

Secondary outcomes

1

DoR

Duration of Response

Time frame
Up to 24 months
2

TTR

Time to Response

Time frame
Up to 24 months
3

DCR

Disease Control Rate

Time frame
Up to 24 months
4

PFS

Progression Free Survival

Time frame
Up to 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: