Not Yet RecruitingPhase 1/2

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

China260 participantsStarted 2025-04-15

Plain-language summary

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

Who can participate

Age range18 Years – 75 Years

SexFEMALE

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Inclusion criteria

✓. 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.
✓. Subjects must submit tumor tissues for test.
✓. Life expectancy of ≥ 12 weeks.
✓. Subjects must have measurable disease according to RECIST (version 1.1).
✓. Adequate organ functions.

Exclusion criteria

✕. 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.
✕. Comorbidities: a. Hemoglobin A1C ≥ 8%; b. Ocular diseases or symptoms present prior to the first dose of study medication; c. Severe respiratory diseases; d. Clinically significant cardiovascular or cerebrovascular diseases within 6 months prior to the first dose of study medication; e. Active autoimmune diseases within 2 years prior to the first dose of study medication, or a history of autoimmune diseases with potential for recurrence; f. Active infections; g. Severe arterial or venous thromboembolic events.
✕. Clinically significant bleeding symptoms or a clear bleeding tendency within 3 months prior to the first dose of medication.
✕. Subjects with central nervous system (CNS) metastases and/or carcinomatous meningitis.
✕. Pleural, peritoneal, or pericardial effusion with clinical symptoms or requiring repeated drainage procedures.

What they're measuring

ORR

Timeframe: Up to 24 months

Trial details

NCT IDNCT06926998

SponsorMabwell (Shanghai) Bioscience Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-05-01

Contact for this trial

Hanmei Lou, Professor

13355783145 louhm@zjcc.org.cn

View on ClinicalTrials.gov More Gynecological Malignancies trials