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NCT Number: NCT06926998

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

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

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Key information

Age range

18 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.
  • Sexually active fertile subjects must agree to use methods of contraception during the study and at least 180 days after termination of study therapy.
  • Subjects are willing to follow study procedures.

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.
  • Prior Treatments: a. Major surgical procedures within 28 days prior to the first dose of study medication; b. Administration of other investigational drugs or experimental medical devices within 28 days prior to the first dose of study medication; c. Use of P-glycoprotein inhibitors or inducers, or potent CYP3A4 inhibitors within 14 days prior to the first dose of study medication; d. Receipt of live vaccines within 28 days prior to the first dose of study medication or planned administration of any live vaccine during the study period; e. Prior allogeneic hematopoietic stem cell transplantation or solid organ transplantation;.
  • Subjects with a history of drug abuse or psychiatric disorders, or suspected allergy, intolerance, or severe infusion reactions to the investigational drug or any of its components.
  • Pregnant or lactating women.
  • Not suitable to receive study treatment for other conditions as per investigator.

Treatment and study plan

9MW2821+other anticancer therapy

Drug

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

Primary outcomes

  1. ORR

    Time frame: Up to 24 months

    Objective Response Rate

Secondary outcomes

  1. DoR

    Time frame: Up to 24 months

    Duration of Response

  2. TTR

    Time frame: Up to 24 months

    Time to Response

  3. DCR

    Time frame: Up to 24 months

    Disease Control Rate

  4. PFS

    Time frame: Up to 24 months

    Progression Free Survival

  5. OS

    Time frame: Up to 24 months

    Overall Survival

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

    Time frame: 24 months

    Maximum observed concentration (Cmax)

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

    Time frame: 24 months

    Area under the concentration-time curve (AUC)

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

    Time frame: 24 months

    Half-life (t1/2)

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

    Time frame: 24 months

    Clearance (CL)

  10. Incidence of Anti-Drug Antibody (ADA)

    Time frame: 24 months

    ADA

Study contacts

Contact information is provided by the study sponsor or research team.

Hanmei Lou, Professor

CONTACT

[email protected]

13355783145

Sponsors and collaborators

Lead sponsor

Mabwell (Shanghai) Bioscience Co., Ltd.

Industry

Registry information

Official study title

An Open-Label, Multicenter Phase Ib/ll Clinical Study Evaluating the Safety and Efficacy of 9MW2821 Combined With Other Antitumor Drugs in Patients With Advanced Gynecological Tumors

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Apr 15, 2025
Registry last updated
Apr 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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