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Gynecological MalignanciesPhase 1/2NCT06926998

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

A Phase 1/2 study testing 9MW2821+other anticancer therapy in people with Gynecological Malignancies, run by Mabwell (Shanghai) Bioscience Co., Ltd. at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

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

Who is it for?
Ages 18 to 75 years, women only
Conditions the study is for
Gynecological Malignancies
What is being tested?
9MW2821+other anticancer therapy
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
260 participants
Where
1 siteChina
Study dates
15 Apr 2025to 1 May 2027
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Hanmei Lou, Professor contact

13355783145

louhm@zjcc.org.cn

China1 site

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang, 310022

    Hanmei Lou, 13355783145, louhm@zjcc.org.cn

Other trials in China

About this study

Official 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

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

Being tested
9MW2821+other anticancer therapy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 9MW2821+other anticancer therapyDrug

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

Study groups in NCT06926998
Study groupRoleWhat they receive
Treatment CohortExperimental9MW2821+ other anti-cancer therapy
Receives: Drug: 9MW2821+other anticancer therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. ORR

    Objective Response Rate

    Measured: Up to 24 months

Secondary outcomes (10)

  1. DoR

    Duration of Response

    Measured: Up to 24 months

  2. TTR

    Time to Response

    Measured: Up to 24 months

  3. DCR

    Disease Control Rate

    Measured: Up to 24 months

  4. PFS

    Progression Free Survival

    Measured: Up to 24 months

  5. OS

    Overall Survival

    Measured: Up to 24 months

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

    Maximum observed concentration (Cmax)

    Measured: 24 months

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

    Area under the concentration-time curve (AUC)

    Measured: 24 months

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

    Half-life (t1/2)

    Measured: 24 months

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

    Clearance (CL)

    Measured: 24 months

  10. Incidence of Anti-Drug Antibody (ADA)

    ADA

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Apr 2025
  2. Study start15 Apr 2025 (estimated)
  3. Primary completion1 May 2027 (estimated)
  4. Study completion1 May 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
260 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06926998
Sponsor's protocol ID
9MW2821-CP204
Status last verified
Apr 2025
First submitted
8 Apr 2025
Last updated
15 Apr 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing 9MW2821+other anticancer therapy in people with Gynecological Malignancies, run by Mabwell (Shanghai) Bioscience Co., Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 15 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Hanmei Lou, Professor (13355783145, louhm@zjcc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

ORR (time frame: Up to 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06926998.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2025.

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