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Advanced Malignant Solid TumorsPhase 1NCT05773937

A Clinical Study of 9MW2821 in Advanced Malignant Solid Tumors

A Phase 1 study testing 9MW2821 in people with Advanced Malignant Solid Tumors, run by Mabwell (Shanghai) Bioscience Co., Ltd. at 2 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This study is a Phase 1, first-in-human, open-label, dose-escalation and cohort expansion study designed to characterize the safety, tolerability, pharmacokinetics, preliminary antitumor activity and immunogenicity of 9MW2821 administered by intravenous (IV) infusion. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Advanced Malignant Solid Tumors
What is being tested?
9MW2821
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
2 sitesChina
Study dates
21 Jun 2022to 31 Dec 2024
Phase
Phase 1
Are there results?
None posted in the registry

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 80 years
  • All sexes
  • 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.
  • Male or female subjects aged 18 to 80 years (including 18 and 80 years).
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Phase Ia：Histologically or cytologically confirmed advanced malignant solid tumors (except sarcoma). Phase Ib：Only local advanced or metastatic UC tumors.
  • Subjects must have received ICIs or GC/GP therapies in the previous treatment.
  • Subjects must submit tumor tissues for test.
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  • Life expectancy of ≥ 3 months.
  • Subjects must have measurable disease according to RECIST (version 1.1).
  • Adequate organ functions.
  • Sexually active fertile subjects, and their partners, must agree to use methods of contraception during the study and at least 6 months after termination of study therapy.
  • Subjects are willing to follow study procedures.

Who cannot join

  • Chemotherapy、radiotherapy or immunotherpy within 14 days prior to the first dose of study drug.
  • Preexisting treatment related toxicity Grade ≥ 2 (except alopecia).
  • Major surgery within 28 days prior to first dose of study drug.
  • History of uncontrolled diabetes mellitus.
  • Preexisting peripheral neuropathy Grade ≥ 2.
  • Received treatment of ADCs with MMAE payload.
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  • Any live vaccines within 4 weeks before first dose of study drug or during the study.
  • Documented history of clinically significant cardiac or cerebrovascular diseases within 6 months prior to the first dose of study drug.
  • Other severe or uncontrolled disease, i.e. severe respiratory system disease, thromboembolic events, active bleeding or active infection.
  • Uncontrolled central nervous system metastases.
  • History of another malignancy within 3 years before the first dose of study drug. Subjects with curable malignancies are allowed.
  • History of autoimmune disease requiring systemic treatment within 2 years before the first dose of study drug.
  • Has ocular conditions that may increase the risk of corneal epithelium damage.
  • Known sensitivity to any of the ingredients of the investigational product; History of drug abuse or mental illness.
  • Any P-glycoprotein (P-gp) inducers/inhibitors or CYP3A4 inducers/inhibitors for high and medium effect within 14 days prior to the first dose of study drug.
  • Use of any investigational drug or device within 30 days prior to the first dose of study drug.
  • Conditions or situations which may put the subject at significant risk.

Trial locations and contacts

2 sites in 1 country.

China2 sites, 2 recruiting

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality, 100142

    Jun Guo, Professor, 13911233048, guoj307@126.com

    Recruiting

  • Beijing University Cancer Hospital

    Beijing, Beijing Municipality, 100142

    Jun Guo, Professor, 139 1123 3048, guoj307@126.com

    Jun Guo, Professor

    Recruiting

Other trials in China

About this study

Official title: A Phase I Clinical Study of the Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of 9MW2821 in Advanced Malignant Solid Tumors

This study is a Phase 1, first-in-human, open-label, dose-escalation and cohort expansion study designed to characterize the safety, tolerability, pharmacokinetics, preliminary antitumor activity and immunogenicity of 9MW2821 administered by intravenous (IV) infusion.

Being tested
9MW2821

What participants receive

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

  • 9MW2821Drug

    All subjects will receive a single intravenous (IV) infusion of 9MW2821 once weekly for the first 3 weeks of every 4 week cycle (i.e., on Days 1, 8 and 15).

Study groups in NCT05773937
Study groupRoleWhat they receive
9MW2821ExperimentalNot described
Receives: Drug: 9MW2821

What is being measured

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

  1. Incidence of adverse events

    Measured: Up to 28 days post last drug administration

Secondary outcomes (11)

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

    Maximum observed concentration (Cmax)

    Measured: 24 months

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

    Area under the concentration-time curve (AUC)

    Measured: 24 months

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

    Half-life (t1/2)

    Measured: 24 months

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

    Clearance (CL)

    Measured: 24 months

  5. Objective Response Rate

    ORR

    Measured: Up to 24 months

  6. Disease Control Rate

    DCR

    Measured: Up to 24 months

  7. Duration of Response

    DoR

    Measured: Up to 24 months

  8. Time to Response

    TTR

    Measured: Up to 24 months

  9. Progression Free Survival

    PFS

    Measured: Up to 24 months

  10. Overall Survival

    OS

    Measured: Up to 24 months

  11. Incidence of Anti-Drug Antibody (ADA)

    ADA

    Measured: Up to 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 posted17 Mar 2023
  2. Study start21 Jun 2022
  3. Primary completion31 Dec 2024 (estimated)
  4. Study completion31 Dec 2024 (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
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05773937
Sponsor's protocol ID
9MW2821-2021-CP101
Status last verified
Sep 2024
First submitted
22 Feb 2023
Last updated
19 Sep 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Zhou W, Fang P, Yu D, Ren H, You M, Yin L, Mei F, Zhu H, Wang Z, Xu H, Cao Y, Sun X, Xu X, Bi J, Wang J, Ma L, Wang X, Chen L, Zhang Y, Cen X, Zhu X, Lou L, Liu D, Tan X, Yang J, Meng T, Shen J. Preclinical Evaluation of 9MW2821, a Site-Specific Monomethyl Auristatin E-based Antibody-Drug Conjugate for Treatment of Nectin-4-expressing Cancers. Mol Cancer Ther. 2023 Aug 1;22(8):913-925. doi: 10.1158/1535-7163.MCT-22-0743.

    PubMed 37196158

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing 9MW2821 in people with Advanced Malignant Solid Tumors, run by Mabwell (Shanghai) Bioscience Co., Ltd. at 2 sites 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 11 inclusion and 17 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: status not confirmed, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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 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.

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

Are results available for this study?

Results are not available in the source record.

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

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of adverse events (time frame: Up to 28 days post last drug administration). 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 NCT05773937, which also lists 1 linked publication.

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 19 Sep 2024.

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