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Advanced Solid TumorPhase 1/2NCT05990452

Phase I/II FIH Study of 9MW2921 in Patients With Advanced Solid Tumors

A Phase 1/2 study testing 9MW2921 in people with Advanced Solid Tumor, run by Mabwell (Shanghai) Bioscience Co., Ltd. at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This is an open-label, Phase I-II, first-in-human (FIH) study of 9MW2921 in patients with locally advanced or metastatic solid tumors refractory to all standard therapies. The objective of this study is to evaluate the safety, tolerability, PK, immunogenicity and Preliminary Antitumor Activity of 9MW2921. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Advanced Solid Tumor
What is being tested?
9MW2921
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
261 participants
Where
1 siteChina
Study dates
28 Aug 2023to 30 Dec 2026
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
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥ 18 and ≤ 75 years old, male or female, voluntarily agree to participate in the study and sign the Informed Consent Form (ICF).
  • ECOG PS is 0 or 1.
  • Subjects must have histologically confirmed advanced and/or metastatic malignancies for which failure of standard treatment or lack/intolerant of effective standard treatment.
  • Subjects must be able to provide fresh or ≥5 slides of unstained tumor tissue.
  • Survival expectation of at least 3 months.
  • At least one measurable lesion according to RECIST v1.1.
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  • The organ function level must meet the protocol requirements.
  • Women and men of reproductive age must agree to use effective contraception from the date of signing the informed consent until 6 months after the last administration of 9MW2921, and women of reproductive age must have negative serum pregnancy test results within 7 days prior to administration.
  • Ability and willingness to understand visits, treatment, laboratory tests and other study procedures.

Who cannot join

  • History of other malignancy within 3 years.
  • Subjects with active central nervous system (CNS) metastasis or meningeal metastasis.
  • History of treatment with topoisomerase I inhibitors.
  • Anti-tumor therapy such as traditional Chinese medicine or immunomodulatory drugs within 14 days prior to the first dose of study drug, or radiotherapy, chemotherapy, biological agents, immunotherapy within the previous 21 days.
  • Adverse reactions related to previous treatments failed to recover to CTCAE 5.0 ≤1.
  • Had major surgery within 28 days before dosing, or has surgery plan during the study time (including the screening time).
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  • Subjects with clinically significant cardiovascular disease within 6 months prior to the first dose of study drug.
  • Any other serious or uncontrolled disease that, in the opinion of the investigator, would make it inappropriate to participate in the trial or would interfere with the subject's compliance with the trial protocol.
  • Subjects with active chronic inflammatory bowel disease (e.g. ulcerative colitis, Crohn's disease) or history of bowel obstruction, gastrointestinal perforation.
  • Live vaccine was administered within 28 days prior to first dose, or has plan to receive any kind of live vaccine during this study.
  • High-dose systemic corticosteroid administration within 2 weeks prior to the first dose of study drug.
  • Subjects who were allergic to any composition of investigational drug.
  • Prior autologous or allogeneic organ transplantation (except corneal transplantation) or stem cell transplantation prior to the first dose of study drug.
  • Subjects participate in other clinical trials such as medicine or medical device and use them within 28 days before the first dose.
  • Has a history of substance abuse, alcohol or drug abuse, or psychiatric illness.
  • Women who are pregnant or breastfeeding.
  • Other conditions deemed ineligible for this study by the investigator.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Fudan University Shanghai Cancer Centel

    Shanghai, 201210

Other trials in China

About this study

Official title: A Phase I/II First-in-human Study of 9MW2921 to Evaluate the Safety, Tolerability and Preliminary Efficacy of 9MW2921 in Patients With Advanced Solid Tumors

This is an open-label, Phase I-II, first-in-human (FIH) study of 9MW2921 in patients with locally advanced or metastatic solid tumors refractory to all standard therapies. The objective of this study is to evaluate the safety, tolerability, PK, immunogenicity and Preliminary Antitumor Activity of 9MW2921.

Being tested
9MW2921

What participants receive

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

  • 9MW2921Drug

    All subjects will receive 9MW2921 by intravenous (IV) every 3 weeks.

Study groups in NCT05990452
Study groupRoleWhat they receive
9MW2921ExperimentalNot described
Receives: Drug: 9MW2921

What is being measured

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

  1. Dose Limited Toxicity (DLT)

    To determine the dose limiting toxicities (DLTs) of 9MW2921

    Measured: 21 Days (first cycle)

  2. Adverse Events and Serious Adverse Events

    Percentage of patients with adverse events (AEs) and serious adverse events (SAEs)

    Measured: up to 2 years or intolerable toxicity, disease progression or death, patient withdrawal of informed consent, withdrawal from the study and so on

  3. ORR

    Defined as the percentage of subjects who experience a best response of either CR or PR.

    Measured: up to 2 years or intolerable toxicity, disease progression or death, patient withdrawal of informed consent, withdrawal from the study and so on

Secondary outcomes (7)

  1. PK Parameters: Cmax

    Maximum concentration(Cmax)

    Measured: 1 years

  2. PK Parameters: AUC

    The area under the curve (AUC)

    Measured: 1 years

  3. PK Parameters: t1/2

    The half life(t1/2)

    Measured: 1 years

  4. Incidence of ADAs Against 9MW2921

    The incidence of ADAs against 9MW2921 during the study will be summarized

    Measured: up to 2 years

  5. Progression free survival(PFS) according to RECIST 1.1

    Time from the date of first infusion to the earliest date of documented disease progression per radiological evidence or death from any cause

    Measured: up to 2 years or intolerable toxicity, disease progression or death, patient withdrawal of informed consent, withdrawal from the study and so on

  6. Duration of Response (DoR) according to RECIST 1.1

    Time from the date of the first complete response (CR) or partial response (PR) to the earliest date of disease progression or death from any cause. DOR is only defined for subjects who have best overall response of CR or PR.

    Measured: up to 2 years or intolerable toxicity, disease progression or death, patient withdrawal of informed consent, withdrawal from the study and so on

  7. Disease Control Rate (DCR) according to RECIST 1.1

    Defined as the percentage of subjects who experience a best response of CR, PR or stable disease (SD).

    Measured: up to 2 years or intolerable toxicity, disease progression or death, patient withdrawal of informed consent, withdrawal from the study and so on

Timeline

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

  1. First posted14 Aug 2023
  2. Study start28 Aug 2023
  3. Primary completion1 Sep 2026 (estimated)
  4. Study completion30 Dec 2026 (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
261 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05990452
Sponsor's protocol ID
9MW2921-2023-CP101
Status last verified
Nov 2024
First submitted
31 Jul 2023
Last updated
21 Nov 2024
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 9MW2921 in people with Advanced Solid Tumor, 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 9 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: under way, not looking for participants, as of the sponsor's last update on 21 Nov 2024. 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose Limited Toxicity (DLT) (time frame: 21 Days (first cycle)). The study lists 3 primary outcomes in all. 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 NCT05990452.

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 21 Nov 2024.

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