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Solid TumorsPhase 1/2NCT07265622

First-in-human Study of 7MW4911 in Patients With Advanced Solid Tumors

A Phase 1/2 study testing 7MW4911 in people with Solid Tumors, run by Mabwell (Shanghai) Bioscience Co., Ltd. at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This is the first-in-human study of 7MW4911 in Chinese patients, to investigate its prelimary safety and efficacy in patients with Advanced Solid Tumors. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Solid Tumors
What is being tested?
7MW4911
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
1 siteChina
Study dates
12 Nov 2025to Dec 2028
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

  • Aged 18~75.
  • ECOG 0-1.
  • Life expectancy ≥ 3 months.
  • Participants with pathologically (histologically or cytologically) confirmed advanced solid tumors.
  • Disease progression after the most recent treatment regimen.
  • At least one measurable lesion according to RECIST v1.1.
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  • Provision of archival tumor tissue or fresh biopsy.
  • Adequte hematologic funciton, liver function and renal function.
  • Comply with contraceptive requirements.

Who cannot join

  • Other concurrent malignancy in the recent 3 years except for adequately treated carcinoma in situ.
  • Active, untreated or symptomatic CNS metastasis.
  • Effusions that require frequent drainage.
  • Patients with active autoimmune disease, except for type I diabetes, hypothyroidism and other autoimmune disease that does not require systemic treatment.
  • Severe respiratory disease that required hospitalization in the last 28 days.
  • Significant and uncontrolled cardiovascular disease or events in the 6 months prior to study drug administration.
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  • Poorly controlled blood glucose with fasting blood glucose above 10 mmol/L.
  • Recipient of allogeneic stem cell transplant or organ transplant
  • Active HIV or hepatitis B/C infection. Infection requiring systemic IV in the 14 days prior to study drug administration.
  • Experiencing toxicities from prior anti-cancer therapies that have not recovered to CTCAE grade 0-1, except for alopecia and endocrinopathies.
  • Prohibited treatment and treatment that requires washout period: (1) Has received another Topo-I payload ADC, and/or another CDH17 targeting therapy. (2) Received other cancer therapy within 5 half-lives or 21 days prior to study drug administration. (3) Major surgeries within 28 days prior to study drug administration. (4) Investigational therapy within 28 days prior to study drug administration. (5) Systemic treatment with immunosuppressive agents within 28 days prior to first drug administration. Physiological dose of glucocorticoid, topical glucocorticoid are allowed. (6) Use of strong CYP3A4 inhibitor or inducer.
  • Known hypersensitivity to 7MW4911 or components of the formulation.
  • Abuse of narcotic or psychoactive drugs.
  • Pregnant or breastfeeding women.
  • Other circumstances or conditions where the investigator judges to be unsuitable for study.

Trial locations and contacts

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

Lei Cong contact

+86-18756936922

lei.cong@mabwell.com

China1 site, 1 recruiting

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality, 200032

    Xianjun Yu, +86-021-64175590, yuxianjun@fudanpci.org

    Recruiting

Other trials in China

About this study

Official title: A Phase I/II Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of 7MW4911 in Patients With Advanced Solid Tumors

This is the first-in-human study of 7MW4911 in Chinese patients, to investigate its prelimary safety and efficacy in patients with Advanced Solid Tumors.

Conditions
Solid Tumors
Being tested
7MW4911

What participants receive

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

  • 7MW4911Drug

    7MW4911 for IV infusion of various dose strengths administered

Study groups in NCT07265622
Study groupRoleWhat they receive
7MW4911ExperimentalNot described
Receives: Drug: 7MW4911

What is being measured

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

  1. Incidence and rates of adverse events

    To assess the safety and tolerability of 7MW4911 in patients with advanced colorectal cancer and other advanced gastrointestinal tumors

    Measured: Up to approximately 2 years

  2. Maximum tolerated dose (MTD), recommended expansion dose (RED) and the recommended phase II dose (RP2D)

    To determine the maximum tolerated dose (MTD) and recommended expansion dose (RED) or the recommended phase II dose (RP2D)

    Measured: Up to approximately 2 years

Secondary outcomes (7)

  1. Objective response rate

    Proportion of patients whose turmor response meet the criteria of complete response or partial response

    Measured: Up to approximately 2 years

  2. Progression-free survival

    Duration in months from treatment to disease progression or death from any cause, whichever occurs first.

    Measured: Up to approximately 2 years

  3. Immunogenicity

    Incidence and rates of ADA

    Measured: Up to approximately 2 years

  4. Tmax

    Time to maximum concentration of 7MW4911 in blood

    Measured: Up to 3 months

  5. Cmax

    Maximum concentration of 7MW4911 in bloood

    Measured: Up to 3 months

  6. t1/2

    Time to decrease of 7MW4911 concentration by 50% in blood

    Measured: Up to 3 months

  7. Area under the curve

    Area Under the Plasma Concentration-Time Curve from Time Zero to Last Measurable Concentration (AUC0-t)

    Measured: Up to 3 months

Timeline

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

  1. First posted5 Dec 2025
  2. Study start12 Nov 2025
  3. Primary completionJul 2027 (estimated)
  4. Study completionDec 2028 (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
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07265622
Sponsor's protocol ID
7MW4911-CP102
Status last verified
Dec 2025
First submitted
16 Nov 2025
Last updated
29 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing 7MW4911 in people with Solid Tumors, 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 15 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: looking for participants now, as of the sponsor's last update on 29 Dec 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 Lei Cong (+86-18756936922, lei.cong@mabwell.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence and rates of adverse events (time frame: Up to approximately 2 years). The study lists 2 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 NCT07265622.

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 29 Dec 2025.

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