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New hope for advanced cancer? experimental drug MHB046C enters human trials

NCT ID NCT06985355

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study tests a new drug called MHB046C in 200 people with advanced solid tumors that no longer respond to standard treatments. The goal is to find a safe dose and see if the drug can shrink tumors. Participants receive the drug intravenously every three weeks.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
MHB046C
What this could lead to
If it works, this could point toward a new treatment option for people with advanced solid tumors who have run out of standard therapies.
What could go wrong
This is a very early, first-in-human trial, so the drug may not work or could cause unexpected side effects. Success in early phases does not guarantee later approval.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 200 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2025

Expected to finish

May 2031

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Voluntarily agrees to participate in the study and signs the informed consent form. 2. Age ≥ 18 years, no restriction on gender. 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. 4. Estimated life expectancy ≥ 3 months. 5. Able to understand and comply with the study protocol and follow-up procedures. 6. Histologically or cytologically confirmed advanced solid tumors that are refractory to standard therapy, intolerant to standard therapy, or have no standard treatment options. 7. At least one measurable lesion per RECIST v1.1 criteria. 8. Adequate organ function. Exclusion Criteria: 1. History of ≥2 primary malignancies within 5 years prior to informed consent. 2. Received chemotherapy within 3 weeks, radiotherapy within 4 weeks (2 weeks for palliative bone radiotherapy), or biologic, endocrine, or immunotherapy within 4 weeks before first study dose. 3. Brain metastases (unless asymptomatic, no edema, stable ≥4 weeks without steroids), leptomeningeal disease, brainstem metastases, or spinal cord compression. 4. Severe lung disease affecting pulmonary function. 5. Active systemic infection requiring treatment within 7 days before dosing. 6. Serious cardiovascular or cerebrovascular diseases 7. Uncontrolled third-space effusions not suitable for enrollment: 8. Uncontrolled diabetes, including ketoacidosis or hyperosmolar state within 6 months. 9. Significant bleeding, bleeding tendency, or non-healing wounds within 1 month before first dose. 10. Known hypersensitivity or delayed allergic reaction to the investigational product or its components. 11. Drug abuse or other medical/psychiatric condition that may interfere with study participation or results. 12. Known alcohol or drug dependence. 13. Pregnant or breastfeeding women, or individuals planning to conceive.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Guangdong Provincial People's Hospital

    RECRUITING

    Guangzhou, Guangdong, China

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