New hope for advanced cancer? experimental drug MHB009C enters human trials
NCT ID NCT07326488
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests a new drug called MHB009C 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. It is an early-stage trial, so the main focus is on safety and how the body handles the drug.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- MHB009C
- What this could lead to
- If successful, 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 an early, first-in-human trial with a small number of participants. The drug may not shrink tumors or could cause unexpected side effects.
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
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 200 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2026
- Expected to finish
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Mar 2029
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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. Histologically or cytologically confirmed advanced solid tumors that are refractory to standard therapy, intolerant to standard therapy, or have no standard treatment options. 6. At least one measurable lesion per RECIST v1.1 criteria or one bone. 7. Adequate bone marrow reserve and 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, or biologic, endocrine, or immunotherapy within 4 weeks before first study dose. 3. Medication of other unmarketed investigational drugs or therapies within 4 weeks before the first dose of investigational drug. 4. Brain metastases, bone marrow metastases, leptomeningeal disease, brainstem metastases, or spinal cord compression. 5. Severe bone damage caused by bone metastasis of prostate cancer. 6. Has adverse reactions from previous anti-tumor treatment that have not recovered to ≤ CTCAE 5.0 Grade 1. 7. Severe lung disease affecting pulmonary function. 8. Vaccinated within 4 weeks before dosing. 9. Active systemic infection requiring treatment within 7 days before dosing. 10. Serious cardiovascular or cerebrovascular diseases. 11. Uncontrolled third-space effusions not suitable for enrollment. 12. Significant bleeding, bleeding tendency, or non-healing wounds within 1 month before first dose. 13. Known hypersensitivity or delayed allergic reaction to the investigational product or its components. 14. Drug abuse or other medical/psychiatric condition that may interfere with study participation or results. 15. Known alcohol or drug dependence. 16. 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.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Fudan University Shanghai Cancer Center, Shanghai
RECRUITINGShanghai, Shanghai Municipality, 201419, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- First-in-Human trial asks whether HG381 is safe and tolerable in advanced solid tumors
- Custom-Built immune cells take aim at a notorious cancer mutation
- Experimental injection SHR-7787 put to the test against advanced solid tumors
- Experimental biologic AWT020 put to the test in Hard-to-Treat cancers
- Can a pill shrink Hard-to-Treat ovarian tumors?
- Oral drug RVU120 put to the test against advanced solid tumors