New drug combo targets Hard-to-Treat cancers
NCT ID NCT07126665
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early-phase trial tests two experimental drugs, MHB088C and MHB039A, given together by IV to people with advanced solid tumors that no longer respond to standard treatments. The study has two stages: first, finding the safest dose, then checking if the combination can shrink tumors. About 116 adults with various advanced cancers will take part.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- MHB088C and MHB039A (two experimental drugs given by IV)
- What this could lead to
- If it works, this could point toward a new combination treatment for advanced solid tumors that have stopped responding to standard therapy.
- What could go wrong
- This is a very early, first-in-human trial with only 116 participants. The drugs may not shrink tumors or could cause serious side effects. Success is far from guaranteed.
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 116 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2025
- Expected to finish
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Aug 2031
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. For the dose escalation stage: Histologically or cytologically confirmed advanced solid tumors that are refractory to standard therapy, intolerant to standard therapy, or have no standard treatment options. 6. For the dose expansion stage: Histologically or cytologically confirmed locally advanced or metastatic advanced solid tumors, not suitable for radical surgery and/or radical concurrent/sequential radiotherapy and chemotherapy. 7. At least one measurable lesion per RECIST v1.1 criteria. 8. Adequate bone marrow reserve and organ function. 9. Eligible participants of childbearing potential (males and females) must agree to take highly reliable contraceptive measures with their partners during the study and within at least 12 weeks after the last dose. 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 dosing. 3. Medication of other unmarketed investigational drugs or therapies within 4 weeks before dosing. 4. Brain metastases, leptomeningeal disease, brainstem metastases, or spinal cord compression. 5. Underwent major organ surgery (excluding biopsy) or significant trauma within 4 weeks before the first dose of investigational drug or requiring elective surgery during the study. 6. Previous or concurrent gastrointestinal perforation, surgical procedures and wound healing complications, as well as bleeding events. 7. Received intravenous thrombolysis treatment within 2 weeks, except for preventive anticoagulation and antiplatelet therapy. 8. Vaccinated within 4 weeks before dosing. 9. Treated with systemic corticosteroids within 14 days before dosing. 10. Severe lung disease affecting pulmonary function. 11. Active systemic infection requiring treatment within 7 days before dosing. 12. Uncontrolled third-space effusion. 13. Serious cardiovascular or cerebrovascular diseases. 14. Known hypersensitivity or delayed allergic reaction to the investigational product or its components. 15. Drug abuse or other medical/psychiatric condition that may interfere with study participation or results. 16. Known alcohol or drug dependence. 17. 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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Ethics Committee of Shanghai East Hospital
RECRUITINGShanghai, Shanghai Municipality, 201419, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Oral drug elraglusib aims to tame advanced solid tumors
- Engineered virus targets Hard-to-Treat cancers from the inside
- Engineered herpes virus takes aim at Hard-to-Treat cancers
- Engineered immune cells take aim at a common cancer target in Hard-to-Treat tumors
- New drug combo aims to shrink Hard-to-Treat tumors
- MRNA cancer shot shows promise in early trial