New drug cocktail aims to fight Hard-to-Treat cancers
NCT ID NCT07241936
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a combination of sirolimus (a targeted therapy) with several antibody-drug conjugates (ADCs) in people with advanced solid tumors that have spread or cannot be removed. The goal is to find a safe dose and see if the combo can shrink tumors. About 444 participants will be enrolled in this early-phase trial.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- sirolimus (albumin-bound) combined with antibody-drug conjugates (DP303c, SYS6043, SYS6002, SYS6010)
- What this could lead to
- If successful, this could point toward a new combination treatment option for advanced solid tumors that are hard to treat.
- What could go wrong
- This is an early-phase trial (Phase 1/2) with a small number of patients, so safety and effectiveness are not yet proven. The combination may cause significant side effects or fail to shrink tumors.
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 444 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2025
- Expected to finish
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Oct 2028
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 to 75 years
- 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\. Subjects aged 18 to 75 years (inclusive). * 2\. Patients with advanced solid tumors that are unresectable or metastatic and confirmed by histology or cytology. * 3\. At least one measurable lesion, as defined by RECIST 1.1 criteria. * 4\. ECOG performance status of 0 or 1. * 5\. Expected survival ≥ 3 months. * 6\. Adequate function of major organs and bone marrow. * 7\. Willing to provide samples of previously removed tumors or undergo fresh tumor biopsy. * 8\. Women or man of childbearing potential must use highly effective contraception. * 9\. Able to understand and voluntarily sign the written informed consent form (ICF). Exclusion Criteria: * 1\. Previous use of antibody-conjugated drugs with similar loading agents for treatment. * 2\. Previous anti-tumor treatment drugs were not adequately removed. * 3\. Active leptomeningeal disease or uncontrolled CNS metastasis. * 4\. Having a history of severe or uncontrolled cardiovascular or cerebrovascular diseases. * 5\. Previous interstitial lung disease requiring glucocorticoid treatment, Or currently suffering from interstitial lung disease/non-infectious pneumonia, or the imaging examination during the screening period cannot rule out interstitial pneumonia/lung disease. * 6\. Patients who developed severe and moderately severe lung diseases that significantly affected lung function within 6 months of the first medication administration; patients requiring supplementary oxygen therapy. * 7\. Individuals who currently have eye diseases such as corneal disorders, retinal disorders, or active ocular infections that require intervention, or who have a history of serious corneal-related eye diseases in the past; or who are unwilling to stop wearing corneal contact lenses during the study; or who have other existing eye diseases that affect the assessment of ocular toxicity after the administration of the investigational drug. * 8\. Currently suffering from skin diseases that require oral or intravenous medication treatment. * 9\. Had a history of ulcerative colitis or Crohn's disease. * 10\. Within 14 days prior to the first administration of the medication, there is a need for systemic antibacterial, antifungal or antiviral treatment for severe chronic or active infections, and there is no cure for active tuberculosis. * 11\. Known to be allergic to any component of the test drug, or allergic to the humanized monoclonal antibody product. * 12\. Participants with poor compliance.
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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
RECRUITINGShanghai, 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