New combo therapy targets Hard-to-Treat cancers
NCT ID NCT06915142
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a new drug called HRS-7058 combined with other cancer drugs in 300 adults with advanced solid tumors that cannot be removed by surgery or have spread. The goal is to find the best dose and see if the combination is safe and shrinks tumors. Participants must have at least one measurable tumor and be in good overall health.
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 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 300 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2025
- Expected to finish
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Oct 2027
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. The subjects gave informed consent to the study before participating in, and voluntarily signed informed consent; 2. 18 to 75 years old (including both ends), gender is not limited; 3. Subjects with unresectable locally advanced or metastatic solid tumour confirmed by histopathology; 4. Having at least one evaluable or measurable lesion according to the solid tumour response Evaluation Criteria (RECIST 1.1); 5. ECOG Performance Status of 0 or 1; 6. The expected survival time is more than 12 weeks; 7. Be able to ingest drugs and be able to comply with trial and follow-up procedures; 8. Adequate bone marrow and organ function; 9. Female subjects of childbearing potential must undergo a serum pregnancy test within 7 days before the first administration of the study drug, and the result must be negative; and they must not be lactating. Female subjects of childbearing potential and male subjects whose partners are females of childbearing potential must agree to comply with contraceptive requirements from the time of signing the informed consent form until 5 months after the last administration of the study drug (for male subjects) or 8 months after the last administration of the study drug (for female subjects). Exclusion Criteria: 1. Accompanied by untreated or active central nervous system (CNS) tumour metastasis; 2. Antitumor therapy within 28 days prior to initial use of the investigational drug; 3. The adverse reactions of previous anti-tumour therapy have not recovered to CTCAE ≤ grade 1; 4. With known or suspected interstitial pneumonia; 5. With severe cardiovascular and cerebrovascular disease 6. Had other malignancies within five years prior to first use of the investigational drug; 7. Severe infection within 28 days prior to first use of the investigational drug; 8. History of immune deficiency; 9. Refractory nausea, vomiting, or other gastrointestinal disorders that affect the use of oral medications; 10. The presence of uncontrolled pleural, abdominal or pericardial effusion; 11. Had undergone major organ surgery within 28 days prior to the first use of the study drug; 12. Women during pregnancy or lactation; 13. Known allergies and contraindications to the investigational drug or any of its components; 14. According to the judgment of the investigator, there are any other circumstances that may increase the risks of participating in the study, interfere with the study results, or make the subjects unsuitable for participating in this study.
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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
2 sites. 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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Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
RECRUITINGBeijing, Beijing Municipality, 100021, China
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Tianjin Cancer Hospital
RECRUITINGTianjin, Tianjin Municipality, 300060, 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