New drug RC288 targets Hard-to-Treat tumors in early trial
NCT ID NCT07537881
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a new drug called RC288 in people with advanced solid tumors that cannot be removed by surgery or have spread. The main goals are to check safety, find the best dose, and see if it shrinks tumors. About 326 adults aged 18 to 75 with good overall health will take part. This is an early-phase trial, so the drug is not yet proven to work.
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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 326 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Apr 2026
An estimate. Start dates often move.
- Expected to finish
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Jun 2030
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. Voluntarily participate in this study, sign the informed consent form, and be able to adhere to the study protocol; 2. Age between 18 and 75 years (including 18 and 75 years); 3. ECOG PS score of 0 or 1; 4. Expected survival ≥12 weeks; 5. According to RECIST v1.1 criteria, based on imaging examinations, there is at least one measurable target lesion; 6. Sufficient bone marrow, liver, kidney, and blood clotting function Exclusion Criteria: 1. Pregnant, breastfeeding, or intending to become pregnant subjects. 2. Subjects with brain metastases. 3. Subjects with unresolved toxicities from prior anti-tumor therapy not recovered to NCI-CTCAE v6.0 Grade 1. 4. Subjects with known hypersensitivity or delayed allergic reactions to any component of the investigational drug or similar drugs. 5. Subjects with acute, chronic, or symptomatic infections. 6. Subjects with uncontrolled cardiovascular diseases. 7. Subjects with confirmed or suspected interstitial lung disease (ILD), drug-related pneumonia, radiation pneumonitis, severely impaired pulmonary function, or other pulmonary diseases. 8. History of underlying pulmonary disease. 9. Subjects with a history of cirrhosis (Child-Pugh B or C class). 10. Clinically significant gastrointestinal disease. 11. Subjects with uncontrolled diabetes (HbA1c ≥ 10%). 12. Occurrence of hemorrhagic events of Grade ≥2 per NCI CTCAE (v6.0) within 4 weeks prior to screening; or clinical manifestations suggestive of a significant bleeding tendency within 4 weeks prior to screening. 13. Imaging during the screening period shows tumor invasion or involvement of vital organs, with imaging evidence judged by the investigator to indicate a risk of bleeding or fistula formation. 14. History of arterial/venous thromboembolic events within 6 months prior to the first dose. 15. Presence of pericardial effusion or cardiac tamponade, or third-space fluid accumulation that, in the investigator's judgment, cannot be stably controlled by drainage or other methods. 16. History of active autoimmune disease requiring systemic therapy within the past 2 years. 17. History of other invasive malignancies within 5 years prior to the first dose, or evidence of residual disease from any previously diagnosed malignancy. 18. History of other acquired or congenital immunodeficiency diseases, or history of organ transplantation. 19. History of or current poorly controlled psychiatric disorder. 20. Poor compliance, and patients who are expected to be unable to cooperate with the completion of trial procedures. 21. Presence of any other disease, metabolic abnormality, physical examination finding, or laboratory abnormality that, in the investigator's judgment, gives reasonable suspicion of a condition that contraindicates the use of the investigational drug, may affect the interpretation of study results, or places the patient at high risk. 22. Local or systemic diseases not caused by malignancy, or diseases or symptoms secondary to the tumor, which may lead to higher medical risks and/or uncertainty in survival assessment.
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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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Hunan Cancer Hospital
Changsha, Hunan, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a new drug shrink advanced solid tumors?
- Can a daily pill target hard-to-treat cancers with EGFR or HER2 mutations?
- Can a Tumor-Directed injection shrink Hard-to-Treat cancers?
- Can a new drug shrink Hard-to-Treat gynecological tumors?
- Can a new drug shrink Hard-to-Treat head and neck tumors?
- Can a new drug tame tumors that resist standard therapy?