New drug RC288 targets Hard-to-Treat tumors in early trial

NCT ID NCT07537881

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

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

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 326 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Apr 2026

An estimate. Start dates often move.

Expected to finish

Jun 2030

An estimate. End dates often move.

Lead sponsor

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

18 to 75 years

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Hunan Cancer Hospital

    Changsha, Hunan, China

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