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New drug HRS-6209 tested in advanced cancer patients

NCT ID NCT05781048

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 early-phase study tests a new drug called HRS-6209 in about 56 adults with advanced solid tumors that have not responded to standard treatments. The main goals are to check the drug's safety, find the right dose, and see if it can shrink tumors. Participants will receive the drug alone and be closely monitored for side effects and tumor response.

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

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

56 people

The number who actually took part.

Started

Mar 2023

Expected to finish

Dec 2026

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 years and older

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. Patients must be willing to participate in the study, sign the informed consent form, have good compliance, and cooperate with follow-up visits. 2. Aged 18-80 years, male or female 3. Patients with advanced malignant tumors confirmed pathologically; 4. Failure of adequate standard treatment, or no effective standard treatment; 5. Patients must have at least 1 extracranial measurable target lesion per RECIST v1.1 ; 6. The expected survival period is more than 12 weeks; 7. The Eastern Cooperative Oncology Group (ECOG) physical fitness score is 0 - 1; 8. Have sufficient bone marrow and organ function (have not received blood transfusion or hematopoietic stimulating factor treatment within 14 days); 9. Female subjects of childbearing age must undergo a serum pregnancy test within 3 days before starting the study medication, and the result is negative, and are willing to use a medically approved high-efficiency contraception during the study period and within 6 months after the last administration of the study drug Measures: For male subjects whose partners are females of childbearing age, they should be surgically sterilized, or agree to use effective methods of contraception during the study period and within 3 months after the last study administration; Exclusion Criteria: 1. Subjects with a history of malignant tumors, except patients with cutaneous basal cell carcinoma, superficial bladder cancer, cutaneous squamous cell carcinoma or cervical carcinoma in situ who have undergone possible curative treatment and did not have disease recurrence within 3 years since starting the treatment; 2. Subjects had cancerous meningitis or untreated central nervous system metastases 3. Subjects experienced intestinal obstruction and gastrointestinal perforation within 3 months prior to initial medication 4. There is third-space effusion that cannot be controlled by drainage and other methods (such as massive ascites, pleural effusion, pericardial effusion); 5. Subjects had clinical cardiac symptoms or disease that was not well controlled within 6 months prior to initial medication 6. Subjects had or currently had idiopathic pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonia , drug pneumonia, or CT during screening showed active pneumonia; 7. Arteriovenous thrombosis occurred within 6 months prior to the first dose 8. Severe infection occurred within 4 weeks prior to initial administration 9. During the screening period/before the first administration, fever of unknown origin\> 38.5°C 10. Known history of human immunodeficiency virus (HIV) seropositive status or acquired immunodeficiency syndrome (AIDS) 11. Subjects had active hepatitis; 12. Subjects received live attenuated vaccine within 4 weeks or planned for the study period prior to initial administration; 13. Subjects were scheduled to receive other systemic antitumor therapies during the study period; 14. Participated in other clinical studies within 4 weeks before starting the study drug treatment; 15. Subjects were unable to swallow pills or capsules normally, or had gastrointestinal abnormalities that the researchers determined might affect drug absorption; 16. Other factors as judged by the investigator that may lead to the termination of the study, such as other serious diseases, serious laboratory test abnormalities, or family or social factors that could affect the safety of the subject, or the collection of study data and samples.

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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.

Contacts and locations

Locations

  • Fudan University Shanghai Cancer Center-

    Shanghai, Shanghai Municipality, 201321, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.