New drug HRS-6209 tested in advanced cancer patients
NCT ID NCT05781048
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.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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56 people
The number who actually took part.
- Started
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Mar 2023
- Expected to finish
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Dec 2026
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 years and older
- 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.
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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
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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.
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