New hope for advanced tumors: HRS-3802 enters human testing
NCT ID NCT06770569
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-stage study tests a new drug called HRS-3802 in 100 adults with advanced solid tumors that have not responded to standard treatments. The main goals are to check the drug's safety, find the best 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
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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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About 100 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2025
- Expected to finish
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Dec 2028
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.
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. Patients must be willing to participate in the study, sign the informed consent form, have good compliance, and cooperate with follow-up visits; 2. Age ≥18 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 7 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 1 months after the last administration of the study drug Measures. Exclusion Criteria: 1. Subjects had cancerous meningitis or untreated central nervous system metastases; 2. Subjects had severe cardiovascular and cerebrovascular diseases; 3. There is third-space effusion that cannot be controlled by drainage and other methods (such as massive ascites, pleural effusion, pericardial effusion); 4. Subjects had or currently had idiopathic pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonia , drug pneumonia, or CT during screening showed active pneumonia; 5. Arteriovenous thrombosis occurred within 6 months prior to the first dose; 6. Severe infection occurred within 4 weeks prior to initial administration; 7. Subjects with refractory nausea, vomiting, or other gastrointestinal disorders that affect the use of oral medications: including malabsorption syndrome; 8. Known history of human immunodeficiency virus (HIV) seropositive status or acquired immunodeficiency syndrome (AIDS); 9. Subjects had active hepatitis; 10. Subjects were scheduled to receive other systemic antitumor therapies during the study period; 11. Known allergies and contraindications to the investigational drug or any of its components; 12. 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.
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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Cancer Hospital Chinese Academy of Medical Sciences
RECRUITINGBeijing, Beijing Municipality, 100021, China
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GenesisCare North Shore (Oncology)
ACTIVE_NOT_RECRUITINGSaint Leonards, New South Wales, 2065, Australia
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GenesisCare St Andrews
ACTIVE_NOT_RECRUITINGAdelaide, South Australia, 5000, Australia
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John Flynn Private Hospital
ACTIVE_NOT_RECRUITINGTugun, Queensland, 4224, Australia
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Macquarie University Hospital
ACTIVE_NOT_RECRUITINGSydney, New South Wales, 2109, Australia
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Peninsula and South Eastern Haematology & Oncology Group
ACTIVE_NOT_RECRUITINGFrankston, Victoria, 3199, Australia
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