Can a new drug HRS-4508 tame advanced solid tumors?
NCT ID NCT06598735
First seen Aug 28, 2026 · Last updated Aug 28, 2026
Summary
This phase 1 trial tests an experimental drug called HRS-4508 in people with advanced or metastatic solid tumors that have not responded to standard treatments. The main goals are to check the drug's safety, find the highest tolerable dose, and learn how the body processes it. Researchers will also watch for signs that the drug shrinks tumors. The study enrolls about 290 adults aged 18 to 75.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- HRS-4508, an experimental drug
- What this could lead to
- If HRS-4508 proves safe and effective, it could become a new treatment option for people with advanced solid tumors who have run out of standard therapies.
- What could go wrong
- This is an early phase 1 trial, so the main goals are safety and dosing, not proof of effectiveness. The drug may cause side effects or fail to shrink tumors.
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 290 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2024
- Expected to finish
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Jun 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 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. 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 18-75 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): ANC≥1.5 ×10e9/L; PLT≥100 × 10e9/L; Hb≥ 90 g/L; Cr)≤1.5 × times the upper limit of normal (ULN) or Clcr≥ 60 mL/min; LVEF≥50%; TBIL≤1.5 × times the upper limit of normal (ULN) ; ALT and AST ≤3×times the upper limit of normal (ULN)(Patients with liver metastasis, ≤5×ULN); International normalized ratio (INR) ≤ 1.5, prothrombin time (PT) and activated partial thromboplastin time (APTT) ≤ 1.5 times ULN. 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 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 had severe cardiovascular and cerebrovascular diseases. 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 or currently had idiopathic pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonia, drug pneumonia, or CT during screening showed active pneumonia. 6. Arteriovenous thrombosis occurred within 6 months prior to the first dose. 7. Severe infection occurred within 4 weeks prior to initial administration. 8. Subjects with refractory nausea, vomiting, or other gastrointestinal disorders that affect the use of oral medications: including malabsorption syndrome. 9. Known history of human immunodeficiency virus (HIV) seropositive status or acquired immunodeficiency syndrome (AIDS). 10. Subjects had active hepatitis. 11. Subjects were scheduled to receive other systemic antitumor therapies during the study period. 12. Known allergies and contraindications to the investigational drug or any of its components. 13. 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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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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