Can a new drug HRS-4508 tame advanced solid tumors?

NCT ID NCT06598735

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 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

Phase 1

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

Participants

About 290 people

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

Started

Nov 2024

Expected to finish

Jun 2028

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. 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.

  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

  • Cancer Hospital Chinese Academy of Medical Sciences

    RECRUITING

    Beijing, Beijing Municipality, 100021, China

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