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New hope for advanced tumors? first human trial of SHR-4712 begins

NCT ID NCT06993116

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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-stage study tests a new drug called SHR-4712 in 15 adults with advanced solid tumors that have not responded to other treatments. The main goal is to check the drug's safety and how the body processes it. Participants receive the drug until their disease gets worse or side effects become too severe.

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

15 people

The number who actually took part.

Started

Jun 2025

Expected to finish

May 2027

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. The subject voluntarily participates in this study and signs the informed consent form. 2. The subject is aged between 18 and 75 years old (inclusive), regardless of gender. 3. The subject must provide tumor tissue samples for biomarker testing. 4. The subject's ECOG performance status is 0 or 1. 5. The expected survival time is ≥ 12 weeks. 6. The subject has at least one measurable lesion that meets the requirements of RECIST v1.1. 7. Laboratory test results confirm that the subject has sufficient functions of vital organs. 8. Female subjects of child-bearing potential must not be breastfeeding, have no possibility of pregnancy, and agree to comply with relevant contraceptive requirements. Exclusion Criteria: 1. The subject has a history of or currently has meningeal metastases, or has symptomatic and active central nervous system metastases. 2. The subject has spinal cord compression that has not been radically treated by surgery and/or radiotherapy. 3. The subject has uncontrollable tumor-related pain as judged by the investigator. 4. The subject has clinically symptomatic moderate or severe ascites, uncontrollable pleural effusion or pericardial effusion of moderate amount or more. 5. The subject has received systemic immunosuppressive treatment within 14 days before the first study drug administration. 6. The subject has active autoimmune diseases or a history of autoimmune diseases with a possibility of recurrence. 7. The subject has severe cardiovascular and cerebrovascular diseases. 8. The subject has other uncontrolled concomitant diseases before the first drug administration. 9. The subject has a history of severe allergic reactions to the test drug and its main formulation components. 10. The subject has a history of immunodeficiency, including positive HIV serological test results, and other acquired or congenital immunodeficiency diseases. 11. The subject has had a severe infection within 4 weeks before the first drug administration. 12. The subject has a history of active pulmonary tuberculosis infection within 1 year before enrollment as found through medical history or CT examination, or has a history of active pulmonary tuberculosis infection more than 1 year ago but has not received regular treatment. 13. The subject has other serious physical or mental diseases, known alcohol or drug dependence, abnormal laboratory test results, and other factors that may increase the risk of participating in the study or interfere with the study results, and any other situations that the investigator deems unsuitable for participation in this study.

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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

  • Fujian Cancer Hospital

    Fuzhou, Fujian, 350014, China

  • Hunan Cancer Hospital

    Changsha, Hunan, 410013, China

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