New hope for advanced tumors? first human trial of SHR-4712 begins
NCT ID NCT06993116
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
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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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15 people
The number who actually took part.
- Started
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Jun 2025
- Expected to finish
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May 2027
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. 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
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Fujian Cancer Hospital
Fuzhou, Fujian, 350014, China
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Hunan Cancer Hospital
Changsha, Hunan, 410013, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Oral drug RVU120 put to the test against advanced solid tumors