New cancer drug SHR-4298 enters early human testing
NCT ID NCT07229612
First seen Jun 25, 2026 · Last updated Aug 13, 2026 · Updated 3 times
Summary
This study is testing an experimental drug called SHR-4298 in 200 people with advanced solid tumors that cannot be removed by surgery or cured by standard treatments. The main goals are to check the drug's safety, find the best dose, and see if it can shrink tumors or slow cancer growth. The trial is not yet recruiting.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- SHR-4298 injection
- What this could lead to
- If successful, this could point toward a new treatment option for people with advanced solid tumors that have not responded to other therapies.
- What could go wrong
- This is an early phase 1/2 trial with only 200 participants, so it is too soon to know if the drug works or is safe. Side effects are unknown and the drug may not shrink tumors or improve survival.
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 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 200 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2025
- Expected to finish
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Nov 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. Subjects must voluntarily agree to participate in the trial and sign a written informed consent form. 2. ECOG performance score of 0-1. 3. Life expectancy ≥ 3 months. 4. Have at least one measurable tumor lesion per RECIST v1.1. 5. Patients with recurrent or metastatic solid tumors confirmed by histopathology and not amenable to radical surgery or radical chemoradiotherapy. 6. Good level of organ function. 7. Provide archived or fresh tumor tissue for vendor test. Exclusion Criteria: 1. Subjects with active central nervous system metastases or meningeal metastases. 2. Suffering from other malignant tumors within five years before the first use of the drug. 3. History of serious cardiovascular and cerebrovascular diseases. 4. Clinically significant bleeding symptoms occurred within 3 months before the first dose of study drug. 5. Subjects with uncontrolled tumor-related pain. 6. Clinically uncontrollable third space effusion or third space effusion requiring intervention within 7 days before the first study treatment. 7. Subjects who had a serious infection within 4 weeks before the first dose of the drug. 8. History of immunodeficiency, including a positive HIV test or active hepatitis B or C. 9. Subjects who received \> 30 Gy of chest radiotherapy within 24 weeks before the first dose of the drug, subjects who received \> 30 Gy of non-chest radiotherapy within 4 weeks before the first dose of the drug, and subjects who received ≤ 30 Gy of palliative radiation within 14 days before the first dose of the drug. 10. Underwent major organ surgery within 28 days before the first dose of the drug. 11. Those who are known to be allergic to any ingredients or excipients of SHR-4298 product. 12. Administered a live attenuated vaccine within 28 days before the first dose. 13. Female subjects who are pregnant, breastfeeding, or planning to become pregnant during the study. 14. Per the investigator's judgment, there are any other circumstances that may increase the risk of participating in the study, interfere with the study results, or make participation in the study inappropriate.
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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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The First Affiliated Hospital of Guangzhou Medical University
RECRUITINGGuangzhou, Guangdong, 510032, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- New drug cocktail aims to tackle Hard-to-Treat cancers
- New MRI scan could sharpen cancer detection