Can a new injection shrink Hard-to-Treat tumors?
NCT ID NCT07769242
First seen Aug 17, 2026 · Last updated Aug 18, 2026 · Updated 1 time
Summary
This trial is testing an investigational drug called SHR-8203, given as an injection, in people with advanced or metastatic solid tumors that have not responded to standard treatments or for which no standard treatment exists. The study aims to find the safest dose, understand how the drug behaves in the body, and see if it can shrink tumors or slow their growth. Participants will receive one of several dose levels, and researchers will monitor side effects and measure treatment response.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- SHR-8203 injection
- What this could lead to
- If successful, this could offer 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 trial, so the drug may not work or may cause unexpected side effects. Success in this small group does not guarantee broader benefit.
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.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2029
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. Age between 18 and 75 years old, gender not limited; 2. Be willing to participate and abide by the requirements of the research protocol, and be willing to cooperate with the follow-up. 3. Participants with advanced or metastatic solid tumors confirmed by histological or cytological pathology who have failed standard treatment (disease progression or toxic intolerance) or have no effective standard treatment; 4. Able to provide sufficient fresh or archived tumor tissue specimens for the third-party central laboratory designated by the sponsor. 5. Have at least one measurable lesion as per RECIST v1.1; 6. ECOG PS score: 0-1; 7. Good organ function level. Exclusion Criteria: 1. Imaging studies show that the tumor invades major blood vessels or has an unclear boundary with blood vessels, and researchers determine that there is a risk of massive hemorrhage; 2. Suffering from hypertension and unable to achieve good control through antihypertensive drug treatment; 3. Pleural effusion, pericardial effusion or peritoneal effusion accompanied by clinical symptoms, poorly controlled, or moderate to severe; 4. Major arterial or venous thrombosis events occurred within 6 months before the first administration of medication; 5. Participants who have experienced severe infections within one month prior to the first medication.
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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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Shanghai East Hospital
Shanghai, Shanghai Municipality, 200433, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- First-in-Human trial asks whether HG381 is safe and tolerable in advanced solid tumors
- Custom-Built immune cells take aim at a notorious cancer mutation
- Experimental injection SHR-7787 put to the test against advanced solid tumors
- Experimental biologic AWT020 put to the test in Hard-to-Treat cancers
- Can a pill shrink Hard-to-Treat ovarian tumors?
- Oral drug RVU120 put to the test against advanced solid tumors