New hope for advanced cancer? first human trial of HS-20122 begins
NCT ID NCT06927570
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early-stage trial tests a new drug called HS-20122 in people with advanced solid tumors who have no other treatment options. The study aims to find the safest dose and check for side effects. Up to 1,050 participants will receive the drug intravenously and be monitored closely.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- HS-20122 (an experimental drug given intravenously)
- What this could lead to
- If it works, this could point toward a new treatment option for people with advanced solid tumors who have run out of standard therapies.
- What could go wrong
- This is a very early Phase 1 trial, so the main goal is safety, not effectiveness. The drug may not shrink tumors or may cause side effects. Success is far from guaranteed.
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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About 1,050 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2025
- Expected to finish
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Jun 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 years and older
- 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: * Males or females, aged ≥ 18 years. * Subjects with histologically or cytologically confirmed locally advanced or metastatic Solid Tumors * Standard treatment is invalid, unavailable or intolerable. * At least 1 target lesion according to RECIST 1.1. * ECOG PS score: 0-1. * Estimated Life expectancy\> 12 weeks. * Men or women should be using adequate contraceptive measures throughout the study. * Women must have the evidence of non-childbearing potential. * Signed and dated Informed Consent Form. Exclusion Criteria: * Any unresolved toxicities from prior therapy greater than Grade 2 according to Common Terminology Criteria for Adverse Events (CTCAE) 5.0 with the exception of alopecia or neurotoxicity * History of other primary malignancies. * Inadequate bone marrow reserve or organ dysfunction. * Evidence of cardiovascular risk. * Subjects with severe or poorly controlled diabetes. * Subjects with severe or poorly controlled hypertension. * Subjects with clinically significant bleeding symptoms or obvious bleeding tendency within 1 month prior to the first dose. * Subjects with severe arteriovenous thrombotic events within 3 months. * Subjects with severe infection within 4 weeks prior to the first dose. * Subjects who have received steroid therapy for more than 30 days . * Presence of known active infectious diseases. * Presence of clinically significant gastrointestinal dysfunction. * Hepatic encephalopathy, hepatorenal syndrome, or liver cirrhosis ≥ Child-Pugh Grade B. * Moderate to severe pulmonary diseases. * Prior history of significant neurological or mental disorders. * Women who are breastfeeding or pregnant or planned to be pregnant during the study period. * Hypersensitivity to any ingredient of HS-20122. * Unlikely to comply with study procedures, restrictions, and requirements in the opinion of the investigator * Any disease or condition that, in the opinion of the investigator, would compromise subject safety or interfere with study assessments Any unresolved toxicities from prior therapy greater than Grade 2 according to Common Terminology Criteria for Adverse Events (CTCAE) 5.0 with the exception of alopecia or neurotoxicity * History of other primary malignancies. * Inadequate bone marrow reserve or organ dysfunction. * Evidence of cardiovascular risk. * Subjects with severe or poorly controlled diabetes. * Subjects with severe or poorly controlled hypertension. * Subjects with clinically significant bleeding symptoms or obvious bleeding tendency within 1 month prior to the first dose. * Subjects with severe arteriovenous thrombotic events within 3 months. * Subjects with severe infection within 4 weeks prior to the first dose. * Subjects who have received steroid therapy for more than 30 days . * Presence of known active infectious diseases. * Presence of clinically significant gastrointestinal dysfunction. * Hepatic encephalopathy, hepatorenal syndrome, or liver cirrhosis ≥ Child-Pugh Grade B. * Moderate to severe pulmonary diseases. * Prior history of significant neurological or mental disorders. * Women who are breastfeeding or pregnant or planned to be pregnant during the study period. * Hypersensitivity to any ingredient of HS-20122. * Unlikely to comply with study procedures, restrictions, and requirements in the opinion of the investigator * Any disease or condition that, in the opinion of the investigator, would compromise subject safety or interfere with study assessments
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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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Ethics Committee of Sun Yat-sen University Cancer Center
RECRUITINGGuangzhou, Guangdong, 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