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New drug HS-20197 put to the test against advanced solid tumors
NCT ID NCT07834359
First seen Sep 22, 2026 · Last updated Sep 22, 2026
Summary
Researchers are running a Phase I trial of HS-20197, an intravenous drug, in adults with advanced solid tumors that have not responded to standard treatments. The study has two parts: first, they slowly increase the dose to find the highest amount people can tolerate, then they test that dose and others in a larger group. They track side effects, how the body processes the drug, and whether tumors shrink. The goal is to find a safe dose for future studies, not to cure cancer in this trial.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- an experimental intravenous drug called HS-20197
- What this could lead to
- If HS-20197 proves safe and shows early signs of shrinking tumors, it could become a candidate for larger studies and, eventually, a new option for some advanced solid tumors.
- What could go wrong
- This is a first-in-human Phase I trial, so the main goal is safety, not cure. Many experimental cancer drugs fail to help, and participants may face side effects from an unproven treatment.
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 595 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Oct 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 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: 1. Males or females, aged ≥ 18 years. 2. Participants with pathologically (histologically or cytologically) confirmed advanced solid tumors. 3. Participants have at least 1 target lesion other than CNS lesions according to RECIST 1.1. \- Exclusion Criteria: 1. Participants have received or are receiving the following treatment: * Anti-tumor drugs within 14 days prior to the first dose of study treatment; any other IMPs or macromolecular anti-tumor drugs within 28 days prior to the first dose of study treatment. * Local radiotherapy within 2 weeks prior to the first dose of study treatment; irradiation of more than 30% of bone marrow or extensive radiotherapy within 4 weeks prior to the first dose of study treatment. * Major surgery within 4 weeks prior to the first dose of study treatment. * Participants previously treated with drugs that are moderate to strong inhibitors or moderate to strong inducers of cytochrome P450 (CYP) 3A4, strong inhibitors or strong inducers of CYP2D6, P-glycoprotein (P-gp), breast cancer resistance protein (BCRP) or drugs with a narrow therapeutic range that are sensitive substrates of P-gp or BCRP within 7 days prior to the first dose of the IMP. Participants who need to receive these drugs during the study period should also be excluded. * Current use of drugs known to prolong the QT interval or that may cause torsade de pointes. Participants who need to receive these drugs during the study period should also be excluded. * Live vaccine or live-attenuated vaccine within 28 weeks prior to the first dose. 2. Participants who have any Grade ≥ 2 residual toxicity according to Common Terminology Criteria for Adverse Events (CTCAE, version 6.0) from prior therapies (except alopecia and residual neurotoxicity). 3. Participants with a history of severe allergy (such as anaphylactic shock), previous severe infusion reactions, or allergy to recombinant human or murine proteins. 4. Participants who are allergic to any component of HS-20197.
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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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Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Experimental drug YH004 put to the test in Hard-to-Treat cancers
- Can a B7-H3-Targeted drug conjugate shrink advanced solid tumors?
- Drug delivered straight to spinal fluid targets cancer spread to brain lining
- Oral drug that targets two cancer drivers tested in first human study
- Mitochondria-Targeting drug gamitrinib tested for first time in humans
- Can a Two-Drug combo outsmart advanced cancer?