New drug HS-20110 enters human testing for Hard-to-Treat cancers
NCT ID NCT06892379
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-stage trial is testing a new drug called HS-20110 in 475 adults with advanced solid tumors that have not responded to standard treatments. The study aims to find a safe dose and see if the drug can shrink tumors. Participants receive HS-20110 by IV infusion in 21-day cycles.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- HS-20110
- 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 trial focused on safety and dosing, so it is too soon to know if HS-20110 will effectively shrink tumors. Side effects are unknown and could be serious.
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 475 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2025
- Expected to finish
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Sep 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 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: 1. Drug therapy targeting CDH17 (such as small molecule targeted drugs, monoclonal antibodies, bispecific antibodies, antibody-drug conjugates, or chimeric antigen receptor T cells). 2. 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. 3. 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. 4. Major surgery within 4 weeks prior to the first dose of study treatment. 5. 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. 6. 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. 7. 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 5.0) from prior therapies (except alopecia and residual neurotoxicity). 3. Inadequate bone marrow reserve or hepatic and renal functions. 4. Participants with a history of severe allergy (such as anaphylactic shock), previous severe infusion reactions, or allergy to recombinant human or murine proteins. 5. Participants who are allergic to any component of HS-20110.
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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
8 sites in 2 countries. 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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BRCR Medical Center INC
RECRUITINGTamarac, Florida, 33321, United States
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Carolina BioOncology Institute
RECRUITINGHuntersville, North Carolina, 28078, United States
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Fort Wayne Medical Oncology and Hematology
RECRUITINGFort Wayne, Indiana, 46804, United States
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NEXT Dallas
RECRUITINGIrving, Texas, 75039, United States
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NEXT Oncology
RECRUITINGSan Antonio, Texas, 78229, United States
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NEXT Virginia
RECRUITINGFairfax, Virginia, 22031, United States
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SUN YAT-SEN University Cancer Center
RECRUITINGGuangzhou, Guangdong, 510000, China
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The University of Texas MD Anderson Cancer Center
RECRUITINGHouston, Texas, 77030, United States
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