Solid TumorsPhase 1NCT06892379
A Study of HS-20110 in Participants With Advanced Solid Tumors
A Phase 1 study testing HS-20110 (Phase Ia：Dose escalation ) and HS-20110 (Phase Ib:Dose expansion ) in people with Solid Tumors, run by Hansoh BioMedical R&D Company at 8 sites in 2 countries.
Trial summary
This is an open-label, multicenter study to evaluate the safety and tolerability of HS-20110 in participants with advanced solid malignant tumors Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumors
- What is being tested?
- HS-20110 (Phase Ia：Dose escalation ) and HS-20110 (Phase Ib:Dose expansion )
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 475 participants
- Where
- 8 sitesin 2 countries
- Study dates
- 26 Feb 2025to 30 Sep 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males or females, aged ≥ 18 years.
- Participants with pathologically (histologically or cytologically) confirmed advanced solid tumors.
- Participants have at least 1 target lesion other than CNS lesions according to RECIST 1.1.
Who cannot join
- Participants have received or are receiving the following treatment:
- Drug therapy targeting CDH17 (such as small molecule targeted drugs, monoclonal antibodies, bispecific antibodies, antibody-drug conjugates, or chimeric antigen receptor T cells).
- 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.
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- 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.
- 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).
- Inadequate bone marrow reserve or hepatic and renal functions.
- Participants with a history of severe allergy (such as anaphylactic shock), previous severe infusion reactions, or allergy to recombinant human or murine proteins.
- Participants who are allergic to any component of HS-20110.
Trial locations and contacts
8 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
Amanda Guo contact
8 sites in 2 countries
United States7 sites, 7 recruiting
- Recruiting
NEXT Virginia
Fairfax, Virginia, 22031
Alexander Spira
- Recruiting
Fort Wayne Medical Oncology and Hematology
Fort Wayne, Indiana, 46804
Sunil Babu
- Recruiting
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
Siqing Fu, MD
- Recruiting
Carolina BioOncology Institute
Huntersville, North Carolina, 28078
980-441-1148
John Powderly
- Recruiting
NEXT Dallas
Irving, Texas, 75039
Michael Song
- Recruiting
NEXT Oncology
San Antonio, Texas, 78229
David Somerhalder
- Recruiting
BRCR Medical Center INC
Tamarac, Florida, 33321
Chintan Gandhi, MD
China1 site, 1 recruiting
- Recruiting
SUN YAT-SEN University Cancer Center
Guangzhou, Guangdong, 510000
About this study
Official title: A Phase I Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of HS-20110 in Participants With Advanced Solid Tumors
This is an open-label, multicenter study to evaluate the safety and tolerability of HS-20110 in participants with advanced solid malignant tumors
- Conditions
- Solid Tumors
- Being tested
- HS-20110 (Phase Ia：Dose escalation ), HS-20110 (Phase Ib:Dose expansion )
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HS-20110 (Phase Ia：Dose escalation )Drug
HS-20110 for IV infusion of various dose strengths administered in 21 day dosing cycles
HS-20110 (Phase Ib:Dose expansion )Drug
The recommended dose from the dose-escalation stage and other potential doses will be further explored
| Study group | Role | What they receive |
|---|---|---|
| HS-20110 (Phase Ia：Dose escalation ) | Experimental | Not described Receives: Drug: HS-20110 (Phase Ia：Dose escalation ) |
| HS-20110 (Phase 1b Dose expansion) | Experimental | Not described Receives: Drug: HS-20110 (Phase Ib:Dose expansion ) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose (MTD) or maximum applicable dose (MAD)
Measured: From day 1 to one months after the last dose in Phase 1a
Objective response rate (ORR) as per RECIST v1.1
Measured: From screening to 2 months after the last dose
Secondary outcomes (4)
Incidence of adverse events (AEs), serious adverse events (SAEs), AEs leading to dose modification or permanent discontinuation, and specific laboratory abnormalities
Measured: From the first dose until 90 days after the last dose
Objective response rate (ORR), disease control rate (DCR), duration of response (DoR), and progression-free survival (PFS) as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1; overall survival (OS)
Measured: From screening to up to 3 years after last dose
Incidence of anti-HS-20110 antibody (ADA)
Measured: From the first dose until 90 days after the last dose
Drug concentrations of the three components of HS-20110 (including antibody-drug conjugates, total antibody, and payload)
Measured: From the first dose until 90 days after the last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2025
- Study start26 Feb 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorsStudies of the same condition, open and under way.
- More trials run by Hansoh BioMedical R&D CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 475 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hansoh BioMedical R&D Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Hoffmann-La Roche
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06892379
- Sponsor's protocol ID
- HS-20110-101
- Status last verified
- Apr 2026
- First submitted
- 24 Feb 2025
- Last updated
- 20 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of HS-20110 in Participants With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT06892379
- Acronym / sponsor ID
- HS-20110-101
- Conditions
- Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 475 participants (estimated)
- Lead sponsor
- Hansoh BioMedical R&D CompanyIndustry (pharma, biotech, devices)
- Collaborators
- Hoffmann-La Roche
- Study start
- 26 Feb 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 24 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an open-label, multicenter study to evaluate the safety and tolerability of HS-20110 in participants with advanced solid malignant tumors
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HS-20110 (Phase Ia：Dose escalation ) | Experimental | Drug: HS-20110 (Phase Ia：Dose escalation ) |
| HS-20110 (Phase 1b Dose expansion) | Experimental | Drug: HS-20110 (Phase Ib:Dose expansion ) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Males or females, aged ≥ 18 years.
- Participants with pathologically (histologically or cytologically) confirmed advanced solid tumors.
- Participants have at least 1 target lesion other than CNS lesions according to RECIST 1.1.
Key exclusion criteria (12 listed)
- Participants have received or are receiving the following treatment:
- 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).
- Inadequate bone marrow reserve or hepatic and renal functions.
- Participants with a history of severe allergy (such as anaphylactic shock), previous severe infusion reactions, or allergy to recombinant human or murine proteins.
- Participants who are allergic to any component of HS-20110.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HS-20110 (Phase Ia：Dose escalation )HS-20110 for IV infusion of various dose strengths administered in 21 day dosing cycles | Drug | HS-20110 (Phase Ia：Dose escalation ) |
| HS-20110 (Phase Ib:Dose expansion )The recommended dose from the dose-escalation stage and other potential doses will be further explored | Drug | HS-20110 (Phase 1b Dose expansion) |
Primary outcome
Maximum tolerated dose (MTD) or maximum applicable dose (MAD)
Time frame: From day 1 to one months after the last dose in Phase 1a
Objective response rate (ORR) as per RECIST v1.1
Time frame: From screening to 2 months after the last dose
4 secondary outcomes
Incidence of adverse events (AEs), serious adverse events (SAEs), AEs leading to dose modification or permanent discontinuation, and specific laboratory abnormalities
Time frame: From the first dose until 90 days after the last dose
Objective response rate (ORR), disease control rate (DCR), duration of response (DoR), and progression-free survival (PFS) as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1; overall survival (OS)
Time frame: From screening to up to 3 years after last dose
Incidence of anti-HS-20110 antibody (ADA)
Time frame: From the first dose until 90 days after the last dose
Drug concentrations of the three components of HS-20110 (including antibody-drug conjugates, total antibody, and payload)
Time frame: From the first dose until 90 days after the last dose
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Amanda Guo contact
8 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HS-20110 (Phase Ia：Dose escalation ) and HS-20110 (Phase Ib:Dose expansion ) in people with Solid Tumors, run by Hansoh BioMedical R&D Company at 8 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States, China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hongyan Wang (15111915273, wanghy10@hspharm.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum tolerated dose (MTD) or maximum applicable dose (MAD) (time frame: From day 1 to one months after the last dose in Phase 1a). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2026.