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Clinical Trials in China / NCT06892379
Recruiting Phase 1

A Study of HS-20110 in Participants With Advanced Solid Tumors

NCT06892379 · tracked via the Priya Life Science China tracker
Sponsor
Hansoh BioMedical R&D Company
Phase
Phase 1
Started
2025-02-26
Last updated
2026-04-20

Condition(s) studied

Solid Tumors

Investigational drug(s) / intervention(s)

HS-20110 (Phase Ia:Dose escalation )HS-20110 (Phase Ib:Dose expansion )

HS-20110 (Phase Ia:Dose escalation ): HS-20110 for IV infusion of various dose strengths administered in 21 day dosing cycles

HS-20110 (Phase Ib:Dose expansion ): The recommended dose from the dose-escalation stage and other potential doses will be further explored

Study summary

This is an open-label, multicenter study to evaluate the safety and tolerability of HS-20110 in participants with advanced solid malignant tumors

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (8)

FacilityCityRegionStatus
BRCR Medical Center INC Tamarac Florida Recruiting
Fort Wayne Medical Oncology and Hematology Fort Wayne Indiana Recruiting
Carolina BioOncology Institute Huntersville North Carolina Recruiting
The University of Texas MD Anderson Cancer Center Houston Texas Recruiting
NEXT Dallas Irving Texas Recruiting
NEXT Oncology San Antonio Texas Recruiting
NEXT Virginia Fairfax Virginia Recruiting
SUN YAT-SEN University Cancer Center Guangzhou Guangdong Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06892379 on ClinicalTrials.gov ↗ ← All trials in China