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

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

Study Overview

• Status: Recruiting
• Conditions: Solid Tumors
• Intervention / Treatment: Drug: HS-20110 (Phase Ia：Dose escalation ); Drug: HS-20110 (Phase Ib:Dose expansion )

• Study Type: Interventional
• Enrollment (Estimated): 475
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Hongyan Wang; Phone Number: 15111915273; Email: wanghy10@hspharm.com
• Study Contact Backup: Name: Amanda Guo; Email: guoj9@hspharm.com

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510000
      • Recruiting
      • Sun Yat-sen University Cancer Center
• United States
  • Florida
    • Tamarac, Florida, United States, 33321
      • Recruiting
      • BRCR Medical Center Inc
      • Principal Investigator: Chintan Gandhi, MD
  • Indiana
    • Fort Wayne, Indiana, United States, 46804
      • Recruiting
      • Fort Wayne Medical Oncology and Hematology
      • Principal Investigator: Sunil Babu
  • North Carolina
    • Huntersville, North Carolina, United States, 28078
      • Recruiting
      • Carolina BioOncology Institute
      • Principal Investigator: John Powderly
      • Contact: Phone Number: 980-441-1148
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • The University of Texas MD Anderson Cancer Center
      • Principal Investigator: Siqing Fu, MD
    • Irving, Texas, United States, 75039
      • Recruiting
      • NEXT Dallas
      • Principal Investigator: Michael Song
    • San Antonio, Texas, United States, 78229
      • Recruiting
      • NEXT Oncology
      • Principal Investigator: David Somerhalder
  • Virginia
    • Fairfax, Virginia, United States, 22031
      • Recruiting
      • Next Virginia
      • Principal Investigator: Alexander Spira

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HS-20110 (Phase Ia：Dose escalation )	Drug: HS-20110 (Phase Ia：Dose escalation ); HS-20110 for IV infusion of various dose strengths administered in 21 day dosing cycles
Experimental: HS-20110 (Phase 1b Dose expansion)	Drug: HS-20110 (Phase Ib:Dose expansion ); The recommended dose from the dose-escalation stage and other potential doses will be further explored

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Maximum tolerated dose (MTD) or maximum applicable dose (MAD)	From day 1 to one months after the last dose in Phase 1a
Objective response rate (ORR) as per RECIST v1.1	From screening to 2 months after the last dose

Secondary Outcome Measures

Outcome Measure	Time Frame
Incidence of adverse events (AEs), serious adverse events (SAEs), AEs leading to dose modification or permanent discontinuation, and specific laboratory abnormalities	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)	From screening to up to 3 years after last dose
Incidence of anti-HS-20110 antibody (ADA)	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)	From the first dose until 90 days after the last dose

Collaborators and Investigators

• Sponsor: Hansoh BioMedical R&D Company
• Collaborators: Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start (Actual): February 26, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): September 30, 2027

Study Registration Dates

• First Submitted: February 24, 2025
• First Submitted That Met QC Criteria: March 18, 2025
• First Posted (Actual): March 24, 2025

Study Record Updates

• Last Update Posted (Actual): April 20, 2026
• Last Update Submitted That Met QC Criteria: April 17, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: HS-20110-101

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No