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

NCT06892379 | Recruiting Phase 1 FDA Drug

• 1 other identifier: HS-20110-101
• Study Type: interventional
• Target: 475
• Locations: 2 countries
• Sites: 8

Brief Summary

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• 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

Study Arms (2)

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 )

Interventions

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 Ia：Dose escalation )

HS-20110 (Phase Ib:Dose expansion ) DRUG

The recommended dose from the dose-escalation stage and other potential doses will be further explored

HS-20110 (Phase 1b Dose expansion)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Hansoh BioMedical R&D Company: lead
• Hoffmann-La Roche: collaborator

Study Sites (8)

BRCR Medical Center INC

Tamarac, Florida, 33321, United States

RECRUITING

Fort Wayne Medical Oncology and Hematology

Fort Wayne, Indiana, 46804, United States

RECRUITING

Carolina BioOncology Institute

Huntersville, North Carolina, 28078, United States

RECRUITING

The University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

NEXT Dallas

Irving, Texas, 75039, United States

RECRUITING

NEXT Oncology

San Antonio, Texas, 78229, United States

RECRUITING

NEXT Virginia

Fairfax, Virginia, 22031, United States

RECRUITING

SUN YAT-SEN University Cancer Center

Guangzhou, Guangdong, 510000, China

RECRUITING

Central Study Contacts

Hongyan Wang

CONTACT

15111915273; wanghy10@hspharm.com

Amanda Guo

CONTACT

guoj9@hspharm.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2025
• First Posted: March 24, 2025
• Study Start: February 26, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): September 30, 2027
• Last Updated: April 20, 2026

Record last verified: 2026-04

Locations

CN (1); US (7)