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

Last updated: April 17, 2026
Sponsor: Hansoh BioMedical R&D Company
Overall Status: Active - Recruiting

Phase

1

Condition

Solid Tumors

Neoplasms

Treatment

HS-20110 (Phase Ia:Dose escalation )

HS-20110 (Phase Ib:Dose expansion )

Clinical Study ID

NCT06892379
HS-20110-101
  • Ages > 18
  • All Genders

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 Criteria

Inclusion

Inclusion Criteria:

  1. Males or females, aged ≥ 18 years.

  2. Participants with pathologically (histologically or cytologically) confirmedadvanced solid tumors.

  3. Participants have at least 1 target lesion other than CNS lesions according toRECIST 1.1.

Exclusion

Exclusion Criteria:

  1. Participants have received or are receiving the following treatment:

  2. Drug therapy targeting CDH17 (such as small molecule targeted drugs, monoclonalantibodies, bispecific antibodies, antibody-drug conjugates, or chimericantigen receptor T cells).

  3. Anti-tumor drugs within 14 days prior to the first dose of study treatment; anyother IMPs or macromolecular anti-tumor drugs within 28 days prior to the firstdose of study treatment.

  4. 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 4weeks prior to the first dose of study treatment.

  5. Major surgery within 4 weeks prior to the first dose of study treatment.

  6. Participants previously treated with drugs that are moderate to stronginhibitors or moderate to strong inducers of cytochrome P450 (CYP) 3A4, stronginhibitors or strong inducers of CYP2D6, P-glycoprotein (P-gp), breast cancerresistance protein (BCRP) or drugs with a narrow therapeutic range that aresensitive substrates of P-gp or BCRP within 7 days prior to the first dose ofthe IMP. Participants who need to receive these drugs during the study periodshould also be excluded.

  7. Current use of drugs known to prolong the QT interval or that may cause torsadede pointes. Participants who need to receive these drugs during the studyperiod should also be excluded.

  8. Live vaccine or live-attenuated vaccine within 28 weeks prior to the firstdose.

  9. Participants who have any Grade ≥ 2 residual toxicity according to CommonTerminology Criteria for Adverse Events (CTCAE, version 5.0) from prior therapies (except alopecia and residual neurotoxicity).

  10. Inadequate bone marrow reserve or hepatic and renal functions.

  11. Participants with a history of severe allergy (such as anaphylactic shock), previoussevere infusion reactions, or allergy to recombinant human or murine proteins.

  12. Participants who are allergic to any component of HS-20110.

Study Design

Total Participants: 475
Treatment Group(s): 2
Primary Treatment: HS-20110 (Phase Ia:Dose escalation )
Phase: 1
Study Start date:
February 26, 2025
Estimated Completion Date:
September 30, 2027

Connect with a study center

  • SUN YAT-SEN University Cancer Center

    Guangzhou, Guangdong 510000
    China

    Active - Recruiting

  • SUN YAT-SEN University Cancer Center

    Guangzhou 1809858, Guangdong 1809935 510000
    China

    Site Not Available

  • BRCR Medical Center INC

    Tamarac, Florida 33321
    United States

    Active - Recruiting

  • BRCR Medical Center INC

    Tamarac 4174738, Florida 4155751 33321
    United States

    Site Not Available

  • Fort Wayne Medical Oncology and Hematology

    Fort Wayne, Indiana 46804
    United States

    Active - Recruiting

  • Carolina BioOncology Institute

    Huntersville, North Carolina 28078
    United States

    Active - Recruiting

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas 77030
    United States

    Active - Recruiting

  • NEXT Dallas

    Irving, Texas 75039
    United States

    Active - Recruiting

  • NEXT Oncology

    San Antonio, Texas 78229
    United States

    Active - Recruiting

  • The University of Texas MD Anderson Cancer Center

    Houston 4699066, Texas 4736286 77030
    United States

    Site Not Available

  • NEXT Dallas

    Irving 4700168, Texas 4736286 75039
    United States

    Site Not Available

  • NEXT Oncology

    San Antonio 4726206, Texas 4736286 78229
    United States

    Site Not Available

  • NEXT Virginia

    Fairfax, Virginia 22031
    United States

    Active - Recruiting

  • NEXT Virginia

    Fairfax 4758023, Virginia 6254928 22031
    United States

    Site Not Available

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