HS-20110 for adults with advanced solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This open-label, multicenter Phase 1 trial enrolls adults with pathologically confirmed advanced solid tumors to examine HS-20110 using a Phase Ia dose-escalation followed by a Phase Ib dose-expansion. The study will enroll participants with at least one target lesion outside the central nervous system and uses RECIST 1.1 to define measurable disease. Key exclusions include prior therapies targeting CDH17, recent systemic anti-tumor drugs or extensive radiotherapy, and major surgery within 4 weeks of dosing. The primary focus is safety and tolerability and identifying appropriate doses for further testing.

Why it matters

Who can join: the full rules

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.

Where it's running

• BRCR Medical Center INC
  Tamarac, Florida, United States Recruiting
• Fort Wayne Medical Oncology and Hematology
  Fort Wayne, Indiana, United States Recruiting
• Carolina BioOncology Institute
  Huntersville, North Carolina, United States Recruiting
• The University of Texas MD Anderson Cancer Center
  Houston, Texas, United States Recruiting
• NEXT Dallas
  Irving, Texas, United States Recruiting
• NEXT Oncology
  San Antonio, Texas, United States Recruiting

Study contacts

• Study coordinator: Hongyan Wang
• Email: wanghy10@hspharm.com
• Phone: 15111915273

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.