HS-20110 for adults 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

HS-20110 will be tested for safety and tolerability in adults with advanced solid tumors who have at least one measurable tumor outside the brain.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 475 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Hansoh BioMedical R&D Company (Industry-sponsored)
• Drugs / interventions: chimeric antigen receptor
• Locations: 8 sites (Tamarac, Florida and 7 other locations)
• Trial ID: NCT06892379 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults aged 18 or older with pathologically confirmed advanced solid tumors and at least one measurable non-CNS lesion who meet the study's timing windows for prior therapies and surgeries are the intended participants.

Not a fit: Patients who previously received therapies targeting CDH17, have only brain metastases, or who cannot meet the required washout periods after recent treatments or major surgery are unlikely to be eligible or benefit from this study.

Why it matters

Potential benefit: If successful, HS-20110 could offer a new treatment option that slows tumor progression for some patients with advanced solid tumors.

How similar studies have performed: Targeting CDH17 is a relatively new approach with limited published clinical results, so this first-in-human phase 1 dose-finding trial is exploratory.

Eligibility criteria

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 this trial is running

Tamarac, Florida and 7 other locations

• 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)
• NEXT Virginia — Fairfax, Virginia, United States (Recruiting)
• SUN YAT-SEN University Cancer Center — Guangzhou, Guangdong, China (Recruiting)

Study contacts

• Study coordinator: Hongyan Wang

Conditions Solid Tumors