Testing HS-20124 for advanced solid tumors

A Phase I, Open-label, Multicenter Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Efficacy of HS-20124 in Patients with Advanced Solid Tumors

This study is testing a new treatment called HS-20124 to see if it can help people with advanced solid tumors feel better and fight their cancer.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 450 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Hansoh BioMedical R&D Company (Industry-sponsored)
• Drugs / interventions: chemotherapy, radiation
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT06763159 on ClinicalTrials.gov

What this trial studies

This Phase 1a/1b clinical trial evaluates HS-20124, a novel antibody-drug conjugate targeting CDH6, in patients with advanced solid tumors. The study employs a multicenter, open-label design with dose escalation and expansion cohorts to assess the maximum tolerated dose, safety, pharmacokinetics, and preliminary anti-tumor activity. Patients with specific advanced solid tumor types will be included in the expansion phase to evaluate efficacy further.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with histologically confirmed advanced solid tumors that have not responded to standard treatments.

Not a fit: Patients who have previously received CDH6 targeted therapy or those currently undergoing other anticancer treatments may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced solid tumors that have limited treatment alternatives.

How similar studies have performed: While this approach is novel, previous studies of antibody-drug conjugates have shown promising results in treating various cancers.

Eligibility criteria

Inclusion Criteria:

1. At least age of 18 years at screening;
2. Histologically or cytologically confirmed, locally advanced or metastatic solid tumors for which standard treatment either does not exist or has proven ineffective or unavailable or intolerable
3. At least one extra-cranial measurable lesion according to RECIST 1
4. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0\~1
5. Life expectancy \>= 12 weeks
6. Men or women should be using adequate contraceptive measures throughout the study;
7. Females subjects must not be pregnant at screening or have evidence of non-childbearing potential
8. Signed and dated Informed Consent Form

Exclusion Criteria:

1.Treatment with any of the following:

1. Previous or current treatment with CDH6 targeted therapy
2. Any cytotoxic chemotherapy and small molecule targeted anticancer drugs within 21 days or five half-livesprior to the first scheduled dose of HS-20124
3. Prior treatment with a monoclonal antibody or investigational agents within 28 days prior to the first scheduled dose of HS-20124
4. Radiotherapy with a limited field of radiation for palliation within 2 weeks, or patients received more than 30% of the bone marrow irradiation, or large-scale radiotherapy within 4 weeks prior to the first scheduled dose of HS-20124
5. Major surgery within 4 weeks prior to the first scheduled dose of HS-20124 2. Subjects with previous or concurrent malignancies 3. Inadequate bone marrow reserve or organ dysfunction 4. Evidence of cardiovascular risk 5. Evidence of current severe or uncontrolled systemic diseases 6. Evidence of mucosal or internal bleeding within 1 month prior to the first scheduled dose of HS-20124 7. Severe infection within 4 weeks prior to the first scheduled dose of HS-20124 8. Subjects with current infectious diseases 9. History of neuropathy or mental disorders 10. Pregnant or lactating female 11. History of severe hypersensitivity reaction, severe infusion reaction or idiosyncrasy to drugs chemically related to HS-20124 or any of the components of HS-20124

Where this trial is running

Shanghai, Shanghai Municipality

• Affiliated Cancer Hospital of Fudan University — Shanghai, Shanghai Municipality, China (Recruiting)

Study contacts

• Study coordinator: Xiaohua Wu, Doctor

Conditions Solid Cancer