HS-20089 Combination Treatment in Subjects With Advanced Solid Tumors
HS-20089 is an investigational antibody-drug conjugate (ADC) composed of a humanized IgG1 anti-B7-H4 monoclonal antibody conjugated to the topoisomerase I inhibitor payload via a protease-cleavable linker, with an average drug-to-antibody ratio of about 6. This is a phase Ⅰ, open-label, multi-center study to evaluate t
| Condition(s) | Advanced Solid Tumors |
|---|---|
| Status | Recruiting |
| Phase | Phase 1 |
| Study type | Interventional |
| Summary | HS-20089 is an investigational antibody-drug conjugate (ADC) composed of a humanized IgG1 anti-B7-H4 monoclonal antibody conjugated to the topoisomerase I inhibitor payload via a protease-cleavable linker, with an average drug-to-antibody ratio of about 6. This is a phase Ⅰ, open-label, multi-center study to evaluate the safety, tolerability, pharmacokinetics (PK) and efficacy of HS-20089 in combination with other antitumor agents (Adebrelimab with or without platinum; Bevacizumab with or without platinum) in subjects with advanced solid tumors. |
| Who can participate | Inclusion Criteria: 1. Males or females aged 18 years or older (≥18 years). 2. Patients diagnosed with pathologically confirmed advanced solid tumors. 3. Subjects have at least one target lesion as assessed per the RECIST 1.1. Patients with only brain and/or bone lesions as target lesions are ineligible. 4. Agree to provide fresh or archival tumor tissue 5. Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 to 1 and no deterioration within 2 weeks before the first dose. 6. Have a life expectancy of at least 12 weeks. 7. Female subjects of childbearing potential are willing to take appropriate contraceptive measures and should not breastfeed from signing the informed consent until 6 months after the last dose; male subjects must agree to use barrier contraception (i. |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Hansoh BioMedical R&D Company |
| Locations | Shanghai, Shanghai Municipality, China |
| Start date | 2024-04-11 |
| NCT ID | NCT06336707 |
| Official listing | https://clinicaltrials.gov/study/NCT06336707 |