ARTEMIS-103: Phase 1b Study of HS-20093 Combinations in Patients with Bone and Soft Tissue Sarcoma.
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorHansoh BioMedical R&D Company
About this trial
HS-20093 is a fully humanized IgG1 antibody-drug conjugate (ADC) which specifically binds to B7-H3, a target wildly expressed on bone and soft tissue sarcoma. The objectives of this study are to investigate the safety, tolerability, pharmacokinetics and anti-tumor activity of HS-20093 in combination with other anti-cancer agents in patients with advanced bone and soft tissue sarcoma.
Eligibility criteria
Qualifiers
At least age of 18 years at screening;
Histologically or cytologically confirmed, locally advanced or metastatic osteosarcoma and soft tissue sarcoma
Cohort1: Dose escalation part will enroll advanced soft tissue sarcoma for which standard treatment has proven ineffective or unavailable or intolerable. Dose expansion part will enroll patients who have not received prior treatment for advanced/metastatic disease.
Cohort2: Advanced osteosarcoma patients for which standard treatment has proven ineffective or unavailable or intolerable.
Disqualifiers
Previous or current treatment with B7-H3 targeted therapy
Previous or current treatment with TOP1i related treatment
Previous or current treatment with PD-L1 inhibitor (Cohort2 )
Intolerable for any Anlotinib(Cohort 1a/1c), Anthracyclines (Cohort 1b/1c) and PD-L1 inhibitor (Cohort2 )
Trial design
Treatments tested in this trial
- HS-20093
- Anlotinib
- Epirubicin
- Adebrelimab
Treatment groups
448 Participants
are divided into 4 treatment groupsLocations
This trial has no locations
Sponsors and collaborators
Hansoh BioMedical R&D Company
Lead sponsor
Source ClinicalTrials.gov