A Study of HS-20089 in Patients With Advanced Solid Tumors
ConditionAdvanced Solid Tumor
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorShanghai Hansoh Biomedical Co., Ltd
About this trial
HS-20089 is a novel DAR-6 antibody-drug conjugate （ADC） targeting B7-H4. In preclinical studies, it inhibited tumor cell growth expressing B7-H4 in vitro and in vivo. The first-in-human trial is conducted to assess the maximum tolerated dose (MTD) and dose limiting toxicity (DLT), to evaluate the pharmacokinetics, safety and preliminary anti-tumor activity of HS-20089 in Patients With Advanced Solid Tumors.
Eligibility criteria
Qualifiers
Men or women aged more than or equal to (≥) 18 years
Advanced solid tumor patients confirmed by histology or cytology for who that standard treatment is invalid, unavailable or intolerable
Patients have at least one target lesion according to RECEST 1.1. The requirements for target lesions are: measurable lesions without local treatment such as irradiation, or with definite progress after local treatment, with the longest diameter ≥ 10 mm in the baseline period (in case of lymph nodes, the shortest axis ≥ 15 mm is required)
ECOG performance status was 0-1 and did not deteriorate in the previous 2 weeks
Disqualifiers
Previous or current treatment with drugs targeting B7-H4
Any cytotoxic chemotherapy, investigational agents or anticancer drugs within 28 days of the first dose of study drug
Radiotherapy with a limited field of radiation for palliation within 2 weeks of the first dose of study drug, or patients received more than 30% of the bone marrow irradiation, or large-scale radiotherapy within 4 weeks of the first dose.
Major surgery (including craniotomy, thoracotomy, or laparotomy, etc.) within 4 weeks of the first dose of study drug.
Trial design
Treatments tested in this trial
- HS-20089 (Phase Ia：Dose escalation )
- HS-20089 (Phase Ib: Dose expansion)
Treatment groups
177 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov