A Study of HS-20124 in Patients with Advanced Solid Tumors
ConditionSolid Cancer
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorHansoh BioMedical R&D Company
About this trial
HS-20124 is a novel DAR-8 antibody-drug conjugate （ADC） targeting CDH6. In preclinical studies, it inhibited tumor cell growth expressing CDH6 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-20124 in Patients With Advanced Solid Tumors.
Eligibility criteria
Qualifiers
At least age of 18 years at screening;
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
At least one extra-cranial measurable lesion according to RECIST 1
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0~1
Disqualifiers
Previous or current treatment with CDH6 targeted therapy
Any cytotoxic chemotherapy and small molecule targeted anticancer drugs within 21 days or five half-livesprior to the first scheduled dose of HS-20124
Prior treatment with a monoclonal antibody or investigational agents within 28 days prior to the first scheduled dose of HS-20124
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
Trial design
Treatments tested in this trial
- HS-20124 (Phase Ia：Dose escalation )
- HS-20124 (Phase Ib: Dose expansion)
Treatment groups
450 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov