A Study of HG381 Administered to Patients With Advanced Solid Tumors
ConditionAdvanced Solid Tumor
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorHitGen Inc.
About this trial
This is a Phase I, first in human, open-label, non-randomized, multicenter study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, preliminary efficacy and establish a recommended dose of HG381 administered intravenously (IV) alone in subjects with advanced solid tumors.
Eligibility criteria
Qualifiers
Capable of giving signed informed consent.
Life expectancy of at least 3 months.
Histological or cytological documentation of an advanced solid tumor，subjects with advanced/recurrent solid tumors, who have progressed on, be intolerant of, or ineligible for, all available therapies for which clinical benefit has been established.
Measurable disease per RECIST version 1.1, there is at least one measurable lesion during the screening period.
Disqualifiers
Chemotherapy, radiotherapy, biological therapy, endocrine therapy, immunotherapy and other anticancer therapy within 4 weeks.
Concurrent medical condition requiring the use of other systemic immunosuppressive treatment within 4 weeks before the first dose of study treatment.
Receipt of any live vaccine within 4 weeks of the start of study treatment.
Receipt of unmarketed clinical trial drugs or treatments within 4 weeks of the start of study treatment.
Trial design
Treatments tested in this trial
- HG381
Treatment groups
57 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov