A Phase Ia/ Ib Study of HS387 in Subjects With Advanced Solid Tumors
ConditionAdvanced Solid Cancers
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorZhejiang Hisun Pharmaceutical Co. Ltd.
About this trial
This is a Phase Ia/Ib, dose escalation and dose expansion study to evaluate the safety, tolerability, PK, and preliminary efficacy of HS387 in subjects with advanced solid tumors. It includes two parts: the dose escalation study (Phase Ia) and the dose expansion study (Phase Ib)
Eligibility criteria
Qualifiers
Men or women ≥18 years old and ≤75 years old.
Subjects with advanced solid tumors who have failed or are intolerant to standard treatment, or have no standard therapy.
Survival expectation is ≥ 3 months.
Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1.
Disqualifiers
Has received other investigational drugs or treatments not yet approved for marketing within 4 weeks prior to the first administration.
Has active infection.
Has meningeal metastases or symptomatic central nervous system (CNS) metastases.
Significant impairment of oral drug absorption.
Trial design
Treatments tested in this trial
- HS387
Treatment groups
110 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov