Study of ESG406 in Adults With Solid Tumors
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-80
SponsorShanghai Escugen Biotechnology Co., Ltd
About this trial
This study is an open-label, dose-escalation and cohort expansion Phase I study, aiming to evaluate the safety, tolerability, PK characteristics and preliminary efficacy of ESG406, and determine the MTD, RP2D and administration regimens of ESG406. The study includes the dose escalation study in Phase Ia and the cohort expansion study in Phase Ib.
Eligibility criteria
Qualifiers
Males and females aged 18 to 80 years.
Histologically or cytologically confirmed advanced or metastatic solid tumor(s) for which no effective standard therapy is available or tolerable.
At least one measurable lesion per RECIST v1.1.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Disqualifiers
Use of any cancer therapy (chemotherapy or other systemic anti-cancer therapies, immunotherapy) within 4 weeks before the first investigational product administration.
Toxicities from prior anti-tumor therapy not recovering to ≤ Grade 1.
Had major surgery within 4 weeks before dosing, or will not have fully recovered from surgery; or has surgery planned during the time the subject is expected to participate in the study or within 4 weeks after the last dose of study drug administration.
Use of any investigational anti-cancer drug within 4 weeks or 5 half-lives before the first investigational product administration.
Trial design
Treatments tested in this trial
- ESG406
Treatment groups
556 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov