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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
ESG406
DrugAdministered via intravenous (IV) infusion.
Treatment groups
556 Participants
are divided into 1 treatment groupGroup A: ESG406 for injectionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Percentage of Participants Experiencing Any Treatment Emergent Adverse Events and Serious Treatment Emergent Adverse Events
Treatment-emergent adverse events (TEAEs) were defined as any adverse events (AEs) that begin or worsen on or after the start of study drug through 30 days after the last dose of study drug. The severity was graded based on the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 5.0. An AE that met one or more of the following outcomes was classified as serious: Fatal Life-threatening Disabling/incapacitating Results in hospitalization or prolongs a hospital stay A congenital abnormality Other important medical events may also be considered serious AEs if they may require medical or surgical intervention to prevent one of the outcomes listed above.
Time frame
First dose date up to last dose plus 30 daysSecondary outcomes
1
Objective Response Rate
Objective Response Rate(ORR) is defined as the rate an overall best response of either complete response (CR) or partial response (PR) .
Time frame
Up to approximately 36 months.2
Progression Free Survival
Progression-free survival (PFS) is defined as the interval from the first dose start date to the date of disease progression defined as documented progressive disease (PD) or death from any cause, whichever occurs first.
Time frame
Up to approximately 36 months.3
Cmax
Maximum observed plasma concentration
Time frame
Up to approximately 36 months.4
AUC0-inf
Area under the serum concentration time curve from time 0 extrapolated to infinity
Time frame
Up to approximately 36 months.Sponsors and contacts
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Source ClinicalTrials.gov