A Phase 1/2 interventional study of ESG401 in Neoplasms, Breast, Neoplasms, Lung and Neoplasms,Colorectal, sponsored by Shanghai Escugen Biotechnology Co., Ltd. Completed at 3 sites in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-09-12.
Sponsored by Shanghai Escugen Biotechnology Co., Ltd · Phase 1/2, Interventional, and Treatment
The primary objective in Phase I is to evaluate the safety and tolerability of ESG401 as a single agent administered in 21-day treatment cycles in previously treated participants with advanced epithelial cancer. In Phase II, the primary objective is to evaluate the safety and efficacy of ESG401 administered in 21-day treatment cycles at a dose selected in Phase I.
Tumor types in the study will include: cervical, colorectal, endometrial, ovarian, esophageal, gastric adenocarcinoma, glioblastoma multiforme, head and neck cancers- squamous cell, hepatocellular, prostate, non-small-cell lung cancer, pancreatic, renal cell, small-cell lung cancer, non-triple negative breast cancer (non-TNBC), triple-negative breast cancer (TNBC) and metastatic urothelial cancer (mUC).
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 156 is above the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Shanghai Escugen Biotechnology Co., Ltd is the lead sponsor of 7 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Note: Subjects with Grade 2 alopecia or anemia are exceptions to this criterion and may qualify for the study.
Subjects with clinically significant cardiovascular disease as defined by the following:
Drug: ESG401
Drug: ESG401
Drug: ESG401
Drug: ESG401
Drug: ESG401
Drug: ESG401
Drug: ESG401
Drug: ESG401
Drug: ESG401
Drug: ESG401
Administered via intravenous (IV) infusion
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 days
Objective Response Rate (ORR) by Independent Central Review (ICR)
ORR is defined as the rate an overall best response of either complete response (CR) or partial response (PR) by ICR assessment according to RECIST1.1. CR was defined as the disappearance of all target lesions and reduction in short axis of any pathologic lymphnode to \<10 mm. PR was defined as ≥ 30% decrease in the sum of diameters of target lesions, taking the baseline sum diameters. Per planned analysis, ORR by ICR will be assessed for the TNBC Target Population in phase 2 only.
Time frame: Up to 49 months
Cmax
Maximum observed plasma concentration
Time frame: Up to 49 months
AUC0-inf
Area under the serum concentration time curve from time 0 extrapolated to infinity
Time frame: Up to 49 months
Objective Response Rate by Local Assessment
ORR is defined as the rate an overall best response of either complete response (CR) or partial response (PR) by local assessment. CR was defined as the disappearance of all target lesions and reduction in short axis of any pathologic lymphnode to \<10 mm. PR was defined as ≥3 0% decrease in the sum of diameters of target lesions, taking the baseline sum diameters. Per planned analysis, ORR by local assessment will be assessed for the Target Population both in phase 1 and phase 2.
Time frame: Up to 49 months
Progression Free Survival (PFS) by Local Assessment
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 49 months
Overall Survival by Local Assessment
Overall survival is defined as the time from the date of the first dose start date to the date of death due to any cause.
Time frame: Up to 49 months
ADA
Incidence of anti-drug antibodies
Time frame: Up to 49 months
Plan to share: No
This study is completed, as verified in May 2025. You cannot join it, but the record below documents what was studied.
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Shanghai Escugen Biotechnology Co., Ltd