Trials / Completed
CompletedNCT04892342
Study of ESG401 in Adults With Solid Tumors
An Open-Label, Multiple Dose, Dose Escalation and Cohort Expansion Phase I/II Study to Investigate the Safety, Tolerability, Pharmacokinetics and Antitumor Activities of ESG401 in Subjects With Locally Advanced/Metastatic Solid Tumors
- Status
- Completed
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 156 (actual)
- Sponsor
- Shanghai Escugen Biotechnology Co., Ltd · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
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).
Conditions
- Neoplasms, Breast
- Neoplasms, Lung
- Neoplasms,Colorectal
- Neoplasms, Bladder
- Neoplasm of Stomach
- Neoplasms,Ovarian
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ESG401 | Administered via intravenous (IV) infusion |
Timeline
- Start date
- 2021-09-14
- Primary completion
- 2025-06-30
- Completion
- 2025-06-30
- First posted
- 2021-05-19
- Last updated
- 2025-09-12
Locations
3 sites across 1 country: China
Source: ClinicalTrials.gov record NCT04892342. Inclusion in this directory is not an endorsement.