A Study of ES014 in Patients With Locally Advanced or Metastatic Solid Tumours
NCT05717348 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 120
Last updated 2025-08-13
Summary
The purpose of this first-in-human, open-label, multicenter, non-randomized study designed to determine the maximum tolerated dose (MTD)/maximum administered dose (MAD), optimal biological dose (OBD), and recommended phase 2 dose (RP2D) of ES014 by evaluating the safety, tolerability, PK, pharmacodynamics, and preliminary clinical activity of ES014 administered intravenously to subjects with advanced solid tumors.
Conditions
- Solid Tumor
- Locally Advanced Solid Tumor
- Metastatic Solid Tumor
Interventions
- DRUG
-
ES014
ES014 is administered via intravenous infusion, once every 14 days, every 28 days as a treatment cycle for a maximum treatment duration per patient of 2 years.
Sponsors & Collaborators
-
Elpiscience (Suzhou) Biopharma, Ltd.
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-02-24
- Primary Completion
- 2027-02-28
- Completion
- 2027-02-28
Countries
- China
Study Locations
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