Status:
RECRUITING
A Study of ES014 in Subjects With Advanced Solid Tumors
Lead Sponsor:
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Collaborating Sponsors:
Elpiscience (Suzhou) Biopharma, Ltd.
Conditions:
Advanced Solid Tumor
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
OVERALL DESIGN: This study is an open-label, single-center, single-arm phase 2 clinical study designed to evaluate the efficacy, safety, and tolerability of ES014 in adults with advanced solid tumors....
Detailed Description
Subject type and number : The study population will be adults with unresectable locally advanced or metastatic solid tumors, whose disease has progressed despite standard therapy and for whom no furth...
Eligibility Criteria
Inclusion
- Histological or cytological documentation of unresectable locally advanced or metastatic solid tumours.
- Presence of at least one measurable lesion (according to RECIST v1.1).
- Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1.
- Life expectancy of at least 12 weeks.
- Adequate hematologic, hepatic, renal and coagulation functions per protocol.
Exclusion
- Any prior therapy targeting CD39, CD73, adenosine A2A receptor, or TGF-β.
- Receipt of any investigational agents or devices within 4 weeks prior to the first dose of study drug.
- Prior treatment with the following therapies:
- Anticancer therapy within 28 days or 5 half-lives of the drug prior to the first dose of study drug, whichever is shorter. At least 14 days must have elapsed between the last dose of prior anticancer agent and the first dose of study drug is administered with certain exceptions. A wash out of at least 2 weeks before the start of study drug for radiation to the extremities and 4 weeks for radiation to the chest, brain, or visceral organs is required.
- Prior allogeneic or autologous bone marrow transplant or solid organ transplant.
- Subject has received an infusion of blood products (including platelets or red blood cells), granulocyte colony-stimulating factor (G-CSF), granulocyte-macrophage colony-stimulating factor (GM-CSF), recombinant erythropoietin, or recombinant thrombopoietin within 14 days prior to the first administration of study treatment.
Key Trial Info
Start Date :
November 25 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2026
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT06543056
Start Date
November 25 2024
End Date
September 30 2026
Last Update
July 30 2025
Active Locations (1)
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1
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, China