Actively Recruiting
A Study of ES014 in Subjects With Advanced Solid Tumors
Led by Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Updated on 2025-07-30
15
Participants Needed
1
Research Sites
96 weeks
Total Duration
On this page
Sponsors
C
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Lead Sponsor
E
Elpiscience (Suzhou) Biopharma, Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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. Adult patients with unresectable locally advanced or metastatic solid tumors will be enrolled in this study. This study is not blinded. 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 further standard therapy exists; or for whom standard therapy has proven to be ineffective or intolerable. This study is expected to enroll no more than 15 subjects, including malignant pleural mesothelioma and myxofibrosarcoma, 4-5, respectively, 2-3 malignant peripheral nerve sheath tumors, and other solid tumors. Duration of treatment: Subjects will be treated with ES014 in 28-day cycles. ES014 will be administered at 1400 mg on days 1 and 15 of each cycle. Each subject will be treated with study drug for a maximum of 24 months. Subjects will be treated according to protocol until disease progression per RECIST v1.1, development of unacceptable toxicity, withdrawal of consent, completion of study treatment of 24 months, end of study, or early termination of study by sponsor, or other discontinuation and withdrawal reason, whichever occurs first.
CONDITIONS
Official Title
A Study of ES014 in Subjects With Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults with histological or cytological confirmation of unresectable locally advanced or metastatic solid tumors
- At least one measurable tumor 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 blood, liver, kidney, and clotting function as defined by the protocol
You will not qualify if you...
- Prior therapy targeting CD39, CD73, adenosine A2A receptor, or TGF-β
- Use of investigational drugs or devices within 4 weeks before starting study drug
- Anticancer therapy within 28 days or 5 half-lives before starting study drug, with some exceptions requiring at least 14 days washout
- Radiation therapy to extremities within 2 weeks or to chest, brain, or visceral organs within 4 weeks before study drug
- Prior allogeneic or autologous bone marrow transplant or solid organ transplant
- Blood product infusions or certain growth factors within 14 days before starting study treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, China
Actively Recruiting
Research Team
N
Ning Li, Ph.D
CONTACT
S
Shuhang Wang, Ph.D
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here