ES014 treatment for adults with advanced solid tumors
An Open-label, Single-arm Phase 2 Study of ES014 in Subjects With Advanced Solid Tumors
This will test whether ES014 can shrink or control advanced, unresectable solid tumors in adults who have progressed after standard therapies.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Cancer Institute and Hospital, Chinese Academy of Medical Sciences Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Beijing) |
| Trial ID | NCT06543056 on ClinicalTrials.gov |
What this trial studies
This open-label, single-center, single-arm phase 2 study plans to enroll up to 15 adults with unresectable locally advanced or metastatic solid tumors, including cohorts for malignant pleural mesothelioma, myxofibrosarcoma, malignant peripheral nerve sheath tumor, and other solid tumors. Participants must have measurable disease by RECIST v1.1, ECOG 0–1, and adequate organ function. ES014 will be given at 1400 mg on days 1 and 15 of each 28-day cycle for up to 24 months or until disease progression or unacceptable toxicity. Safety, tolerability, and anti-tumor activity will be monitored with imaging and standard response criteria, and patients previously treated with agents targeting CD39, CD73, the adenosine A2A receptor, or TGF-β are excluded.
Who should consider this trial
Good fit: Adults with unresectable locally advanced or metastatic solid tumors, measurable disease, ECOG performance status 0–1, and adequate organ function who have progressed on or are intolerant of standard therapies.
Not a fit: Patients previously treated with therapies targeting CD39, CD73, the adenosine A2A receptor, or TGF-β, those with ECOG >1, or with inadequate organ function are unlikely to benefit or are excluded from participation.
Why it matters
Potential benefit: If successful, ES014 could provide tumor control or extend survival for patients with advanced solid tumors who have exhausted standard treatment options.
How similar studies have performed: Dual targeting of CD39 and TGF-β is a relatively new approach with limited clinical data, though single-target agents against TGF-β or the adenosine pathway have shown preliminary activity in some solid tumors.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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.
Where this trial is running
Beijing
- Cancer Hospital, Chinese Academy of Medical Sciences — Beijing, China (Recruiting)
Study contacts
- Principal investigator: Ning Li, Ph.D — Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- Study coordinator: Ning Li, Ph.D
- Email: lining@cicams.ac.cn
- Phone: +86 010-87788495
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.