Testing ES014 in patients with advanced solid tumors
An Open-label, Multicenter, Dose-escalation and Cohort Expansion Phase 1 Clinical Study of ES014 Administered in Patients Locally Advanced or Metastatic Solid Tumours
This study is testing a new treatment called ES014 in people with advanced solid tumors to see how safe it is and what the best dose is.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Elpiscience Biopharma, Ltd. Industry-sponsored |
| Drugs / interventions | radiation |
| Locations | 1 site (Shanghai) |
| Trial ID | NCT05717348 on ClinicalTrials.gov |
What this trial studies
This is a first-in-human, open-label, multicenter, non-randomized study aimed at determining the maximum tolerated dose (MTD) and optimal biological dose (OBD) of ES014 in patients with locally advanced or metastatic solid tumors. The study will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary clinical activity of ES014 administered intravenously. Participants will be closely monitored for their response to the treatment and any adverse effects.
Who should consider this trial
Good fit: Ideal candidates are patients with unresectable locally advanced or metastatic solid tumors who have shown disease progression despite standard treatments.
Not a fit: Patients who have previously received therapies targeting CD39, CD73, adenosine A2A receptor, or TGF-β may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced solid tumors who have exhausted standard treatment options.
How similar studies have performed: While this approach is novel, similar studies targeting advanced solid tumors have shown promise, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 1. Unresectable locally advanced or metastatic solid tumour diagnosed by pathology or cytology and which meets the criteria of 1) disease progression has occurred despite receiving standard treatment and no other standard treatment is available; or 2) standard treatment has been proven to be ineffective, intolerant or considered unsuitable. 2. Provide tumor tissue samples. 3. At least one measurable lesion per RECIST v1.1. 4. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1. Part 1: ECOG PS 0-1. Part 2: ECOG PS 0-2. 5. Life expectancy of at least 12 weeks. 6. Adequate hematologic, hepatic, renal and coagulation functions per protocol. 7. Male and female subjects of childbearing potential must be willing to completely abstain or agree to use a highly effective method of contraception. Exclusion Criteria: * 1. Any prior therapy targeting CD39, CD73, adenosine A2A receptor, or TGF-β. 2. Receipt of any investigational agents or devices within 4 weeks prior to the first dose of study drug. 3. Prior treatment with the following therapies: 1) Anticancer therapy within 30 days or 5 half-lives of the drug prior to the first dose of study drug. 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. 2) 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. 4. Prior allogeneic or autologous bone marrow transplantation or solid organ transplantation. 5. Toxicity from previous anticancer treatment per protocol. 6. Treatment with systemic immunosuppressive medications within 4 weeks prior to the first dose of study drug. 7. Subjects who received transfusion of blood products (including platelets or red blood cells), G-CSF, GM-CSF, recombinant erythropoietin, or recombinant thrombopoietin within 14 days prior to the first dose of study treatment. 8. Major surgery within 4 weeks prior to the first dose of study treatment. 9. Live vaccine therapies within 4 weeks prior to the first dose of study treatment. 10. Recent history of allergen desensitization therapy within 4 weeks prior to the first dose of study treatment. 11. Known allergies to CHO-produced antibodies, which in the opinion of the Investigator suggests an increased potential for an adverse hypersensitivity to ES014. 12. Invasive malignancy or history of invasive malignancy other than disease under study within the last two years per protocol. 13. CNS metastases. 14. Active autoimmune disease or documented history of autoimmune disease that required systemic steroids or other immunosuppressive medications per protocol. 15. Active interstitial lung disease (ILD) or pneumonitis or a history of ILD or pneumonitis requiring treatment with steroids or other immunosuppressive medications. 16. Active infection requiring systemic therapy, known human immunodeficiency virus (HIV) infection, or positive test for hepatitis B active infection (HBsAg) or hepatitis C active infection (hepatitis C antibody). 17. Current active liver or biliary disease with certain exceptions. 18. History or evidence of cardiac abnormalities per protocol. 19. History of bleeding tendency or a recent major bleeding event which, in the opinion of the investigator, indicates that the subject is at high risk of receiving study treatment. 20. Pregnant or nursing females. 21. Any known, documented, or suspected history of substance abuse that would preclude subject from participation with certain exceptions. 22. Any other disease or clinically significant abnormality in a laboratory parameter, including serious medical or psychiatric disease/condition, that in the opinion of the investigator may compromise the safety of the subject or the integrity of the study, interfere with the subject's participation in the trial or affect the purpose of the trial. 23. Those involved in the design and/or implementation of the study. 24. Those deemed by the investigator to be unable to comply with the steps, limitations and requirements of the study.
Where this trial is running
Shanghai
- Shanghai Chest Hospital — Shanghai, China (Recruiting)
Study contacts
- Study coordinator: Sarah Zhuang
- Email: ClinicalOperation@elpiscience.com
- Phone: (+86) 21 50651310
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.