Testing ESG206 in adults with B-cell blood cancers
A Phase I, Open Label, Multiple Dose, Dose Escalation Study to Investigate the Safety, Tolerability, Pharmacokinetics and Antitumor Activities of Anti-BAFFR mAb(Monoclonal Antibody), ESG206 in Subjects With B-cell Lymphoid Malignancies
This study is testing a new treatment called ESG206 to see if it is safe and effective for adults with hard-to-treat B-cell blood cancers.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Shanghai Escugen Biotechnology Co., Ltd Industry-sponsored |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 1 site (Beijing) |
| Trial ID | NCT05822843 on ClinicalTrials.gov |
What this trial studies
This phase 1 study is designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of ESG206 in adult patients with B-cell lymphoid malignancies. It will utilize a multicenter, open-label, sequential-cohort, dose escalation approach to determine the maximum tolerated dose and the recommended phase II dose of ESG206. Participants must have a confirmed diagnosis of incurable B-cell malignancy that has not responded to standard treatments.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with incurable B-cell hematologic malignancies that have progressed despite standard therapies.
Not a fit: Patients who have recently undergone chemotherapy or other systemic treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new treatment option for patients with difficult-to-treat B-cell malignancies.
How similar studies have performed: While this approach is being explored in this specific context, similar studies have shown promise in evaluating new therapies for B-cell malignancies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Willing and able to provide written informed consent for the trial. * Male or female and at least 18 years of age. * Subjects must have a histologically confirmed (or documented), incurable B-cell hematologic malignancy that had progressed despite standard of care therapy and for which there was no alternative therapy of proven benefit or no effective standard therapy is available or tolerable. * Measurable or evaluable Disease. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. * Subject must have adequate organ function. Exclusion Criteria: * Has had prior chemotherapy, targeted therapy, immunotherapy or any other agents used as systemic treatment for cancer, within 14 days before first dosing. * Had major surgery within 4 weeks before first dosing. * Had undergone an autologous stem cell transplant within 100 days before first dosing. * Evidence of severe or uncontrolled systemic diseases (e.g., unstable or uncompensated respiratory, hepatic, or renal disease). * Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to the investigational product or excipients. * Pregnant or breastfeeding women. * Unwillingness or inability to follow the procedures outlined in the protocol.
Where this trial is running
Beijing
- Beijing Cancer Hospital — Beijing, China (Recruiting)
Study contacts
- Study coordinator: Xiaoyan Xing, PhD
- Email: xingxiaoyan@escugen.com
- Phone: +86 21 5855 6098
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.