Clinical trial · Interventional
A First-in-Human Phase I Study of ESG206 in Subjects With B-cell Lymphoid Malignancies
A First-in-Human Phase I, Open Label, Multiple Dose, Dose Escalation Study to Investigate the Safety, Tolerability, Pharmacokinetics and Antitumor Activities of Anti-BAFFR mAb, ESG206 in Subjects With B-cell Lymphoid Malignancies
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Due to the company's development strategy adjustment
Summary
Brief summary (as posted)
This is a first-in-human phase I, multicenter, open label, sequential-cohort, dose escalation study of ESG206. The purpose is to evaluate the clinical safety, tolerability, PK, and preliminary efficacy and to establish the MTD, if any, and RP2D(s) of ESG206 in adult subjects with B lymphoid malignancies.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| B-cell Lymphoid Malignancies | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ESG206 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (5)
- type
- EXPERIMENTAL
- label
- ESG206 dose level 1
- description
- ESG206 will be administered intravenously at dose level 1 every two weeks in a 28-day cycle.
- interventionNames
- Drug: ESG206
- type
- EXPERIMENTAL
- label
- ESG206 dose level 2
- description
- ESG206 will be administered intravenously at dose level 2 every two weeks in a 28-day cycle.
- interventionNames
- Drug: ESG206
- type
- EXPERIMENTAL
- label
- ESG206 dose level 3
- description
- ESG206 will be administered intravenously at dose level 3 every two weeks in a 28-day cycle.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available