Status:
WITHDRAWN
A First-in-Human Phase I Study of ESG206 in Subjects With B-cell Lymphoid Malignancies
Lead Sponsor:
Shanghai Escugen Biotechnology Co., Ltd
Collaborating Sponsors:
Escugen (Australia) Biotechnology Pty Ltd
Conditions:
B-cell Lymphoid Malignancies
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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 efficac...
Detailed Description
This is a first-in-human phase I, multicenter, open label, sequential-cohort, dose escalation study of ESG206. The study will follow a modified 3+3 dose escalation scheme. Dose escalation will continu...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2026
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT05263739
Start Date
December 1 2025
End Date
December 1 2026
Last Update
September 12 2025
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