Clinical Trials List
Protocol NumberHCB101-101
Active
2023-03-19 - 2026-03-16
Phase I
Recruiting3
A Phase 1, Open-label, Multi-center, Dose Escalation Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Anti-tumor Activity of HCB101 in Subjects with Advanced Solid Tumors or Relapsed and Refractory non-Hodgkin Lymphomas
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Trial Applicant
STATPLUS, INC.
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Sponsor
FBD Biologics Limited
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Trial scale
Multi-Regional Multi-Center
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Update
2026/02/01
Investigators and Locations
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Jih-Hsiang Lee 無
- WEI-LI MA 無
- Wei-Wu Chen 無
- Shang-Ju Wu 無
- 徐偉勛 無
- MING YAO 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Principal Investigator
Wei-Hong Cheng
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Advanced Solid Tumors or Relapsed and Refractory non-Hodgkin Lymphomas
Objectives
To evaluate the safety and tolerability of
HCB101
Test Drug
injection
Active Ingredient
HCB101
Dosage Form
270
Dosage
150MG/10ML
Endpoints
Number/incidence and percentage of subjects with
AEs, SAEs, TEAEs, and DLTs
ADA/nADA concentrations derived from serum
samples
AEs, SAEs, TEAEs, and DLTs
ADA/nADA concentrations derived from serum
samples
Inclution Criteria
1. Subjects are able to understand and willing to provide signed informed consent as described in
Appendix 1, Section 10.1.3, which includes compliance with the requirements and restrictions
listed in the informed consent form (ICF) and in this protocol, including study visits and studyrelated procedures
Appendix 1, Section 10.1.3, which includes compliance with the requirements and restrictions
listed in the informed consent form (ICF) and in this protocol, including study visits and studyrelated procedures
Exclusion Criteria
1. With a known history of hypersensitivity to any components of the study intervention.
2. Primary tumor in the central nervous system (CNS), or active or untreated CNS metastases
and/or carcinomatous meningitis. Subjects with previously treated brain metastases may
participate, provided they are clinically stable for at least 28 days and have no evidence of new
or enlarging brain metastases and no requirements for high-dose corticosteroids 14 days prior
to dosing with study intervention. Subjects on low-dose corticosteroids (<20 mg prednisone or
equivalent per day) may participate.
3. Subjects who have undergone major surgery, or have undergone radical radiotherapy within
28 days prior to the first dose of study intervention, or have undergone palliative radiotherapy
within 14 days prior to the first dose of study intervention, or have used a radioactive drug
(Strontium, Samarium, etc.) within 56 days prior to the first dose of the study intervention.
4. Clinically significant cardiovascular condition, including:
• History of congestive heart failure (New York Heart Association Class >2);
• History of unstable angina within 6 months prior to the first dose of study intervention;
• New-onset angina or myocardial infarction within 6 months prior to the first dose of study
intervention;
2. Primary tumor in the central nervous system (CNS), or active or untreated CNS metastases
and/or carcinomatous meningitis. Subjects with previously treated brain metastases may
participate, provided they are clinically stable for at least 28 days and have no evidence of new
or enlarging brain metastases and no requirements for high-dose corticosteroids 14 days prior
to dosing with study intervention. Subjects on low-dose corticosteroids (<20 mg prednisone or
equivalent per day) may participate.
3. Subjects who have undergone major surgery, or have undergone radical radiotherapy within
28 days prior to the first dose of study intervention, or have undergone palliative radiotherapy
within 14 days prior to the first dose of study intervention, or have used a radioactive drug
(Strontium, Samarium, etc.) within 56 days prior to the first dose of the study intervention.
4. Clinically significant cardiovascular condition, including:
• History of congestive heart failure (New York Heart Association Class >2);
• History of unstable angina within 6 months prior to the first dose of study intervention;
• New-onset angina or myocardial infarction within 6 months prior to the first dose of study
intervention;
The Estimated Number of Participants
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Taiwan
21 participants
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Global
90 participants
