Trial Title:
A Safety and Efficacy Study of HCB101, Fc-fusion Protein Targeting SIRPα-CD47 Pathway, in Solid or Hematological Tumors
NCT ID:
NCT05892718
Condition:
Advanced Solid Tumor
Refractory Non-Hodgkin Lymphoma
Conditions: Official terms:
Lymphoma
Lymphoma, Non-Hodgkin
Conditions: Keywords:
Immunotherapy
CD47
SIRPα
Solid Tumor
Lymphoma
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
HCB101
Description:
HCB101 administered via. intravenous (IV) infusion.
Arm group label:
HCB101
Other name:
SIRPα-Fc fusion protein
Summary:
The purpose of this study is to find out whether IV injection of HCB101 is an effective
treatment for different types of advanced solid tumors or relapsed and refractory
non-Hodgkin lymphoma and what side effects (unwanted effects) may occur in subjects aged
18 years old and above.
Detailed description:
This is an open-label, multi-center, dose-escalation, Phase 1 study. This study is to
evaluate the safety, tolerability, pharmacokinetics (PK), anti-tumor activity, and
identification of maximum tolerated dose (MTD) of HCB101 intravenous injection in adults
with advanced solid tumors or relapsed and refractory non-Hodgkin lymphoma.
Eligible subjects must have failed standard therapies, been intolerable, or been
considered medically inappropriate by the investigator. Subjects will be treated until
unacceptable AEs, radiographic or clinical documented disease progression, withdrawal of
consent, loss to follow-up, death, or termination of the study, whichever occurs first.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Able to understand and willing to sign the ICF.
2. Male and female subjects of ≥18 years of age.
3. Histologically/cytologically confirmed, locally advanced solid tumor: subjects with
histologically or cytologically confirmed advanced solid tumors refractory to
standard therapy, or for which no standard treatment exists or non-Hodgkin lymphoma,
relapsed or refractory to at least 2 prior lines of therapy.
4. For subjects with advanced solid tumor - must have at least 1 measurable lesion as
defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 at baseline.
5. For subjects with non-Hodgkin lymphoma - must have non-Hodgkin lymphoma that is
measurable or assessable for response per Lugano Classification (with 2016
refinement).
6. Must have ECOG performance status of 0 to 2 at Screening.
7. Able to provide tumor tissue samples.
8. Have life expectancy of ≥12 weeks.
Exclusion Criteria:
1. With known history of hypersensitivity to any components of HCB101.
2. Known active or untreated CNS metastases and/or carcinomatous meningitis.
3. Have undergone a major surgery or radical radiotherapy or palliative radiotherapy or
have used a radioactive drug that is not completed at least 2 weeks prior to the
first dose of HCB101.
4. Clinically significant cardiovascular condition.
5. Any previous treatment-related toxicities which have not recovered to ≤ Grade 1 as
evaluated by National Cancer Institute, Common Terminology Criteria for Adverse
Events (NCI CTCAE) version 5.0 or baseline, except alopecia and anemia.
6. With known inherited or acquired bleeding disorder or bleeding diathesis. .
7. Have RBC transfusion within 4 weeks prior to Screening.
8. With a previously documented diagnosis of hemolytic anemia or Evans Syndrome in the
last 3 months.
9. Any investigational or approved systemic cancer therapy.
10. Active use of vitamin K antagonist anticoagulant like warfarin. Use of low molecular
weight heparin and factor Xa inhibitors will be permitted on case by case basis.
There will be no restriction for daily aspirin ≤ 81 mg/QD.
11. Have used herbal medication within 14 days prior to the first dose of HCB101.
12. Have received any treatment targeting the CD47 or SIRPα pathway.
13. Have other malignancies requiring treatment within 2 years prior to the first dose
of HCB101.
14. Participation in another clinical study with an investigational product administered
in the last 14 days prior to receiving the first dose of HCB101.
15. An investigational device used within 28 days prior to the first dose of HCB101.
16. Positive for hepatitis B, active hepatitis C infections, positive for HIV, or known
active or latent tuberculosis.
17. Known to have a history of alcoholism or drug abuse.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Hematology-Oncology Associates of the Treasure Coast
Address:
City:
Port Saint Lucie
Zip:
34952
Country:
United States
Status:
Recruiting
Contact:
Last name:
Christine Gerdes
Phone:
772-408-5159
Investigator:
Last name:
Nicholas Iannotti, Dr.
Email:
Principal Investigator
Facility:
Name:
Carolina BioOncology
Address:
City:
Huntersville
Zip:
28078
Country:
United States
Status:
Recruiting
Contact:
Last name:
Ashley Wallace
Phone:
980-441-1021
Investigator:
Last name:
John Powderly, Dr.
Email:
Principal Investigator
Facility:
Name:
Greenville Hospital System University Medical Center (ITOR)
Address:
City:
Greenville
Zip:
29605
Country:
United States
Status:
Recruiting
Contact:
Last name:
Jill Roemmich
Phone:
864-455-3600
Investigator:
Last name:
Jeffery Edenfield, Dr.
Email:
Principal Investigator
Facility:
Name:
UT Southwestern Medical Center
Address:
City:
Dallas
Zip:
75390
Country:
United States
Status:
Recruiting
Contact:
Last name:
Shannon Garcia
Phone:
214-648-4118
Investigator:
Last name:
Tian Zhang, Dr.
Email:
Principal Investigator
Facility:
Name:
Taipei Medical University - Shuang Ho Hospital, Ministry of Health and Welfare
Address:
City:
New Taipei City
Zip:
23561
Country:
Taiwan
Status:
Recruiting
Contact:
Last name:
Yu-Yan Hong
Phone:
886-2-22490088
Phone ext:
8767
Investigator:
Last name:
Wei-Hong Cheng, Dr.
Email:
Principal Investigator
Facility:
Name:
National Taiwan University Hospital
Address:
City:
Taipei
Zip:
10002
Country:
Taiwan
Status:
Recruiting
Contact:
Last name:
Chia-Hsuan Yang
Phone:
886-2-23123456
Phone ext:
68057
Investigator:
Last name:
Chia-Chi Lin, Dr.
Email:
Principal Investigator
Facility:
Name:
Taipei Veterans General Hospital
Address:
City:
Taipei
Zip:
11217
Country:
Taiwan
Status:
Recruiting
Contact:
Last name:
Pei-Ling Chiu
Phone:
886-2-28757270 ext 2999
Investigator:
Last name:
Mu-Hsin Chang, Dr.
Email:
Principal Investigator
Start date:
October 2, 2023
Completion date:
November 15, 2025
Lead sponsor:
Agency:
FBD Biologics Limited
Agency class:
Industry
Source:
FBD Biologics Limited
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05892718
