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A Safety and Efficacy Study of HCB101, Fc-fusion Protein Targeting SIRPα-CD47 Pathway, in Solid or Hematological Tumors

Primary Purpose

Advanced Solid Tumor, Refractory Non-Hodgkin Lymphoma

Status
Recruiting
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
HCB101
Sponsored by
FBD Biologics Limited
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Advanced Solid Tumor focused on measuring Immunotherapy, CD47, SIRPα, Solid Tumor, Lymphoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Able to understand and willing to sign the ICF. Male and female subjects of ≥18 years of age. 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. 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. For subjects with non-Hodgkin lymphoma - must have non-Hodgkin lymphoma that is measurable or assessable for response per Lugano Classification (with 2016 refinement). Must have ECOG performance status of 0 to 2 at Screening. Able to provide tumor tissue samples. Have life expectancy of ≥12 weeks. Exclusion Criteria: With known history of hypersensitivity to any components of HCB101. Known active or untreated CNS metastases and/or carcinomatous meningitis. 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. Clinically significant cardiovascular condition. 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. With known inherited or acquired bleeding disorder. Have RBC transfusion within 4 weeks prior to Screening. With a previously documented diagnosis of hemolytic anemia or Evans Syndrome in the last 3 months. Any investigational or approved systemic cancer therapy. Are under continuous anticoagulation treatment. Have used herbal medication within 14 days prior to the first dose of HCB101. Have received any treatment targeting the CD47 or SIRPα pathway. Have other malignancies requiring treatment within 2 years prior to the first dose of HCB101. Participation in another clinical study with an investigational product administered in the last 28 days prior to receiving the first dose of HCB101. An investigational device used within 28 days prior to the first dose of HCB101. Positive for hepatitis B, active hepatitis C infections, positive for HIV, or known active or latent tuberculosis. Known to have a history of alcoholism or drug abuse.

Sites / Locations

  • Hematology-Oncology Associates of the Treasure CoastRecruiting
  • Carolina BioOncologyRecruiting
  • Greenville Hospital System University Medical Center (ITOR)Recruiting
  • Taipei Medical University - Shuang Ho Hospital, Ministry of Health and WelfareRecruiting
  • National Taiwan University Hospital
  • Taipei Veterans General Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

HCB101

Arm Description

HCB101 in subjects with advanced solid tumors or relapsed and refractory non-Hodgkin lymphoma. Dosage levels: 0.08 mg/kg, 0.16 mg/kg, 0.32 mg/kg, 0.64 mg/kg, 1.28 mg/kg, 2.56 mg/kg, and 5.12 mg/kg sequentially.

Outcomes

Primary Outcome Measures

Number/incidence and percentage of subjects with adverse events, including ADA.
To evaluate the safety and tolerability of HCB101
Number of subjects with MTD of HCB101
To evaluate the safety and tolerability of HCB101

Secondary Outcome Measures

Overall Rate Response (ORR)
ORR is defined as the proportion of participants who have a partial response (PR) or critical response (CR)
Duration of Response (DoR)
DOR is defined as time from date of initial documentation of a response (PR or CR) to date of first documented evidence of progressive disease (PD)
Disease Control Rate (DCR)
DCR is defined as the proportion of participants who have a partial response (PR), critical response (CR), or disease stable (SD)
Progression-Free Survival (PFS)
Defined as the duration from the start of treatment until tumor progression or death of any cause.
Peak Plasma Concentration (Cmax) of HCB101
Peak Plasma Concentration (Cmax) of HCB101 following single and repeated IV doses of HCB101 at different dose levels.
Area under the plasma concentration versus time curve (AUC) of HCB101
Area under the plasma concentration versus time curve (AUC) of HCB101 following single and repeated IV doses of HCB101 at different dose levels.
Time to maximum drug concentration in plasma (Tmax) of HCB101
Time to maximum drug concentration in plasma (Tmax) of HCB101 following single and repeated IV doses of HCB101 at different dose levels.
Terminal elimination half-life (t1/2) of HCB101
Terminal elimination half-life (t1/2) of HCB101 following single and repeated IV doses of HCB101 at different dose levels.

Full Information

First Posted
May 9, 2023
Last Updated
October 1, 2023
Sponsor
FBD Biologics Limited
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1. Study Identification

Unique Protocol Identification Number
NCT05892718
Brief Title
A Safety and Efficacy Study of HCB101, Fc-fusion Protein Targeting SIRPα-CD47 Pathway, in Solid or Hematological Tumors
Official Title
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 Lymphoma
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 2, 2023 (Actual)
Primary Completion Date
May 30, 2025 (Anticipated)
Study Completion Date
November 15, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
FBD Biologics Limited

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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 or 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Solid Tumor, Refractory Non-Hodgkin Lymphoma
Keywords
Immunotherapy, CD47, SIRPα, Solid Tumor, Lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
HCB101
Arm Type
Experimental
Arm Description
HCB101 in subjects with advanced solid tumors or relapsed and refractory non-Hodgkin lymphoma. Dosage levels: 0.08 mg/kg, 0.16 mg/kg, 0.32 mg/kg, 0.64 mg/kg, 1.28 mg/kg, 2.56 mg/kg, and 5.12 mg/kg sequentially.
Intervention Type
Drug
Intervention Name(s)
HCB101
Other Intervention Name(s)
SIRPα-Fc fusion protein
Intervention Description
HCB101 administered via. intravenous (IV) infusion.
Primary Outcome Measure Information:
Title
Number/incidence and percentage of subjects with adverse events, including ADA.
Description
To evaluate the safety and tolerability of HCB101
Time Frame
12 months
Title
Number of subjects with MTD of HCB101
Description
To evaluate the safety and tolerability of HCB101
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Overall Rate Response (ORR)
Description
ORR is defined as the proportion of participants who have a partial response (PR) or critical response (CR)
Time Frame
12 months
Title
Duration of Response (DoR)
Description
DOR is defined as time from date of initial documentation of a response (PR or CR) to date of first documented evidence of progressive disease (PD)
Time Frame
12 months
Title
Disease Control Rate (DCR)
Description
DCR is defined as the proportion of participants who have a partial response (PR), critical response (CR), or disease stable (SD)
Time Frame
12 months
Title
Progression-Free Survival (PFS)
Description
Defined as the duration from the start of treatment until tumor progression or death of any cause.
Time Frame
12 months
Title
Peak Plasma Concentration (Cmax) of HCB101
Description
Peak Plasma Concentration (Cmax) of HCB101 following single and repeated IV doses of HCB101 at different dose levels.
Time Frame
12 months
Title
Area under the plasma concentration versus time curve (AUC) of HCB101
Description
Area under the plasma concentration versus time curve (AUC) of HCB101 following single and repeated IV doses of HCB101 at different dose levels.
Time Frame
12 months
Title
Time to maximum drug concentration in plasma (Tmax) of HCB101
Description
Time to maximum drug concentration in plasma (Tmax) of HCB101 following single and repeated IV doses of HCB101 at different dose levels.
Time Frame
12 months
Title
Terminal elimination half-life (t1/2) of HCB101
Description
Terminal elimination half-life (t1/2) of HCB101 following single and repeated IV doses of HCB101 at different dose levels.
Time Frame
12 months
Other Pre-specified Outcome Measures:
Title
CD47 receptor occupancy on circulating red blood cells (RBCs)
Description
CD47 receptor occupancy on circulating red blood cells (RBCs) will be measured as an indication of target engagement.
Time Frame
12 months
Title
Concentration of potential PD biomarkers in participants will be assess.
Description
Changes in macrophage function related cytokines will be assess after HCB101 treatment.
Time Frame
12 months
Title
ctDNA detection
Description
ctDNA detection in participants using next-generation sequencing (NGS ).
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Able to understand and willing to sign the ICF. Male and female subjects of ≥18 years of age. 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. 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. For subjects with non-Hodgkin lymphoma - must have non-Hodgkin lymphoma that is measurable or assessable for response per Lugano Classification (with 2016 refinement). Must have ECOG performance status of 0 to 2 at Screening. Able to provide tumor tissue samples. Have life expectancy of ≥12 weeks. Exclusion Criteria: With known history of hypersensitivity to any components of HCB101. Known active or untreated CNS metastases and/or carcinomatous meningitis. 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. Clinically significant cardiovascular condition. 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. With known inherited or acquired bleeding disorder. Have RBC transfusion within 4 weeks prior to Screening. With a previously documented diagnosis of hemolytic anemia or Evans Syndrome in the last 3 months. Any investigational or approved systemic cancer therapy. Are under continuous anticoagulation treatment. Have used herbal medication within 14 days prior to the first dose of HCB101. Have received any treatment targeting the CD47 or SIRPα pathway. Have other malignancies requiring treatment within 2 years prior to the first dose of HCB101. Participation in another clinical study with an investigational product administered in the last 28 days prior to receiving the first dose of HCB101. An investigational device used within 28 days prior to the first dose of HCB101. Positive for hepatitis B, active hepatitis C infections, positive for HIV, or known active or latent tuberculosis. Known to have a history of alcoholism or drug abuse.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
FBD Clinical
Phone
+886-2-27921366
Email
HCB101-101@hanchorbio.com
Facility Information:
Facility Name
Hematology-Oncology Associates of the Treasure Coast
City
Port Saint Lucie
State/Province
Florida
ZIP/Postal Code
34952
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christine Gerdes
Phone
772-408-5159
Facility Name
Carolina BioOncology
City
Huntersville
State/Province
North Carolina
ZIP/Postal Code
28078
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ashley Wallace
Phone
980-441-1021
Facility Name
Greenville Hospital System University Medical Center (ITOR)
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29605
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jill Roemmich
Phone
864-455-3600
Facility Name
Taipei Medical University - Shuang Ho Hospital, Ministry of Health and Welfare
City
New Taipei City
ZIP/Postal Code
23561
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yu-Hsuan Li
Phone
886-2-22490088 ext 8767
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
10002
Country
Taiwan
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chen-Yu Chiu
Phone
886-2-23123456 ext 67851
Facility Name
Taipei Veterans General Hospital
City
Taipei
ZIP/Postal Code
11217
Country
Taiwan
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ling-Ling Chiu
Phone
886-2-28757270 ext 2999

12. IPD Sharing Statement

Learn more about this trial

A Safety and Efficacy Study of HCB101, Fc-fusion Protein Targeting SIRPα-CD47 Pathway, in Solid or Hematological Tumors

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