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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Advanced Solid Tumor; Refractory Non-Hodgkin Lymphoma
• Intervention / Treatment: Drug: HCB101

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.

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: FBD Clinical; Phone Number: +886-2-27921366; Email: HCB101-101@hanchorbio.com

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310000
      • Recruiting
      • Hangzhou First People's Hospital
      • Principal Investigator: Ying Wang
      • Contact: Ying Wang; Phone Number: +8618367124548; Email: nancywangying@163.comm
• Taiwan
  • New Taipei City, Taiwan, 23561
    • Recruiting
    • Taipei Medical University - Shuang Ho Hospital, Ministry of Health and Welfare
    • Contact: Yu-Yan Hong; Phone Number: 8767 886-2-22490088
    • Principal Investigator: Wei-Hong Cheng, Dr.
  • Taipei, Taiwan, 10002
    • Recruiting
    • National Taiwan University Hospital
    • Contact: Chia-Hsuan Yang; Phone Number: 68057 886-2-23123456
    • Principal Investigator: Chia-Chi Lin, Dr.
  • Taipei, Taiwan, 11217
    • Recruiting
    • Taipei Veterans General Hospital
    • Contact: Pei-Ling Chiu; Phone Number: 886-2-28757270 ext 2999
    • Principal Investigator: Mu-Hsin Chang, Dr.
• United States
  • Florida
    • Port Saint Lucie, Florida, United States, 34952
      • Recruiting
      • Hematology-Oncology Associates of the Treasure Coast
      • Contact: Christine Gerdes; Phone Number: 772-408-5159
      • Principal Investigator: Nicholas Iannotti, Dr.
  • North Carolina
    • Huntersville, North Carolina, United States, 28078
      • Recruiting
      • Carolina BioOncology
      • Contact: Ashley Wallace; Phone Number: 980-441-1021
      • Principal Investigator: John Powderly, Dr.
  • South Carolina
    • Greenville, South Carolina, United States, 29605
      • Recruiting
      • Greenville Hospital System University Medical Center (ITOR)
      • Contact: Jill Roemmich; Phone Number: 864-455-3600
      • Principal Investigator: Jeffery Edenfield, Dr.
  • Texas
    • Dallas, Texas, United States, 75390
      • Recruiting
      • UT Southwestern Medical Center
      • Contact: Shannon Garcia; Phone Number: 214-648-4118
      • Principal Investigator: Tian Zhang, Dr.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HCB101; 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, 5.12 mg/kg, 8.00 mg/kg, 12.00 mg/kg, 18.00 mg/kg, 24.00 mg/kg, 30.00 mg/kg and 36 mg/kg sequentially.	Drug: HCB101; HCB101 administered via. intravenous (IV) infusion.; Other Names: SIRPα-Fc fusion protein

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number/incidence and percentage of subjects with adverse events, including ADA.	To evaluate the safety and tolerability of HCB101	12 months
Number of subjects with MTD of HCB101	To evaluate the safety and tolerability of HCB101	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Rate Response (ORR)	ORR is defined as the proportion of participants who have a partial response (PR) or critical response (CR)	12 months
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)	12 months
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)	12 months
Progression-Free Survival (PFS)	Defined as the duration from the start of treatment until tumor progression or death of any cause.	12 months
Peak Plasma Concentration (Cmax) of HCB101	Peak Plasma Concentration (Cmax) of HCB101 following single and repeated IV doses of HCB101 at different dose levels.	12 months
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.	12 months
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.	12 months
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.	12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
CD47 receptor occupancy on circulating red blood cells (RBCs)	CD47 receptor occupancy on circulating red blood cells (RBCs) will be measured as an indication of target engagement.	12 months
Concentration of potential PD biomarkers in participants will be assess.	Changes in macrophage function related cytokines will be assess after HCB101 treatment.	12 months
ctDNA detection	ctDNA detection in participants using next-generation sequencing (NGS ).	12 months

Collaborators and Investigators

• Sponsor: FBD Biologics Limited

Study record dates

Study Major Dates

• Study Start (Actual): October 2, 2023
• Primary Completion (Estimated): May 30, 2027
• Study Completion (Estimated): November 15, 2029

Study Registration Dates

• First Submitted: May 9, 2023
• First Submitted That Met QC Criteria: May 28, 2023
• First Posted (Actual): June 7, 2023

Study Record Updates

• Last Update Posted (Actual): February 4, 2026
• Last Update Submitted That Met QC Criteria: February 2, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Immunotherapy; Lymphoma; Solid Tumor; CD47; SIRPα
• Additional Relevant MeSH Terms: Neoplasms; Immune System Diseases; Neoplasms by Histologic Type; Lymphatic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Hemic and Lymphatic Diseases; Lymphoma; Lymphoma, Non-Hodgkin
• Other Study ID Numbers: HCB101-101

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No