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

Advanced Solid Tumor Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05892718
• Other study ID #: HCB101-101
• Status: Recruiting
• Phase: Phase 1
• Start date: October 2, 2023
• Est. completion date: November 15, 2025

Study information

• Verified date: April 2024
• Source: FBD Biologics Limited
• Contact: FBD Clinical
• Phone: +886-2-27921366
• Email: HCB101-101[@]hanchorbio.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: November 15, 2025
• Est. primary completion date: May 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 SIRPa 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.

Related Conditions & MeSH terms

• Advanced Solid Tumor
• Lymphoma
• Lymphoma, Non-Hodgkin
• Refractory Non-Hodgkin Lymphoma

Intervention

Drug:
• HCB101
HCB101 administered via. intravenous (IV) infusion.

Locations

Country	Name	City	State
Taiwan	Taipei Medical University - Shuang Ho Hospital, Ministry of Health and Welfare	New Taipei City
Taiwan	National Taiwan University Hospital	Taipei
Taiwan	Taipei Veterans General Hospital	Taipei
United States	UT Southwestern Medical Center	Dallas	Texas
United States	Greenville Hospital System University Medical Center (ITOR)	Greenville	South Carolina
United States	Carolina BioOncology	Huntersville	North Carolina
United States	Hematology-Oncology Associates of the Treasure Coast	Port Saint Lucie	Florida

Sponsors (1)

Lead Sponsor	Collaborator
FBD Biologics Limited

Countries where clinical trial is conducted

United States,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Concentration of potential PD biomarkers in participants will be assess.	Changes in macrophage function related cytokines will be assess after HCB101 treatment.	12 months
Other	ctDNA detection	ctDNA detection in participants using next-generation sequencing (NGS ).	12 months
Primary	Number/incidence and percentage of subjects with adverse events, including ADA.	To evaluate the safety and tolerability of HCB101	12 months
Primary	Number of subjects with MTD of HCB101	To evaluate the safety and tolerability of HCB101	12 months
Secondary	Overall Rate Response (ORR)	ORR is defined as the proportion of participants who have a partial response (PR) or critical response (CR)	12 months
Secondary	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
Secondary	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
Secondary	Progression-Free Survival (PFS)	Defined as the duration from the start of treatment until tumor progression or death of any cause.	12 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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