NCT05892718

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 and refractory non-Hodgkin lymphoma and what side effects (unwanted effects) may occur in subjects aged 18 years old and above.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P75+ for phase_1

Timeline
43mo left

Started Oct 2023

Longer than P75 for phase_1

Geographic Reach
3 countries

8 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress42%
Oct 2023Nov 2029

First Submitted

Initial submission to the registry

May 9, 2023

Completed
29 days until next milestone

First Posted

Study publicly available on registry

June 7, 2023

Completed
4 months until next milestone

Study Start

First participant enrolled

October 2, 2023

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2027

Expected
2.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2029

Last Updated

February 4, 2026

Status Verified

February 1, 2026

Enrollment Period

3.7 years

First QC Date

May 9, 2023

Last Update Submit

February 2, 2026

Conditions

Advanced Solid TumorRefractory Non-Hodgkin Lymphoma

Keywords

ImmunotherapyCD47SIRPαSolid TumorLymphoma

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (8)

  • Overall Rate Response (ORR)

    12 months

  • Duration of Response (DoR)

    12 months

  • Disease Control Rate (DCR)

    12 months

  • Progression-Free Survival (PFS)

    12 months

  • Peak Plasma Concentration (Cmax) of HCB101

    12 months

  • +3 more secondary outcomes

Other Outcomes (3)

  • CD47 receptor occupancy on circulating red blood cells (RBCs)

    12 months

  • Concentration of potential PD biomarkers in participants will be assess.

    12 months

  • ctDNA detection

    12 months

Study Arms (1)

HCB101

EXPERIMENTAL

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

Interventions

HCB101DRUG

HCB101 administered via. intravenous (IV) infusion.

Also known as: SIRPα-Fc fusion protein
HCB101

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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 or bleeding diathesis. .
  • 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.
  • 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.
  • 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 14 days prior to receiving the first dose of HCB101.
  • An investigational device used within 28 days prior to the first dose of HCB101.
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Hematology-Oncology Associates of the Treasure Coast

Port Saint Lucie, Florida, 34952, United States

RECRUITING

Carolina BioOncology

Huntersville, North Carolina, 28078, United States

RECRUITING

Greenville Hospital System University Medical Center (ITOR)

Greenville, South Carolina, 29605, United States

RECRUITING

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

RECRUITING

Hangzhou First People's Hospital

Hangzhou, Zhejiang, 310000, China

RECRUITING

Taipei Medical University - Shuang Ho Hospital, Ministry of Health and Welfare

New Taipei City, 23561, Taiwan

RECRUITING

National Taiwan University Hospital

Taipei, 10002, Taiwan

RECRUITING

Taipei Veterans General Hospital

Taipei, 11217, Taiwan

RECRUITING

MeSH Terms

Conditions

Lymphoma, Non-HodgkinLymphoma

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Central Study Contacts

FBD Clinical

CONTACT

+886-2-27921366HCB101-101@hanchorbio.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 9, 2023

First Posted

June 7, 2023

Study Start

October 2, 2023

Primary Completion (Estimated)

May 30, 2027

Study Completion (Estimated)

November 15, 2029

Last Updated

February 4, 2026

Record last verified: 2026-02

Locations

TW(3)US(4)CN(1)