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

RECRUITINGPHASE1

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

NCT05892718•FBD Biologics Limited

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.
+7 more criteria

Locations (8)

Hematology-Oncology Associates of the Treasure Coast

Port Saint Lucie, Florida, United States

Carolina BioOncology

Huntersville, North Carolina, United States

Greenville Hospital System University Medical Center (ITOR)

Greenville, South Carolina, United States

UT Southwestern Medical Center

Dallas, Texas, United States

Hangzhou First People's Hospital

Hangzhou, Zhejiang, China

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, Taiwan

Key Dates

Start Date

October 2, 2023

Primary Completion Date

May 30, 2027

Completion Date

November 15, 2029

Last Updated

February 4, 2026

Enrollment

ESTIMATED participants

Conditions

Advanced Solid TumorRefractory Non-Hodgkin Lymphoma

Interventions

HCB101

DRUG

Contacts

FBD Clinical

CONTACT

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

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 4, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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