RECRUITING

An Engineered Sirpα Fused to Anti-Pd-L1 And Tgf-β Fusion Protein (HCB301) in Subjects With Selected Advanced Tumors

Conditions

Advanced Solid Tumor Refractory Hodgkin Lymphoma Immunotherapy CD47 PD-L1 TGF-beta Tumor Cancer

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of this study is to find out whether IV injection of HCB301 is an effective treatment for different types of advanced solid tumors and relapsed and refractory classical Hodgkin lymphomas and what side effects (unwanted effects) may occur in subjects aged 18 years old and above.

Official Title

A Phase 1, Open-label, Multicenter, Dose-escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of HCB301 in Subjects With Advanced Solid Tumors or Relapsed and Refractory cHL

Quick Facts

Study Start:2025-04-02

Study Completion:2026-08-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06487624

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Able to understand and be willing to sign the ICF. 2. Male and female subjects of ≥18 years of age. 3. Histologically/cytologically confirmed, locally advanced solid tumor: 4. For subjects with advanced solid tumors - 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 classical Hodgkin lymphoma - must have classical Hodgkin lymphoma that is measurable or assessable for response. 6. Must have ECOG performance status of 0 to 1 at Screening. 7. Able to provide tumor tissue samples. 8. Have a life expectancy of ≥12 weeks.	1. With known history of hypersensitivity to any components of HCB301. 2. Known active or untreated CNS metastases and/or carcinomatous meningitis. 3. Have undergone a major surgery or radical radiotherapy within 28 days or palliative radiotherapy within 14 days or have used a radioactive drug within 56 days prior to the first dose of HCB301. 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 administered within 21 days or 5 half-lives, whichever is shorter, before the first dose of the study drug. 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 ≤ 100 mg/QD. 11. Have used herbal medication within 14 days prior to the first dose of HCB301. 12. Have received any treatment targeting the SIRPα-CD47, PD-L1, or TGF-β pathway. 13. Have other malignancies requiring treatment within 2 years prior to the first dose of HCB301. 14. An investigational device used within 28 days prior to the first dose of HCB301. 15. Positive for hepatitis B, active hepatitis C infections, positive for HIV, or known active or latent tuberculosis. 16. Known to have a history of alcoholism or drug abuse.

Inclusion Criteria

Exclusion Criteria

1. Able to understand and be willing to sign the ICF.
2. Male and female subjects of ≥18 years of age.
3. Histologically/cytologically confirmed, locally advanced solid tumor:
4. For subjects with advanced solid tumors - 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 classical Hodgkin lymphoma - must have classical Hodgkin lymphoma that is measurable or assessable for response.
6. Must have ECOG performance status of 0 to 1 at Screening.
7. Able to provide tumor tissue samples.
8. Have a life expectancy of ≥12 weeks.

1. With known history of hypersensitivity to any components of HCB301.
2. Known active or untreated CNS metastases and/or carcinomatous meningitis.
3. Have undergone a major surgery or radical radiotherapy within 28 days or palliative radiotherapy within 14 days or have used a radioactive drug within 56 days prior to the first dose of HCB301.
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 administered within 21 days or 5 half-lives, whichever is shorter, before the first dose of the study drug.
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 ≤ 100 mg/QD.
11. Have used herbal medication within 14 days prior to the first dose of HCB301.
12. Have received any treatment targeting the SIRPα-CD47, PD-L1, or TGF-β pathway.
13. Have other malignancies requiring treatment within 2 years prior to the first dose of HCB301.
14. An investigational device used within 28 days prior to the first dose of HCB301.
15. Positive for hepatitis B, active hepatitis C infections, positive for HIV, or known active or latent tuberculosis.
16. Known to have a history of alcoholism or drug abuse.

Contacts and Locations

Study Contact

FBD Clinical

CONTACT

+886-2-27921366

HCB301-101@hanchorbio.com

Study Locations (Sites)

Prisma Health-Upstate

Greenville, South Carolina, 29605

United States

Collaborators and Investigators

Sponsor: FBD Biologics Limited

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-04-02

Study Completion Date2026-08-31

Study Record Updates

Study Start Date2025-04-02

Study Completion Date2026-08-31

Terms related to this study

Keywords Provided by Researchers

Immunotherapy
CD47
PD-L1
TGF-beta
Tumor
Cancer

Additional Relevant MeSH Terms

Advanced Solid Tumor
Refractory Hodgkin Lymphoma