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

NCT06487624 | Recruiting Phase 1 FDA Drug

• 1 other identifier: HCB301-101
• Study Type: interventional
• Target: 50
• Locations: 3 countries
• Sites: 7

Brief Summary

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.

Conditions

Refractory Hodgkin Lymphoma; Advanced Solid Tumor

Keywords

Immunotherapy; CD47; PD-L1; TGF-beta; Tumor; Cancer

Outcome Measures

Primary Outcomes (2)

• Number/incidence and percentage of subjects with adverse events, including ADA.

  To evaluate the safety and tolerability of HCB301.

  12 months

• Number of subjects with MTD and RDE of HCB301.

  To determine the MTD and RDE.

  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 HCB301

  12 months

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 (7)

Experimental: 0.3 mg/kg HCB301

EXPERIMENTAL

0.3 mg/kg HCB301 in subjects with advanced solid tumors or relapsed and refractory classical Hodgkin lymphomas.

Drug: HCB301

Experimental: 0.6 mg/kg HCB301

EXPERIMENTAL

0.6 mg/kg HCB301 in subjects with advanced solid tumors or relapsed and refractory classical Hodgkin lymphomas.

Drug: HCB301

Experimental: 1.2 mg/kg HCB301

EXPERIMENTAL

1.2 mg/kg HCB301 in subjects with advanced solid tumors or relapsed and refractory classical Hodgkin lymphomas.

Drug: HCB301

Experimental: 2.4 mg/kg HCB301

EXPERIMENTAL

2.4 mg/kg HCB301 in subjects with advanced solid tumors or relapsed and refractory classical Hodgkin lymphomas.

Drug: HCB301

Experimental: 4.8 mg/kg HCB301

EXPERIMENTAL

4.8 mg/kg HCB301 in subjects with advanced solid tumors or relapsed and refractory classical Hodgkin lymphomas.

Drug: HCB301

Experimental: 9.6 mg/kg HCB301

EXPERIMENTAL

9.6 mg/kg HCB301 in subjects with advanced solid tumors or relapsed and refractory classical Hodgkin lymphomas.

Drug: HCB301

Experimental: 15.0 mg/kg HCB301

EXPERIMENTAL

15.0 mg/kg HCB301 in subjects with advanced solid tumors or relapsed and refractory classical Hodgkin lymphomas.

Drug: HCB301

Interventions

HCB301 DRUG

HCB301 administered via. intravenous (IV) infusion.

Also known as: 2023-3979 Solid Tumors

Experimental: 0.3 mg/kg HCB301; Experimental: 0.6 mg/kg HCB301; Experimental: 1.2 mg/kg HCB301; Experimental: 15.0 mg/kg HCB301; Experimental: 2.4 mg/kg HCB301; Experimental: 4.8 mg/kg HCB301; Experimental: 9.6 mg/kg HCB301

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able to understand and be willing to sign the ICF.
• Male and female subjects of ≥18 years of age.
• Histologically/cytologically confirmed, locally advanced solid tumor:
• subjects confirmed advanced solid tumors who have relapsed or refractory and should have no options for standard or approved therapies known to potentially confer clinical benefit or classical Hodgkin lymphoma, relapsed or refractory to at least 2 prior lines of systemic therapy.
• 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.
• For subjects with classical Hodgkin lymphoma - must have classical Hodgkin lymphoma that is measurable or assessable for response.
• Must have ECOG performance status of 0 to 1 at Screening.
• Able to provide tumor tissue samples.
• Have a life expectancy of ≥12 weeks.

You may not qualify if:

• With known history of hypersensitivity to any components of HCB301.
• Known active or untreated CNS metastases and/or carcinomatous meningitis.
• 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.
• 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 administered within 21 days or 5 half-lives, whichever is shorter, before the first dose of the study drug.
• 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.
• Have used herbal medication within 14 days prior to the first dose of HCB301.
• Have received any treatment targeting the SIRPα-CD47, PD-L1, or TGF-β pathway.
• Have other malignancies requiring treatment within 2 years prior to the first dose of HCB301.
• An investigational device used within 28 days prior to the first dose of HCB301.
• Positive for hepatitis B, active hepatitis C infections, positive for HIV, or known active or latent tuberculosis.

Sponsors & Collaborators

• FBD Biologics Limited: lead
• HanchorBio Inc.: collaborator

Study Sites (7)

Prisma Health-Upstate

Greenville, South Carolina, 29605, United States

RECRUITING

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, China

RECRUITING

Zhejiang Provincial Cancer Hospital

Hangzhou, China

RECRUITING

Xuzhou Central Hospital

Xuzhou, China

RECRUITING

Yantai Yuhuangding Hospital

Yantai, China

RECRUITING

Southern Medical University Zhujiang Hospital

Zhujiang, China

RECRUITING

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, Taiwan

RECRUITING

MeSH Terms

Conditions

Hodgkin Disease; Camurati-Engelmann Syndrome; Neoplasms

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Osteochondrodysplasias; Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

FBD Clinical

CONTACT

+886-2-27921366; HCB301-101@hanchorbio.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2024
• First Posted: July 5, 2024
• Study Start: April 2, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): May 31, 2027
• Last Updated: April 13, 2026

Record last verified: 2026-04

Locations

TW (1); US (1); CN (5)