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

Part of paid clinical trials in Port Saint Lucie, Florida.

Sponsor
FBD Biologics Limited
Study ID
NCT05892718
Phase
PHASE1
Status
Recruiting
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Conditions

  • Advanced Solid Tumor
  • Refractory Non-Hodgkin Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • HCB101 — DRUG
    HCB101 administered via. intravenous (IV) infusion.

Study Details

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.

Key Dates

Start date
Oct 2, 2023
Status verified
Feb 2026
Primary completion
May 30, 2027
Completion
Nov 15, 2029

Study Design

Enrollment
80 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: HCB101
    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.

Primary Outcome Measure

Number/incidence and percentage of subjects with adverse events, including ADA. [ Time Frame: 12 months ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
Hematology-Oncology Associates of the Treasure CoastPort Saint LucieFlorida34952
Christine Gerdes
772-408-5159
Nicholas Iannotti, Dr. (PRINCIPAL_INVESTIGATOR)
Carolina BioOncologyHuntersvilleNorth Carolina28078
Ashley Wallace
980-441-1021
John Powderly, Dr. (PRINCIPAL_INVESTIGATOR)
Greenville Hospital System University Medical Center (ITOR)GreenvilleSouth Carolina29605
Jill Roemmich
864-455-3600
Jeffery Edenfield, Dr. (PRINCIPAL_INVESTIGATOR)
UT Southwestern Medical CenterDallasTexas75390
Shannon Garcia
214-648-4118
Tian Zhang, Dr. (PRINCIPAL_INVESTIGATOR)

Find similar trials in Port Saint Lucie, FL

By research site
Hematology-Oncology Associates of the Treasure Coast· Port Saint Lucie, FLCarolina BioOncology· Huntersville, NCGreenville Hospital System University Medical Center (ITOR)· Greenville, SCUT Southwestern Medical Center· Dallas, TX

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