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

Part of paid clinical trials in Greenville, South Carolina.

Sponsor
FBD Biologics Limited
Study ID
NCT06487624
Phase
PHASE1
Status
Recruiting
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Conditions

  • Advanced Solid Tumor
  • Refractory Hodgkin Lymphoma

Eligibility Criteria

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

Interventions

  • HCB301 — DRUG
    HCB301 administered via. intravenous (IV) infusion.

Study Details

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.

Key Dates

Start date
Apr 2, 2025
Status verified
Apr 2026
Primary completion
Dec 31, 2026
Completion
May 31, 2027

Study Design

Enrollment
50 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Experimental: 0.3 mg/kg HCB301
    0.3 mg/kg HCB301 in subjects with advanced solid tumors or relapsed and refractory classical Hodgkin lymphomas.
  • Experimental: Experimental: 0.6 mg/kg HCB301
    0.6 mg/kg HCB301 in subjects with advanced solid tumors or relapsed and refractory classical Hodgkin lymphomas.
  • Experimental: Experimental: 1.2 mg/kg HCB301
    1.2 mg/kg HCB301 in subjects with advanced solid tumors or relapsed and refractory classical Hodgkin lymphomas.
  • Experimental: Experimental: 2.4 mg/kg HCB301
    2.4 mg/kg HCB301 in subjects with advanced solid tumors or relapsed and refractory classical Hodgkin lymphomas.
  • Experimental: Experimental: 4.8 mg/kg HCB301
    4.8 mg/kg HCB301 in subjects with advanced solid tumors or relapsed and refractory classical Hodgkin lymphomas.
  • Experimental: Experimental: 9.6 mg/kg HCB301
    9.6 mg/kg HCB301 in subjects with advanced solid tumors or relapsed and refractory classical Hodgkin lymphomas.
  • Experimental: Experimental: 15.0 mg/kg HCB301
    15.0 mg/kg HCB301 in subjects with advanced solid tumors or relapsed and refractory classical Hodgkin lymphomas.

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Prisma Health-UpstateGreenvilleSouth Carolina29605-

Find similar trials in Greenville, SC

By research site
Prisma Health-Upstate· Greenville, SC

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