A Safety and Efficacy Study of HCB101, Fc-fusion Protein Targeting SIRPα-CD47 Pathway, in Solid or Hematological Tumors
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorFBD Biologics Limited
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Able to understand and willing to sign the ICF.
Male and female subjects of ≥18 years of age.
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.
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.
Disqualifiers
With known history of hypersensitivity to any components of HCB101.
Known active or untreated CNS metastases and/or carcinomatous meningitis.
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.
Clinically significant cardiovascular condition.
Trial design
Design model
Single group
Treatments tested in this trial
HCB101
DrugHCB101 administered via. intravenous (IV) infusion.
Treatment groups
80 Participants
are divided into 1 treatment groupGroup A: HCB101Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Number/incidence and percentage of subjects with adverse events, including ADA.
To evaluate the safety and tolerability of HCB101
Time frame
12 months2
Number of subjects with MTD of HCB101
To evaluate the safety and tolerability of HCB101
Time frame
12 monthsSecondary outcomes
1
Overall Rate Response (ORR)
ORR is defined as the proportion of participants who have a partial response (PR) or critical response (CR)
Time frame
12 months2
Duration of Response (DoR)
DOR is defined as time from date of initial documentation of a response (PR or CR) to date of first documented evidence of progressive disease (PD)
Time frame
12 months3
Disease Control Rate (DCR)
DCR is defined as the proportion of participants who have a partial response (PR), critical response (CR), or disease stable (SD)
Time frame
12 months4
Progression-Free Survival (PFS)
Defined as the duration from the start of treatment until tumor progression or death of any cause.
Time frame
12 monthsOther outcomes
1
CD47 receptor occupancy on circulating red blood cells (RBCs)
CD47 receptor occupancy on circulating red blood cells (RBCs) will be measured as an indication of target engagement.
Time frame
12 months2
Concentration of potential PD biomarkers in participants will be assess.
Changes in macrophage function related cytokines will be assess after HCB101 treatment.
Time frame
12 months3
ctDNA detection
ctDNA detection in participants using next-generation sequencing (NGS ).
Time frame
12 monthsSponsors and contacts
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Source ClinicalTrials.gov