An Engineered Sirpα Fused to Anti-Pd-L1 And Tgf-β Fusion Protein (HCB301) in Subjects With Selected Advanced 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 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Able to understand and be willing to sign the ICF.
Male and female subjects of ≥18 years of age.
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.
Disqualifiers
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.
Trial design
Design model
Sequential
Treatments tested in this trial
HCB301
DrugHCB301 administered via. intravenous (IV) infusion.
Treatment groups
50 Participants
are divided into 7 treatment groups7
Treatment groupsSee each treatment group below.
Group A: Experimental: 0.3 mg/kg HCB301Experimental treatment 1 intervention
Group B: Experimental: 0.6 mg/kg HCB301Experimental treatment 1 intervention
Group C: Experimental: 1.2 mg/kg HCB301Experimental treatment 1 intervention
Group D: Experimental: 2.4 mg/kg HCB301Experimental treatment 1 intervention
Group E: Experimental: 4.8 mg/kg HCB301Experimental treatment 1 intervention
Group F: Experimental: 9.6 mg/kg HCB301Experimental treatment 1 intervention
Group G: Experimental: 15.0 mg/kg HCB301Experimental 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 HCB301.
Time frame
12 months2
Number of subjects with MTD and RDE of HCB301.
To determine the MTD and RDE.
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 CD47 receptor occupancy on circulating CD3+ T cells and TGFβ1, 2, 3 will be assessed after HCB301 treatment.
Time frame
12 months3
ctDNA detection
ctDNA detection in participants using next-generation sequencing (NGS ).
Time frame
12 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
FBD Biologics Limited
Lead sponsor
HanchorBio Inc.
Collaborator
Source ClinicalTrials.gov