A Phase 1 Study of HCB303 in Participants With Advanced Malignancies
ConditionAdvanced Malignancies
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorFBD Biologics Limited
About this trial
A Phase 1, Open-label, Multi-regional, Multicenter, Dose escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity, and Preliminary Antitumor Activity of HCB303 in Participants with Advanced Malignancies
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
The participant is able to understand and willing to provide signed informed consent, including compliance with the requirements and restrictions described in the ICF and protocol.
Male or female participant ≥18 years of age at the time of signing the ICF.
Histologically or cytologically confirmed advanced solid tumor with relapsed, refractory, or progressive disease and no available standard therapy known to provide clinical benefit.
At least 1 measurable lesion per RECIST v1.1, as assessed by the Investigator.
Disqualifiers
Other malignancies requiring treatment within 2 years before the first dose of HCB303, except for adequately treated locally curable malignancies, such as basal cell or squamous cell skin cancer, or other malignancies treated with no relapse within 2 years.
Primary central nervous system (CNS) tumor, active or untreated CNS metastases, or carcinomatous meningitis. Participants with previously treated brain metastases may participate if clinically stable for at least 28 days, have no evidence of new or enlarging brain metastases, and do not require high-dose corticosteroids within 14 days before the first dose of HCB303. Participants receiving low-dose corticosteroids, defined as <20 mg prednisone or equivalent per day, may participate.
Trial design
Design model
Single group
Treatments tested in this trial
HCB303
DrugDose escalation from 0.03 mg/kg to 30 mg/kg.
Treatment groups
150 Participants
are divided into 1 treatment groupGroup A: HCB303Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
Evaluate the safety and tolerability of HCB303; determine the MTD and the RDE.
Number/incidence, percentage, severity, and relationship of AEs, SAEs, TEAEs, and DLTs; MTD, if reached, and RDE of HCB303.
Time frame
28 days after 1st dose.Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
FBD Biologics Limited
Lead sponsor
HanchorBio Inc.
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: