A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of YK012
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorExcyte Biopharma Ltd
About this trial
This study aims to provide a basis for further clinical development of YK012.
Eligibility criteria
Qualifiers
Written informed consent obtained from the patient prior to performing any study-related procedures, including screening visits.
Males or females aged ≥ 18 to ≤ 65 years.
Participants with an Eastern Cooperative Oncology Group (ECOG) performance score of ≤ 1.
Participants with an estimated survival time of more than 12 weeks.
Disqualifiers
History of malignancy other than B-cell NHL within 5 years prior to study entry, except for local cancers that have been clearly cured or have been free of disease for at least 5 consecutive years.
Participants with clinically symptomatic metastases to the central nervous system or meninges, or other evidence of uncontrolled metastases to the CNS or meninges, judged by the Investigator.
a) History of or current relevant CNS pathology as epilepsy, seizure, paresis, aphasia, apoplexia, severe brain injuries, cerebellar disease, organic brain syndrome, psychosis; b) Evidence for presence of inflammatory lesions and/or vasculitis on cerebral MRI.
Known allergy to monoclonal antibody drugs or immunoglobulin.
Trial design
Treatments tested in this trial
- YK012
Treatment groups
48 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov