A Study of HC006 in Subjects With Advanced Solid Tumors
ConditionAdvanced Solid Tumor
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorHC Biopharma Inc.
About this trial
The purpose of this study is to characterize the safety, tolerability, pharmacokinetics (PK), Immunogenicity and preliminary antitumor activity of HC006 in subjects with advanced solid tumor malignancies. This study is a first-in-human (FIH) study of HC006 in subjects with advanced solid tumors.
Eligibility criteria
Qualifiers
Subjects must have histologically confirmed and documented diagnosis of locally advanced unresectable or metastatic advanced solid tumor that is refractory to standard treatment, or intolerant to standard treatment, or for which no standard treatment exists.
At least one measurable disease for expansion cohorts per Response Evaluation Criteria in Solid Tumours (RECIST) v1.1(dose escalation only requires at least one assessable lesion)
Agree to provide archived or fresh tumor tissue samples of primary or metastatic lesions for expansion cohorts.
Life expectancy ≥12 weeks
Disqualifiers
Prior exposure to CCR8 inhibitor or hypersensitivity to any ingredient of the study drug.
Treatment with any systemic anti-cancer treatment within 4 weeks before first dose of study drug.
Use of any live attenuated vaccines within 28 days.
With primary central nervous system (CNS) tumors or unstable CNS metastases.
Trial design
Treatments tested in this trial
- HC006
Treatment groups
76 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov