Study of HC006 in Combination With a PD-1 Inhibitor in Patients With Advanced Solid Tumors
ConditionAdvanced Cancer
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorHC Biopharma Inc.
About this trial
This is an open-label, multicenter Phase 1b clinical study to evaluate the safety, tolerability, pharmacokinetics, immunogenicity and preliminary efficacy of HC006 in combination with a PD-1 inhibitor in patients with advanced solid tumors. The trial is divided into two stages: dose-escalation and dose expansion. First, the dose-escalation study is completed to determine the recommended dose for subsequent extension studies, and then the dose expansion study is conducted in the proposed tumors with potential treatment benefits.
Eligibility criteria
Qualifiers
Fully understand this trial and voluntarily sign the informed consent form;
Advanced solid tumors diagnosed by histology or cytopathology;
Be able to provide archived (within 2 years after the first treatment with study drug) or fresh tumor tissue samples for relevant biological sample analysis required by the protocol;
At least one measurable lesion according to RECIST Version 1.1 (patients with only brain lesion as target lesion are not accepted);
Disqualifiers
Patients with imaging findings showing tumor invasion of great vessels or unclear demarcation from blood vessels;
Patients with combined brain metastasis, meningeal metastasis, spinal cord compression or leptomeningeal disease;
Previous treatment with monoclonal antibodies, bispecific antibodies, small molecule compounds and cells targeting CCR8 at any time;
Conditions may significantly affect the autoimmune status;
Trial design
Treatments tested in this trial
- HC006
- KEYTRUDA ®( Pembrolizumab)
Treatment groups
252 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov