This is a first in human, Phase 1/2 open-label multi-center, dose escalation and
expansion study to evaluate the safety, tolerability, PK, PD and efficacy of RNK05047
when administered an intravenous (IV) infusion to subjects with advanced solid tumors,
including diffuse large B-cell lymphoma (DLBCL).
This is a 2-part study (dose escalation, cohort expansion) with sequential enrollment.
Additional locations may be listed on ClinicalTrials.gov for NCT05487170.
See trial information on ClinicalTrials.gov for a list of participating sites.
In Part 1, enrolled subjects will receive IV RNK05047 once weekly for 3 consecutive weeks
in a 4-week cycle (no treatment in the fourth week). The dose-escalation phase will
follow a standard 3+3 design, with 3 subjects enrolled into the first dosing cohort to
receive RNK05047 at the starting dose of 0.75 mg/kg.
In Part 2, once RP2D has been established, additional subjects (3 to 5 cohorts of
approximately 15 subjects per cohort) will be enrolled in the cohort-expansion phase of
the study. Tumor types for these cohorts will be determined based on data from the
dose-escalation phase of the study and emerging results from preclinical studies or other
scientific data. These dose expansion cohorts in all groups may be done concurrently.
Lead OrganizationRanok Therapeutics (Hangzhou) Co., Ltd.
