A Study of RNK05047 in Subjects With Advanced Solid Tumors/Diffuse Large B-cell Lymphoma (CHAMP-1)
Start Date
7/12/2022
Completion Date
9/1/2025
Summary
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.
Detailed Description
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.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
RNK05047
Conditions
Locations
Emory University Winship Cancer Institute
Atlanta, Georgia 30322
United States
Norton Cancer Institute
Louisville, Kentucky 40202
United States
Weill Cornell - NY Presbyterian Hospital
New York, New York 10065
United States
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality 100021
China
Beijing Cancer Hospital
Beijing, Beijing Municipality 100142
China