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A Study of RNK05047 in Subjects With Advanced Solid Tumors/Diffuse Large B-cell Lymphoma (CHAMP-1)
Sponsor: Ranok Therapeutics (Hangzhou) Co., Ltd.
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.
Official title: A Phase 1/2, Open-label Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of Chaperone-mediated Protein Degrader RNK05047 in Subjects With Advanced Solid Tumors (CHAMP-1)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
32
Start Date
2022-07-12
Completion Date
2025-09-01
Last Updated
2025-03-04
Healthy Volunteers
No
Conditions
Interventions
RNK05047
RNK05047 is a chaperone-mediated protein degrader administered as IV infusion once weekly for 3 consecutive weeks in a 4-week cycle (no treatment in the fourth week).
Locations (5)
Emory University Winship Cancer Institute
Atlanta, Georgia, United States
Norton Cancer Institute
Louisville, Kentucky, United States
Weill Cornell - NY Presbyterian Hospital
New York, New York, United States
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
Beijing Cancer Hospital
Beijing, Beijing Municipality, China