A Study of RNK05047 in Subjects With Advanced Solid Tumors/Diffuse Large B-cell Lymphoma (CHAMP-1)
NCT05487170 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 32
Last updated 2025-03-04
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.
Conditions
- Advanced Solid Tumor
- DLBCL
Interventions
- DRUG
-
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).
Sponsors & Collaborators
-
Ranok Therapeutics (Hangzhou) Co., Ltd.
lead INDUSTRY
Principal Investigators
-
Linda Grummer · Ranok Therapeutics
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-07-12
- Primary Completion
- 2025-06-01
- Completion
- 2025-09-01
- FDA Drug
- Yes
Countries
- United States
- China
Study Locations
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