A Study of RNK05047 in Subjects With Advanced Solid Tumors/Diffuse Large B-cell Lymphoma (CHAMP-1)
Part of paid clinical trials in Atlanta, Georgia.
- Sponsor
- Ranok Therapeutics (Hangzhou) Co., Ltd.
- Study ID
- NCT05487170
- Phase
- PHASE1/PHASE2
- Status
- Recruiting
Conditions
- Advanced Solid Tumor
- DLBCL
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- RNK05047 — DRUGRNK05047 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).
Study Details
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.
Key Dates
- Start date
- Jul 12, 2022
- Status verified
- Feb 2025
- Primary completion
- Jun 1, 2025
- Completion
- Sep 1, 2025
Study Design
- Enrollment
- 32 participants (estimated)
- Allocation
- NA
- Intervention model
- SEQUENTIAL
- Primary purpose
- TREATMENT
Arms
- Experimental: RNK05047Dose-escalation of RNK05047 IV infusion
Primary Outcome Measure
Part 1: Incidence of DLTs [ Time Frame: through 1 cycle/4 weeks ]
Central Contacts
- Linda Grummer, RN, BSN405-921-1605
Locations (3)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Emory University Winship Cancer Institute | Atlanta | Georgia | 30322 | - |
| Norton Cancer Institute | Louisville | Kentucky | 40202 | - |
| Weill Cornell - NY Presbyterian Hospital | New York | New York | 10065 | - |
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