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 — DRUG
    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).

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: RNK05047
    Dose-escalation of RNK05047 IV infusion

Primary Outcome Measure

Part 1: Incidence of DLTs [ Time Frame: through 1 cycle/4 weeks ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Emory University Winship Cancer InstituteAtlantaGeorgia30322-
Norton Cancer InstituteLouisvilleKentucky40202-
Weill Cornell - NY Presbyterian HospitalNew YorkNew York10065-

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