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RECRUITING
NCT05487170
PHASE1/PHASE2

A Study of RNK05047 in Subjects With Advanced Solid Tumors/Diffuse Large B-cell Lymphoma (CHAMP-1)

Sponsor: Ranok Therapeutics (Hangzhou) Co., Ltd.

View on ClinicalTrials.gov

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

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).

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