RecruitingPhase 1Phase 2NCT05487170

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

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)

Sponsor

Ranok Therapeutics (Hangzhou) Co., Ltd.

Enrollment

32 participants

Start Date

Jul 12, 2022

Study Type

INTERVENTIONAL

Conditions

Advanced Solid Tumor DLBCL

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study (CHAMP-1) is testing a new investigational drug called RNK05047 for people with advanced solid tumors or a type of aggressive blood cancer called Diffuse Large B-cell Lymphoma (DLBCL) that no longer responds to standard treatments. **You may be eligible if...** - You are 18 or older - You have a locally advanced or metastatic solid tumor, or DLBCL - Your cancer has stopped responding to or you cannot tolerate all available standard treatments - You have measurable disease - You have archived tumor tissue available - Your general health status is good (ECOG 0–1) - Your liver, kidney, blood, and clotting function all meet the required thresholds - You are willing to use effective contraception during and for at least 4 months after treatment **You may NOT be eligible if...** - You are currently receiving any other anticancer treatment - You have unresolved significant side effects from prior cancer therapy - You have active cancer in the brain or spinal cord lining - You have significant peripheral nerve damage or neuropathy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGRNK05047

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).