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

Active:	Yes
Cancer Type:	Hematopoietic Malignancies Lymphoma Non-Hodgkin Lymphoma Solid Tumor Unknown Primary	NCT ID:	NCT05487170
Trial Phases:	Phase I Phase II	Protocol IDs:	RNK05047-01 (primary) NCI-2022-09252
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	Ranok Therapeutics (Hangzhou) Co., Ltd.
NCI Full Details:	http://clinicaltrials.gov/show/NCT05487170

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.

Objectives

In Part 1, enrolled subjects will receive IV RNK05047 once weekly for 3 consecutive weeks in
a 4-week cycle (no treatment in the fourth week). The dose-escalation phase will follow a
standard 3+3 design, with 3 subjects enrolled into the first dosing cohort to receive
RNK05047 at the starting dose of 0.75 mg/kg.

In Part 2, once RP2D has been established, additional subjects (3 to 5 cohorts of
approximately 15 subjects per cohort) will be enrolled in the cohort-expansion phase of the
study. Tumor types for these cohorts will be determined based on data from the
dose-escalation phase of the study and emerging results from preclinical studies or other
scientific data. These dose expansion cohorts in all groups may be done concurrently.

Treatment Sites in Georgia

Winship Cancer Institute of Emory University
1365 Clifton Road NE
Building C
Atlanta, GA 30322
404-778-5180
winshipcancer.emory.edu

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