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)

Ranok Therapeutics (Hangzhou) Co., Ltd.5 sites in 2 countries32 target enrollmentJuly 12, 2022

ConditionsAdvanced Solid Tumor DLBCL

InterventionsRNK05047

DrugsRNK05047

Overview

Phase: Phase 1
Intervention: RNK05047
Conditions: Advanced Solid Tumor
Sponsor: Ranok Therapeutics (Hangzhou) Co., Ltd.
Enrollment: 32
Locations: 5
Primary Endpoint: Part 1: Incidence of DLTs
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Detailed Description

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.

Registry

clinicaltrials.gov

Start Date

July 12, 2022

End Date

September 1, 2025

Last Updated

last year

Study Type

Interventional

Study Design

Sequential

Sex

All

Investigators

Sponsor

Ranok Therapeutics (Hangzhou) Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Pathologically documented locally advanced or metastatic solid tumor
•Refractory or intolerant to all available standard-of-care therapies for advanced disease
•Measurable disease
•Archived tumor tissue collected
•ECOG Performance Status of 0 or 1
•BMI ≥ 18 kg/m2
•Adequate liver, renal, hematologic, and coagulation parameters
•Negative serum pregnancy test (for women of childbearing potential) at Screening and a negative urine or serum pregnancy test on Day 1 prior to the first infusion
•Males and females of childbearing potential must agree to use a highly effective method of contraception during treatment and for at least 4 months after the last dose of study treatment.
•Must be able to understand and comply with the conditions of the protocol and must have read and understood the consent form and provided written informed consent.

Exclusion Criteria

•Concurrent anticancer therapy: Radiotherapy, chemotherapy, biological therapy, or other anticancer investigational agents NOTE: at least 5 half-lives must have been ensued for any prior systemic cancer therapy agent before subject received the study drug on Day 1
•Unresolved toxicities from prior anticancer therapy, defined as not having resolved according to CTCAE version 5.0 Grade ≤ 1, excluding Grade 1 alopecia
•Presence or suspicion of active central nervous system (CNS) metastases and/or leptomeningeal carcinomatosis
•Peripheral neurotoxicity ≥ Grade 2 according to CTCAE v5.0
•Known active infection with HIV, HTLV-1, hepatitis B or C
•Women who are pregnant or breastfeeding
•History of another malignancy unless the subject has been treated with curative intent for this malignancy

Arms & Interventions

RNK05047

Dose-escalation of RNK05047 IV infusion

Intervention: RNK05047

Outcomes