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

NCT05487170 | Recruiting Phase 1 FDA Drug

• 1 other identifier: RNK05047-01
• Study Type: interventional
• Target: 32
• Locations: 2 countries
• Sites: 5

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.

Conditions

Advanced Solid Tumor; DLBCL

Keywords

protein degrader

Outcome Measures

Primary Outcomes (7)

• Part 1: Incidence of DLTs

  through 1 cycle/4 weeks

• Part 1: Incidence of TEAEs

  through study completion, an average of 1 year

• Part 2: Incidence of TEAEs

  through study completion, an average of 1 year

• Part 2: Objective response rate (ORR) based on RECIST 1.1/RECIL 2017

  through study completion, an average of 1 year

• Part 2: Duration of response (DoR) based on RECIST 1.1/RECIL 2017

  through study completion, an average of 1 year

• Part 2: Progression-free Survival (PFS) based on RECIST 1.1/RECIL 2017

  through study completion, an average of 1 year

• Part 2: Disease Control Rate (DCR) based on RECIST 1.1/RECIL 2017

  through study completion, an average of 1 year

Secondary Outcomes (7)

• Part 1: Plasma concentration RNK05047

  Through Cycle 3/approximately 12 weeks

• Part 1: ORR based on RECIST 1.1/RECIL 2017

  through study completion, an average of 1 year

• Part 1: DoR based on RECIST 1.1/RECIL 2017

  through study completion, an average of 1 year

• Part 1: PFS based on RECIST 1.1/RECIL 2017

  through study completion, an average of 1 year

• Part 1: DCR based on RECIST 1.1/RECIL 2017

  through study completion, an average of 1 year

Study Arms (1)

RNK05047

EXPERIMENTAL

Dose-escalation of RNK05047 IV infusion

Drug: RNK05047

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).

RNK05047

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Ranok Therapeutics (Hangzhou) Co., Ltd.: lead

Study Sites (5)

Emory University Winship Cancer Institute

Atlanta, Georgia, 30322, United States

COMPLETED

Norton Cancer Institute

Louisville, Kentucky, 40202, United States

COMPLETED

Weill Cornell - NY Presbyterian Hospital

New York, New York, 10065, United States

COMPLETED

Cancer Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100021, China

RECRUITING

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

RECRUITING

Study Officials

• Linda Grummer

  Ranok Therapeutics

  STUDY DIRECTOR

Central Study Contacts

Linda Grummer, RN, BSN

CONTACT

405-921-1605; lindagrummer@ranoktherapeutics.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2022
• First Posted: August 4, 2022
• Study Start: July 12, 2022
• Primary Completion: June 1, 2025
• Study Completion: September 1, 2025
• Last Updated: March 4, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (3); CN (2)