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

Advanced Solid Tumor Clinical Trial

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05487170
• Other study ID #: RNK05047-01
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: July 12, 2022
• Est. completion date: October 2024

Study information

• Verified date: December 2022
• Source: Ranok Therapuetics Co. Ltd.
• Contact: Linda Grummer, RN, BSN
• Phone: 405-921-1605
• Email: lindagrummer[@]ranoktherapeutics.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 105
• Est. completion date: October 2024
• Est. primary completion date: February 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

• Adequate tumor sample

• 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

Related Conditions & MeSH terms

• Advanced Solid Tumor
• DLBCL
• Neoplasms

Intervention

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

Country	Name	City	State
United States	Emory University Winship Cancer Institute	Atlanta	Georgia
United States	Pennsylvania Cancer Specialists & Research Institute	Gettysburg	Pennsylvania
United States	Horizon Oncology and Research Center	Lafayette	Indiana
United States	Weill Cornell - NY Presbyterian Hospital	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Ranok Therapeutics (Hangzhou) Co., Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Part 1: Incidence of DLTs		through 1 cycle/4 weeks
Primary	Part 1: Incidence of TEAEs		through study completion, an average of 1 year
Primary	Part 2: Incidence of TEAEs		through study completion, an average of 1 year
Primary	Part 2: Objective response rate (ORR) based on RECIST 1.1/RECIL 2017		through study completion, an average of 1 year
Primary	Part 2: Duration of response (DoR) based on RECIST 1.1/RECIL 2017		through study completion, an average of 1 year
Primary	Part 2: Progression-free Survival (PFS) based on RECIST 1.1/RECIL 2017		through study completion, an average of 1 year
Primary	Part 2: Disease Control Rate (DCR) based on RECIST 1.1/RECIL 2017		through study completion, an average of 1 year
Secondary	Part 1: Plasma concentration RNK05047		Through Cycle 3/approximately 12 weeks
Secondary	Part 1: ORR based on RECIST 1.1/RECIL 2017		through study completion, an average of 1 year
Secondary	Part 1: DoR based on RECIST 1.1/RECIL 2017		through study completion, an average of 1 year
Secondary	Part 1: PFS based on RECIST 1.1/RECIL 2017		through study completion, an average of 1 year
Secondary	Part 1: DCR based on RECIST 1.1/RECIL 2017		through study completion, an average of 1 year
Secondary	Part 2: Plasma concentration RNK05047		Through Cycle 3/approximately 12 weeks
Secondary	Part 2: Overall Survival (OS)		through study completion, an average of 1 year