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A Study of RNK05047 in Subjects With Advanced Solid Tumors/Diffuse Large B-cell Lymphoma (CHAMP-1)
NCT05487170 · Ranok Therapuetics Co. Ltd.
In plain English
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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)
About this study
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.
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
Study design
Enrollment target: 32 participants
Allocation: na
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2022-07-12
Estimated completion: 2025-09-01
Last updated: 2025-03-04
Interventions
Drug: RNK05047
Primary outcomes
- • 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)
Sponsor
Ranok Therapeutics (Hangzhou) Co., Ltd. · industry
Contacts & investigators
ContactLinda Grummer, RN, BSN · contact · lindagrummer@ranoktherapeutics.com · 405-921-1605
InvestigatorLinda Grummer · study_director, Ranok Therapeutics
All locations (5)
Emory University Winship Cancer InstituteCompleted
Atlanta, Georgia, United States
Norton Cancer InstituteCompleted
Louisville, Kentucky, United States
Weill Cornell - NY Presbyterian HospitalCompleted
New York, New York, United States
Cancer Hospital, Chinese Academy of Medical SciencesRecruiting
Beijing, Beijing Municipality, China
Beijing Cancer HospitalRecruiting
Beijing, Beijing Municipality, China