Evaluating RNK05047 for advanced solid tumors and DLBCL
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)
PHASE1; PHASE2 · Ranok Therapuetics Co. Ltd. · NCT05487170
This study is testing a new drug called RNK05047 to see if it can safely help people with advanced solid tumors and diffuse large B-cell lymphoma feel better.
Quick facts
| Phase | PHASE1; PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 32 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Ranok Therapuetics Co. Ltd. (industry) |
| Drugs / interventions | chemotherapy |
| Locations | 5 sites (Atlanta, Georgia and 4 other locations) |
| Trial ID | NCT05487170 on ClinicalTrials.gov |
What this trial studies
This is a first-in-human, Phase 1/2 open-label study designed to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of RNK05047 administered via intravenous infusion to patients with advanced solid tumors, including diffuse large B-cell lymphoma (DLBCL). The study consists of two parts: a dose escalation phase where patients receive RNK05047 weekly for three weeks, followed by a cohort expansion phase that will enroll additional subjects based on the established recommended Phase 2 dose (RP2D). The study aims to identify effective dosing and gather data on the drug's impact on various tumor types.
Who should consider this trial
Good fit: Ideal candidates include individuals with pathologically documented advanced solid tumors or DLBCL who are refractory or intolerant to all available standard-of-care therapies.
Not a fit: Patients currently receiving other anticancer therapies or those with uncontrolled comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced solid tumors and DLBCL who have exhausted standard therapies.
How similar studies have performed: While this approach is novel in its specific application, similar studies using protein degraders have shown promise in treating various cancers.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Atlanta, Georgia and 4 other locations
- Emory University Winship Cancer Institute — Atlanta, Georgia, United States (COMPLETED)
- Norton Cancer Institute — Louisville, Kentucky, United States (COMPLETED)
- Weill Cornell - NY Presbyterian Hospital — New York, New York, United States (COMPLETED)
- Cancer Hospital, Chinese Academy of Medical Sciences — Beijing, Beijing Municipality, China (RECRUITING)
- Beijing Cancer Hospital — Beijing, Beijing Municipality, China (RECRUITING)
Study contacts
- Study coordinator: Linda Grummer, RN, BSN
- Email: lindagrummer@ranoktherapeutics.com
- Phone: 405-921-1605
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Advanced Solid Tumor, DLBCL, protein degrader