Tests RNK05047 in adults with advanced solid tumors or lymphoma
Tests the drug RNK05047 in adults with advanced solid tumors or diffuse large B-cell lymphoma.
Plain-language title generated from the registry record
Registry title: A Study of RNK05047 in Subjects With Advanced Solid Tumors/Diffuse Large B-cell Lymphoma (CHAMP-1)
Key facts
- Where
- Atlanta, Louisville, and New York, United StatesSee the 3 sites
- Phase
- Phase 1/2
Where in United States
- Emory University/Winship Cancer InstituteAtlanta, United StatesNo longer taking part
- Norton Cancer InstituteLouisville, United StatesNo longer taking part
- Weill Cornell - NY Presbyterian HospitalNew York, United StatesNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Ranok Therapeutics (Hangzhou) Co., Ltd.
- Trial code
- NCT05487170
- Record updated
- 4 March 2025
- Original description
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).Read full original descriptionShow less
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)
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.
Inclusion: 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: 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; Known active infection with HIV, HTLV-1, hepatitis B or C; History of another malignancy unless the subject has been treated with curative intent for this malignancy; Presence or suspicion of active central nervous system (CNS) metastases and/or leptomeningeal carcinomatosis; Peripheral neurotoxicity ≥ Grade 2 according to CTCAE v5.0; Women who are pregnant or breastfeeding.