NCT05487170RecruitingPhase 1/2
A Study of RNK05047 in Subjects With Advanced Solid Tumors/Diffuse Large B-cell Lymphoma (CHAMP-1)
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)
Source: ClinicalTrials.gov · Last updated 4 Mar 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 32 (estimated)
- First submitted
- 12 Jul 2022
- Start date
- 12 Jul 2022
- Primary completion date
- 1 Jun 2025
- Lead sponsor
- Ranok Therapeutics (Hangzhou) Co., Ltd.
- Diseases
- Diffuse large B-cell lymphoma
- NCT number
- NCT05487170
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 32
- From 12 Jul 2022 to the primary completion date, 1 Jun 2025
- 5 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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
Other
- 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
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Beijing Cancer Hospital Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
| Cancer Hospital, Chinese Academy of Medical Sciences Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
| Emory University/Winship Cancer Institute Coordinator of this site? Confirm its status | Atlanta | United States | Completed |
| Norton Cancer Institute Coordinator of this site? Confirm its status | Louisville | United States | Completed |
| Weill Cornell - NY Presbyterian Hospital Coordinator of this site? Confirm its status | New York | United States | Completed |
This page is information, not medical advice. Discuss any trial with your doctor.