Actively Recruiting
A Phase 1/2 Open-label Study Evaluating Safety, Tolerability, and Efficacy of RNK05047 in Subjects With Advanced Solid Tumors Including Diffuse Large B-cell Lymphoma
Led by Ranok Therapeutics (Hangzhou) Co., Ltd. · Updated on 2025-03-04
32
Participants Needed
5
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating RNK05047, a chaperone-mediated protein degrader, in adults with advanced solid tumors, including diffuse large B-cell lymphoma (DLBCL). This Phase 1/2 open-label study aims to assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and efficacy of RNK05047 when given as an intravenous infusion. The study involves dose escalation and expansion to determine the recommended dose and explore treatment effects in specific tumor types. In the first part, participants receive weekly IV infusions of RNK05047 for three weeks followed by one week off in each 4-week cycle. The dose is gradually increased following a standard 3+3 design starting at 0.75 mg/kg. The second part enrolls additional participants in expansion cohorts based on results from the dose escalation phase, with about 15 subjects per cohort. These cohorts may run concurrently and focus on tumor types guided by emerging data. Participants will undergo regular assessments including monitoring for dose-limiting toxicities (DLTs), treatment-emergent adverse events (TEAEs), and objective tumor responses using RECIST 1.1/RECIL 2017 criteria over approximately one year. Blood samples will measure drug levels during early cycles. The study also tracks progression-free survival, duration of response, disease control rate, and overall survival. Safety and treatment effects are closely observed throughout the study duration.
CONDITIONS
Brief Title
A Study of RNK05047 in Subjects With Advanced Solid Tumors/Diffuse Large B-cell Lymphoma (CHAMP-1)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
- Body mass index (BMI) of at least 18 kg/m2
- Adequate liver, kidney, blood, and clotting function
- Negative pregnancy test for women of childbearing potential at screening and before first infusion
- Agree to use highly effective contraception during treatment and for at least 4 months after last dose if of childbearing potential
- Able to understand and comply with study requirements and provide written informed consent
You will not qualify if you...
- Receiving any other anticancer treatment such as radiotherapy, chemotherapy, biological therapy, or investigational agents without sufficient washout period
- Unresolved side effects from prior cancer treatments above Grade 1 (except mild hair loss)
- Active or suspected central nervous system metastases or leptomeningeal carcinomatosis
- Peripheral nerve damage of Grade 2 or higher
- Known active infections with HIV, HTLV-1, hepatitis B or C
- Pregnant or breastfeeding women
- History of another cancer unless treated with curative intent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated 4-week cycles until disease progression or discontinuation
Participants receive RNK05047 through intravenous infusions once weekly for 3 consecutive weeks followed by a week without treatment in each 4-week cycle.
Weekly visits for infusions during treatment weeks
Duration - Up to 1 year after treatment completion
Participants are monitored for safety, efficacy, and overall health after completing treatment, including assessments of tumor response and survival.
Periodic visits for up to 1 year
Trial Site Locations
Total: 5 locations
1
Emory University Winship Cancer Institute
Atlanta, Georgia, United States, 30322
Completed
2
Norton Cancer Institute
Louisville, Kentucky, United States, 40202
Completed
3
Weill Cornell - NY Presbyterian Hospital
New York, New York, United States, 10065
Completed
4
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China, 100021
Actively Recruiting
5
Beijing Cancer Hospital
Beijing, Beijing Municipality, China, 100142
Actively Recruiting
Research Team
L
Linda Grummer, RN, BSN
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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