Actively Recruiting
A Study of RNK05047 in Subjects With Advanced Solid Tumors/Diffuse Large B-cell Lymphoma (CHAMP-1)
Led by Ranok Therapeutics (Hangzhou) Co., Ltd. · Updated on 2025-03-04
32
Participants Needed
5
Research Sites
163 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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
- BMI 63; 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.
You will not qualify if you...
- Concurrent anticancer therapy: Radiotherapy, chemotherapy, biological therapy, or other anticancer investigational agents (must have completed at least 5 half-lives before Day 1)
- Unresolved toxicities from prior anticancer therapy above Grade 1, excluding Grade 1 alopecia
- Presence or suspicion of active central nervous system (CNS) metastases and/or leptomeningeal carcinomatosis
- Peripheral neurotoxicity Grade 2 or higher
- Known active infection with HIV, HTLV-1, hepatitis B or C
- Women who are pregnant or breastfeeding
- History of another malignancy unless treated with curative intent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
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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