A Study of RNK05047 in Subjects With Advanced Solid Tumors/Diffuse Large B-cell Lymphoma (CHAMP-1)
Recruiting now · Phase 1/Phase 2
Conditions studied: Advanced Solid Tumor, DLBCL
In brief
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.
Key facts
- Study ID
- NCT05487170
- Run by
- Ranok Therapeutics (Hangzhou) Co., Ltd.
- People needed
- 32
- Starts
- 2022-07-12
- Expected to finish
- 2025-09-01
- Last updated by the study team
- 2025-03-04
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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 it is running
- Cancer Hospital, Chinese Academy of Medical Sciences — Beijing, Beijing Municipality, China (enrolling)
- Beijing Cancer Hospital — Beijing, Beijing Municipality, China (enrolling)
- Emory University Winship Cancer Institute — Atlanta, Georgia, United States
- Norton Cancer Institute — Louisville, Kentucky, United States
- Weill Cornell - NY Presbyterian Hospital — New York, New York, United States
Full record on ClinicalTrials.gov
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