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A Study of RNK05047 for Advanced Solid Tumors and DLBCL

This study is testing a new treatment called RNK05047 for people with advanced solid tumors or diffuse large B-cell lymphoma (DLBCL), a type of blood cancer. RNK05047 is given through an IV (into a vein) once a week for three weeks, followed by one week off, in repeating cycles. The main goals are to see how safe RNK05047 is, how well your body handles it, and if it helps shrink tumors. To join, you must have a solid tumor that has spread or DLBCL, and your cancer must not have responded to other standard treatments. You'll also need to have measurable disease and good overall health. The study plans to enroll 32 participants.

Study design
This is a Phase 1/2, open-label study, meaning both you and your doctors will know which treatment you are receiving. It involves two parts: first, a small group will help find the right dose, then more people will join to further test the treatment.
What's involved
You will receive RNK05047 as an IV infusion once weekly for three consecutive weeks, followed by a week without treatment. The study will track your health and any side effects through completion, which is expected to be about one year.
Compensation
Not stated in the trial record.
Follow-up
Your health and any side effects will be monitored through study completion, which is expected to be about one year.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05487170

A Study of RNK05047 in Subjects With Advanced Solid Tumors/Diffuse Large B-cell Lymphoma (CHAMP-1)

Recruiting
PHASE1Ages 18+InterventionalTreatment
Ranok Therapeutics (Hangzhou) Co., Ltd.
~32 participants
Updated 2025-03-04 on ClinicalTrials.gov
What's tested:RNK05047

At a glance

Recruiting sites
2 of 5 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Part 1: Incidence of DLTs
Measured over through 1 cycle/4 weeks
+6 more outcomes measured

Conditions

Advanced Solid Tumor
DLBCL

Explore related trials

Diffuse Large B-Cell LymphomaSolid Neoplasm

NCT05487170

Where you'd take part

This study runs at 5 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality, Chinano site contact published

    Recruiting

  • Cancer Hospital, Chinese Academy of Medical Sciences

    Beijing, Beijing Municipality, Chinano site contact published

    Recruiting

  • Emory University Winship Cancer Institute

    Atlanta, Georgiano site contact published

    Completed

  • Norton Cancer Institute

    Louisville, Kentuckyno site contact published

    Completed

  • Weill Cornell - NY Presbyterian Hospital

    New York, New Yorkno site contact published

    Completed

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Linda Grummer · STUDY_DIRECTOR · Ranok Therapeutics

Who to contact

Linda Grummer, RN, BSN
[email protected]
405-921-1605
Email the study team

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Eligibility criteria

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
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

What this trial measures

  • Part 1: Incidence of DLTsthrough 1 cycle/4 weeks
  • Part 1: Incidence of TEAEsthrough study completion, an average of 1 year
  • Part 2: Incidence of TEAEsthrough study completion, an average of 1 year
  • Part 2: Objective response rate (ORR) based on RECIST 1.1/RECIL 2017through study completion, an average of 1 year
  • Part 2: Duration of response (DoR) based on RECIST 1.1/RECIL 2017through study completion, an average of 1 year
  • Part 2: Progression-free Survival (PFS) based on RECIST 1.1/RECIL 2017through study completion, an average of 1 year
  • Part 2: Disease Control Rate (DCR) based on RECIST 1.1/RECIL 2017through study completion, an average of 1 year