RNK05047 for Cancer

Recruiting at 4 trial locations

Overseen By Linda Grummer, RN, BSN

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Ranok Therapeutics (Hangzhou) Co., Ltd.

Must not be taking: Anticancer therapy

Disqualifiers: CNS metastases, HIV, Hepatitis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

32 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called RNK05047 for individuals with advanced solid tumors, including diffuse large B-cell lymphoma. The study aims to assess the safety and effectiveness of this treatment when administered through an IV drip. It consists of two parts: determining the right dose and evaluating the treatment's efficacy. Individuals who have exhausted all standard treatments without success and have a measurable tumor may qualify for this trial. As a Phase 1 trial, this research seeks to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this new drug.

Will I have to stop taking my current medications?

The trial protocol does not specify if you must stop taking your current medications, but you cannot be on any concurrent anticancer therapy. You must wait for at least 5 half-lives of any prior systemic cancer therapy before starting the study drug.

Is there any evidence suggesting that RNK05047 is likely to be safe for humans?

Research has shown that RNK05047, a new treatment being tested for advanced solid tumors and diffuse large B-cell lymphoma (DLBCL), appears safe for humans. Early clinical results suggest that RNK-series compounds, like RNK05047, are generally safe and effective in treating various diseases, especially cancer.

Since the study for RNK05047 is in its early stages, the main goal is to assess its tolerability. This involves checking for any side effects or negative reactions. Although detailed safety information is not yet available, the drug's progression through early trials suggests that any observed side effects can be managed.

As with any new treatment, ongoing monitoring will ensure RNK05047's safety for trial participants. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

RNK05047 is unique because it introduces a novel approach to treating cancer through a dose-escalation IV infusion. Unlike traditional chemotherapy that targets rapidly dividing cells indiscriminately, RNK05047 potentially offers a more targeted mechanism, which might mean fewer side effects. Researchers are excited about its potential to provide a more precise treatment option, improving patient outcomes and quality of life.

What evidence suggests that RNK05047 might be an effective treatment for cancer?

Research has shown that RNK05047, a new treatment under study in this trial, could help fight cancer by breaking down a protein called BRD4, often found in tumors. Early clinical results suggest that RNK-series treatments, like RNK05047, are safe and effective across various cancer types. This treatment targets specific proteins in cancer cells, potentially leading to better outcomes and fewer side effects. Although direct evidence in humans is still being gathered, the mechanism of RNK05047 offers a promising new approach to attacking cancer cells. ^{2 3 5 6 7}

Who Is on the Research Team?

Linda Grummer

Principal Investigator

Ranok Therapeutics

Are You a Good Fit for This Trial?

This trial is for adults with advanced solid tumors or diffuse large B-cell lymphoma who've run out of standard treatment options. They must be in fairly good health, understand the study, and agree to use effective birth control. Pregnant women, those with certain infections like HIV or hepatitis, and people with unresolved side effects from past cancer treatments can't join.

Inclusion Criteria

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.

My liver, kidneys, blood, and clotting functions are all within normal ranges.

I agree to use effective birth control during and for 4 months after treatment.

Exclusion Criteria

I might have cancer spread to my brain or spinal cord.

I had cancer before but was treated with the goal of curing it.

I experience significant numbness or pain in my hands or feet.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Participants receive IV RNK05047 once weekly for 3 consecutive weeks in a 4-week cycle, following a 3+3 design

4 weeks per cycle

3 visits (in-person) per cycle

Cohort Expansion

Additional subjects are enrolled to receive RNK05047 at the established RP2D, with tumor types determined based on prior data

Varies by cohort

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• RNK05047

Trial Overview The trial is testing RNK05047 given through an IV to see if it's safe and works against advanced cancers. It has two parts: first finding the right dose (dose escalation) and then giving that dose to more people (cohort expansion).

How Is the Trial Designed?

Group I: RNK05047 Experimental Treatment 1 Intervention

Dose-escalation of RNK05047 IV infusion

Who Is Running the Clinical Trial?

Ranok Therapeutics (Hangzhou) Co., Ltd.

Lead Sponsor

Trials

2

Recruited

180+

Ranok Therapuetics Co. Ltd.

Lead Sponsor

Trials

1

Recruited

30+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05487170

A Study of RNK05047 in Subjects With Advanced Solid ... RNK05047 is a chaperone-mediated protein degrader administered as IV infusion once weekly for 3 consecutive weeks in a 4-week cycle (no treatment in the fourth ...

2. georgiacancerinfo.org georgiacancerinfo.org/trialDetailPrint.aspx?trialID=5343

Clinical Trial Details | GCI A Study of RNK05047 in Subjects With Advanced Solid Tumors/Diffuse Large B-cell Lymphoma (CHAMP-1) ; Active: Yes ; Cancer Type: Hematopoietic Malignancies

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/B9780443338854000421

RNK-05047: a chaperone-mediated protein degrader that ... Initial clinical results indicate that RNK-series compounds are safe and effective in various disease models, particularly in cancer. Looking ahead, the ...

4. ranoktherapeutics.com ranoktherapeutics.com/newsinfo/902510.html

Ranok Therapeutics Expands Clinical Testing of CHAMP ... “RNK05047 degrades BRD4 protein preferentially in tumors, which may potentially lead to improved safety and efficacy. We look forward to sharing ...

5. letswinpc.org letswinpc.org/research/protein-degradation-advanced-tumors/

Targeted Protein Degradation to Treat Advanced Solid ... A clinical trial tests the effectiveness of a molecule that causes protein degradation in tumor cells, including pancreatic cancer cells.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05487170

A Study of RNK05047 in Subjects With Advanced Solid ... Also called a data safety and monitoring board, or DSMB. Early Phase 1 ... RNK05047 in Subjects With Advanced Solid Tumors (CHAMP-1). Conditions.

7. synapse.patsnap.com synapse.patsnap.com/blog/ranok-initiates-china-phase-1-trial-for-champ-brd4-degrader-rnk05047

Ranok Initiates China Phase 1 Trial for CHAMP® BRD4 ... RNK05047 is a novel, small-molecule degrader that targets BRD4, a key regulator in cancer, and is currently undergoing Phase 1 trials in the US and China.