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Monoclonal Antibodies
RNK05047 for Cancer
Phase 1 & 2
Recruiting
Research Sponsored by Ranok Therapeutics (Hangzhou) Co., Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 1 year
Awards & highlights
Study Summary
This trial is testing a new drug (RNK05047) for cancer. The study will find out if it is safe, how well it works, and what side effects it causes.
Who is the study for?
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.Check my eligibility
What is being tested?
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).See study design
What are the potential side effects?
Since this is a first-in-human study for RNK05047, specific side effects are not yet known but may include typical reactions related to IV infusions such as pain at injection site, fever, chills, nausea or allergic reactions.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, an average of 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Part 1: Incidence of DLTs
Part 1: Incidence of TEAEs
Part 2: Disease Control Rate (DCR) based on RECIST 1.1/RECIL 2017
+4 moreSecondary outcome measures
Part 1: DCR based on RECIST 1.1/RECIL 2017
Part 1: DoR based on RECIST 1.1/RECIL 2017
Part 1: ORR based on RECIST 1.1/RECIL 2017
+4 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: RNK05047Experimental Treatment1 Intervention
Dose-escalation of RNK05047 IV infusion
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Who is running the clinical trial?
Ranok Therapeutics (Hangzhou) Co., Ltd.Lead Sponsor
Ranok Therapuetics Co. Ltd.Lead Sponsor
Linda GrummerStudy DirectorRanok Therapeutics
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.I might have cancer spread to my brain or spinal cord.Standard treatments for my advanced disease haven't worked or caused severe side effects.I had cancer before but was treated with the goal of curing it.I experience significant numbness or pain in my hands or feet.I haven't had cancer treatments like chemo or radiotherapy in a time frame that would interfere with the study drug.I am not pregnant or breastfeeding.I have a sufficient sample of my tumor for testing.I am fully active or can carry out light work.I do not have an active infection with HIV, HTLV-1, hepatitis B or C.I don't have lasting side effects from cancer treatment, except for mild hair loss.My cancer is advanced and has spread from where it started.
Research Study Groups:
This trial has the following groups:- Group 1: RNK05047
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this trial currently recruiting participants?
"This clinical trial, whose details were initially made available on July 12th 2022, is currently inviting patients to participate. The most recent update was recorded on August 23rd of the same year."
Answered by AI
Are there numerous medical facilities conducting research with this protocol in Canada?
"Patients are invited to join the trial at Emory University Winship Cancer Institute in Atlanta, Georgia, Horizon Oncology and Research Center in Lafayette, Indiana, Pennsylvania Cancer Specialists & Research Institute in Gettysburg, Pennsylvania among other sites."
Answered by AI
What is the total participant count for this investigation?
"Affirmative. Data hosted on clinicaltrials.gov confirms that this medical study, which was first revealed on July 12th 2022, is presently recruiting volunteers. Approximately 105 individuals must be recruited from 4 distinct health centres."
Answered by AI
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