Named CHAMP-1, the trial will assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of RNK05047 in these patients.
The two-part trial will have dose escalation and cohort expansion.
In Part 1, subjects will be given intravenous (IV), once-a-week doses of RNK05047 for three successive weeks in a four-week cycle.
On identifying the recommended Phase II dose (RP2D), the Part 2 cohort-expansion phase of the trial will enrol more participants.
In the trial, measures of anti-tumour activity and pharmacodynamics will be evaluated as the secondary endpoints.
The company expects to report initial trial findings in the second half of next year.
RNK05047 is a small-molecule, tumour- and BRD4-selective protein degrader.
BRD4 is a bromodomain transcription factor and a key MYC and BCL2 oncogenes regulator type.
The company discovered and developed RNK05047 leveraging its CHAMP technology, a targeted protein degradation approach.
Ranok Therapeutics founder and CEO Weiwen Ying said: “RNK05047 is Ranok’s first therapy based on our proprietary CHAMP technology, as well as the first BRD4 protein degrader in the pharmaceutical industry to enter clinical testing.
“RNK05047 is designed to selectively degrade BRD4 protein preferentially in tumours, thereby improving safety and efficacy, which differentiates it from other investigational therapies such as non-selective BET inhibitors.”
A clinical-stage biopharmaceutical company, Ranok focuses on the development of new approaches for targeted protein degradation to treat cancer, as well as various other serious ailments.