Treadwell Therapeutics has begun dosing of the subject in the Phase Ib/II TWT-203 clinical trial of CFI-402257 in advanced solid tumour and ER+/Her2- breast cancer patients.
The first subject in the trial was dosed at START Mountain Region in Salt Lake City, Utah, US.
CFI-402257 is an oral Threonine Tyrosine Kinase (TTK) inhibitor.
The multicentre, open-label, dose optimisation trial will analyse the safety, tolerability, pharmacokinetic and pharmacodynamic profiles of CFI-402257 as monotherapy in advanced solid tumours or in combination with fulvestrant in ER+/Her2- breast cancer patients.
The treatment combination will be analysed in breast cancer patients following the progression of the disease after receiving CDK4/6 inhibitor and endocrine therapy previously.
Nearly 40 subjects are anticipated to be enrolled in the trial at up to ten sites in the US.
The trial will have a dose confirming portion in advanced solid tumours and expansions at the recommended Phase II dose as a single agent in solid tumours and along with fulvestrant in patients with breast cancer.
Treadwell Therapeutics co-CEO Dr Michael Tusche said: “We are excited about the initiation of TWT-203 with our potent and selective TTK inhibitor.
“Previous clinical studies have demonstrated that CFI-402257 has a tolerable safety profile and confirmed responses in ER+/Her2- breast cancer after progression on CDK4/6 inhibitors.
“We look forward to the continued development of this molecule in breast cancer.”
Treadwell focuses on developing new therapies to address unmet needs in cancer patients.
The internally developed clinical pipeline of the company comprises CFI-400945, a PLK4 inhibitor as well as HPK1 inhibitors, CFI-402257 and CFI-402411.