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news.Senhwa Biosciences announced enrollment of the first patient in a multicenter Phase I/II clinical trial to evaluate Senhwa's investigational product CX-5461 in triple-negative breast cancer (TNBC) patients with known BRCA1/2 mutation or Homologous Recombination Defect (HRD).
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This trial will study the use of CX-5461, a small molecule G-quadruplex stabilizer, to selectively kill tumors defective in the BRCA1/2 or HR related genes through the concept of synthetic lethality.
BRCA1/2 mutations or HRD is believed to account for approximately 50% of the TNBC population. TNBC is the most aggressive of all breast cancers and unlike the other types of breast cancer, TNBC currently has limited treatment options.
"There is a high unmet medical need in this setting that must be filled. Positive result in this indication may propel the development of CX-5461 in additional solid tumor indications, such as ovary, lung, pancreas, prostate, and gastrointestinal (GI) tract cancers," stated John Soong, MD, Senior Medical Officer at Senhwa Biosciences.
The Canadian Cancer Trials Group (CCTG) is the sponsor of the study, which will be conducted with the support of the Ontario Institute for Cancer Research through funding provided by the Government of Ontario. SU2C Canada-Canadian Breast Cancer Foundation Breast Cancer Dream Team-affiliated physicians and scientists from the BC Cancer Agency, Ottawa Hospital Research Institute, and University Health Network (Toronto) are participating.
The multicenter Phase I/II trial will initially assess the safety and tolerability of increasing doses of CX-5461, followed by a Simon 2-stage study that assesses antitumor activity in TNBC patients with BRCA1/2 mutations or HRD. The primary endpoint is the evaluation of the Objective Response Rate (ORR). Secondary endpoints, including Progression Free Survival (PFS), will be assessed using RECIST criteria. Further details about the study may be found on www.clinicaltrials.gov.
About CX-5461 and DNA repair
CX-5461 has been administered in Phase 1 clinical trials to fourteen patients with advanced haematologic malignancies. CX-5461 is well tolerated with low grade manageable adverse events to date. To date, this study has not yet reached a MTD and the trial continues to enroll patients with dose escalation.
CX-5461 is a potent G-quadruplex stabilizer that trigger replication and transcription associated DNA damage in cancer cells with defective DNA damage repair due to BRCA1/2 mutation or HR deficiency. Normal cells have all of their DNA repair mechanisms intact allowing them to survive. By stabilizing G-quadruplex, CX-5461 selectively kill tumors through the concept of synthetic lethality.