Dr. John Hilton, the Study Co-Chair of IND.231, gave an oral presentation of the results to date from IND.231, A Phase I/II Study of CX-5461, at the Targeted Anti-Cancer Therapies (TAT) International Congress 2018 - "the home of phase I in oncology". The conference was held in Paris, France on March 5-7, 2018.
TAT focuses on early-phase development and translational research. The programme covers targeted agents, immuno-oncology and combinations involving such agents.
You can read more about the results of this study and find a link to the abstract by using this link ... https://academic.oup.com/annonc/article/29/suppl_3/mdy048.003/4917515?searchresult=1
CCTG IND.231: A phase 1 trial evaluating CX-5461 in patients with advanced solid tumors
Background: G-quadruplexes are secondary DNA structures that reversibly form in guanine-rich regions that can lead to replication fork collapse and double-stranded DNA breaks. Preclinical work by our group has demonstrated that CX-5461 can stabilize G-quadruplexes, resulting in synthetic lethality in BRCA1/2 deficient cell lines and xenograft models.
Methods: We conducted a phase I study of 7 dose levels of CX-5461 (DLs: 50, 100, 150, 200, 250, 325, 475 mg/m2) administered intravenously on days 1 and 8 of a 4-week cycle in patients with advanced solid tumors with a PS 0-2 and adequate organ function using a 3 + 3 design. Patients were treated until disease progression. The primary objective was the determination of RP2D. The DLT evaluation period was cycle 1 and AEs needed to be maximally managed (i.e diarrhea, phototoxicity, nausea/vomiting) to be considered a DLT. Secondary objectives include ORR (RECIST 1.1), PK, and toxicity (CTCAEv4.0).