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Preliminary Ongoing Results with CYT-0851 in Combination with Capecitabine or Gemcitabine in Advanced Solid Tumors Show Early Clinical Activity and Generally Well Tolerated Safety Profile
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0 KommentareCyteir Therapeutics, Inc. (“Cyteir”) (Nasdaq: CYT), a clinical stage oncology company, today presented results from a Phase 1 study with CYT-0851 in combination with capecitabine or gemcitabine in a poster titled “Phase 1 Results of CYT-0851, a Monocarboxylate Transporter (MCT) Inhibitor, in Combination with Capecitabine or Gemcitabine in Advanced Solid Tumors” (Abstract: 3099, Poster: 297) at the 2023 American Society of Clinical Oncology (ASCO) annual meeting in Chicago, Illinois.
“We are encouraged by the preliminary data from the Phase 1 dose escalation study with CYT-0851 in combination with capecitabine and gemcitabine and are pleased that the safety profile of CYT-0851 continues to be generally tolerable even when combined with these standard chemotherapy agents,” said Markus Renschler, MD, President and Chief Executive Officer of Cyteir. “The Cyteir team is diligently executing on the clinical development of CYT-0851 as a potential combination therapy, and we look forward to sharing preliminary data for all patients in these cohorts mid-year.”
Phase 1 Study Objectives
The primary objective of the ongoing Phase 1 study is to determine the recommended Phase 2 dose and maximum tolerated dose of CYT-0851 in combination with capecitabine or gemcitabine. Key secondary objectives include evaluation of safety and tolerability, determination of the pharmacokinetic parameters, optimal dosing regimen for each combination and characterization of preliminary anti-tumor activity of the combinations.
Phase 1 Study Preliminary Findings
The data presented in the poster are the first report of preliminary results of an ongoing study.
As of the May 1, 2023 data cutoff, 22 patients were enrolled in the capecitabine cohort across four dose-escalation cohorts from 100 mg to 400 mg once daily dose and 13 patients were enrolled in the gemcitabine cohort across three dose-escalation cohorts from 100 mg to 300 mg once daily dose. Fourteen patients in the capecitabine arm were response evaluable and eight patients in the gemcitabine arm were response evaluable.
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The recommended Phase 2 dose in the capecitabine combination is 400 mg once a day with no dose limiting toxicities observed. The maximum tolerated dose in the combination of CYT-0851 with capecitabine was not identified. The dose escalation of CYT-0851 in combination with gemcitabine is ongoing and the study has cleared the 200 mg dose.
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