A Phase I/IIa, First-in-human, Open-label, Dose Escalation and Expansion Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of AZD8421 Alone or in Combination in Participants with Selected Advanced or Metastatic Solid Tumors (CYCAD-1)

Patients with ER+ HER2- advanced breast cancer and patients with high-grade serious ovarian cancer (HGSOC)

Incidence of AEs, SAEs and DLTs, Clinically significant changes from baseline in clinical laboratory parameters, vital signs, and ECG results, Discontinuation of AZD8421 due to toxicity

Efficacy: According to the RECIST v1.1 by Investigator assessment (Eisenhauer et al 2009): • ORR • BOR • DoR • DCR at 24 weeks • Percentage change in tumor size • PFS, Summary PK profiles and descriptive statistics of After first dose: following PK parameters may be evaluated for AZD8421; Cmax, AUCinf, AUClast, tmax, λz, t½λz, CL/F, V/F, and Vz/F (additional PK parameters may be determined where appropriate). If data allows following PK parameters for metabolite(s) may be evaluated; Cmax, AUCinf, AUClast, tmax, t½λz (additional PK parameters may be determined where appropriate)., continued...After multiple doses: following PK parameters may be evaluated for AZD8421; Cssmax, AUC0-tau, AUCsslast, AUCss0-t, tssmax, t½λssz, CLss/F, Vss/F (additional PK parameters may be determined where appropriate) If data allows following PK parameters for metabolite(s) may be evaluated; Cssmax, AUC0-tau, AUCsslast, tssmax, t½λssz, CLss/F, Vss/F, ARCmax, ARAUC (additional PK parameters may be determined where appropriate), Module 1B only: Tumor protein analysis of the candidate biomarker and broader proteomic and phosphoproteomic profiling. Tumor and peripheral assessment including, but not limited to, DNA, mRNA, protein, epigenetic, and immune analyses.

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