C4161001: PHASE 1/2A DOSE ESCALATION, FINDING AND EXPANSION STUDY EVALUATING SAFETY, TOLERABILITY, PHARMACOKINETICS, PHARMACODYNAMICS AND ANTI TUMOR ACTIVITY OF PF-07104091 AS A SINGLE AGENT AND IN COMBINATION THERAPY

Breast Cancer, Ovarian Cancer, SCLC (Part 1 also had TNBC and NSCLC)

Part 1A, Part 1B and Part 1C: •First cycle DLTs. •AEs as characterized by type, frequency, severity, timing, seriousness, and relationship to study therapy. •Laboratory abnormalities as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), and timing. •Vital sign abnormalities. •Heart rate corrected QT interval (eg, QTcF)., Part 2 •Preliminary antitumor activity measure for efficacy includes ORR, as assessed using RECIST 1.1. •Safety and tolerability: •Adverse Events as characterized by type, frequency, severity (as graded by NCI CTCAE v 5.0), timing, seriousness, and relationship to study therapy.•“Please refer protocol section 3 for more details.”

PK parameters of PF-07104091: •Single Dose Cmax, Tmax, AUClast, and as data permit, AUCinf, CL/F, Vz/F, and t1/2. •Multiple Dose (assuming steady state is achieved) Cmax,ss, Tmax,ss, AUCτ,ss, Cmin,ss, CL/F,ss, and as data permit, V/F, ss, t1/2, and Rac (AUCτ,ss/AUCτ,sd)., ORR, as assessed using RECIST version 1.1., Time to event endpoints: eg, DoR, PFS, TTP, CBR., Time to event endpoints: eg, DoR, PFS, CBR, overall survival OS and TTP., •PK parameters of PF-07104091. •Single dose: Cmax, Tmax and AUClast. •Multiple dose (assuming steady state is achieved): Cmax,ss, Tmax,ss, AUClast, Cmin,ss, and Rac., PK parameters of PF-07104091 given with and without food., Changes in cell cycle biomarkers (eg, phosphor Rb, Ki 67) in paired pre- and on treatment tumor biopsies.

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