This is a 2-part, phase 1/2, open-label, multicenter study designed to evaluate the safety, tolerability, PK, pharmacodynamics, PGx, and efficacy of fadraciclib administered orally BID. This study consists of Phase 1 and Phase 2 components in subjects with advanced solid tumors and lymphoma who have progressed despite having standard therapy or for which no standard therapy exists.
Phase 1 part of the study will consist of a dose-escalation and a dose-finding component . Phase 2 will enroll subjects with locally advanced, recurrent, or metastatic, histologically confirmed advanced solid tumors or lymphoma, who have failed all standard therapies or for whom standard therapy does not exist, into 8 groups: Group 1: Endometrial or Ovarian cancer Group 2: Biliary tract cancer Group 3: HCC Group 4: Breast cancer, meeting any of the following criteria: * HER-2 refractory MBC * HR positive, HER-2 negative, MBC post-CDK4/6 inhibitor * Triple-negative breast cancer (TNBC) Group 5: B-cell lymphoma Group 6: T-cell lymphoma (CTCL and PTCL) Group 7: mCRC, including KRAS mutated mCRC Group 8: Basket cohort: Tumor types suspected to have a related mechanism of action such as MCL1, MYC or CCNE amplification/overexpression not included in previous groups.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
330
Fadraciclib is a highly selective, orally- and intravenously- available, 2nd generation amino-purine inhibitor of CDK2 and CDK9.
City of Hope
Duarte, California, United States
RECRUITINGMD Anderson Cancer Center
Houston, Texas, United States
RECRUITINGSeoul National University Hospital
Seoul, South Korea
RECRUITINGMaximum tolerated dose
The incidence rate of dose-limiting toxicities (first cycle only) at each dose level
Time frame: 6 months
Overall Response Rate (ORR)
Assessment of response criteria according to RESIST, Lugano or mSWAT
Time frame: 18 months
Adverse events
Type, frequency, and severity of adverse drug reactions
Time frame: 24 months
AUC
Fadraciclib plasma concentrations
Time frame: 6 months
Cmax
Fadraciclib plasma concentrations
Time frame: 6 months
Tmax
Fadraciclib plasma concentrations
Time frame: 6 months
T1/2
Fadraciclib plasma concentrations
Time frame: 6 months
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Hospital Universitario Vall d'Hebron
Barcelona, Spain
RECRUITING