This is an open-label, non-randomized, first-in-human Phase 1/2 study designed to evaluate the safety and tolerability of CFT8634 in subjects with synovial sarcoma and SMARCB1-null tumors who: have received prior systemic therapy; have relapsed/refractory tumors; have unresectable or metastatic disease; and are not candidates for available therapies known to confer clinical benefit. The study will characterize the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of CFT8634.
The study was intended to be Phase 1/2 trial but did not advance to Phase 2.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
49
Oral dose of CFT8634
City of Hope
Duarte, California, United States
Sarcoma Oncology Research Center
Santa Monica, California, United States
University of Colorado - Aurora Cancer Center
Aurora, Colorado, United States
Mayo Clinic - Jacksonville
Jacksonville, Florida, United States
University of Iowa Hospital and Clinics
Iowa City, Iowa, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Mayo Clinic - Rochester
Rochester, Minnesota, United States
Washington University School of Medicine
St Louis, Missouri, United States
David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center
New York, New York, United States
Columbia University
New York, New York, United States
...and 2 more locations
Frequency and severity of AEs and serious adverse events (SAEs)
Phase 1 and Phase 2
Time frame: From screening until at least 30 days after completion of study treatment
Number of subjects with changes between baseline and post-baseline safety assessments based on safety laboratory results graded by CTCAE v5.0
Phase 1 and Phase 2
Time frame: From screening until at least 30 days after completion of study treatment
Frequency of dose interruptions and dose reductions
Phase 1 and Phase 2
Time frame: From first dose until end of treatment
Incidence of dose limiting toxicities (DLTs)
Phase 1 only
Time frame: From first dose until 28 days after first dose
Overall Response Rate (ORR)
Phase 2 only according to RECIST v1.1 criteria
Time frame: Up to approximately 24 months
Plasma concentration of CFT8634 to characterize the pharmacokinetics (PK) parameters of CFT8634
Plasma concentration of CFT8634 at the scheduled timepoints
Time frame: At multiple time points up to approximately 24 weeks
Asses dose proportionality assessment
Dose proportionately assessment at the scheduled timepoints
Time frame: At multiple time points up to approximately 24 weeks
Assess the pharmacodynamics by percent reduction from baseline of target protein
Tumor BRD9 degradation at scheduled timepoints
Time frame: At multiple time points up to approximately 24 weeks
ORR
Phase 1 only according to RECIST v1.1 criteria
Time frame: Up to approximately 24 months
Duration of Response (DOR)
DOR defined as time from first assessment of PR or CR to follow-on first assessment of progressive disease (PD)
Time frame: Up to approximately 24 months
Progression Free Survival (PFS)
PFS defined as the time from first treatment received until PD is assessed
Time frame: Up to approximately 24 months
Overall Survival (OS)
OS is defined as the time from first dose of study treatment to the date of death, irrespective of the cause of death. (Phase 2 only)
Time frame: Up to approximately 48 months
Time to next treatment
Interval from the date of initiation of a treatment to the date of commencement of the next line of therapy
Time frame: Up to approximately 8 months
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