A Phase 1/2a study to assess the safety, tolerability, PK and biological activity of CCS1477 (inobrodib) in patients with Non-Hodgkin Lymphoma, Multiple Myeloma, Acute Myeloid Leukaemia or High Risk Myelodysplastic syndrome.
This includes patients with Peripheral T-cell lymphoma.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
250
Incidence of treatment-related adverse events
Treatment-related adverse events and serious adverse events
Time frame: Up to 12 months
Incidence of laboratory abnormalities
Laboratory abnormalities characterised by type, frequency, severity and timing
Time frame: Up to 12 months
Response rate
Defined as number of patients who have a response according to * RECIL criteria (NHL) * IMWG criteria (Multiple myeloma) * ELN recommendations 2017 (AML)
Time frame: Up to 12 months
Duration of Response
Defined as the time from start of treatment until disease progression
Time frame: Up to 12 months
AUC of CCS1477
Area under the plasma concentration-time curve (AUC) from time 0 to the time of the last measurable concentration of CCS1477
Time frame: 35 days
Cmax of CCS1477
Maximum observed plasma concentration (Cmax) of CCS1477
Time frame: 35 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Powder suspension for Injection
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Powder for solution for injection
Oral capsule
Solution for injection
Solution for injection
Oral capsule
Solution for injection, concentrate for solution for infusion
Emory Winship Cancer Institute
Atlanta, Georgia, United States
RECRUITINGCommunity Health Network
Indianapolis, Indiana, United States
RECRUITINGThe Center for Cancer and Blood Disorders (CCBD)
Bethesda, Maryland, United States
RECRUITINGNebraska Cancer Specialists
Omaha, Nebraska, United States
RECRUITINGUniversity of Nebraska Medical Center
Omaha, Nebraska, United States
RECRUITINGPenn Medicine - Abramson Cancer Center Perelman
Philadelphia, Pennsylvania, United States
RECRUITINGInstitute Bergonie
Bordeaux, France
COMPLETEDGustave Roussy
Villejuif, France
COMPLETEDHospital Germans Trias i Pujol/ ICO Badalona
Badalona, Spain
RECRUITINGUniversity Hospital Vall D'Hebron
Barcelona, Spain
COMPLETED...and 29 more locations