An Open-label Phase I/IIa Study to Evaluate the Safety and Efficacy of CCS1477 as Monotherapy and in Combination in Patients With Advanced Haematological Malignancies.
Summary
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.
Detailed description
This includes patients with Peripheral T-cell lymphoma.
Arms & interventions
- DrugCCS1477
Oral capsule
- DrugPomalidomide
oral capsule
- DrugDexamethasone
oral tablet
- DrugAzacitidine
Powder suspension for Injection
- DrugVenetoclax
Oral tablet
- DrugBortezomib
Powder for solution for injection
- DrugIxazomib
Oral capsule
- DrugElranatamab
Solution for injection
- DrugTeclistamab
Solution for injection
- DrugLenalidomide
Oral capsule
- DrugDaratumumab
Solution for injection, concentrate for solution for infusion
Outcome measures
Primary
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
Secondary
Response rate
Time frame: Up to 12 months
Duration of Response
Time frame: Up to 12 months
AUC of CCS1477
Time frame: 35 days
Cmax of CCS1477
Time frame: 35 days
Eligibility criteria
Study locations (6)
Emory Winship Cancer Institute
Atlanta, Georgia, 30322
Community Health Network
Indianapolis, Indiana, 46227
The Center for Cancer and Blood Disorders (CCBD)
Bethesda, Maryland, 20817
Nebraska Cancer Specialists
Omaha, Nebraska, 68130
University of Nebraska Medical Center
Omaha, Nebraska, 68198-6846
Penn Medicine - Abramson Cancer Center Perelman
Philadelphia, Pennsylvania, 19104